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Vaccine Archives - Virus Reports http://virusreports.net/tag/vaccine/ Sat, 12 Sep 2020 13:21:02 +0000 en-US hourly 1 https://wordpress.org/?v=6.7.7 https://s3.us-west-1.wasabisys.com/virusreports/2020/05/cropped-virus-favicon-32x32.png Vaccine Archives - Virus Reports http://virusreports.net/tag/vaccine/ 32 32 Why A COVID-19 Vaccine That’s Only 50% Effective Could Still Help Stop The Pandemic : Shots http://virusreports.net/why-a-covid-19-vaccine-thats-only-50-effective-could-still-help-stop-the-pandemic-shots/ http://virusreports.net/why-a-covid-19-vaccine-thats-only-50-effective-could-still-help-stop-the-pandemic-shots/#respond Sat, 12 Sep 2020 13:21:02 +0000 https://virusreports.net/why-a-covid-19-vaccine-thats-only-50-effective-could-still-help-stop-the-pandemic-shots/ As we get closer to a COVID-19 vaccine, it's exciting to imagine a day when the virus is gone. But a vaccine will not be a magic bullet. In fact, it may be only about 50% effective. Dr. Anthony Fauci, chief of the National Institute of Health and Infectious Disease, has tried to set realistic…

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As we get closer to a COVID-19 vaccine, it's exciting to imagine a day when the virus is gone. But a vaccine will not be a magic bullet. In fact, it may be only about 50% effective.

As we get closer to a COVID-19 vaccine, it's exciting to imagine a day when the virus is gone. But a vaccine will not be a magic bullet. In fact, it may be only about 50% effective.

As we get closer to a COVID-19 vaccine, it’s exciting to imagine a day when the virus is gone. But a vaccine will not be a magic bullet. In fact, it may be only about 50% effective.

Dr. Anthony Fauci, chief of the National Institute of Health and Infectious Disease, has tried to set realistic expectations when discussing the importance of a vaccine. “We don’t know yet what the efficacy might be. We don’t know if it will be 50% or 60%,” Fauci said during a Brown University event in August. I’d like it to be 75% or more,” Fauci said, but he acknowledged that may not be realistic.

Meanwhile, the Food and Drug Administration has said that once a vaccine is shown to be safe and at least 50% effective it could be approved for use in the U.S.

So what does 50% efficacy mean?

How Can You Tell If A COVID-19 Vaccine Is Working?

“When we talk ‘vaccine effectiveness,’ what we’re talking about is, ‘How effective was the vaccine at preventing actual disease,’ ” explains scientist L.J. Tan, chief strategist of the nonprofit Immunization Action Coalition.

In other words, Tan says, “If you vaccinate 100 people, 50 people will not get disease.”

This may not sound like an impressive rate of infection prevention, but there are other potential benefits to individuals and the community from getting vaccinated.

“It’s possible that the [COVID-19] vaccine will reduce the severity of disease” in the other 50% who do get sick, says physician Bill Miller of The Ohio State University, College of Public Health. “It may mean that people are less likely to be hospitalized, require ICU care, or die.”

“That’s certainly the case with the influenza vaccine,” Miller adds. “People who get the vaccine may still get the flu, but, for the most part, their disease is milder than if they hadn’t had the vaccine.”

Michael Ison, an infectious disease physician at Northwestern University Feinberg School of Medicine, echoes that sentiment. While it’s true that 50 out of 100 people who get the vaccine could still end up getting infected with the coronavirus,hopefully the majority will have milder disease,” Ison says. But he cautions there’s a lot to learn in that regard, given that the studies of COVID-19 vaccine candidates are still very much underway.

“We really need to get some information from the trials that are ongoing to best understand what the impact will be,” he says. Ison is a member of the research team at Northwestern that is conducting studies on COVID-19 and on influenza vaccines.

And here’s the next reality check: The extent to which any vaccine that emerges will help halt the COVID-19 pandemic depends on how many people get the immunization.

In order to put this pandemic in the rearview mirror, a large percentage of the population needs to either be vaccinated, or gain immunity via an infection with the virus (a much riskier route, that would include many more deaths).

President Trump's New COVID-19 Adviser Is Making Public Health Experts Nervous

When a large portion of the population has immunity to the virus because of this sort of “herd immunity,” it’s unlikely to keep spreading. Even people who haven’t been vaccinated (such as very young babies and the immunocompromised) are protected once this level of immunity in a population is achieved, because the illness has little opportunity to spread within the community — most people who run into the virus in this scenario are immune.

For the coronavirus, Ison says, ” ‘herd immunity’ is seen when we have somewhere between 60% to 70% of the population having some degree of protection.”

So — here’s a little math — if 20% of the U.S. population ends up getting exposed to the virus and developing an infection before we have a vaccine (as is estimated to be the level of immunity in the New York City metro area right now), then we’d still need an additional 40% of the population to gain protection via a vaccine.

And in order to get 40% of a population immune through vaccination — if you have a vaccine with 50% efficacy — “you’re going to have to vaccinate 80% of the population,” says Carlos del Rio, an infectious disease expert at Emory University. “So it’s not going to happen right away.”

For starters, Michael Ison says, there are logistical challenges to getting everyone vaccinated, given the mammoth undertaking of manufacturing and distributing a vaccine.

“It’s going to take us months to get the entire population vaccinated if they are willing to get vaccinated,” he says — which is another big “if.” An NPR/PBS/Marist poll in August found that more than a third of Americans — 35% — say they won’t get vaccinated when a vaccine comes available.

Why Are So Many Americans Hesitant To Get A COVID-19 Vaccine?

9 Drugmakers Sign Safety Pledge In Rush To Develop Coronavirus Vaccine

What’s more, most of the candidate vaccines now being tested would require two separate doses to trigger their most effective protection, Ison says. So at a minimum, he notes, you’ve got a full month between the two doses of vaccine and a short period of time after the second dose before someone who was been vaccinated would be protected.

It’s also still not known how long the immunity gained through any of the current COVID-19 vaccine candidates will last or to what extent the virus might mutate or change in a way that makes that vaccine less effective.

“What we will only know once we have the vaccine [approved and rolled out] is how effective it is, how long lasting the protection is, and how much pressure it applies to the virus to change, to escape the pressures of the vaccine,” Ison says.

Despite all these remaining unknowns, it is safe to say that any such vaccine against the coronavirus could play a significant role in reducing the spread of the virus.

“If a vaccine is 50% effective, that’s still good,” Miller says. That means that you have a good possibility of being protected. He says we should think about its effectiveness the way we do about the benefits of cancer treatments, for example.

“In some severe cancers, we’d be pretty happy to get a drug that gets us to 50% effectiveness,” he notes.

Why do we need to test a proposed vaccine in so many people?

For now, it’s important to see the experimental trials of each vaccine candidate through to the end, Miller says. The phase three trials will tell us a lot about the safety of a vaccine as well as its effectiveness.

The large studies now underway are being conducted as double-blind, placebo-controlled trials, which is considered the gold standard in scientific research. This means half the participants get the real vaccine and “half the patients get a placebo — a water shot,” Ison says. And nobody — not the researchers or the participants — will know until after the study is complete who got the placebo and who got the real vaccine.

COVID-19 Vaccine Trial Paused Due To Illness In Volunteer

“What we would like to see is that there’s a difference in the rate of COVID-19 — with a much lower rate in patients who get the vaccine than in the patients who get the placebo,” Ison says. But it takes time, and a lot of people to see that sort of effect, and to answer questions about safety.

The vaccine makers are aiming to enroll about 30,000 people in each trial.

“Side effects of vaccines [can be] very rare, so you need a lot of people to see if the vaccine causes any unexpected problems,” Bill Miller explains. “These side effects must also be monitored carefully post-marketing to ensure that every important problem is identified.”

Ison notes that there’s another benefit to a large study — it helps researchers know how strong the immune response to a vaccine needs to be to be protective.

Will the vaccine protect older people? And what if I’m heavy?

With age, the immune system often mounts a lesser response to vaccination; that’s why, for example, adults 65 and older can opt for a high-dose flu shot — that’s thought to help bolster their protection. And scientists also know from prior research that the flu vaccine is less effective in people who carry a lot of extra weight. Ison says it’s too soon to know if obesity or age will be a factor in the immune response to the COVID-19 vaccine candidates now being considered for use.

In research results so far, he says, “the small, phase one data shows that you can generate antibody responses even in older adults, but it’ll be these larger studies that will tell us [whether] we need to use higher doses or more doses of the vaccine in certain cases.” Results from phase three trials of safety and effectiveness are expected in the coming months.

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Coronavirus vaccine will be safe, or ‘it won’t be moved along,’ federal officials say http://virusreports.net/coronavirus-vaccine-will-be-safe-or-it-wont-be-moved-along-federal-officials-say/ http://virusreports.net/coronavirus-vaccine-will-be-safe-or-it-wont-be-moved-along-federal-officials-say/#respond Wed, 09 Sep 2020 16:21:04 +0000 https://virusreports.net/coronavirus-vaccine-will-be-safe-or-it-wont-be-moved-along-federal-officials-say/ Top health officials told Congress on Wednesday they will not let politics override science in the push for a coronavirus vaccine, amid fears that campaign pressures are eroding public confidence in the effort. “Otherwise, I’ll have no part of it,” National Institutes of Health Director Francis Collins told the Senate Health Committee. U.S. Surgeon General…

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Top health officials told Congress on Wednesday they will not let politics override science in the push for a coronavirus vaccine, amid fears that campaign pressures are eroding public confidence in the effort.

“Otherwise, I’ll have no part of it,” National Institutes of Health Director Francis Collins told the Senate Health Committee.

U.S. Surgeon General Jerome M. Adams said there “will be no shortcuts.”

“This vaccine will be safe, it will be effective, or it won’t be moved along,” Dr. Adams testified.

He said his own family will be “in line to get it” once it is available.

They offered their assurance amid widespread fears that Election Day will morph into a deadline for federal regulators who must sign off on the shots before they reach American arms.

President Trump is floating the idea of an October “surprise” even as medical experts and administration scientists say it may take until the end of the year to secure sufficient data on safety and efficacy of lead candidates in Phase-3 trials of 30,000 people each.

Also Wednesday, Dr. Adams said the federal government will use every lever it has to offer the eventual coronavirus vaccine free of charge to all Americans.

“I will give you a very direct answer: Yes, as surgeon general of the United States, we will use every tool we have to make sure cost is not an obstacle,” he told Sen. Bernard Sanders, Vermont independent, who reminded the officials that taxpayers had shelled out billions for the vaccine candidates’ development.

“I share that 100%,” Dr. Collins said.

Officials testified as AstraZeneca, a British-Swedish company, said it was forced to pause Phase-3 trials of its COVID-19 vaccine candidate because of a suspected adverse reaction.

Dr. Collins referred to a New York Times report that said the British participant was found to have transverse myelitis, an inflammatory syndrome that affects the spinal cord and can be caused by viral infections.

“I don’t have any other details than that,” Dr. Collins told Sen. Bill Cassidy, Louisiana Republican, who inquired about the participant’s condition.

It’s unclear if the condition is linked to the vaccine trial or not, so the company is investigating.

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Covid-19 Live Updates: Trump Administration Vaccine Chief Casts Doubt on Vaccine by Election Day http://virusreports.net/covid-19-live-updates-trump-administration-vaccine-chief-casts-doubt-on-vaccine-by-election-day/ http://virusreports.net/covid-19-live-updates-trump-administration-vaccine-chief-casts-doubt-on-vaccine-by-election-day/#respond Thu, 03 Sep 2020 23:21:31 +0000 https://virusreports.net/covid-19-live-updates-trump-administration-vaccine-chief-casts-doubt-on-vaccine-by-election-day/ The New York Times surveyed more than 1,500 colleges, and found that over two-thirds have reported at least one case. Madrid’s leader said it was “probable that all children would get infected, one way or another.”Right NowJust days after filming resumed on “The Batman” at studios outside London, it shut down again after its lead…

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The New York Times surveyed more than 1,500 colleges, and found that over two-thirds have reported at least one case. Madrid’s leader said it was “probable that all children would get infected, one way or another.”

Right Now

Just days after filming resumed on “The Batman” at studios outside London, it shut down again after its lead actor, Robert Pattinson, tested positive for the coronavirus.

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Credit…Agence France-Presse, via Henry Ford Health System

President Trump’s vaccine chief sees a ‘very, very low chance’ of a vaccine by Election Day.

Moncef Slaoui, the chief adviser for the White House vaccine program, said on Thursday that it was “extremely unlikely but not impossible” that a vaccine could be available by the end of October.

In an interview with National Public Radio, Dr. Slaoui, the chief scientific adviser of the Trump administration’s coronavirus vaccine and treatment initiative, called Operation Warp Speed, explained that the Centers for Disease Control and Prevention’s guidance to states to prepare for a vaccine as early as late October — a notification Dr. Slaoui said he had learned of through the news media — was “the right thing to do” in case a vaccine was ready by that time. “It would be irresponsible not to be ready if that was the case,” he said.

However, he described that as a “very, very low chance.”

That message ran counter to the optimistic assertions in recent days from the White House that a vaccine could be ready for distribution before Election Day in November. President Trump, during the Republican National Convention, said a vaccine could be ready “before the end of the year or maybe even sooner.” And he and others have tried to project confidence in a quick victory.

Dr. Slaoui confirmed that the two main candidates, referred to as Vaccine A and Vaccine B, were being developed by Pfizer and Moderna. He said that there was “no intent” to introduce a vaccine before clinical trials were completed, and that trials would only be completed when an independent safety monitoring board, separate from the government, affirmed the effectiveness of the vaccine.

The interviewer, Mary Louise Kelly, raised the timing of a possible vaccine given in the documents the C.D.C. recently sent to public health officials, and asked directly whether the delivery of the vaccine was being motivated by political concerns.

“For us there is absolutely nothing to do with politics,” Dr. Slaoui responded, saying that those involved were working as hard as they could because so many people were dying every day. “Many of us may or may not be supportive of this administration. It’s irrelevant, frankly.”

Though he continued to express doubt that a vaccine would be ready by the end of October, Dr. Slaoui said, “I firmly believe that we will have a vaccine available before the end of the year and it will be available in quantities that can immunize patients, subjects at the highest risk,” including the elderly and those who are working in jobs with high exposure to the virus.

He estimated that there would be enough vaccine by the end of the year to immunize “probably between 20 and 25 million people.” He said that manufacturing would be ramped up so that there would be enough vaccine doses to immunize the U.S. population “by the middle of 2021.”

Hydroxychloroquine prescriptions soar on President Trump’s say-so.

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Credit…Anna Moneymaker for The New York Times

Prescriptions for hydroxychloroquine, the anti-malaria drug promoted by President Trump as a treatment for the virus, skyrocketed in March and April after the Food and Drug Administration issued an emergency waiver for its use against Covid-19, but tapered off to more normal levels in May and June, the Centers for Disease Control and Prevention reported on Thursday.

The F.D.A. withdrew its emergency use authorization for hydroxychloroquine (and its less-prescribed sister drug, chloroquine) in June after scientists concluded that its benefits did not outweigh its risks for Covid-19; the review that led to the revocation found more than 100 cases — including 25 deaths — of serious heart disorders in Covid-19 patients taking the drug. Clinical trials also showed it was of little benefit in treating the disease.

Even so, the C.D.C. reported that more than 1.3 million prescriptions — new and refills — were written in March and April, up from about 819,000 during the same period last year. The strong spike in usage suggests the influence that Mr. Trump and emergency waivers from the F.D.A. can have in driving medical decision-making — even in the absence of limited evidence of a drug’s effectiveness.

But perhaps the most striking finding was that “nonroutine prescribers” — specialists who would not typically have a reason to prescribe the drug — wrote more than 75,000 hydroxychloroquine or chloroquine prescriptions in the month of March alone. That is 80 times the number written during March 2019.

Hydroxychloroquine and chloroquine are approved to treat autoimmune diseases like lupus as well as malaria. Mr. Trump, who said he took hydroxychloroquine himself, called it a possible “game changer” and repeatedly promoted it during his daily briefings this spring.

The disease control centers analyzed prescriptions of the drug to gauge the effects of the F.D.A.’s emergency waiver, which was issued March 28 to allow the drugs to be distributed from the national stockpile. “During March and April 2020, nonroutine prescribers accounted for the largest percentage increase in new prescriptions compared with the same period in 2019,” the agency wrote, adding, “The nonroutine prescribing specialties with the highest prescribing volume and growth in March 2020 were ophthalmology, anesthesiology, and cardiology.”

But new prescriptions written by such prescribers have tapered off considerably. In June, roughly 1,900 were written.

The virus is surging at U.S. colleges, where more than 51,000 cases have been identified so far.

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Credit…Sean Rayford/Getty Images

More than 51,000 cases of the coronavirus have been identified at American colleges and universities over the course of the pandemic, including thousands that have emerged in recent days as students returned to campus for the fall.

The New York Times surveyed more than 1,500 colleges, and found that over two-thirds have reported at least one case. More than 100 of the institutions have reported at least 100 cases, including several large public universities in the Midwest and South that have tested aggressively but struggled to contain the spread. Auburn, Illinois State and South Carolina are among at least six universities with more than 1,000 known cases.

Direct campus-to-campus comparisons are not meaningful because of differences in colleges’ size, mission and reporting practices. But it is clear that the pandemic has affected every segment of higher education. Small religious colleges, stand-alone medical schools, Ivy League universities, community colleges and public research institutions have all had significant outbreaks.

The reopening of campuses has led to case surges in several college towns, quarantines at fraternity and sorority houses, and pleas for students to avoid large gatherings. Iowa State scrapped plans to allow fans at its first football game. Virginia Commonwealth had to find more isolation space after a large cluster emerged. And California State University, Chico, sent its students home after dozens of cases emerged in the first days of the fall term.

“I, like you, wish the story of this semester had been much different,” Gayle Hutchinson, the university’s president, wrote in a letter announcing the decision.

Education Roundup

A small college in Pennsylvania has locked down every single student. It may be a first.

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Credit…John Greim/LightRocket, via Getty Images

Gettysburg College in Pennsylvania has ordered its entire student body to quarantine in their dorm rooms, becoming possibly the first American campus to lock down all its students because of coronavirus cases.

The small liberal arts school reported on Tuesday that 24 students had tested positive in the previous two days, a positivity rate of about 7 percent. (The World Health Organization recommends that the positivity rate be 5 percent or lower for 14 days before schools and businesses reopen.)

It then directed all its full-time students — its enrollment is generally about 2,500 — to remain in their rooms except to get takeout meals at campus dining facilities, use the bathroom, go for a coronavirus test or speak with a counselor. The lockdown could last through the end of the week, officials said.

In a letter to students, Julie Ramsey, the college’s dean of students, said that many of the infections “were connected to certain affinity groups or social gatherings.” Some students assert that Greek life organizations holding gatherings for rush week were responsible for the campus’s uptick in positive cases.

Many larger universities have created special isolation housing for students who test positive, or have ordered individual dormitories or fraternity houses to quarantine after outbreaks. But Jo Ellen Parker, a spokeswoman for the Council of Independent Colleges, said she knew of no other college that had asked an entire student body to quarantine in their rooms.

One Gettysburg student, Alexander Bove, a freshman, summed it up starkly: “It’s essentially a prison situation.”

“Our administration goes home to their families,” he said. “They can buy things. They can go to events. And they’re not being held to the same standard as we are.”

Thousands of coronavirus cases have been reported at American colleges and universities in recent day as more students return to campuses.

In other education news:

  • Temple University, which had planned to be online-only for just the first two weeks of classes, said Thursday that it would remain virtual for the rest of the fall term because of the continued spread of the virus. . As of Tuesday, the university had reported 212 active cases among students on and off campus, and none of them had more than moderate symptoms.

  • After testing found “uncontrolled spread” in its fraternity and sorority houses, the Indiana University has told the 2,600 students who live in them to move out and go home if possible. Thirty of the 42 Greek houses and communal living facilities connected with the campus in Bloomington, Ind., were already under quarantine orders, and five have had more than half their residents test positive. The houses were required to have safe living plans in place before opening for the fall, “but many of those plans are proving to be ineffective in adequately providing for the health and safety of the students living in the houses,” the college said in a statement Thursday.

  • The State University of New York at Oneonta closed its campus Thursday, canceling all in-person classes and ordering students to move out less than two weeks after the school opened. Nearly 400 students have tested positive for the coronavirus, according to the school’s Covid-19 dashboard. It is the first New York state school to close its campus after beginning classes.

Filming on ‘The Batman’ shuts down after its star, Robert Pattinson, tests positive.

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Credit…Chris Delmas/Agence France-Presse — Getty Images

Just days after filming resumed on “The Batman” at studios outside London, it shut down again after its lead actor, Robert Pattinson, tested positive for the virus.

In a statement Thursday, Warner Bros. confirmed that filming was “temporarily paused” and that “a member of ‘The Batman’ production has tested positive for Covid-19, and is isolating in accordance with established protocols.”

Work on the film first shut down in March because of the pandemic, which has staggered the entertainment industry. Filming began last September.

In the title role, Mr. Pattinson, 34, plays a young Bruce Wayne early in his career as the DC comic-book vigilante.

Backed by U.S. federal funds, new virus tests are hitting the market.

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Credit…Christopher (KS) Smith for The New York Times

With the pandemic still raging as fall approaches, the government’s efforts to support development and deployment of a variety of testing methods are a rare if belated bright spot amid widespread failures to contain the coronavirus.

In the latest round of U.S. government backing, the National Institutes of Health said on Wednesday that it was providing nine more companies with $123.3 million from a $2.5 billion pot of money allocated last spring by the stimulus bill to support testing. That will bring the total amount disbursed so far by the N.I.H. to $372 million across 16 companies.

The goal is to support production of a broad spectrum of tests, making them more widely available and perhaps ultimately as easy to use as a home pregnancy test. Tests must show that they meet the Food and Drug Administration’s standards for safety and accuracy before they can be sold.

“It’s going to be a wonderful competition,” Dr. Francis S. Collins, the N.I.H. director, said in an interview on Tuesday evening.

Yet even as the government helps rush new tests to market, the administration continues to issue conflicting — and sometimes flatly contradictory — messages about how many and what types of tests are needed, when they should be administered and to whom.

President Trump has long derided testing, complaining that it drives up the number of confirmed cases. The lack of a clear national strategy has confused the public, deeply frustrated public health officials and befuddled pharmaceutical executives.

But as testing options have multiplied, easing some of the shortages and laboratory bottlenecks that hampered the early response to the pandemic, universities, employers, state and local governments and other institutions have been increasingly filling in some of the vacuum left by the administration with their own testing plans.

In a recent interview, Dr. Bruce J. Tromberg, who directs the N.I.H.’s test development program, estimated that the United States needed to test about six million people a day, citing reports by experts at the Rockefeller Foundation and other organizations. Without federal assistance, he said, companies would at best produce only half that number by the end of the year.

Trump administration officials like Adm. Brett P. Giroir, the testing czar and an assistant secretary of health, say they want states and localities to create their own testing plans that fit their specific needs rather than to be forced to follow federal dictates. But many experts complain that the lack of federal decision-making — including how many tests a day the United States should aim for — is an impediment in the nation’s battle against the virus, which so far has killed more than 184,000 people and infected more than six million.

“Let’s not just say we are ramping up and hope we get there. Let’s have a goal in mind,” said Dr. Mark McClellan, the director of the Duke-Margolis Center for Health Policy and the commissioner of the Food and Drug Administration under former President George W. Bush. “It’s not just a matter of getting the tests to market.”

Tracking the Coronavirus ›

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Pfizer may know if its vaccine is effective by next month, its chief executive says.

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transcript

Pfizer Expects Vaccine Results by End of October

Pfizer’s chief executive, Dr. Albert Bourla, said the drug-making company is in a “very advanced stage” and should know by the end of October whether the coronavirus vaccine they are developing is safe and effective.

We are in a very advanced stage. We started end of July — the big, big trial. But it is the only trial that will tell us if we have an effective and safe vaccine or not. And this is a trial that will completed — we will have to enroll at least 30,000 participants to be able to come to conclusion. Right now, we have enrolled yesterday 23,000 patients were already enrolled in this study, and a significant number of them already started getting the second dose of the vaccine. We expect to, by the end of October, normal group should be able to have enough events to say if the product works or not. And we have already worked on the rest of the file. So, which means that help make the vaccine, if the vaccine is safe. And we are going to start submitting to the F.D.A. on their own and to other regulatory agencies. So what I want to say is that if we have enough events we may be able to say the product is safe and efficacious in the October timeframe, and submit immediately for approval.

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Pfizer’s chief executive, Dr. Albert Bourla, said the drug-making company is in a “very advanced stage” and should know by the end of October whether the coronavirus vaccine they are developing is safe and effective.CreditCredit…Chandan Khanna/Agence France-Presse — Getty Images

Pfizer’s chief executive, Dr. Albert Bourla, said Thursday that the company expects to know whether its vaccine is effective by the end of October, and that it would apply immediately for approval if that was the case.

His remarks, made to the International Federation of Pharmaceutical Manufacturers and Associations, a global trade group, come as a handful of companies are racing to finish a vaccine that could help end the pandemic, and as scientists have increasingly worried that the Trump administration is pushing prematurely for a vaccine approval before the Nov. 3 presidential election.

Dr. Bourla said that about 23,000 people have enrolled in the company’s late-stage clinical trial, out of a goal of about 30,000, and that “a significant number” of them have received the second booster shot. Half of the participants receive the vaccine, half receive a placebo, and then researchers wait to see how many people in each group develop Covid-19.

If significantly more people get Covid-19 on the placebo than the vaccine, that is evidence that the vaccine is effective. The F.D.A. has indicated that vaccine makers should aim for 50 percent protection in order to be considered effective.

“If we have enough events, we may be able to say the product is safe and efficacious in the October time frame and submit it immediate for approval or authorization,” Dr. Bourla said.

Two other companies, Moderna and AstraZeneca, are in late-stage trials in the United States, but neither has laid out a similarly aggressive timeline, instead saying they expect to have a vaccine by the end of the year.

In planning documents sent last week to public health agencies around the country, the Centers for Disease Control and Prevention described preparations for two coronavirus vaccines they refer to simply as Vaccine A and Vaccine B. The technical details of the vaccines, including the time between doses and their storage temperatures, match well with the two vaccines furthest along in clinical tests in the United States, made by Moderna and Pfizer.

Here’s what you need to know about how the vaccines work, how they’re being tested and how they might be rolled out to the public — if, and it’s still a big if, they are proven to work.

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Michigan will reopen exercise and sports facilities.

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Credit…Michigan Governors Office, via Associated Press

Michigan gyms, fitness centers, pools and other sports facilities that have been closed since March can reopen on Sept. 9.

Gov. Gretchen Whitmer signed an executive order opening the facilities on Thursday. The order also allows organized sports to resume, although the state recommends against contact sports like football, soccer and basketball.

Dr. Joneigh S. Khaldun, the state’s chief medical officer, said 30 Covid outbreaks in August were connected to athletic teams. “We are not out of the woods yet,” Dr. Khaldun said. “Covid-19 is still a very real threat to our families.”

Gyms and fitness centers will have to maintain social distancing of at least six feet, require all members to wear masks while working out and keep a database of when members use the facilities.

Sporting events will be limited to two guests for each of the players.

Shortly after the announcement, the Michigan High School Athletic Association, which had postponed the fall sports season last month, reinstated it for high schools across the state.

Left off the list of businesses that can reopen were movie theaters, which will remain closed except for theaters in northern Michigan and the Upper Peninsula, which have had a lower number of coronavirus cases and were able to reopen in July.

Ms. Whitmer shut down much the state on March 23 to prevent the spread of coronavirus. As of Wednesday, 104,395 cases of Covid-19 have been reported in Michigan, along with 6,519 deaths, according to the Michigan Department of Health and Human Services.

Several business organizations have filed lawsuits to try to reverse Ms. Whitmer’s executive order, but none have been successful. In May, heavily armed agitators — cheered on by President Trump on Twitter — stormed the Michigan statehouse demanding the state reopen.

A Republican-led petition drive to repeal a state law that gives the governor emergency powers during a public health crisis is underway and could be considered by the legislature later this year.

A day after record highs, a tech-led tumble drives the worst market close in months.

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Credit…Andrew Kelly/Reuters

Tech stocks stumbled sharply on Thursday, causing the S&P 500 to close with its worst drop since June.

The S&P 500 dropped 3.5 percent, while the tech-heavy Nasdaq composite was down nearly 5 percent. The Dow Jones industrial average briefly lost 1,000 points and ended the day down more than 800 points. Apple was down 8 percent. Amazon was down more than 4.5 percent, and Microsoft was down more than 6 percent.

As investors bet that the coronavirus crisis would amplify the dominance of the tech companies’ business models, share prices of large-cap technology companies have surged, generating the lion’s share of the stock market’s gains.

The rip-roaring race for tech shares has increasingly pulled in armchair investors, who have taken up speculating on stocks amid the work-from-home environment. Many of those traders have opted not to buy actual shares but instead to speculate in options trades, which are essentially leveraged bets on where share prices will go.

Analysts say dealers have rushed to boost their bets on falling shares in recent days in an attempt to hedge their risks, amplifying the sell-off in technology shares.

“I think today for tech stocks, you’re seeing that dynamic play out,” said Yousef Abbasi, director of U.S. institutional equities at StoneX, a brokerage firm.

Amid a turbulent market, the number of U.S. workers filing new state jobless claims remained at a historically high level last week, though it is gradually falling.

The government reported on Thursday that 833,000 workers filed new claims for state unemployment benefits last week. An additional 759,000 claims were filed by unemployed freelancers, part-time workers and others who are receiving federal relief under a separate emergency relief program.

Neither figure is seasonally adjusted. On that basis, both totals represented an increase from the previous week. The seasonally adjusted number of new state claims was 881,000.

Malls in N.Y.C. and casinos statewide can reopen on Sept. 9, the governor says.

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Credit…Chang W. Lee/The New York Times

Malls in New York City and casinos across the state will be allowed to reopen on Sept. 9 with certain limits, Gov. Andrew M. Cuomo announced on Thursday.

Casinos will be allowed to operate at 25 percent capacity and malls at 50 percent capacity. Both will need to be equipped with specialized air conditioning systems capable of filtering out virus particles.

The announcement is the latest effort to return some semblance of normalcy to New York, which has for weeks managed to keep positivity rates and hospitalizations low after the virus ravaged the state, killing more than 30,000 people.

The governor said he was eager to restart indoor dining in New York City, where it remains prohibited since mid-March even as he has permitted indoor dining to resume in the rest of the state. Dining will still not be permitted inside the city’s malls and casinos. This week, New Jersey announced indoor dining would restart with limits on Friday.

Mr. Cuomo said he was concerned about New York City’s ability to enforce social distancing and capacity rules inside restaurants, and suggested the New York Police Department be involved in enforcement efforts. But involving the police could prove a delicate issue in the wake of protests against police brutality and after the police’s uneven enforcement of social distancing rules in the spring led predominantly to arrests of Black people.

FEMA funds will no longer be available for disinfecting schools and public transit.

The Trump administration moved to eliminate millions in federal funding for states to disinfect schools, public transportation systems and government buildings this week, in an apparent escalation of President Trump’s efforts to cut support to cities controlled by Democrats. The move will most severely affect New York and California, which have each received around $1 billion of the funds, significantly more than any other state.

Since the pandemic’s onset, the Federal Emergency Management Agency has offered states billions in emergency aid for coronavirus-fighting efforts like disinfecting public buildings and purchasing personal protective equipment for public employees.

But this week, FEMA changed its rules for that funding to prevent the aid from being used to buy P.P.E. for nonmedical public employees or to disinfect public buildings. The shift will go into effect on Sept. 15 — a week before schools are set to reopen for in-person learning in New York.

“This is a downright dirty decision that nonsensically changes the rules in the middle of the game just when we need to keep sanitizing and PPE a federal priority,” said Senator Chuck Schumer, the minority leader and a New York Democrat.

More than 7,000 health workers have died in the pandemic, Amnesty International reports.

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Credit…Rebecca Blackwell/Associated Press

More than 7,000 health care workers have died from Covid-19 around the world, Amnesty International reported on Thursday, up from a July 3 tally of 3,000.

Mexico has suffered the highest toll, with 1,320 health worker deaths. After that comes the United States, with 1,077 dead. Britain, Brazil, Russia and India each have lost about 600 workers.

“For over 7,000 people to die while trying to save others is a crisis on a staggering scale,” said Steve Cockburn, head of economic and social justice at Amnesty International.

Mexico’s high death toll includes many hospital cleaners who were not given adequate protective equipment.

One cleaner at a state hospital, Don Alejandro, 70, told Amnesty in May that he had asked to be allowed to clean administrative areas instead of medical ones because he had a high risk of contracting the virus. His employer allowed him to move, but cut his income by 16 percent.

There were 97,632 cases of COVID-19 among the country’s health workers as of Aug. 25, the Mexican Ministry of Health said.

Medscape, a medical information site for clinicians, maintains a memorial page for health workers around the world who have died from COVID-19. Listed are more than 1,800 names of physicians, nurses, assistants, technicians, orderlies, administrators, volunteers, drivers, porters, EMTs and more from 64 countries. It includes people like Dr. Niloofar Esmail Beigi, 34, a physician in Iran, and Dr. Aleksey Aristov, 62, a deputy chief of surgery in Russia.

The youngest memorialized is 20, the oldest 99.

For its numbers, Amnesty used sources such as memorial pages, government figures, lists compiled by national medical associations, and lists and obituaries published in media globally. For the U.S. death count, researchers used a joint database from The Guardian and Kaiser Health News that specifically tracks deaths of the country’s health workers.

The Centers for Disease Control and Prevention, however, lists only 672 health worker deaths in the U.S. as of Thursday. The C.D.C. said that it was working with limited data.

roundup

Madrid leader issues dire warning on children as schools start to reopen.

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Credit…Pablo Blazquez Dominguez/Getty Images

Returning to school this fall has been fraught for parents everywhere. But in Spain, a message from the leader of the Madrid region that all schoolchildren would probably end up with the coronavirus was particularly alarming.

Speaking to a local radio station, Isabel Díaz Ayuso, who heads the Madrid region’s government, said Wednesday that it was “probable that all children would get infected, one way or another.”

But, she added, school was probably as safe as any place to be as a child was just as likely to catch Covid-19 at a family weekend gathering, or while out in the park.

“We don’t know, because the virus is everywhere,” she told esRadio. Ms. Díaz Ayuso did not say what scientific evidence she used to predict that the infection rate would be so high among children.

Madrid is once more the epicenter of Spain’s virus pandemic, accounting for almost one quarter of the 1,830 patients hospitalized in the country in the past week.

In response, Madrid is now requiring testing of all teachers returning to school, as is the case in other regions.

The result on Wednesday was chaotic: huge queues of school staff outside packed test centers forced the testing process to be suspended.

As the situation worsens in Madrid, some other regional leaders have been voicing their concerns about allowing residents from the capital region into their towns.

But Salvador Illa, Spain’s health minister, on Thursday ruled out the idea of imposing a lockdown around the Madrid area.

In other developments from around the world:

  • Thailand has gone 100 days without a reported case of local transmission, but its success in halting the spread of the virus has come at a significant financial cost. Thailand’s last reported case of community transmission was confirmed on May 24. Hundreds of cases have been found since then among residents returning from abroad, but all were detected during the required 14-day quarantine periods. As of Thursday, Thailand had reported 3,425 cases and 58 deaths, according to a Times database.

  • India reported 83,883 new cases on Thursday, breaking its own global record. It has the third-highest number of cases and deaths after the United States and Brazil.

  • The Czech Republic reported 650 new cases on Thursday, its highest single-day increase.

  • Turkey will impose restrictions on weddings and other social events amid a surge in new cases. The daily number of cases has reached almost 1,600 in the last week.

Reporting was contributed by Liz Alderman, Ilise S. Carter, Choe Sang-Hun, Patricia Cohen, Ben Casselman, Michael Gold, Christina Goldbaum, Kathleen Gray, Luis Ferré-Sadurní, Jacey Fortin, Ethan Hauser, Jennifer Jett, Juliana Kim, Isabella Kwai, Sharon LaFraniere, Raphael Minder, Matt Phillips, Campbell Robertson, Amanda Rosa, Eleanor Stanford, Jim Tankersley, Katie Thomas, Lucy Tompkins, Neil Vigdor, Allyson Waller, Lauren Wolfe, Katherine J. Wu and Carl Zimmer.

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DPH: Flu vaccine required for all students of Massachusetts schools http://virusreports.net/dph-flu-vaccine-required-for-all-students-of-massachusetts-schools/ http://virusreports.net/dph-flu-vaccine-required-for-all-students-of-massachusetts-schools/#respond Wed, 19 Aug 2020 21:21:03 +0000 https://virusreports.net/dph-flu-vaccine-required-for-all-students-of-massachusetts-schools/ BE FOLLOWING BREAKING NEWS, NEARLY ALL MASSACHUSETTS STUDENTS, DA CARE, PRESCHOOL, COLLEGE, YOU WILL BE REQUIRED TO GET A FLU VACCINE BEFORE DECEMBER 31. THIS IS TO MINIMIZE THE HEALTH IMPACT THROUGH THE PANDEMIC OF FLU SEASON. THERE ARE EXEMPTIONS, MEDICAL AND RELIGIOUS EXEMPTIONS MUST BE PROVIDED IF APPLICABLE. HOMESCHOOLED STUDENTS AND COLLEGE STUDENTS ENGAGED…

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BE FOLLOWING BREAKING NEWS, NEARLY ALL MASSACHUSETTS STUDENTS, DA CARE, PRESCHOOL, COLLEGE, YOU WILL BE REQUIRED TO GET A FLU VACCINE BEFORE DECEMBER 31. THIS IS TO MINIMIZE THE HEALTH IMPACT THROUGH THE PANDEMIC OF FLU SEASON. THERE ARE EXEMPTIONS, MEDICAL AND RELIGIOUS EXEMPTIONS MUST BE PROVIDED IF APPLICABLE. HOMESCHOOLED STUDENTS AND COLLEGE STUDENTS ENGAGED IN REMOTE O

DPH: Flu vaccine required for all students of Massachusetts schools

Flu shots will now be required for all students in Massachusetts schools, from child care through colleges, the Department of Public Health announced Wednesday. Students older than six months will have to be vaccinated by Dec. 31, unless either a medical or religious exemption is provided.”The new vaccine requirement is an important step to reduce flu-related illness and ​the overall impact of respiratory illness during the COVID-19 pandemic,” officials wrote in an announcement of the new policy. Students who are homeschooled are exempt from the policy, but health officials said students at elementary and secondary schools that are using a remote learning model are not exempt. College or university students who are entirely off-campus will also be exempt from the mandate. DOWNLOAD: Updated table of school immunization requirements from DPH”Every year, thousands of people of all ages are affected by influenza, leading to many hospitalizations and deaths,” the medical director of DPH’s Bureau of Infectious Disease and Laboratory Sciences, Dr. Larry Madoff, said in a statement. “It is more important now than ever to get a flu vaccine because flu symptoms are very similar to those of COVID-19 and preventing the flu will save lives and preserve healthcare resources.”

BOSTON —

Flu shots will now be required for all students in Massachusetts schools, from child care through colleges, the Department of Public Health announced Wednesday.

Students older than six months will have to be vaccinated by Dec. 31, unless either a medical or religious exemption is provided.

“The new vaccine requirement is an important step to reduce flu-related illness and ​the overall impact of respiratory illness during the COVID-19 pandemic,” officials wrote in an announcement of the new policy.

Students who are homeschooled are exempt from the policy, but health officials said students at elementary and secondary schools that are using a remote learning model are not exempt.

College or university students who are entirely off-campus will also be exempt from the mandate.

“Every year, thousands of people of all ages are affected by influenza, leading to many hospitalizations and deaths,” the medical director of DPH’s Bureau of Infectious Disease and Laboratory Sciences, Dr. Larry Madoff, said in a statement. “It is more important now than ever to get a flu vaccine because flu symptoms are very similar to those of COVID-19 and preventing the flu will save lives and preserve healthcare resources.”

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Vaccine misinformation can be dispelled by conversation http://virusreports.net/vaccine-misinformation-can-be-dispelled-by-conversation/ http://virusreports.net/vaccine-misinformation-can-be-dispelled-by-conversation/#respond Tue, 18 Aug 2020 13:21:14 +0000 https://virusreports.net/vaccine-misinformation-can-be-dispelled-by-conversation/ A new study assesses the influence of anti-vaccination tweets on residents of the United States counties where they were sent.Share on PinterestOnline misinformation about vaccines may have a negative influence on people’s attitudes and behavior.Health professionals consider vaccines to be one of the great achievements of modern medicine. Even so, skepticism over their value and…

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A new study assesses the influence of anti-vaccination tweets on residents of the United States counties where they were sent.

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Online misinformation about vaccines may have a negative influence on people’s attitudes and behavior.

Health professionals consider vaccines to be one of the great achievements of modern medicine. Even so, skepticism over their value and safety has always existed, dating back to the smallpox vaccines of the 1800s.

Today, many people still oppose vaccines, while anti-vaccine misinformation proliferates online.

However, a new study finds the effect of online anti-vaccine misinformation minimizes in people who talk about vaccines with friends and family.

The study looks at anti-vaccination sentiment during the 2018–2019 flu season. It explores the impact of online misinformation about vaccines and the flu, and its lasting effects.

The research, which appears in the journal Vaccine, combines an analysis of tweets with surveys of U.S. adults. The study authors are Man-pui Sally Chan and Dolores Albarracín of the University of Illinois at Urbana-Champaign, and Kathleen Hall Jamieson of The Annenberg Public Policy Center of the University of Pennsylvania in Philadelphia.

“What we find,” says Albarracín, “is that some online discussions appear to have a negative influence on people’s attitudes and vaccine behavior — which makes the people exposed to them less likely to get a flu shot.”

This is particularly concerning due to the potential arrival of a COVID-19 vaccine. As Albarracín says, “What’s going to happen when we have a COVID-19 vaccine? If public health officials don’t offer clear, consistent messaging on vaccination, whatever circulates on Twitter — however crazy it is — may have an impact. We cannot trivialize it.”

Fortunately, the study finds conversation can reverse the damage done by misinformation. It is a problem, Albarracín says, if people “do not have real-world discussions about vaccination with family and friends. But if they discuss it with others, that effect goes away.”

Because “[t]weets, including retweets, are informative about popular topics and conversations within a community,” as the study asserts, the researchers used unsupervised machine learning to analyze 115,330 tweets relating to vaccine and flu-related messages.

Tweets were geolocated, since understanding where they came from has proven valuable in the past. The authors explain:

“Prior studies have shown that county-level tweets can provide signals for predicting HIV/STI infections, and are associated with attitudes, knowledge, and behaviors of infectious diseases, such as Zika across U.S. counties.”

The researchers examined the tweets alongside survey data collected in five waves, with each wave including up to 3,005 participants. They questioned each individual about their opinion of vaccines, their history of receiving them, and whether they discussed vaccination with anyone else.

Ten topics were identified from the tweet analysis, with two strongly associated with local anti-vaccine attitudes and behaviors among survey respondents who had not discussed vaccines with others.

The study authors named the tweet topics “Vaccine Fraud and Children” and “Vaccine Science Matters.”

  • “Vaccine Fraud and Children” tweets included the words “child,” “kid,” and “worldwide.” These tweets repeated discredited anti-vaccine claims from 2014 and included comments regarding kidney pathology.
  • “Vaccine Science Matters” consisted of tweets with the words “vaxwithme,” “ivcx,” and “cancer.” Tweets posted in November to February were positively linked to local vaccination attitudes in February and March.

A third topic, “Big Pharma,” was also associated with negative vaccine attitudes and behaviors.

The researchers caution that although they found “strong to very strong associations” between tweets and attitudes and behaviors relating to vaccines, associations do not prove causality, and further experiments are needed.

Despite this, the research suggests a simple but effective way to resist online misinformation about vaccines.

Lead author Chan adds, “Combating the current ‘infodemic’ online is critical, but so is getting communities to talk about vaccines in daily life.”

“We should be inviting families and communities to have open discussions on these issues,” says Albarracín. “You don’t necessarily have to tell people what to do, but that at least puts the issue on the table.”

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Coronavirus vaccine threatened by ‘cold chain’ issues http://virusreports.net/coronavirus-vaccine-threatened-by-cold-chain-issues/ http://virusreports.net/coronavirus-vaccine-threatened-by-cold-chain-issues/#respond Thu, 13 Aug 2020 23:22:10 +0000 https://virusreports.net/coronavirus-vaccine-threatened-by-cold-chain-issues/ Two years ago, health workers responding to an Ebola outbreak in extremely remote parts of the Democratic Republic of Congo faced a quandary — trial vaccines for the deadly disease had to be stored at sub-freezing temperatures as they traveled deep into tropical forests by helicopter or motorcycle. America’s highways and byways are far more…

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Two years ago, health workers responding to an Ebola outbreak in extremely remote parts of the Democratic Republic of Congo faced a quandary — trial vaccines for the deadly disease had to be stored at sub-freezing temperatures as they traveled deep into tropical forests by helicopter or motorcycle.

America’s highways and byways are far more advanced than Congo’s, but the so-called “cold chain” is one of several concerns that federal officials are working through as they assemble a massive vaccination campaign to defeat COVID-19.

Messenger RNA vaccines being developed by companies like Pfizer and Moderna — must be held in temperatures as low as minus-80 or minus-70 degrees Celsius.

“It’s an issue,” said Paul Offit, a pediatrics professor at the University of Pennsylvania and member of the Food and Drug Administration’s vaccine advisory panel. He said tens of millions of vaccine doses are slated to go out in the first round of delivery but risk being spoiled if they aren’t handled correctly.

“That is a massive effort,” he said. “It’s going to be interesting, how they plan on maintaining the potency from tarmac to arm.”

Company officials say they’re confident in their methods for safeguarding the shots, while administration officials announced Thursday they soon will be awarding contracts to distributors as they remain on track for delivering doses no later than January 2021. Each of the contract awardees will have to demonstrate the ability to store and transport the shots in the right way.

In fact, “one of our manufacturers is developing its own containers and method,” said Paul Mango, deputy chief of staff for policy at the Department of Health and Human Services.

It’s just one facet of the sprawling and unprecedented effort, including calculations on who will get the shots first.

“There won’t be enough on day one for everyone in the United States,” Mr. Mango said.

Distribution of the initial millions of doses will be prioritized. That’s still being worked out, but panels looking at this are focused on the elderly, such as nursing home residents, and health-care workers and other essential workers who interact with the public.

The coronavirus discovered in Wuhan, China, in December has upended normal life and killed over 166,000 people in the U.S.

Operation Warp Speed — an initiative set up by the Trump White House — is working to speed up the development, manufacture and distribution of a vaccine in record time. Officials said they will not cut corners in vetting clinical data in the coming weeks and months, and there is never a “100%” guarantee of landing a successful vaccine.

However, “we believe we are maximizing our probability of success,” Mr. Mango said.

As part of the effort, the administration has extended manufacturing support to six leading candidates — from AstraZeneca, Johnson and Johnson, Moderna, Novavax, Pfizer and Sanofi/GSK.

Many of them are in massive phase-three trials involving tens of thousands of human participants.

National Institutes of Health Director Francis Collins said he feels confident about the effort because there are so many options.

“If we were putting all of our efforts in a single vaccine, I’d be really worried right now,” he said, adding that there is still “plenty of illness” in the U.S. to conduct trials here instead of abroad.

Officials on Thursday said the Department of Defense will be “very involved” in standing up the manufacturing immense amount of raw materials that have to be acquired for the effort.

“Those factories have to be equipped, those workers have to be trained,” Mr. Mango said.

The Centers for Disease Control and Prevention will track patients and communicate with states, according to the administration. Also, the agency’s Advisory Committee on Immunization Practices (ACIP) is working on who will get the shots first.

Early deliberations suggest health workers will probably be first in line, along with essential workers — for instance, transit workers or people who staff meat-packing plants. The next phase would include at-risk persons such as nursing home residents, and a third phase would consist of the general public.

The committee is still drawing in the lines, and some of the distribution will depend on how the third-phase vaccine trials go, as scientists see which shots work in certain populations.

The advisory group is also working on ways to main local flexibility to ensure that shots don’t sit in the refrigerator — helping no one — after priority groups are served, a lesson the government learned during the H1N1 vaccination effort in 2009, according to William Schaffner, an infectious diseases specialist at Vanderbilt University.

Nate Wardle, a spokesman for the Pennsylvania Health Department, said “while guidance will come from the federal level, we expect that decisions on prioritization will ultimately be made at the state/local jurisdiction.”

He said Pennsylvania has protocols to make sure vaccines are properly stored and maintain their cold chains.

“The COVID-19 vaccine is a novel vaccine, and we expect it will be unlike anything we have seen before. We are working to finalize our vaccination plan and protocols with our partners, including at the federal level, to ensure we are prepared for all aspects of this vaccine,” he said.

A vaccine is considered the most important tool in defeating the coronavirus, which has killed nearly 750,000 people worldwide.

Countries and U.S. states have taken a series of drastic measures to keep people apart and slow transmission, resulting in economic downturns, though flare-ups are a regular occurrence due in part to lax behaviors and gaps in testing and tracing of the disease.

The seven-day rolling average of U.S. cases stands at less than 54,000 per day — down from nearly 66,000 three weeks ago.

Adm. Brett Giroir, the coronavirus testing czar, said Thursday the recent drop in nationwide cases is real and not because of fluctuations in testing. He said less than 7% of tests are returning positive nationwide, compared to the 9% rate he described July 23.

“We have decreased cases because we have decreased cases,” Adm. Giroir said.

There are over 130 vaccines in development for the coronavirus around the world, including eight in phase-3 human trials.

Russian President Vladimir Putin on Tuesday said that his country had approved the world’s first coronavirus vaccine and that one of his adult daughters was among the first to get a dose. American officials greeted the news with skepticism.

Dr. Collins said Russia appeared to declare victory early limited trials. If anything, the Russians appear to be behind the Americans and European scientists who are engaged in rigorous phase-3 trials.

Vaccines that can be stored at ordinary refrigerator temperatures are much easier to deliver than those that have to be stored at extremely low temperatures.

Pfizer said its potential COVID-19 vaccine will need to be stored around minus-70 degrees Celsius, significantly colder than the average winter temperature at the South Pole. The company said, though, that it hopes to have a “lyophilized formulated” version by the end of 2021 that can be stored between minus-8 and minus-2 degrees.

Company spokeswoman Kim A. Bencker said the company has “a tremendous amount of experience and confidence” to deliver and store doses.

She said Pfizer is working closely with the government on contracts and that points of delivery may vary, from hospitals and outpatient clinics to mass community vaccination locations and large pharmacies.

“We have developed detailed logistical plans and tools to support effective vaccine transport, storage and temperature monitoring. Our distribution is built on a flexible just in time system which will ship the frozen vials to the point of vaccination,” Ms. Bencker said.

Also, the company says it’s developed packaging and storage “innovations” to fit the range of locations where vaccination might take place, including “specially designed, temperature-controlled containers” that maintain storage conditions for up to 10 days.

Amesh Adalja, a senior scholar at the Johns Hopkins University Center for Health Security, said safeguarding vaccines will be a particular concern in developing countries, as COVID-19 remains a global crisis.

“Maintaining the cold chain has been really important,” he said, “when you think about developing country vaccine delivery where electricity may be spotty.”

Gavi, The Vaccine Alliance, said it is planning for “all eventualities” as it prepares for its role in combatting COVID-19 as a leading public-private partnerships in vaccinating poorer countries. Things are better than they used to be, however.

“Ten years ago, delivering a COVID-19 vaccine globally would have been a massive challenge, potentially impossible,” the alliance said. “Now after two decades of work by Gavi and our partners, most countries’ cold chain is in good shape.”

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And The COVID-19 Vaccine Winner Is: ‘BioNTech SE’ http://virusreports.net/and-the-covid-19-vaccine-winner-is-biontech-se/ http://virusreports.net/and-the-covid-19-vaccine-winner-is-biontech-se/#respond Mon, 03 Aug 2020 09:22:35 +0000 https://virusreports.net/and-the-covid-19-vaccine-winner-is-biontech-se/ Source of the BioNTech graphic: Wikipedia. BioNTech SE (BNTX) is a Germany-based biotechnology company which has teamed up with Pfizer (NYSE:PFE) to bring a COVID-19 vaccine to the market. There are no market or economic precedents for this pandemic or for how to estimate a value for a successful COVID-19 vaccine, or how to estimate…

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Source of the BioNTech graphic: Wikipedia.

BioNTech SE (BNTX) is a Germany-based biotechnology company which has teamed up with Pfizer (NYSE:PFE) to bring a COVID-19 vaccine to the market. There are no market or economic precedents for this pandemic or for how to estimate a value for a successful COVID-19 vaccine, or how to estimate the value of a company who succeeds at a vaccine. Following an approach to assess development progress, prospects for success, commercial positioning and competitive advantages, I will do indicative calculations to reach a success-based value for BioNTech shares.

BioNTech was founded in 2008 on the understanding that every cancer patient’s tumor is unique and therefore each patient’s treatment should be individualized. From our roots in Mainz, Germany, we are driven to become the leading global biotechnology company for individualized cancer medicine.”

The research done by BioNTech in collaboration with Pfizer to develop mRNA-based vaccines for the prevention of influenza was a perfect fit for both parties to initiate a new collaboration on COVID-19 when the opportunity presented.

BioNTech and Pfizer announced their COVID-19 vaccine collaboration on March 17, 2020, and commented as follows:

The collaboration aims to accelerate development of BioNTech’s potential first-in-class COVID-19 mRNA vaccine program, BNT162, which is expected to enter clinical testing by the end of April 2020.”

The collaboration between BioNTech and Pfizer excludes China as BioNTech had already signed a strategic alliance deal with Fosun Pharma on March 16, 2020, for its COVID-19 vaccine.

BioNTech received regulatory approval from German authority Paul-Ehrlich-Institut to commence the first clinical trial of COVID-19 vaccine candidates on April 22, 2020, and announced on April 29, 2020, that they have completed dosing for the first cohort of Phase 1/2 trial of COVID-19 vaccine candidates in Germany. The efficiency and professionalism of the BioNTech/Pfizer team are amply demonstrated already at this early stage in late April 2020. The Phase 1/2 trail then escalated to the USA and on May 5, 2020, BioNTech announced the dosing of the first participants in the U.S. as part of its global COVID-19 mRNA Vaccine Development Program.

BioNTech tested different iterations of its vaccine in a strategy to eventually select the best-performing iteration with regards to safety and efficacy to take forward.

Let’s just simplify this mRNA vaccine for the assessment of likelihood of success. Visualize it as a custom-built vehicle designed to carry a “safe” piece of the COVID-19 causing virus in its boot. The vehicle is then injected into a human body and will trick the immune system into producing an immune response as if it had encountered COVID-19. Traditionally, vaccines will use a naturally occurring virus as a vehicle or a weakened version of the actual COVID-19 causing virus. Not using a “custom built vehicle,” as I will explain later, may present problems for other vaccine makers.

BioNTech financed its COVID-19 vaccine development through the issue of debt and raising capital which allowed the company to follow a profit-orientated commercialization strategy not beholden to governments for grants.

BioNTech announced on July 1, 2020, positive preliminary results from the ongoing Phase 1/2 Study of its mRNA-based Vaccine Candidate against SARS-CoV-2. On July 13, 2020, BioNTech “announced that two of the companies’ four investigational vaccine candidates from their BNT162 mRNA-based vaccine program (BNT162b1 and BNT162b2) being developed to help protect against SARS-CoV-2 (the virus that causes COVID-19), received Fast Track designation from the U.S. Food and Drug Administration (FDA).”

BioNTech reported early success on July 20, 2020, when it provided information on the Phase 1/2 clinical studies. What we are looking for is an antibodies response, a T cell response and safety with references to dosage levels. BioNTech delivered on all three:

Antibodies

The vaccine elicited high, dose level-dependent SARS-CoV-2-neutralizing titers and RBD-binding IgG concentrations after the second dose. Day 43 SARS-CoV-2 neutralizing geometric mean titers were in the range of 0.7-fold (1 µg) to 3.2-fold (50 µg) compared to that of a panel of SARS-CoV-2 infection convalescent human sera.”

T Cell responses

In addition, the initial German trial results demonstrate, for the first time for the BNT62b1 candidate, a concurrent induction of high level CD4+ and CD8+ T cell responses against the SARS-CoV-2 RBD.

The strength of T cell responses varied between subjects. There was no clear dose level dependency of the T cell response between 1 µg to 50 µg, indicating that stimulation and robust expansion of T cells might be accomplished at low mRNA dose levels.”

Safety

Overall, the data suggested that BNT162b1 could potentially be administered safely, with a manageable tolerability profile. Local reactions and systemic events after injection with BNT162b1 at all dose levels were transient, generally mild to moderate, with occasional severe events (Grade 3) of flu-like symptoms and injection site reactions. All adverse events resolved spontaneously and were managed with simple measures. No serious adverse events (SAEs) were reported, and there were no withdrawals due to adverse events related to the vaccine.”[My bold]

These excellent results were sufficient to move the UK government to pre-purchase (on terms and conditions not disclosed) 30 million doses of the BioNTech vaccine on the same date, July 20, 2020.

BioNTech announced two days later on July 22, 2020, that the USA government has joined the UK government by pre-purchasing up to 600 million doses of the vaccine, this time actually disclosing pricing. “U. S. government placed an initial order of 100 million doses for $1.95 billion and can acquire up to 500 million additional doses”

The pre-purchase agreements with the UK and the USA were followed also by Japan and BioNTech announced on July 31, 2020, that it will supply Japan with 120 million doses of its BNT162 mRNA-based Vaccine Candidate.

On July 27, 2020, BioNTech announced that they have chosen vaccine iteration BNT162b2 to take forward in a Phase 2/3 vaccine trial, following which, they will apply for FDA approval targeting October 2020.

Assuming clinical success, Pfizer and BioNTech [are] on track to seek regulatory review as early as October 2020 and, if regulatory authorization or approval is obtained, plan to supply up to 100 million doses by the end of 2020 and approximately 1.3 billion doses by the end of 2021”

The big question everybody is asking about the vaccine developers is, can they deliver? BioNTech in collaboration with Pfizer is adamant that they can. The CEO of Pfizer responded to the question in an interview on CNBC on July 28 as follows:

Albert Bourla, CEO of Pfizer: “Our estimations are for real. And off course it is difficult to execute but we have a very, very long experience in executing…” “You need to have a meticulous execution to be able to deliver these results.” “We believe that with normal efficacy of the vaccine, we will have results, enough events that demonstrates statistical significance difference by the end of September, beginning of October. The more efficacious the vaccine is, that [statistical evidence] could come even earlier.” “We are going to cut zero corners [on safety].” “In October we will have enough data, I believe, so that FDA can make [up] their mind about providing approval…”

None of the other vaccine candidate producers can make the same claims as the BioNTech/Pfizer team on pre-selling, FDA anticipated approval, a global footprint and scaled production. Some may claim to be on the same clinical phase, some may claim to have had pre-orders, some may claim to have potential production facilities but no other candidate can make all four claims for the target dates, production volumes, international footprint and government pre-orders which the BioNTech/Pfizer team has placed on record.

It is worth listening to the Pfizer’s CEO interview on CNBC explaining the timeline and expressing confidence in the success of the vaccine as well as delivering scaled production.

That brings us to the “assuming clinical success” provision. Are they likely to succeed?

Dr. Anthony Fauci, Director, National Institute of Allergy and Infectious Diseases, commented in an interview on CNN with Wolf Blitzer on July 27, 2020, on the Phase 3 trial of Moderna (NASDAQ:MRNA) in the USA when asked “will it work”: “…no guarantee, however I must say, in the same breath Wolf, that if you look at the early data, particularly the data from the Phase 1 trial and you look at the kinds of responses that were induced in those volunteers, there were robust antibody responses, they were of a magnitude that you would see in convalescent plasma of individuals who’ve recovered from infection [of COVID-19] and that’s one of the hallmarks of prediction of the success of a vaccine. If you can induce a response with the vaccine that’s comparable to or even better than a response of natural infection, then that’s really a good start. So that’s why it makes me cautiously optimistic even though we can’t guarantee anything but cautiously optimistic that we will have a vaccine that works.”

I have quoted above the excellent results obtained by BioNTech in its Phase 1/2 clinical trials regarding antibodies, “robust” T cell responses exceeding the standards mentioned by Dr. Fauci and meeting safety standards.

The BioNTech Phase 2/3 clinical trial started on the same day (July 27, 2020) as the Moderna Phase 2/3 clinical trial and will be conducted on the same principles.

Pfizer enters last stage of testing for Covid-19 vaccine trial

More information on the vaccines and how they work can be obtained from this excellent National Geographic article.

On July 27, Pfizer and BioNTech launched a trial that combines phase two and three by enrolling a diverse population in areas with significant SARS-CoV-2 transmission. It will examine the vaccine’s effect in 30,000 people from 39 U.S. states and from Brazil, Argentina, and Germany.”

The FDA approval benchmark for the COVID-19 vaccine is 50% efficacy and when the Operation Warp Speed chief adviser was asked by CNN Senior Medical Correspondent Elizabeth Cohen: “Some vaccines are 97% effective, others are 60%, where do you think we’re going to fall with the COVID vaccine?” he answered:

It is very hard to predict, of cause, that’s why we are doing the trail. My personal opinion based on my experience and the biology of this virus, I think this vaccine is going to be highly efficacious. I wouldn’t be surprised if it’s in the 90% [range].” said Moncef Slaoui, chief adviser of Operation Warp Speed. “I think the question that’s open is, for how long will the vaccine afford efficacy.”

His final comment is very important, “for how long will the vaccine afford efficacy?”

Research so far indicates that immunity fades within 2-3 months.

CIDRAP, Centre for Infectious Disease and Policy at the University of Minnesota reports on a study in China that antibodies in COVID-19 patients fade quickly.

“The study, which focused on 37 asymptomatic and 37 symptomatic patients, showed that more than 90% of both groups showed steep declines in levels of SARS-COV-2–specific immunoglobulin G (IgG) antibodies within 2 to 3 months after onset of infection, …”

Antibody levels dropped 70%

Among the main findings was that IgG levels in 93% (28/30) of the asymptomatic group and 97% (30/31) of the symptomatic group declined greatly during the early convalescent phase (by 8 weeks after release from the hospital). Antibody levels dropped by 71.1% in asymptomatic patients and 76.2% in the symptomatic group.”

I have mentioned that success means antibodies and T cell responses but now it seems that “success” is only going to last 2-3 months.

This is an important question for the number of vaccine doses to be commercialized. Moncef Slaoui asked, for how long will the vaccine afford efficacy? The reporter did not follow it up.

BioNTech indicated that its vaccine achieved immune responses specific to the SARS-CoV-2 protein. Does that mean that its vaccine will last longer than 2 months to 3 months? In time we will have the data and the answer, but for now the biological answer is that immunity (judged by antibodies, which still needs to be proven) lasts 2 to 3 months. It follows that it is probable that people will have to receive booster shots every 2 to 3 months. That is why this question is controversial and why this aspect is underreported. The development path of the vaccine is already being questioned by anti-vaxxers and quarterly booster shots are certainly going to be controversial.

We know from the clinical trial data above that the vaccine will most likely be delivered in two initial doses. Judging from the biological immune response data, it would be fair to expect a booster dose quarterly.

I had mentioned above that BioNTech uses a custom made vehicle to deliver an inactive portion of the virus to the human body. The point is that the body must respond to the inactive portion of the COVID-19 causing virus and not to the vehicle. Using a naturally occurring virus as the vehicle can cause the body to respond to the “vehicle” rather than the COVID-19 causing virus, particularly if the body had previously encountered the “vehicle.” This response to the vehicle may become an additional problem with multiple booster shots. Having a custom-built vehicle will be a significant advantage.

Armed with the information above on the development progress, prospects for success, commercial positioning and competitive advantages, we can do initial calculations on the commercialization of a COVID-19 vaccine. That will assist us in estimating the commercial value for BioNTech and what a fair value would be for its shares.

Who needs it? The whole world population of 7.8bn people.

What is the indicative price? See the pre-order from the USA government, $1.95bn for 100 million doses. That is $19.5 per dose and each person will need 2 doses to start out.

It is likely that each person would require quarterly booster shots. That means at least 4 shots per annum.

Not everybody will get vaccinated but this is such an economic emergency that it is likely that vaccination will exceed 60%, so let’s work with 60% of the global population being vaccinated.

The commercialization of all COVID-19 vaccines would therefore be worth $91.26bn based on 60% of the population per shot. The 2 initial shots will be worth twice that at $182.5bn. The 4 annual shots will be worth $365bn.

Moving on to the BioNTech/Pfizer team and given its competitive advantages, it would be fair to estimate that it could capture up to 50% of the market, particularly in the 2020 to 2023 period.

That would calculate a revenue stream of $91.26bn for the 1st two shots over 4 years and booster shots worth $182bn per annum after the 4 years.

This is not a definitive calculation, it is an indicative calculation using current available information. The information and basis for calculation may change going forward or may substantially remain the same. We just do not know but these are very substantial potential revenue streams.

The BioNTech/Pfizer team has not disclosed how they will share the potential revenue stream, but let’s use a 50/50 division for a calculation which will allow us to drill down to BioNTech. It then follows that BioNTech will build up to a revenue stream of $91.26bn by 2023 with substantial income generation already taking place in 2020.

An enterprise value of 2 times revenue would indicate that BioNTech should grow to a market capitalization of around $182.5bn ignoring all its other potential products and the potential future income from the technology of having a proven mRNA delivery vehicle. BioNTech currently has 226 262 336 shares in issue, excluding a small rights offer in progress, for a market cap of around $20bn at its closing price on July 31, 2020, at $82.11. The share price will have to increase to $806 to reach a market cap of $182.5 but one would expect some dilution with rights offers along the way. It is reasonable to place a target price of $200-300 on BioNTech shares by the end of 2020 based on the information available.

I believe that the information available also shows the BioNTech/Pfizer team to be in a commanding position to gain the largest market share from the development of a COVID-19 vaccine. October 2020 is a very near date for data and commercialization certainty. The governments of the USA, the UK and Japan seem to agree.

Disclosure: I am/we are long BNTX. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

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Who should get the Covid-19 vaccine first? It’s way trickier than you might think http://virusreports.net/who-should-get-the-covid-19-vaccine-first-its-way-trickier-than-you-might-think/ http://virusreports.net/who-should-get-the-covid-19-vaccine-first-its-way-trickier-than-you-might-think/#respond Sat, 01 Aug 2020 19:21:05 +0000 https://virusreports.net/who-should-get-the-covid-19-vaccine-first-its-way-trickier-than-you-might-think/ U.S. President Donald Trump delivers a speech during a visit to the Fujifilm Diosynth Biotechnologies' Innovation Center, a pharmaceutical manufacturing plant where components for a potential coronavirus disease (COVID-19) vaccine candidate are being developed, in Morrrisville, North Carolina, U.S., July 27, 2020.Carlos Barria | ReutersThe hunt is on for a vaccine for Covid-19, which has…

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U.S. President Donald Trump delivers a speech during a visit to the Fujifilm Diosynth Biotechnologies’ Innovation Center, a pharmaceutical manufacturing plant where components for a potential coronavirus disease (COVID-19) vaccine candidate are being developed, in Morrrisville, North Carolina, U.S., July 27, 2020.

Carlos Barria | Reuters

The hunt is on for a vaccine for Covid-19, which has killed more than 600,000 people.

The current frontrunners include an mRNA vaccine from Moderna; a candidate vaccine from AstraZeneca and Oxford University; a Chinese vaccine from the military and biotech company CanSigo Biologisc; and an mRNA-based vaccine from German company BioNTech and Pfizer.

While a candidate could be approved this year, it remains to be seen whether the vaccine will confer temporary or long-term immunity, or how many doses will be required, as doubling the number of jabs could complicate worldwide immunization efforts.

But bioethicists and public health experts all agree that manufacturing doses for 8 billion people quickly is an insurmountable challenge. 

So someone will have to decide who should get the vaccine first — and why. 

In the United States, committees have begun to form to discuss this tricky issue. An advisory committee of external health experts is advising the Centers for Centers for Disease Control and Prevention on an equitable framework. The National Academies of Medicine announced earlier this month that its committee will “develop an overarching framework to assist policymakers in the U.S. and global health communities.”

Some of the most challenging questions they face include whether pregnant women (normally the last to get a vaccine) should be higher up on the list, or whether Black and Latino people — who have been disproportionately affected by the virus — should get access to the vaccine before the rest of the population. 

Then there are the global considerations. Task forces have formed to come up with a “fair and equitable” framework to distribute the vaccine between countries, but face numerous practical challenges.

Arthur Caplan, professor of bioethics at New York University Langone Medical Center, thinks some countries will have vaccines to spare, while others won’t have access to many at all. Some nations could use their leverage over vaccines as a way to curry favor or to negotiate trade deals. Enforcing safety and efficacy is another sticking point because not every country has the same quality-control processes.

“Internationally, there’s a lot of talk about how every life is valuable,” he said. “But that doesn’t address what you do in practical terms if there’s a shortage.”

Caplan is also concerned about the rise of black markets, which might allow rich people in certain countries to jump the line and buy vaccines for themselves and their families.

Other bio-ethicists note complicated questions around responsibility and need. For instance, countries like New Zealand have done a very good job at flattening the curve, while others like Brazil are struggling to contain active outbreaks. So should the countries that have largely stamped out Covid-19 vaccinate their populations last? 

“We need to think through how to distribute vaccines to reduce harm internationally,” said Ezekiel Emanuel, an oncologist and senior fellow at the Center for American Progress. “And some countries are really suffering more than others.”

So who gets the vaccine first?

Within the U.S., bioethicists hope that vaccines are distributed in a centralized and coordinated way. Back in April and May, the lack of coordination from the federal government meant that states had to compete for supplies, including ventilators, and manufacturers were confused about where to send equipment. 

“I’m worried that there will not be the kind of national leadership on the issue that we need to avoid fights from breaking out as people jockey to get access,” said Michelle Mello, professor of law and medicine at Stanford University. 

Even if the federal government steps up, there isn’t yet consensus on who should get access to the vaccines first. 

Most of the experts had a set of categories in mind. Lawrence Gostin, a professor of global health law and director of the O’Neill Institute for National and Global Health Law at Georgetown, helped draft policy papers on the issue for the Obama administration during the H1N1 crisis of 2009. 

His strategy would be using the vaccine first to prevent further spread of the virus.

“That is, we might need a kind of ring vaccination strategy for major clusters of cases that don’t we want to spread to other other cities or states,” he said. 

Next, he would prioritize health workers on the front lines of the pandemic. Once they’re vaccinated inside hospitals, he would turn his attention to other essential workers, including police, sanitation workers, and workers who are critical to maintaining our food supply. Then he’d select the most vulnerable, including the elderly or marginalized populations or those with pre-existing conditions. 

Other experts have different ideas.

Nisarg Patel, a surgeon at UC San Francisco and a co-author of an op-ed on the topic, would start with the people at highest risk, including health workers, essential municipal workers, vulnerable groups and the elderly.

But given that nearly half of Americans have at least one chronic illness, there might need to be some consideration about who gets prioritized within that group. For instance, should immunocompromised patients in the midst of cancer treatment get access to the vaccine before tens of millions of people with Type 2 diabetes?

“The way you think through them is to think through the outcomes,” said Mello, although she notes the evidence is still accumulating on that. She also points out, however, that it might be the case that not everyone will want the vaccine immediately – so some might wait and see what happens with the first cohort. 

Even then, it’s not that simple.

Bioethicists point out that some of these decisions can only really be made once the specifics of the vaccine are better understood.

Vulnerable populations including the frail and elderly might not mount a robust immune response to the vaccine, for instance. The data on that from clinical trials is still limited. And health care workers might not get first dibs if they have sufficient PPE to protect themselves. The first round might be limited to those who treat Covid-19 patients specifically. 

“A lot will depend on the vaccine, but also the modeling that we do,” said Emanuel. “We might even find that the best way to reduce the spread of the virus is to vaccinate the most common transmitters, like grocery store workers or policemen,” he said. 

How about the anti-vaxxers?

Another question that will need to be determined by committees: If sufficient people aren’t willing to volunteer for a vaccine, should governments require that certain groups get vaccinated? 

“Voluntary is always better,” said Emanuel. “It’s never the first option to mandate it, but it may be a necessary one.”

Caplan agrees that discussions should be underway on this issue, as a lot of people might be reluctant to get vaccinated. Anti-vaccination sentiment is far from limited to the United States, he points out. In countries like France, surveys have shown that 1 in 3 people do not feel that vaccines are safe. 

Caplan doesn’t have a clear solution for hardline anti-vaxxers, who might never be willing to get the vaccine. But he does think that a lot can be done to sway those who are reluctant or hesitant by showing data from the first group that gets vaccinated. In the United States, he would message to the public that vaccination is required for certain freedoms, like travel or sending their kids to school. Emanuel suggests that public health workers might even consider teaming up with celebrities and influencers to help spread the word. 

These challenges — and many more surrounding vaccine allocation — are surmountable with the right planning and coordination, Emanuel stresses.

“We shouldn’t give up,” he said. 

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Experimental J&J vaccine protects monkeys in a single dose-study http://virusreports.net/experimental-jj-vaccine-protects-monkeys-in-a-single-dose-study/ http://virusreports.net/experimental-jj-vaccine-protects-monkeys-in-a-single-dose-study/#respond Thu, 30 Jul 2020 11:21:03 +0000 https://virusreports.net/experimental-jj-vaccine-protects-monkeys-in-a-single-dose-study/ By Julie SteenhuysenCHICAGO, July 30 (Reuters) - Johnson & Johnson on Thursday kicked off U.S. human safety trials for its COVID-19 vaccine after releasing details of a study in monkeys that showed its best-performing vaccine candidate offered strong protection in a single dose.When exposed to the virus, six out of six animals who got the…

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By Julie Steenhuysen

CHICAGO, July 30 (Reuters) – Johnson & Johnson on Thursday kicked off U.S. human safety trials for its COVID-19 vaccine after releasing details of a study in monkeys that showed its best-performing vaccine candidate offered strong protection in a single dose.

When exposed to the virus, six out of six animals who got the candidate vaccine were completely protected from lung disease and five out of six were protected from infection as measured by the presence of virus in nasal swabs, according to the study published in the journal Nature.

“This gives us confidence that we can test a single-shot vaccine in this epidemic and learn whether it has a protective effect in humans,” Dr. Paul Stoffels, J&J’s chief scientific officer, told Reuters in a telephone interview.

The U.S. government is backing J&J’s vaccine effort with $456 million in funding as part of a spending spree aimed at speeding production of a vaccine to end the pandemic, which has infected millions and killed more than 660,000 people.

Stoffels said prior tests of this type of vaccine in other diseases found that a second shot significantly increases protection. But in a pandemic a single-shot vaccine has a significant advantage, sidestepping a lot of the logistical issues involved in getting people to come back for their second dose.

The company plans to take up the question of one or two doses in its phase 1 trial, which kicked off this week in the United States.

Depending on those results, J&J plans to start large-scale, phase 3 testing with a single-shot regimen in the second half of September. Around the same time, the company will start a parallel phase 3 study testing a two-shot regimen of the vaccine, Stoffels said.

J&J’s vaccine uses a common cold virus known as adnovirus type 26 or Ad26 to ferry coronavirus proteins into cells in the body, causing the body to mount an immune defense against the virus.

In the monkey study, scientists from J&J and Harvard’s Beth Israel Deaconess Medical Center studied seven different potential vaccines in 32 animals and compared the results to 20 control animals who got placebo shots.

Six weeks later, all of the animals were exposed to the SARS-CoV-2 virus. All 20 animals that received the placebo developed high levels of virus in their lungs and nasal swabs.

In the best-performing candidate, which J&J selected for human testing, none of the animals had virus in their lungs and only one showed low levels of virus in nasal swabs. Lab tests showed they all had developed antibodies capapable of neutralizing the virus after a single shot.

“This study shows that even just a single immunization with the Ad26 vaccine leads to neutralizing antibody responses and robust protection of monkeys against COVID-19,” said Dr. Dan Barouch, a vaccine researcher at Beth Isreal Deaconness who led the research in collaboration with J&J.

(Reporting by Julie Steenhuysen; editing by Richard Pullin)

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