Breaking News: FDA approves Pfizer vaccine

The Food and Drug Administration has given full approval for the Pfizer vaccine 8 months after the first dose was administered under emergency authorization use.  

On Aug. 23, the FDA approved the Pfizer vaccine, now renamed Comirnaty, for ages 16 and above, with an authorization for ages 12 to 15. This is an important milestone for the coronavirus vaccination, as FDA approval requires that a drug’s effects have been thoroughly reviewed, that the drug is “safe and effective for its intended use,” and that the overall benefits outweigh the possible risks of the drug. The original authorization was an emergency use procedure indicating that the research on the vaccine proved that it was safe for use, although not every trial required for approval has been executed.

“The moment you’ve been waiting for is here. It’s time for you to go get your vaccination and get it today. Today,” said President Biden in a press conference about the approval. 

As of Aug. 23, 52% of Americans were fully vaccinated, and 61.5% of Americans had at least one dose of the vaccine. Many scientists and public health officials are hopeful that the recent approval will increase these rates and encourage more cautious Americans to get vaccinated. A CDC study on July 25 in Los Angeles County outlined that infection rates were five times more likely, and hospitalizations were 29 times more likely in unvaccinated people. With the Delta variant becoming more prevalent, these numbers are likely to increase. 

“There are those individuals who understandably, in some respects, don’t want to get vaccinated until they get the full stamp of approval. … So you’re going to have a group of people who otherwise would not have got vaccinated,” said Dr. Anthony Fauci on NPR’s All Things Considered radio show. “What I think is going to be equally as impactful would be that there are going to be organizations and enterprises and companies – whoever – are going to feel much more empowered now to mandate vaccines.”

In fact, the Pentagon has already placed a mandate on the U.S. military. Multiple other companies, like Walt Disney World, Chevron, and Walmart, also require vaccines for their employees in the wake of the approval. 

New York and Washington D.C. are both on their way to mandating vaccination for government officials, and California now requires proof of vaccination or weekly testing for state officials and health care workers. Some, like Walmart employee Matthew Dickson, criticize these moves as potentially harmful to employees with potential adverse reactions to the Pfizer vaccine.

“It literally broke my heart. I was very distraught by that, to think that company I love and have worked for many years would make me have to make a decision for whether or not I could provide for my family, or whether or not I would have to take a medical procedure,” Dickson said. 

However, according to a CDC study conducted from Dec. 14, 2020, to Aug. 16, 2021, only 0.0019% of vaccinated Americans have died due to the vaccine, and non-lethal adverse reactions are also rare

Ultimately, vaccine approval is viewed relatively positively in the United States. A poll conducted by the Kaiser Family Foundation on June 30 shows that 33% of unvaccinated adults would have been more likely to get the vaccine if it received full approval. Health officials continue to hope that these statistics carry out with the situation no longer being hypothetical. 

Biden said, “We’re in the midst of a wartime effort to beat this pandemic. It’s one of the biggest and most complicated challenges in our history. And it is based on an unparalleled vaccination program that is saving lives and beating this virus. It’s the vaccination program that is getting us back to our loved ones and the way of life we were used to.”