The U.S. Food and Drug Administration fully approved Pfizer’s COVID-19 vaccine, with an announcement coming Monday. Health experts say this could lead to more people getting vaccinated and more schools and businesses mandating the shots.
The vaccine from Pfizer and partner BioNTech was the first COVID-19 vaccine to go from emergency use authorization to full approval in the United States.
The California Department of Public Health issued a statement Monday from State Public Health Officer Dr. Tomás J. Aragón following federal approval of the Pfizer BioNTech COVID-19 vaccine for individuals ages 16 and older.
“Today’s announcement by our federal partners underscores the safety and efficacy of the COVID-19 vaccine and comes at a critical juncture as many of our communities are grappling with increasing cases fueled by the faster spreading Delta variant,” said Aragón.
“For weeks we have watched cases go up at an alarming pace among individuals who are not vaccinated while the vaccinated are largely protected, especially against severe and long-term illness. We know the vaccines work. We know vaccines are safe. We know they save lives. If you are not vaccinated, let this be the milestone that gets you there. Get vaccinated to protect yourself and help put an end to this deadly pandemic.”
California Gov. Gavin Newsom also used the FDA's announcement as an opportunity to urge all state residents to get vaccinated.
“The FDA’s full approval further confirms that the Pfizer vaccine meets a rigorous, scientific standard for safety and efficacy, protecting against serious illness, hospitalization and death. With COVID-19 cases rising across the nation due to the Delta variant, I encourage all Californians to trust the science and protect themselves and their community by getting vaccinated,” said Newsom.
“With more than 80 percent of Californians 18 and up having received at least one dose, our work continues to close the gap in our most impacted communities and bring an end to this pandemic.”
Some businesses, school districts and state and local governments have already required employees to be fully vaccinated. Mandates could become even more common now that Pfizer has received full approval.
“I do believe that once the vaccine is fully approved, that’s gonna give more impetus to some businesses, schools to mandate vaccination,” Dr. Scott Gottlieb, former FDA commissioner and Pfizer board member, said on CBS’ “Face the Nation” on Sunday.
“They’ve been waiting for full approval. They feel they’ll be on stronger legal ground to mandate vaccination in that setting.”
Gottlieb and other health experts are also hopeful the portion of people considered to be vaccine-hesitant, who were waiting for full FDA approval, would become comfortable and get the vaccine.
There is a significant difference in the amount of information needed to get emergency use authorization versus full FDA approval. A decision for emergency use is based on the best evidence available at the time, and the FDA makes a product available “when there are no adequate, approved and available options.”
When a company applies for a Biologics License Application (BLA) for full approval — which Pfizer and BioNTech initiated on May 7 — FDA officials go over a massive amount of data. The submittal includes information about clinical trial participants up to six months after they received their second dose. There are thorough details about the manufacturing process and the facilities where the vaccine is produced.
“You have a lot more data to review than for an emergency use authorization,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, told The Washington Post earlier this month. “In terms of pages to review the change is an order of magnitude. It’s going from tens of thousands of pages to hundreds of thousands of pages.”
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Full approval means Pfizer will be allowed to market its vaccine to the public, and it could remain in the marketplace for an indefinite amount of time. Vaccines and drugs that are granted emergency use authorization can only remain available as long as an emergency is in effect.
Moderna began the process of seeking a BLA about a month after Pfizer did, and so far, a timeline on FDA approval is not clear. Johnson & Johnson is expected to follow suit sometime in the coming months.
The Biden administration is looking to begin the distribution of booster shots the week of Sept. 20, with the expectation that people would get boosters eight months after receiving their second dose of either the Pfizer or Moderna vaccines. Currently, only those who are immunocompromised can get a booster.