Pfizer's COVID-19 vaccine has now received approval from the U.S. Food and Drug Administration (FDA) full , making it the first coronavirus vaccine to pass the entire review process.
The FDA on Monday approved the mRNA COVID-19 vaccine developed by Pfizer and its partner BioNTech for people ages 16 and older. The vaccine was previously granted an emergency use authorization, which is still in effect for the Moderna and Johnson & Johnson vaccines.
See also: Israel COVID-19: Reduced effectiveness of the Pfizer vaccine?
“While this and other vaccines meet the FDA’s rigorous scientific standards for emergency authorization, it is now the first fully FDA-approved vaccine for COVID-19, meaning the public can be very confident that this vaccine meets the high standards for safety, effectiveness , and quality that the FDA requires for an approved product,” an FDA official said. “Today’s milestone brings us one step closer to changing the course of this pandemic in the United States.”
The FDA is expected to make it easier for local governments, schools and businesses to require vaccinations and may encourage people who have been hesitant to get vaccinated because of safety concerns. That's likely true, as 3 in 10 unvaccinated adults have already said they would more readily get a vaccine that has full FDA approval than one that has been granted emergency authorization.
See also: COVIDSafe: COVID-19 detection app continues to be used
During his remarks on Monday, US President Joe Biden urged American citizens who had not been vaccinated to get a vaccine now that Pfizer is FDA-approved.
“If you are one of the millions of Americans who said they would not get the vaccine until it received full and final FDA approval, do so because that is now,” Biden said. “The moment you have been waiting for has arrived. It is time to go get your vaccine. Do it today.”
More than 203 million doses of the Pfizer vaccine have been administered in the U.S., according to data from the Centers for Disease Control and Prevention. The vaccine also has emergency authorization for use in children ages 12 to 15.
See also: Pfizer & Moderna: Vaccine studies begin in children aged 5 to 11
In reviewing the Pfizer vaccine, the FDA reviewed data and information submitted for emergency use authorization, along with “clinical data and information, as well as details of the manufacturing process, test results, and inspections of the vaccine manufacturing facilities,” according to the statement. The tests showed the vaccine was 91% effective in preventing COVID-19.
Moderna is also seeking FDA approval for its COVID-19 vaccine, although according to information such a decision may take several weeks.
Source: CNET
