The FDA has officially approved the Pfizer Vaccine. Let’s Talk.

Tim Hunter BSN RN CCM

If you have been following the news, you probably already know that the U.S. Food and Drug Administration (FDA), has officially approved the Pfizer-BioNTech COVID-19 vaccine. The vaccine, which will now be marketed under the name Comirnaty (koe-mir’-na-tee), has been available on an Emergency Use Authorization (EUA) basis since December 11, 2020. Since May 10, 2021, the EUA has been extended for use on children ages 12 to 15. At this time, the full approval is limited to those age 16 and older.

So what does this mean? Acting FDA Commissioner, Janet Woodcock, M.D., believes this marks a new era in fighting the pandemic, and the official approval may help those that have been skeptical about getting vaccinated. “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated.” (U.S. Food and Drug Administration, 2021).

How do vaccines get approved?

The process through which the FDA approves vaccines is rooted in quality, safety, and effectiveness. First, the FDA evaluates the drug manufacturer’s submission of data, which is referred to as a Biologics License Application (BLA). The application that was submitted for Pfizer’s Comirnaty vaccine was built on the considerable data obtained during the trial phases of the vaccine’s EUA. In Phase III of the Pfizer/BioNTECH trial there were a total of 43,448 participants; these subjects are all considered part of the historic introduction of the first-approved COVID-19 vaccine.

How do mRNA vaccines work?

The vaccine’s ability to work lies in its RNA (mRNA) genetic material. This material is used by our body to mimic the protein structure of the virus that causes COVID-19. This protein does not become a part of, nor does it alter a recipient's genetic makeup. FDA Director of the Center for Biologics Evaluation and Research, Peter Marks MD Ph.D., elaborates on the credibility of the approval process: “Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine. 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” (US Food and Drug Administration, 2021).

At the time of this article, there have been over 5 Billion doses of COVID-19 vaccines (not just Pfizer), given world-wide, and 24.6% of the world’s population have been vaccinated. Currently, we are administering vaccines globally at a rate of 33.56 Million doses per day. At this time only 1.4% of people in low-income countries have received at least one (1) dose of a COVID-19 vaccine (Our World in Data, 2021).

Stay tuned to Angle Health’s social media accounts for continued attention to the COVID-19 pandemic. Our Utah-based members interested in additional information about the vaccine or where to get vaccinated, should visit COVID-19 Vaccine Information to learn more. Stay well, friends.

Sources: FDA Approves First COVID-19 Vaccine | FDA

Pfizer and BioNTECH Phase 3 Trial Results

Our World In Data: COVID 19 Vaccination Data

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