Was FDA right to approve Pfizer COVID vaccine?


Fact Box

  • The FDA approved the first COVID vaccine, Pfizer - BioNTech, on August 23, 2021, for the “prevention of COVID-19 disease in individuals 16 years of age and older.” Based on the results of 22,000 vaccine recipients and 22,000 placebo recipients, the vaccine was 91% effective in preventing the disease. 
  • As of Monday, August 23, 2021, over half (51.5%) of the US population has been fully vaccinated while 60.7 percent have at least one dose. 
  • There are currently three COVID vaccines: Pfizer - BioNTech, Moderna, and Johnson & Johnson. Both Pfizer and Moderna are mRNA vaccines and require two doses, while Johnson & Johnson is a viral vector vaccine in one dose. 
  • Potential side effects of vaccines are well-known: fever, headache, dizziness, severe allergic reaction, and seizure. If a child has an allergic reaction to a certain vaccine, the primary care doctor will suspend the following dose.

Tyler (Yes) 

The FDA's approval of Pfizer's COVID vaccine was the product of diligent research performed by the organization's scientists and doctors. The US FDA took nearly nine months to approve the vaccine after it was authorized for emergency use in early December. The FDA's patience towards the dilemma should remind us that they also have an interest in protecting their reputation as an organization. This vaccine has met every FDA requirement, from its manufacturing process to its effectiveness over time. The FDA closely monitored 12,000 vaccine recipients for six months and proved the vaccine prevents hospitalization and generally lowers the possibility of infection. Hopefully, this FDA approval will remove some panic from people that are reluctant to get vaccinated due to any reservations they might have had. 

However, prominent institutions like the military and school boards across the nation were awaiting the FDA's approval to release significantly stricter vaccine and testing mandates than before. The University of Virginia recently received national attention for disenrolling 238 students who did not follow COVID protocol, following a similar move made by New York Governor Bill De Blasio, who enforced a mandatory vaccinations for public Schools with no exceptions or frequent testing options. 

After being vaccinated, studies that followed numerous people determine the vaccine is 91% effective in preventing COVID. The Delta variant is rampant and has shown to be up to 60% more transmissible than previous strains. A study in England covering over 14,000 people determined that the Pfizer vaccine is just over 80% effective in treating the Delta variant. This is good news for anyone who cares to move on from this pandemic.

Bill (No)

The FDA was wrong to fast-track approval of Pfizer’s COVID vaccine—there is no compelling reason to do so. COVID is not a problem for most Americans, even if they test positive for it. Only 6.7% of Americans sought treatment in a hospital after showing symptoms of COVID. And the vast majority of those hospitalized survived COVID. Moreover, the hospitalization rate is inflated since at least 25% of Americans do not have a primary care physician and instead go directly to an urgent care clinic or hospital emergency room for treatment.

Especially alarming about the FDA’s decision is its apparent disregard of the vast amounts of data detailing adverse effects experienced by those inoculated by the vaccine—hundreds of thousands, including a total of over 30,000 who died, were permanently disabled, or sustained life-threatening complications. How can the FDA examine the demographic data about the relatively low risks of COVID and the potentially horrifying side effects of receiving the vaccine and be comfortable fast-tracking the Pfizer vaccine?

The FDA does a disservice to Americans by fast-tracking the approval of the Pfizer vaccine in favor of recommending non-vaccine alternatives to treat COVID, specifically, losing weight and using available effective medications to treat COVID. Obesity is a significant risk factor for COVID. Over 78% of those hospitalized are overweight or obese, and COVID deaths increase proportionally with body mass. Immunity-boosting Chinese herbal compound Artemisinin and other remedies like the nasal spray Budesonide are alternative interventions to treat COVID without introducing the potentially lethal side effects of the Pfizer vaccine. The FDA should be rightly criticized for its decision to approve the vaccine.

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