FDA advisory panel votes in favor of Pfizer’s coronavirus vaccine; US prepares for distribution

Washington-DC

WASHINGTON (NewsNation Now) — The U.S. Food and Drug Administration’s panel of outside advisors voted the Pfizer COVID-19 vaccine benefits outweigh its risk for use in individuals 16 years of age and older, effectively endorsing Pfizer’s coronavirus vaccine for emergency use authorization approval by the FDA in the United States.

The FDA is expected to follow the recommendation issued Thursday by its expert advisers. A final FDA decision is expected within days.

The panel called Vaccines and Related Biological Products Advisory Committee consists of independent external experts. The FDA released its review of the vaccine earlier this week, ahead of the Thursday meeting.

Thursday afternoon, the panel began discussing the voting question: “Based on the totality of scientific evidence available, do the benefits of the Pfizer-BioNTech COVID-19 Vaccine outweigh its risks for use in individuals 16 years of age and older?”

17 of the panel members voted in favor of the question, four voted against and one person abstained from voting.

NewsNation spoke with Dr. Stephen Thomas, principal investigator for the Pfizer and BioNTech clinical trial and professor of medicine at Upstate University Hospital, about the advisory panel’s vote Thursday.

Thomas explained why several members of the panel voted no.

“Based on the deliberation that I was hearing, it was not surprising to me that it was a split vote, and the split I believe was because of the lower age range. So when the trial first began it, primarily was from 18 to 85 years of age, and then they expanded it to include 16 and 17 year olds, and they’re asking for an emergency use authorization for ages 16 and above,” Dr. Thomas said. “But there’s not as much information in that 16 and 17-year-old age group, and so there were some people on the committee that had some concerns about that.”

“Not only is there pressure to go quickly, there’s pressure to get it right,” said Dr. Rick Kennedy from the Vaccine Research Group at Mayo Clinic.

Dr. Kennedy said the panel’s questions weren’t simply focused on Pfizer’s trial results. They also were looking ahead.

“What are the restrictions they’re going to place on the EUA, is it going to be open to all age groups,” he said.  

Pfizer has asked for broad authorization for use of its two-dose vaccine in people aged 16 to 85. The vaccine has already received regulatory green lights from the UK and Canada.

“It’s effective in people under and over 55, [it’s also] effective in African-Americans, Hispanics, in Whites and Asians,” John Grabenstein with the Immunization Action Coalition said.

Once the vaccine is cleared, Pfizer has said it has an ethical responsibility to tell participants if the vaccine is available to them outside of the trial. It has asked the FDA to allow it to give the vaccine to volunteers who had been in the placebo group that request it.

The concern, expressed by both the FDA and members of the advisory panel, is that “unblinding” the trial will make it harder to continue collecting data on long-term safety and effectiveness, and would make it more challenging for companies still testing vaccines to conduct blinded trials, in which people do not know if they got the experimental vaccine or a placebo.

“Once you unblind, you can never go back. We can never collect those data that we need and people want unless you completely redo the whole study,” said Dr. Gregory Poland, a virologist from the Mayo Clinic in Rochester, Minnesota, who has previously served two terms on the FDA advisory panel.

Dr. Steven Goodman of Stanford University School of Medicine said in a presentation to the panel that offering the vaccine to people who got a placebo could result in them “jumping the line,” by receiving the vaccine before they otherwise would under priorities recommended by the U.S. Centers for Disease Control and Prevention.

Goodman recommended instead of a blinded double crossover design, in which people in the trial who got a placebo would be offered the vaccine, and those who received the vaccine would be offered the placebo. With that approach, everybody eventually gets the vaccine without being tempted to leave the trial to get it elsewhere.

Some vaccine trial participants have complained of sore arms and minor aches and pains. Doctors in the U.K. report two vaccine recipients – who both suffer from severe allergies – had allergic reactions to the vaccine. British regulators are now advising those with severe allergic reactions to avoid being vaccinated. It’s not yet clear what caused the reactions.

FDA Commissioner Steven Hahn, ahead of Thursday’s meeting, said the agency was carefully reviewing all the data on Pfizer’s vaccine, including potential allergic reactions following the UK warning.

Dr. Jim Baker, the former CEO of the National Food Allergy Foundation said the reactions to the UK vaccine are not well-defined.

“They were in people who had allergic reactions before to many different things but not to this vaccine. I think the really valuable thing the British could do is look at these two cases and see what the real cause was,” Dr. Baker said.

“FDA is the gold standard for regulatory approval or authorization of medical products,” Hahn said. “If our career scientists say that the vaccine is safe and effective, I have complete confidence in that decision, and I think the American people should as well.”

The panel voted on its recommendations at the end of the meeting, after presentations from the FDA, Pfizer, other public health officials, and members of the general public. The FDA is expected to make its authorization decision within days of the meeting.

This is the fastest-developed vaccine in history, but doctors said it’s safe and the process of working toward emergency-use authorization has been methodical.

During an Operation Warp Speed meeting, U.S. Secretary of Health and Human Services Dr. Alex Azar said, “All of the statistical significance requirements for efficacy are the same that they would have been for a full license.”

“This vaccine is really the only way out of the pandemic. We’ve done social distancing we’ve done masks – and they help – but they haven’t stopped the deaths and the infections overall,” Dr. Baker added.

Depending upon how quickly the FDA acts, the first recipients could receive their shot within the next few days.

US prepares for shipments of first coronavirus vaccine

As the country waits for FDA approval of Pfizer’s COVID-19 vaccine, officials are preparing for distribution from the warehouses where the vials of the vaccine sit in ultra-cold freezers to state health departments across the country readying local hospitals for the first shipments of the vaccine.

The vials of the COVID-19 vaccine are in two Pfizer distribution centers awaiting the green light from the FDA. One is in Kalamazoo, Michigan, and the other, Pleasant Prairie, Wisconsin. NewsNation’s Rudabeh Shabazi reports live from outside the Pleasant Prairie center. Watch her exclusive report in the player below.

The FDA called the meeting “an important step in the review process.”

“Providing an opportunity for outside experts to provide valuable advice and input for the agency to consider as part of its review. Importantly, the final decision about whether to authorize the vaccine for emergency use will be made by FDA’s career officials,,” the agency said in a statement.

President-elect Joe Biden issued a statement praising the emergency use authorization of the vaccine, which hasn’t yet happened. His office later issued a clarification about the statement.

Yesterday marked another tragic milestone in our fight against COVID-19. Jill and I grieve with everyone mourning a loved one lost to this deadly virus.

But today’s approval by the Food & Drug Administration of the Pfizer-BioNTech COVID-19 vaccine is a bright light in a needlessly dark time. We are grateful to the scientists and researchers who developed this vaccine. And, we are grateful to the scientists and public health experts who evaluated the safety and efficacy of this vaccine free from political influence. The integrity of science led us to this point.

Vaccines don’t equal vaccinations. Our challenge now is to scale up manufacturing and distribution to distribute 100 million shots in the first 100 days of my administration. We are putting together an experienced team to do just that. Before I take office, we need the Trump Administration to purchase the doses it has negotiated with Pfizer and Moderna and to work swiftly to scale manufacturing for the U.S. population and the world. And, we will need Congress to fund our distribution efforts.

As we mark this important milestone, we know it didn’t have to be this bad. My administration will manage a robust and aggressive plan to contain this virus starting on day one. My first 100 days won’t end COVID-19, but we can and will slow the spread of the disease while we manufacture and distribute this vaccine. It will take everyone doing their part: mask wearing, social distancing, and limiting their travel over the holidays.

Together, we will find more bright lights through the dark times.

President-elect Joe Biden

President Donald Trump hadn’t commented yet.

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