FDA Approves Comirnaty | Pfizer-BioNTech

Updated: Jan 13


A long-awaited approval from the FDA allows widespread speculation of the covid 19 vaccination, to resonate a little bit easier with Americans. Predictions show many more to receive the shot in crucial timing, as the Delta variant begins to make its way around.

As of August 23rd, the U.S. Food and Drug Administration has approved the first Covid 19 vaccination for individuals 16 and older. With 3 vaccines currently being distributed, the first one adopted into the FDA’s approval list is Pfizer, now marketed under brand name Comirnaty, and comes from the German biotech company, BioNTech SE. Founded in 2008, their 13 years running and headquartered in Mainz, Germany.

Their project to develop a vaccine began mid-January, following the release of the SARS-Cov-2 genetic sequence. Just 6 months later, they began taking orders to distribute the vaccine to almost every major country. From early December, the vaccines began getting distributed across the US under EUA (Emergency use Authorization). Being the first vaccine to be used in the US, Moderna, and Johnson & Johnson /Jansen followed shortly after.

“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, 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 acting FDA Commissioner, Janet Woodcock, M.D.

According to the FDA, Pfizer has a 91% covid prevention rate and is recommended to anyone over the age of 12, without a severe allergic reaction. While you can still contract the virus after being vaccinated, the effect shows to be less potent if you have received the vaccine.

“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 analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities,”

Said director of FDA’s Center for Biologics Evaluation and Research, Peter Marks, M.D., Ph.D.

That said, the vaccination consists of two shots, 21 days apart. Suggesting that some immunocompromised people should get a 3rd shot.

As mentioned earlier, this vaccine comes at a critical time as the delta variant is beginning to sweep through the nation. With a little over 50 percent of the US being vaccinated, this news will likely encourage everybody that has been on the fence, to go out and get the shot.

As for the rest, there remains a large majority of individuals that remain opposed to getting the shot. With such reasons differing, one of the main rationales is the pressure politicians and the media have been putting on it. The matter has developed such a political stance, resulting in anti-trust from the people. With all the mask mandates and vaccination requirements, parties began to become authoritarian in their stance. Officials would be saying one thing, yet do another. This has caused confusion and the whole topic of covid began to take many different directions. Thus forming strong beliefs from irritation, a large majority have been pretty assertive on not getting vaccinated.

As many with this view come coincidentally from the political right, planted from anti-mask regulations and political narratives during this past election cycle, even Trump recommended the vaccination at a recent rally in Florida. The act resulted in many boo’s, but it goes to show how everything has gotten twisted over the past year. Trump was determined on getting vaccinations out and distributed from the very beginning. The Biden administration was the ones critical of the vaccine, due to their lack of trust in Trump. Then as the Biden administration took office, they pushed the vaccines constantly taking full credit for the distribution. However, Trump nor Biden created the vaccine. The development has nothing to do with either party other than funding and distribution. There is no valid reason not to trust on political grounds.

Where most of the splits and narratives came into play, was over mask mandates, shutdowns, and the bills passed to aid the people and economy in getting past the pandemic. That is where the left has tended to exercise authoritative tendencies, and the right has been scrutinized for not taking enough precautions, and that opens up a whole list of conversations that tend to cloud our judgment on the vaccine itself.

In the end, we all come from different backgrounds and views, but the vaccines are out. One is now officially FDA approved, while the rest are expected to follow. We are all going to make our own decision, and I believe it should be a personal choice. This is all still very new, and it is within anybody's right to be skeptical. We can’t and shouldn’t force people to do what they don’t want to. After all, we live in a free country. If you're vaccinated, great, there is no reason to worry. If you're not, that’s your choice. All in all, the death rate remains quite small, less than 1,000 per week as of 8/23, and we have much bigger things to dedicate our focus on now.