Covid-19 Vaccine Gets Full Approval From the FDA

On August 23, 2021, the U.S. Food and Drug Administration (FDA) gave the Covid-19 vaccine—created by the American company Pfizer and Germany’s BioNTech—its full approval for people aged 16 and older. This means the medicine, which protects against the virus that causes Covid-19, has been through the same amount of testing and review as other longstanding vaccines.

Since December 2020, the Pfizer-BioNTech vaccine has been available through an emergency use authorization (see “U.S. Authorizes First Vaccine for Covid-19,” Science World, December 11, 2020). During public health crises like the Covid-19 pandemic, pharmaceutical companies can ask the U.S. government for emergency use authorization to get vital medical treatments to people faster. While an emergency use authorization does bring products to market sooner, it can be reversed at any time. Full approval means that this can’t happen anymore. 

“The public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality,” said Janet Woodcock, commissioner of the FDA, in a statement announcing the vaccine’s full approval.

Before asking for emergency use authorization for its vaccine, Pfizer and BioNTech completed multiple trials, which showed that their two-dose vaccine was safe and effective. Their final round of trials involved 44,000 people. 

To receive an emergency authorization, the FDA required that the companies submit data after monitoring the study participants for two months—when potentially harmful side effects from a vaccine are most likely to occur. To receive full approval, the FDA required the companies to present at least six more months of follow-up data. The FDA also inspected manufacturing facilities, to make sure the vaccine can be produced safely and reliably. 

Pfizer and BioNTech will continue to study the long-term safety of the vaccine, which has been officially named Comirnaty (co-MEER-nah-tee), for the next several years. Government officials believe that the vaccine is safe for almost all people. In rare cases, the vaccine might lead to myocarditis—inflammation of the heart muscle—or pericarditis—inflammation of the lining of the heart—both of which can be treated.

People who are 12 to 15 years old can still get the Pfizer-BioNTech vaccine under the emergency use option. Two other vaccines, from the companies Moderna and Johnson & Johnson (see “The Johnson & Johnson Vaccine, Explained,” Science World, March 16, 2021), are available via emergency use for anyone 18 and older.

As of September 4, 2021, more than 206 million Americans, or 63 percent of the total population, had received at least one dose of the available vaccines. And almost 54 percent of the country is fully vaccinated. At this stage of the pandemic, most of the people hospitalized with complications from Covid-19 are unvaccinated. And as more contagious variants, or forms, of the Covid-19 virus start to spread more widely, health experts say they hope that the FDA’s full approval of the Pfizer-BioNTech vaccine will encourage more people to get vaccinated. 

“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,” said Woodcock. Granting vaccines full approval “puts us one step closer to altering the course of this pandemic in the U.S.”