The FDA Approves Pfizer Vaccine

With COVID cases going up, there has been a scramble in the last year and a half to provide some sort of defense from COVID. Vaccines were released in America and around the world to help combat the virus. In America, there was a lot of combativity from some of the population arguing that it was nothing more than 'an experiment,' but now, with approval from the FDA, it's much harder to make that claim. Being approved by the FDA means that the drug has gone through extensive research and testing, and it is safe for the general public to be administered. The FDA states, "Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals."

This is certainly really big news, and a big sigh of relief from the people who were questioning the legitimacy of the vaccine. The FDA explains:

"FDA-approved vaccines undergo the agency’s standard process for reviewing the quality, safety and effectiveness of medical products. For all vaccines, the FDA evaluates data and information included in the manufacturer’s submission of a biologics license application (BLA). A BLA is a comprehensive document that is submitted to the agency providing very specific requirements. For Comirnaty, the BLA builds on the extensive data and information previously submitted that supported the EUA, such as preclinical and clinical data and information, as well as details of the manufacturing process, vaccine testing results to ensure vaccine quality, and inspections of the sites where the vaccine is made. The agency conducts its own analyses of the information in the BLA to make sure the vaccine is safe and effective and meets the FDA’s standards for approval. "

This is certainly the next big step in our fight against COVID, but it certainly is no where near the last one. For now, we keep waiting for more breakthroughs that will lead us towards the light at the end of the tunnel.