Federal health officials fully approved the Pfizer COVID-19 vaccine on Monday, determining that the vaccine is both safe and effective and calling the decision a major milestone in efforts to slow the deadly coronavirus pandemic.
“Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.,” said Dr. Janet Woodcock, acting director of the U.S. Food and Drug Administration (FDA), the federal agency that oversees new drugs.
Full approval of the first COVID-19 vaccine in the U.S. should instill more confidence in people who have hesitated to get vaccines which are proven to protect them from COVID-19, Woodcock and others said.
More than 4 billion doses of all types of COVID-19 vaccines already have been given to people around the world since the vaccines were first authorized for emergency use in December, 2020.
In the U.S., nearly 400 million doses have been given so far, the majority of which have been mRNA vaccines made by Pfizer and Moderna.
The vaccines have proven to be among the safest and most effective vaccines in history.
To earn full FDA approval, the Pfizer vaccine went through a full and thorough review.
“We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of (the vaccine’s) safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities,” said Dr. Peter Marks, director of FDA’s Center for Biologics Evaluation and Research.
“The public is counting on safe and effective vaccines. The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S.”
The Pfizer vaccine now will be called Comirnaty. It has been fully approved for people ages 16 and older. Under an emergency use authorization, the Pfizer vaccine is also allowed for children and teens ages 12 to 15. Full approval for younger people is still pending as is full approval of the Moderna vaccine.
“The COVID-19 vaccines are among our most effective vaccines,” Campbell said.
“The FDA took the necessary time to look closely at the safety and efficacy data,” Campbell said. “The significance of these vaccines is already being measured. The vast majority of people who get hospitalized for COVID-19 now are unvaccinated.
“We can really see in very concrete terms that these vaccines are helping maintain the health and wellbeing of people in the U.S.”
Campbell said it’s clear that COVID-19 is a very dangerous disease while the vaccines have been proven to have relatively minor side-effects, and only rarely, result in any risks to recipients.
“The benefits greatly outweigh the risks,” Campbell said. “We also know that the benefits extend beyond individuals. When I get vaccinated, I get protection myself. I also protect all the people with whom I come into contact.
“Vaccines protect my family, my loved ones and other people who have chronic illnesses and cancer who may not respond as well to vaccines,” said Campbell who is also a professor of medicine and infectious diseases at the University of Colorado School of Medicine.
Full approval of the Pfizer vaccine underscores the safety and efficacy of the vaccines and also will make improve access to vaccines.
“It will be much easier for individual physicians to administer vaccines in their office. People will be able to get vaccines at their doctor’s office, just like they do for every other vaccine,” he said.
In addition to easier access, Campbell said full authorization will make it easier for Pfizer and others to market and promote the vaccines.
“Approval may increase public awareness,” Campbell said. “Every additional person who we can get vaccinated is important. And, getting more people vaccinated requires greater understanding of vaccine hesitancy. People are hesitating to get their COVID-19 vaccines for a variety of reasons. We need to have tailored approaches that take into account individual perceptions.
“The more approaches we can take, the better,” he said.