Pfizer’s COVID-19 Vaccine Just Got Emergency Approval In The U.S.

You might want to sit down. The U.S. Food and Drug Administration granted emergency use authorization (EUA) for the Pfizer COVID-19 vaccine, according to a press release the agency released at about 9:30 p.m. Eastern time Friday, Dec. 11.

“The FDA’s authorization for emergency use of the first COVID-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world,” FDA Commissioner Stephen M. Hahn, M.D. said in the press release. “Today’s action follows an open and transparent review process that included input from independent scientific and public health experts and a thorough evaluation by the agency’s career scientists to ensure this vaccine met FDA’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization."

The news was met with enthusiasm from those in the medical community.

“The first emergency use authorization of a COVID-19 vaccine by FDA marks an exciting and hopeful moment," Jesse L. Goodman, MD, the former FDA Chief Scientist and professor of medicine and infectious diseases at Georgetown University, said in a press release shortly after the decision was reported on.

"As a health care provider who treats people with COVID-19, I’m looking forward to being vaccinated and protected. Important in my decision to be vaccinated and to recommend vaccination to others at risk, is that FDA scientists, despite tremendous pressure from the highest levels of government, have protected the integrity of their vaccine review process, promoting transparency and incorporating external expert input in its deliberations," Dr. Goodman added.

In the next 24 hours, 6.4 million doses of the mRNA vaccine are expected to leave warehouses; about half of those will be shipped out across the country, while officials will hold back the other half so the first wave of recipients can get a second dose of the vaccine after 21 days, The New York Times reports. People could be getting vaccinated by Monday or Tuesday of next week, said Alex Azar, the United States Secretary of Health and Human Services, in an interview with Good Morning America on Friday morning. 

Each state will decide how to roll out the vaccine, though the Centers For Disease Control and Prevention has recommended vaccinating front line workers and nursing home residents first. By the end of December 2021, the entire country may be vaccinated, based on an analysis of data from Operation Warp Speed, the federal program designed in part to expedite the vaccine distribution.

The COVID-19 vaccine was developed by Pfizer and BioNTech, and clinical trial data — vetted and reanalyzed by the FDA —  found it to be 95% effective. 

“This feels like an early Christmas present,” Preeti N. Malani, MD, chief health officer at the University of Michigan, says of the news. She’s been on the front lines all year, as COVID-19 killed nearly 11,000 people in her state. (In the entire U.S., more than  291,000 people have died as a result of the virus). Dr. Malani says she can’t wait to take the vaccine herself, and believes it will “ultimately be part of the path out of this pandemic — which is great news, especially against the backdrop of more than [or nearly] 3,000 deaths a day for the last few days.” 

Although the vaccine may have been given the EUA, which is granted when there is a major medical threat with no FDA-approved treatment, the FDA’s job isn’t done. The health agency will still closely monitor the Pfizer trial for long-term effects — something they’d do even if the vaccine was fully approved. 

“Like any new vaccine, as it’s used in much larger numbers of people, more diverse populations, in people with chronic illnesses, there’s going to be extensive safety monitoring to make sure there [are no] less common adverse events,” Dr. Goodman told Refinery29 at a COVID Vaccine Analysis Team (COVAT) Zoom meeting mid-day Friday. “Those results will be communicated with the public.” 

“As we roll out vaccines to millions of people, we’ll learn more about them — including if there are very rare side effects, but the benefits of vaccination will far outweigh the risks,” added Nate Favini, MD, medical lead at Forward. 

This EUA comes after the majority of an independent advisory panel known as the Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted yes to the question: "Based on the totality of scientific evidence available, do the benefits of the Pfizer-BioNTech COVID-19 vaccine outweigh its risk for use in individuals 16 years of age and older?" The FDA didn’t have to take the committee’s recommendation, though precedent dictated it would. The committee of scientists and infectious disease experts voted 17 to 4, with one person abstaining. One reported reason some experts voted no was because they believed there wasn’t enough data to support approving the vaccine for 16- and 17 -year olds. The majority, however, agreed the benefits of giving the vaccine to this age group outweighed the risks. 

The vaccine has largely been shown to be safe, particularly when compared with the lasting effects and mortality rates of COVID-19. That said, some people will experience temporary effects. 

Data from Pfizer, which was analyzed by the FDA, showed that short-term effects were common. More than half of people ages 16 to 55 who received the vaccine experienced headache and fatigue. Such effects aren’t out of step with other fully approved vaccines, including the flu shot. “There are symptoms associated with getting this vaccine, especially after the second dose and especially in people younger than 65,” Paul A. Offit, MD, a member of the VRBPAC panel, a professor of pediatrics, and director of the Vaccine Education Center, told Refinery29 at the COVAT meeting. While notable, these side effects  are to be expected — and a sign that the vaccine is working, he says. “When your immune system is activated, it releases a series of proteins like cytokines and chemokines that can have a physiological effect,” Dr. Offit says. “That’s just your immune system working for you. That’s a good thing.” 

Everyone who receives the vaccine should be prepared to experience such effects, and may even want to anticipate needing to take a day off work. In fact, at Dr. Offit’s hospital, the emergency department won’t all be immunized on the same day with this in mind. But that shouldn’t be cause for alarm, he says.

“If you don’t get vaccinated, you’re at risk for getting COVID-19,” Glen Nowak, PhD, director of the Grady Center for Health Communications at the University of Georgia, told Refinery29 at the COVAT meeting. Simply put, the VRBPAC found that the risks of contracting the virus — for yourself, for your loved ones, for your community — far outweigh the risks associated with the vaccine. 

“I think it’s remarkable,” Dr. Offit said of a vaccine approval mid-day Friday. “I don’t think you would have found a scientist on this planet that could have predicted this 11 months ago.” 

“All of us in infectious diseases, and medicine as a whole, have been hopeful for so long that this may come to pass,” adds Paul Pottinger, MD, a professor specializing in infectious disease at the University of Washington School of Medicine. “We are so encouraged that we now have a safe, effective vaccine, which will become a crucial part of the response to the COVID-19 pandemic. We encourage everyone who is eligible to receive this vaccine at their soonest convenience, in accordance with public health guidelines.” 

“This is a wonderful example of investments over the last 10 to 20 years in new technology,” Dr. Goodman says. “But we also have a long way to go. We hardly have any vaccine [supply] yet. The pandemic is raging.” That’s why, he says, covering your face and socially distancing (yes, even if you’re wearing a mask) are still incredibly important steps, and will continue to be despite the EUA. 

“Deploying this vaccine and others like it will take time,” Dr. Pottinger says. “Now is not the time for us to slack off. Instead, you should continue to do all the things to keep yourselves and your loved ones safe. Do not leave home if you are sick or have been exposed to someone with the infection, cover your face if you do leave home, and make sure you give others plenty of personal space.”

This year was truly defined by the pandemic, so to end 2020 with news of an EUA for a vaccine is especially gratifying. Yes, we’ll still be wearing our face masks for the foreseeable future — but at least tonight, we have a reason to smile under them.