Coronavirus vaccine threatened by ‘cold chain’ issues

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 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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