Pfizer BioNTech's coronavirus vaccination was approved by the Food and Drug Administration (FDA), Monday, August 23rd.
This is the first time a COVID-19 vaccination has been approved in the United States. It could open the door to more mandated vaccines and lessen the concerns of unvaccinated people.
Over 170 million Americans have been fully vaccinated in the U.S. with COVID-19 vaccines. This is known as emergency use authorizations. It's a fast-tracked approval of medical products for emergency situations such as a pandemic.
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The vaccines must meet high standards in order to be approved for emergency approvals. Moderna, Johnson & Johnson, and Pfizer BioNTech had to provide detailed data and prove they were safe and effective in protecting against COVID-19 before being granted emergency approval. To ensure that there were no side effects, trial participants were monitored for two months following vaccination.
In December 2020, Pfizer-BioNTech became the first COVID-19 vaccine company to receive an emergency use authorization. According to the Centers for Disease Control and Prevention, the emergency approval has resulted in more than 92,000,000 Americans being fully vaccinated using the Pfizer BioNTech vaccine.
Companies must submit a "biologics licence application" to be approved. This includes at least six months of follow-up on participants in clinical trials, more information about the manufacturing process and quality testing of vaccine samples.
"We evaluated scientific information and information contained in hundreds of thousands pages," Dr. Peter Marks, director at FDAs Center for Biologics Evaluation and Research said in a Monday statement.
Experts believe that a full approval could help to ease some vaccine-reticent people's concerns.
"The FDA's approval for this vaccine is a landmark as we continue our fight against the COVID-19 epidemic," Dr. Janet Woodcock (acting commissioner of FDA) stated in the statement. While millions have received Covid-19 vaccines safely, we acknowledge that some people may need additional assurance to get vaccinated.
According to NBC News, more mandates could be issued if full approval is granted. Many businesses were waiting to get full approval before requiring employees to have their vaccinations.
Full approval of Pfizer BioNTech is for people aged 16 or older. However, children 12-15 years old can still get the vaccine under emergency authorization. According to NBC News, Moderna has applied for full approval. Johnson & Johnson have not yet applied (both have Emergency Use Authorizations).
Pfizer-BioNTech will now market the vaccine as Comirnaty.
Original publication on Live Science
