The Food and Drug Administration has issued an emergency use authorization for the first COVID-19 vaccinations in the United States.
This means that the Pfizer and BioNTech vaccine has received the go-ahead to be utilized during an emergency without full FDA approvals. Pfizer will still need to file a separate application for the coronavirus vaccine to be fully licensed by the FDA.
This rushed order has drawn widespread criticism about the safety of the vaccine, especially among African Americans who have compared it to the infamous Tuskegee Syphilis Study, where black sharecroppers were given placebo medications without their knowledge so that researchers could monitor the effects of Syphilis on the body over time.
However, FDA Commissioner Dr. Stephen Hahn has assured people that while the vaccine’s turnaround time was fast, this was a vital step to stopping COVID-19.
“The FDA’s authorization for emergency use of the first COVID-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world,” he said Friday in a statement.
Millions of the vaccine doses will arrive in the U.S. in a few days, with nearly 20 million expected to be vaccinated within upcoming weeks. Though the emergency authorization was granted, a US Centers for Disease Control and Prevention immunization advisory committee will still need to vote to recommend the vaccine, according to CNN. The CDC will then have to accept that recommendation. That meeting is scheduled for Saturday morning.
The nation’s top medical advisor Dr. Fauci stands by the coronavirus vaccine. However, he understands why many may be hesitant.
“I think the majority of people who are hesitant don’t really have the data and don’t understand things like why we were able to go so quickly. They may think that we were being a bit reckless in how fast we went from the discovery of a new virus to the point where you actually are giving vaccines to people like we’re doing right now.”
Fauci later added, “It’s not reckless speed, and it doesn’t compromise safety, and it doesn’t compromise scientific integrity.”
The vaccine will be administered in two doses. After the first dose, you will need to return within 21 to 28 days to receive the second dose. While there is some evidence to suggest that the first dose could be effective on its own, the two combined showed a 95% success rate.
