First COVID vaccine recommended for emergency use in US. What happens next?
A U.S. Food and Drug Administration panel recommended the Pfizer-BioNTech coronavirus vaccine for emergency use authorization Thursday after an advisory committee reviewed the latest clinical trial data, deciding that the benefits outweigh the risks.
It’s the first COVID-19 vaccine to be recommended for emergency use in the U.S for people 16 years of age and older. It’s unclear when the FDA is planning on officially authorizing the vaccine.
The FDA’s Vaccines and Related Biological Products Advisory Committee started its review of the vaccine’s clinical data on Nov. 20, when Pfizer and its partner BioNtech submitted their request for an emergency use authorization.
The same shot was first authorized by the United Kingdom on Dec. 2; the first two people were vaccinated on Tuesday. Canada was the second nation to authorize the vaccine Wednesday, with shots expected to roll out next week, according to the New York Times.
Chief Operating Officer of Operation Warp Speed General Gustave Perna said during a media briefing last week that states should receive allocated doses “within 24 hours” of the FDA’s authorization. Distributions are based on a state’s population size, rather than the number of people in groups that are at high risk of infection, McClatchy News previously reported.
The decision comes after the FDA released a 53-page document on Pfizer and its partner BioNTech’s latest phase 3 clinical trial data on Tuesday.
The document revealed that the vaccine, which requires two doses 21 days apart, offers some protection within the first week after the first dose and nearly full protection after the second one.
Dr. William Gruber, senior vice president of Pfizer Vaccine Clinical Research and Development, told the New York Times that the vaccine’s efficacy stands at about 52% following dose one, and about 95% after dose two.
“This is what an A+ report card looks like for a vaccine,” Dr. Akiko Iwasaki, an immunologist at Yale University, told the outlet.
Another expert, Dr. Greg Poland, director of the Mayo Clinic’s Vaccine Research Group in Minnesota, told NBC News on Tuesday that he could “see absolutely no reason why this emergency use authorization would not be granted.”
Some members of the advisory committee said during the meeting Thursday that more data is still needed to know how safe the vaccine is for specific demographics, such as pregnant women, women of child bearing age, marginalized communities of color and people with a history of severe allergies.
However, the FDA’s panel’s decision to recommend authorization of the vaccine overrides these risks, citing the more powerful benefits. The administration said data collection on vaccine safety and efficacy will continue even after Americans outside of clinical trials receive the vaccine.
The Centers for Disease Control and Prevention announced last week that health care workers and residents of long-term care facilities should be first in line to get the vaccine; next, essential workers such as teachers, firefighters and corrections officers; then, adults with high-risk medical conditions and those over 65.
Only after these groups get their shots will vaccine supplies be ready for the general population sometime in spring, officials say. And by that point, there will likely be more than two authorized vaccines on the market.
Moderna’s vaccine will likely be recommended for authorization when the FDA holds a similar meeting on Dec. 17.
AstraZeneca and partner University of Oxford, and the Janssen Pharmaceutical Companies of Johnson & Johnson both have vaccine candidates in phase 3 clinical trials, the last step before submitting data to the FDA for review.
But the availability of multiple vaccines doesn’t necessarily mean you’ll be able to pick for yourself — as staggered roll outs, various storage requirements and other unknowns will likely complicate the process.
It’s important to note that an FDA “authorization” is not the same thing as an “approval,” a CDC spokesperson told McClatchy News in a telephone interview last week.
Both Pfizer and Moderna have applied for an emergency use authorization, which would allow the use of their still “unapproved” vaccine in emergency situations, such as a pandemic, to help fight against COVID-19, for which “there are no adequate, approved, and available alternatives.”
This story was originally published December 10, 2020 at 2:38 PM with the headline "First COVID vaccine recommended for emergency use in US. What happens next?."
