The post Pfizer coronavirus vaccine deal touted by Trump appeared first on Virus Reports.
]]>Pfizer will provide 100 million doses of its coronavirus vaccine if and when it is approved later this year under a “historic” deal with the government, President Trump said Wednesday, as three states and D.C. scrambled in the meantime to stanch the virus by mandating masks outside the home.
Mr. Trump used a White House briefing to trumpet the nearly $2 billion agreement with Pfizer and its partner, Germany company BioNTech, which includes rights to obtain 500 million more doses and is part of a broader effort to begin administering a vaccine by 2021.
Federal officials said the shots would be provided to Americans at no cost after a Food and Drug Administration review, which is on track for the fall.
“Hopefully the approval process will go very quickly,” Mr. Trump said. “We think we have a winner there.”
He also said his administration is surging testing to nursing homes, where many COVID-19 deaths have occurred, and sent a “message of love” to seniors who are hunkered in their homes due to the dangers the virus poses to them.
The president took the briefing-room podium solo, without his top scientists, for the second time in as many days after holding his first coronavirus briefing in over two months on Tuesday.
Mr. Trump is highlighting scientific progress even as he acknowledges a surge in infections and hospitalizations across the Sun Belt.
The president partly blamed the increase on racial-justice protests that erupted in late May and early June. He also blamed social events at bars and beaches, though said states like Arizona are showing some signs of improvement.
“They’re all doing a good job, they’re very talented people,” Mr. Trump said of hard-hit states with Republican governors.
The post Pfizer coronavirus vaccine deal touted by Trump appeared first on Virus Reports.
]]>The post Pfizer, BioNTech Get $1.95 Billion Covid-19 Vaccine Order From U.S. Government appeared first on Virus Reports.
]]>The U.S. has agreed to pay Pfizer Inc. and BioNTech SE nearly $2 billion to secure 100 million doses of their experimental Covid-19 vaccine to provide to Americans free of charge.
Under the $1.95 billion agreement, the U.S. Department of Health and Human Services and the Defense Department will receive 100 million doses of the vaccine should it be cleared by regulators, and can also acquire an additional 500 million doses. The vaccine, which has shown promising preliminary results in small groups of patients, is set to enter…
The post Pfizer, BioNTech Get $1.95 Billion Covid-19 Vaccine Order From U.S. Government appeared first on Virus Reports.
]]>The post Pfizer coronavirus vaccine fast-tracked by FDA appeared first on Virus Reports.
]]>The Trump administration fast-tracked trial vaccines for the coronavirus Monday as states across the South and West buckled from the rapid spread of COVID-19, forcing California to close indoor dining, museums and theaters while Miami considers another lockdown.
The Food and Drug Administration said it will speed the review of two vaccine candidates from pharmaceutical giant Pfizer and partner company BioNTech. The fast-track status was granted based on preliminary data from phase one and two studies in the U.S. and Germany. The company expects to enroll 30,000 people in its next phase of trials.
If the trials are successful, the companies hope to make 100 million doses by the end of the year and possibly more than 1.2 billion doses by the end of 2021. The administration is investing in a range of vaccine approaches with the hope of landing a successful shot before the year ends.
In the meantime, a wide swath of America is reeling from the spread of the coronavirus, making it difficult to resume normal life and complicating efforts to reopen schools.
While President Trump continued to blame increased testing for the surge in cases, California Gov. Gavin Newsom, a Democrat, said the virus is spreading at such an alarming rate that he must close indoor activities at restaurants, wineries, theaters, zoos and museums. Bars were ordered to close completely.
He ordered an additional 30 counties to close indoor operations at fitness centers, houses of worship, malls, and hair salons and barbershops.
“COVID-19 is not going away anytime soon, until there is a vaccine and/or an effective therapy,” Mr. Newsom said. His state is averaging about 8,000 new cases a day, about double from a month ago.
California’s largest school districts, in Los Angeles and San Diego, announced they would begin the academic year with students at home despite Mr. Trump’s push to resume in-person learning.
Oregon Gov. Kate Brown, a Democrat, banned indoor gatherings of 10 or more people and required masks to be worn in public.
In Florida, Miami Mayor Francis Suarez, a Republican, said he is considering another lockdown order because of a record-shattering surge of COVID-19 cases in the state.
“We definitely saw a significant flattening of the curve when we implemented a stay-at-home order in March, April,” Mr. Suarez said on CNN. “If we get to a point where we don’t feel like we can care for the people that are getting sick, that’s something that we’re going to have to strongly look at.”
Florida on Monday reported more than 12,600 cases from the previous day, its second-highest total of the pandemic after shattering the single-day record for any U.S. state on Sunday by reporting over 15,000.
Florida Gov. Ron DeSantis, a Republican, acknowledged the “long road ahead” but said the state had secured supplies of remdesivir, a drug that has been shown to speed recovery, and still has enough hospital beds. He said the key will be maintaining hospital personnel for COVID-19 cases and other medical needs, so they are shuffling around staff.
“We can’t get swept away in fear,” Mr. DeSantis said.
He said he would like to get Florida’s 15% rate of positive tests below 10%, a threshold recommended to ensure enough cases are being diagnosed.
The virus was discovered in Wuhan, China, in December and rapidly spread to other countries. Nearly 13 million cases of COVID-19 have been reported worldwide and nearly 570,668 have died, though more than 7.1 million have recovered. The world population is about 7.8 billion.
“Let me be blunt: Too many countries are headed in the wrong direction. The virus remains public enemy No. 1,” WHO Director-General Tedros Adhanom Ghebreyesus said Monday.
With a population of 209.5 million, Brazil has emerged as an epicenter and has tallied the second-highest number of confirmed cases behind the U.S. at more than 1.8 million and 72,100 deaths.
Mr. Tedros cautioned that the pandemic is likely to get worse if countries fail to abide by suggested health care precautions.
“If basics are not followed, the only way this pandemic is going to go, it is going to get worse and worse and worse,” Mr. Tedros said. “But it does not have to be this way.”
In the U.S., cases are rising in about two-thirds of states. Mr. Trump has said the trend is partly a result of widespread testing.
“When you test, you create cases,” the president said, noting that the mortality is down overall. Therapeutics have advanced, and Southern states say many cases are concentrated in young people who are less likely to die.
Still, the surges are accompanied by hospital visits that are taxing capacity in hard-hit places such as Houston.
New York Gov. Andrew Cuomo, A Democrat, celebrated a sharp decline in cases and deaths within his state but warned residents not to get complacent as the economy continues to reopen. He said he was also worried about cases from out of state and cited a cluster in Rensselaer County that was traced back to travelers from Georgia.
Mr. Cuomo said all out-of-state visitors to airports statewide will have to fill out a form stating their travel origins and their plans within New York. Violators face a $2,000 fine.
He drew a contrast between his state, which faced a big spike before a testing system was operable and the nation realized how widespread the virus was, and states that showed upticks after nationwide lockdowns.
“They haven’t ticked up. They’ve actually gone down. So the reopening strategy has worked,” Mr. Cuomo said. “It shows that this nation can defeat COVID. There was no reason to have these states on the increase.”
Mr. DeSantis has faced criticism for his handling of the response in Florida after boasting about his efforts when the disease was more widespread in places in the Northeast.
A protester interrupted Mr. DeSantis as he began his press conference.
“You’re doing nothing,” he shouted.
In Miami, Mr. Suarez said he is hopeful that rules mandating masks in public and the rollback in some reopenings “start flattening the curve.”
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said it is not tenable to stay “completely shut down for a very prolonged period of time” from economic and public health perspectives.
“We need to drop back a few yards and say, ‘OK, we can’t stay shut down forever,’” he said.
Dr. Fauci, who spoke to the dean of the Stanford School of Medicine via livestream, said the U.S. didn’t shut down entirely like some other countries, and that is why COVID-19 case numbers rose, started to fall and then plateaued at a relatively high level of about 20,000 infections per day.
More recently, new cases in the U.S. have routinely topped 50,000 a day.
“As we started to reopen, we’re seeing the surges that we’re seeing today as we speak in California, in Arizona, in Texas, in Florida and in several other states,” he said.
Dr. Fauci lamented that some states moved from shutdown mode to “complete[ly] throwing caution to the wind.”
“Bars that were crowded, people without masks,” he said.
“There are things that you can do now: physical distance, wearing a mask, avoiding crowds, washing hands,” he said. “Those things, as simple as they are, can turn it around, and I think we can do that, and that’s what we’ve got to do looking forward.”
Those measures likely will be a part of life until a successful vaccine is developed.
Administration officials, citing early data, said they are confident about their push to have tens of millions of vaccine doses by the end of the year. Somewhat paradoxically, the outbreaks across the country will help scientists test trial vaccines in areas of live transmission.
Pfizer called its fast-track status “an important milestone” in working alongside the FDA to develop safe and effective shots. It is one of several prominent players in the race for the vaccine.
The federal government is spending billions of dollars to support the companies and secure millions of doses of any successful candidate.
Administration officials have said that while a successful shot is not guaranteed, they are confident they can produce one by the end of the year or early next year.
Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security, said there is no “biological barrier” to developing a vaccine to the pathogen, citing effective shots for other coronaviruses within veterinary medicine.
“When the vaccine appears, it will likely be tiered with health care workers and high-risk individuals prioritized,” he said, “similar to the process with the 2009 H1N1 pandemic influenza vaccine.”
⦁ Lauren Meier contributed to this report.
The post Pfizer coronavirus vaccine fast-tracked by FDA appeared first on Virus Reports.
]]>The post Pfizer launches four late-stage studies on vaccine candidates appeared first on Virus Reports.
]]>Pfizer (NYSE:PFE) has initiated Phase 3 clinical trials on vaccine candidates for preventing pneumonia, RSV and meningitis.
20-valent pneumococcal vaccine (20vPnC): Two studies, NCT04382326 and NCT04379713, will assess a four-dose series in healthy infants. The former is aimed at determining immunologic non-inferiority to Prevnar 13.
RSV vaccine (RSVpreF): Study NCT04424316 is assessing the vaccine in infants born to immunized women.
Pentavalent meningococcal vaccine (MenABCWY): Study NCT04440163 is assessing the vaccine in adolescents and young adults aimed at determining non-inferiority to licensed vaccines.
The post Pfizer launches four late-stage studies on vaccine candidates appeared first on Virus Reports.
]]>The post Pfizer/BioNTech to Begin Coronavirus Vaccine Study in Germany appeared first on Virus Reports.
]]>Sanofi (SNY): Free Stock Analysis Report
Pfizer Inc. (PFE): Free Stock Analysis Report
Moderna, Inc. (MRNA): Free Stock Analysis Report
BioNTech SE Sponsored ADR (BNTX): Free Stock Analysis Report
To read this article on Zacks.com click here.
Zacks Investment Research
The post Pfizer/BioNTech to Begin Coronavirus Vaccine Study in Germany appeared first on Virus Reports.
]]>The post Pfizer Rises on Nod to Start First In-Human COVID-19 Vaccine Trial in Germany appeared first on Virus Reports.
]]>Pfizer and BioNTech said they expected shortly to get regulatory approval to also start clinical trials in the U.S. Pfizer shares rose as much as 10% in early morning trading and were priced at $36.38 around midday. BioNtech stock surged 14% to $48.35.
The Phase 1/2 trial comprises 4 vaccine candidates. The trial will include about 200 healthy individuals between the ages of 18 to 55 and aims to test the safety and immunogenicity of the vaccine. The study will also evaluate the effects of repeated immunization for three of the four vaccine candidates which utilize uRNA or modRNA. Individuals with a higher risk for a severe COVID-19 infection will be included in the second part of the study.
“We are pleased to have completed pre-clinical studies in Germany and will soon initiate this first-in-human trial ahead of our expectations,” said BioNtech CEO and Co-founder Ugur Sahin. “The speed with which we were able to move from the start of the program to trial initiation speaks to the high level of engagement from everyone involved.”
Wall Street analysts have a Moderate Buy consensus rating for both Pfizer and BioNtech. For Pfizer ratings are evenly divided between 4 Buys and 4 Holds and for BioNtech they are divided between 2 Buys and 2 Holds.
The $41.61 average price target for Pfizer projects 14% upside potential for the drugmaker’s shares in the coming 12 months. (See Pfizer stock analysis on TipRanks).
While for BioNTech, analysts forecast 9.4% downside potential setting the average price target at $43.75. (See BioNTech stock analysis on TipRanks).
“Now that the work in Germany can commence, we are looking forward to and actively preparing for the potential start of this unique and robust clinical study program in the United States in the near future,” said Pfizer Chairman and CEO Albert Bourla.
Related News:
Gilead, oNKo-innate Look To Natural Killer Cells For New Cancer Treatment
Exact Sciences Reports 63% Reduction For Cologuard Testing in April
Biogen Announces 1Q20 Beat, But Aducanumab Update Steals The Show
More recent articles from Smarter Analyst:
- Karyopharm (KPTI) Bulls Find More Reasons to Smile
- Facebook Will Weather the Coronavirus Storm, Says Wedbush
- Atossa Genetics Joins the Race to Find COVID-19 Treatment; Analyst Says ‘Buy’
- Disney Heiress Slams $1.5 Billion Executive Bonuses Amid Furloughs
The post Pfizer Rises on Nod to Start First In-Human COVID-19 Vaccine Trial in Germany appeared first on Virus Reports.
]]>The post Pfizer and BioNTech on go with COVID-19 vaccine study in Germany appeared first on Virus Reports.
]]>Germany’s Paul-Ehrlich Institut has signed off on a Phase 1/2 clinical trial evaluating BioNTech’s (NASDAQ:BNTX) COVID-19 vaccine program, BNT192, for the prevention of the respiratory infection, the first such study there.
The dose escalation portion will enroll ~200 subjects aimed at determining the optimal dose for further studies and assessing initial safety and immunogenicity. The trial will also evaluate the effects of repeat immunization for three of the four vaccine candidates that use uRNA or modRNA. Patients with higher risk of developing severe COVID-19 infection will be included in the second part.
A U.S.-based trial should launch shortly.
Pfizer (NYSE:PFE) is the company’s development partner.
BNTX will host a conference call tomorrow, April 23, at 8: 00 am ET to discuss the study.
BNTX is up 50% premarket and PFE is up 6%, both on modest volume.
The post Pfizer and BioNTech on go with COVID-19 vaccine study in Germany appeared first on Virus Reports.
]]>