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Pfizer Receives FDA Approval

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8/30/21—In a new development for COVID-19 vaccines, the Pfizer-BioNTech COVID-19 vaccine has become the first to receive full Food and Drug Administration (FDA) approval. Under this new approval, this well-known vaccine will be redistributed under the name “Comirnaty,” and will maintain availability to all individuals aged 16 and up. While the vaccine has already been administered since early 2021, the new FDA status carries with it some notable changes in overall vaccine status and reception.

While Pfizer’s vaccine was approved for public use in December 2020, it has been under the status of Emergency Use Authorization (EUA) by the FDA. This classification is given to medical countermeasures, such as vaccines, during public health emergencies. Under an EUA, the FDA may allow the use of unapproved medical treatments to prevent life-threatening diseases when certain criteria are met with extensive safety standards. In receiving an EUA classification, the FDA clarifies that the benefits of treatments outweigh the risks. According to the FDA, the EUA process differs from FDA clearance slightly. In an emergency, EUA makes a product accessible using the best evidence available, without waiting for all the evidence needed for FDA approval. Since it received EUA status, the FDA has been scrupulously studying and working to provide full approval.

“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine, said the FDA’s Center for Biologics Evaluations and Research Director Peter Marks. “We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities.”

A major effect of this new FDA approval will be instilled confidence in getting a vaccine which has received rigorous safety testing and approval. “As the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” said FDA Commissioner Janet Woodcock. With this confidence, health experts hope to see a positive change in vaccine hesitancy among unvaccinated Americans. According to the KFF Vaccine Monitor, an ongoing study conducted by the Kaiser Family Foundation (KFF), a full FDA approval could yield an uptake in vaccinations, with about 32 percent of unvaccinated adults saying FDA approval would make them more likely to get vaccinated.

This new confidence and uptick in vaccinations is integral in arming Americans against current or future variants and cases of COVID-19. As hospital numbers and COVID-related deaths have continued to climb, a majority of them are being seen in unvaccinated individuals, who not only can carry but spread COVID to both vaccinated and unvaccinated individuals. The key difference is that vaccinated individuals with breakthrough cases of COVID suffer far less severe symptoms, typically not requiring hospitalization.

With an increase in vaccinations, experts hope to see alleviation on hospital strain associated with COVID-19 cases, along with slowed spread in COVID-19 across the country and prevention of future variants. While vaccination is key, there are other methods individuals should take to help contain spread, as more and more individuals make the decision to vaccinate. A multi-layered approach is recommended by the Centers for Disease Control and Prevention (CDC) and includes a few factors. Masking and social distancing are still recommended for all individuals inside, as well as in outdoor areas where there is a high amount of people. Proper hand washing and sanitization, along with contact tracing and COVID testing are all needed to continue the fight against COVID-19 spread.

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