Pfizer’s COVID-19 Vaccine Could Be Recommended For Emergency U.S. Approval Today
December 10, 2020BruceDayne
Today, the Pfizer vaccine is expected to be cleared for emergency approval by a U.S. Food and Drug Administration committee. Experts are calling this a “light at the end of the tunnel” moment — particularly at a time when nearly 290,000 people have died of COVID-19 in the U.S., and more than a third of citizens are living in areas where hospitals are running out of beds in intensive care units. We’re at the beginning of a long, deadly winter, and our bright beacon of hope is a vaccine that may become available thanks to a provisional approval process many of us had never heard of prior to the pandemic: Emergency Use Authorization (EUA).
The panel, known as the Vaccines and Related Biological Products Advisory Committee (VRBPAC), is meeting today, Dec. 10, to determine whether or not they’ll advise the FDA to grant the EUA. After the VRBPAC meeting, which should officially wrap around 5:15 p.m. Eastern, the decision could come down at any time. Some reports say the FDA could officially grant the EUA as soon as this weekend. Within 24 hours of that, 2.9 million doses of the vaccine could be shipped out across the country.
The EUA program was created in 2004 in response to the anthrax attacks of 2001. EUAs are issued somewhat rarely by the FDA, and they’re only given out in urgent situations when there’s a major medical threat and there are not adequate treatments available that are fully approved by the FDA. When these authorizations are handed down, the FDA can’t wait for all the evidence they’d need for full approval — which, in the past, has taken years to collect for vaccines, says Derek Lowe, PhD, a pharmaceutical expert and the author of In The Pipeline. Instead, they balance the risks of unproven products with the benefits of making the vaccine more widely available to the public. They do this more quickly than they normally would, but they do move mindfully and with science and safety at the top of mind. Imagine an ambulance that’s racing down the highway with a critically ill passenger. Yes, the driver is going over the speed limit, but it’s in the name of helping people. And they’re doing so with every precaution in mind so accidents don’t happen.
EUAs can be given out for vaccines, drugs and even certain medical equipment. There was one for Convalescent plasma. Hydroxychloroquine also received an EUA early on in the pandemic, but it was revoked in June. “The data on Hydroxychloroquine wasn’t very good, and I think rescinding was a good idea,” Dr. Lowe says. “That approval had the stink of politics around it because [the FDA] was under pressure to do something, anything… But the vaccine data is a different situation. This data is good, and shows it’s effective.”
If VRBPAC decides to recommend the vaccine developed by Pfizer and BioNTech for EUA, the FDA is expected to make the final call in the coming days based on their vote. The panel is made of scientists and health officials who are independent of the FDA. “I know those scientists, and they’re people of integrity who’ll carefully look at the data and make the best recommendations,” says Anna Wald, MD, a virologist and professor of medicine at the University of Washington.
Most experts agree that the EUA will be granted. This is largely because on Dec. 8, the FDA released documents that confirmed the vaccine was in line with their EUA guidelines. In a 53-page brief, the vaccine was shown to be 95% effective in patients who hadn’t previously been infected with COVID-19 seven days after the second dose. The vaccine was largely safe with few adverse reactions.
Some folks who got the vaccine developed health conditions that would have occurred whether or not they had received it — but trials control for this by comparing health outcomes between the placebo group and the people who actually got the shot. In this case, they found no “meaningful imbalances” between the two groups. The FDA noted in their brief that four people in the vaccine group developed Bell’s palsy, a form of typically temporary facial paralysis, with none in the placebo group. But the small number of folks this occurred in wasn’t statistically significant.
Otherwise, the data showed that more than half of folks between ages 16 and 55 experienced mild symptoms, like fatigue and headaches, after receiving the shots. This is common with vaccines (some people report such reactions to the flu shot) and should not be cause for alarm. Some doctors suggest taking a day off if you’re able to after getting your dose. “A sizable portion of people will have mild symptoms like fevers and fatigue,” Preeti N. Malani, MD, chief health officer at the University of Michigan, told Refinery29. “Hospitals are making plans because you don’t want to, say, vaccinate all your heart surgeons on the same day.”
The FDA said there was not enough data to make conclusions about safety for people younger than 16, pregnant women, and those with compromised immune systems, which means they may not be cleared for approval. “All medications have some side effects, but, with any product, it’s balancing the risks versus the benefits,” Dr. Wald says. “Safety is so important and very carefully evaluated with vaccines because we give them to young, healthy people, and we don’t want to make somebody not well if they’re well.”
After granting an EUA, the FDA would continue to monitor the Pfizer trial closely to determine any long term side effects. “We have a vigorous post-authorization process for assessing both safety and effectiveness,” FDA Commissioner Stephen M. Hahn, MD, told NPR.
“You have to weigh the chance of some late side effect showing up with what you know happens with COVID,” adds Robert M. Wachter, MD, professor and chairman of the department of medicine at the University of California at San Francisco. “We know there are more than 100,000 in U.S. hospitals today and the number of people who’ve died is equivalent to the city of Pittsburgh. With that, I’m quite confident that the vaccine is the better choice.”
One of the most promising factors about the U.S.’s process for emergency approval is how shockingly transparent it’s been so far. Aside from the briefing document, we’ll be able to livestream the meeting today here. Experts say this should reassure folks that the FDA isn’t making their decision because of political pressure or simply because the U.K. and Canada gave emergency approval. “As far as public trust goes, look at the process,” Norman Baylor, PhD, the former director of the FDA’s Office of Vaccines Research and Review and the president and CEO of Biologics Consulting, told Refinery29 at a COVAT Zoom meeting. “The people here should feel good. They did a thorough review, it’s out for the public to see… The public has an opportunity to submit questions to the agency, and then there’s a public comment period. It’s a very transparent process.”
Following today’s advisory committee meeting, the FDA’s career professional staff will consider the VRBPAC’s input and continue their evaluation to determine whether the available safety and effectiveness and manufacturing data support an emergency use authorization of the specific COVID-19 vaccine in the United States, a spokesperson for the FDA tells Refinery29. Pfizer has not yet responded to Refinery29’s request for comment.
So what’s next? With an EUA in place, hundreds of thousands of doses would be sent out across the U.S. packed in dry ice, as the Pfizer vaccine needs to be stored at minus-94 degrees Fahrenheit. Nursing homes and health care workers will get it first, as The Centers For Disease Control and Prevention has recommended. The states will make the final decision on who gets the vaccine and when. Earlier this month, Dr. Wachter projected that there would be enough shots to vaccinate 20 million people by this January, based on an analysis of data and statements made by Operation Warp Speed — a government project designed, in part, to accelerate the development, testing, and distribution of effective, safe COVID-19 vaccines. Dr. Wachter says the entire country — yes 329 million people — could be vaccinated by December 2021. But Jessica Malaty Rivera, infectious disease epidemiologist and science communication lead at The COVID Tracking Project, fears that some are overestimating when they’ll be able to get the vaccine. “I think people should be calibrating their expectations. I myself am not expecting to be vaccinated until fall or winter of next year,” she says. “An EUA and a vaccine doesn’t mean that everything will immediately go back to normal.” That means masks-wearing and social distancing will still be crucial.
And, there are some complications. Under President Donal Trump, the U.S. only reserved 100 million doses of the Pfzier vaccine in July — about a sixth of what’s needed. Now that the vaccine is well on its way to an EUA, we’re frantically scrambling to secure more shots. The New York Times reports that Trump’s officials could have secured between 100 and 500 million additional doses. If an EUA is officially granted, demand will be high, and there will be more people who want the vaccine than there are available doses. “In retrospect, [not securing more doses] was a mistake,” says Dr. Wachter. “To be a little charitable, we didn’t know then that the vaccines would work and that we’d be in the middle of a hellish spike… Now it’s going to take three or four months until we get to a place where we can vaccinate all the people at high risk of getting sick from COVID.” In a surge like the one we’re in now, the difference between having enough vaccines and not is tens of thousands of lives, Dr. Wachter says.
Another barrier: Nearly 40% of Americans said they definitely or probably would not get a vaccine, though roughly half the group said they might change their minds if others get it first and more information becomes available, according to a Pew Research survey conducted on 12,648 adults in November.
Yet another concern is that the Pfizer vaccine needs to be stored at such cold temperatures, and there’s a chance that folks in more rural areas and who have lower incomes will need to travel further to facilities that can keep it cool, says Dr. Lowe. This is where we could also use an EUA for the Moderna vaccine, which could be decided this month by the FDA as well.
Malaty Rivera says it’s important to get the word out widely that the vaccine is safe and efficacious. This should happen in a widespread campaign that’s clear and culturally sensitive. Dr. Wachter says educational campaigns need to reach communities who are being hit the hardest by the vaccine, including Black Americans and people of color who’ve been dying at higher rates from COVID-19 and the 40% of people who are wary of getting vaccinated. “We need education, not only to ensure the access is there, but to make sure that when the vaccine is available, people want to take it,” Dr. Wachter says. “We also need influencers. It’s not only about whether [Anthony] Fauci takes it, but it’s also about whether your pastor took it or your favorite sports star took it.”
The upshot: President-elect Joe Biden has promised to get “at least 100 million Covid vaccine shots into the arms of the American people” in his first 100 days as president. Former Presidents Barack Obama, George W. Bush and Bill Clinton have also committed to taking the vaccine on camera.
Of course, all of this is contingent on the news today and the EUA approval. Until then, we’ll be waiting patiently, and watching the VRBPAC meeting here.
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