Coronavirus (Covid-19) and the vaccine: F.D.A. gives full approval to Pfizer vaccine

Filed Under: Costs, Health plans, Patients

The Food and Drug Administration granted full approval of the Pfizer coronavirus vaccine today, according to a press release.

“Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine,” the release said. “The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.

“’The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,’ said Acting FDA Commissioner Janet Woodcock, M.D. ‘While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.’”

Many Americans who have not yet been vaccinated have cited the lack of full approval as their reason. The vaccines were rolled out under an “emergency use authorization” from the F.D.A., which fell short of full approval. While Pfizer’s vaccine won full approval today, the Moderna and Johnson & Johnson vaccines are expected to win full approval soon.

After the Pfizer approval was announced, President Biden urged people to get vaccinated. “So let me say this loudly and clearly: If you’re one of the millions of Americans who said that they will not get the shot until it has full and final approval of the FDA, it has now happened. The moment you’ve been waiting for is here,” the president said, according to CBS News.

CBS added that he noted that vaccines “are free, safe, easy, effective and convenient. He also emphasized that the vast majority of hospitalizations and deaths are among the unvaccinated.”

‘Wait and see’ group

The Kaiser Family Foundation cited that resistance in a June study. “Consistent with last month’s results, three in ten unvaccinated adults, rising to about half of those in the ‘wait and see’ group, say they would be more likely to get vaccinated if one of the vaccines currently authorized for emergency use were to receive full approval from the FDA. However, this finding likely suggests that FDA approval is a proxy for general safety concerns, as two-thirds of adults (including a large majority of unvaccinated adults) either believe the vaccines currently available in the U.S. already have full approval from the FDA or are unsure whether they have full approval or are authorized for emergency use.”

The study added: “Unvaccinated adults cite a variety of reasons why they have not gotten a COVID-19 vaccine, with half citing worries about side effects and the newness of the vaccine as major reasons (53% each). Other major reasons include just not wanting to get the vaccine (43%), not trusting the government (38%), thinking they do not need the vaccine (38%), not believing the COVID-19 vaccines are safe (37%), and not trusting vaccines in general (26%). Fewer cite as major reasons that they have a medical reason for not getting vaccinated (14%), they are too busy or have not had the time to get it (12%), they don’t like getting shots (12%), they are worried about missing work (7%), they would have difficulty traveling to a vaccination site (6%), they are worried about having to pay (5%), or they are not sure how or where to get the vaccine (5%).

“When unvaccinated adults are asked to choose the main reason they have not yet gotten the COVID-19 vaccine, one in five cite the newness of the vaccine, followed by 11% each who say the main reason is that they are worried about side effects, they don’t trust the government, they don’t think they need the vaccine, and they just don’t want to get the vaccine.”

Barbara D. Alexander, MD, president of the Infectious Diseases Society of America, said in a statement: “The FDA’s full approval of the Pfizer-BioNTech COVID-19 vaccine marks a pivotal milestone in the nation’s quest to control the effects of this pandemic. This approval is the culmination of intense, collaborative scientific research.

“The FDA’s announcement gives people who have not yet taken the vaccine additional assurance that this vaccine is safe and effective.

“The most important takeaway from today’s announcement is to get vaccinated. The Pfizer-BioNTech COVID-19 vaccine has been proven to be safe and effective by the most rigorous, respected safety agency in the world.””