FDA hesitates with booster shot effectiveness

Daniel Costa

Assistant News Editor


Photo via Modern Healthcare

There has been a significant debate amongst scientists and experts regarding the effectiveness of a COVID-19 booster shot. Many, including vaccine producer Pfizer, are urging the Food and Drug Administration (FDA) to approve the measures proposed. On September 17th, the FDA reached a decision on the mass production and issuance of a Pfizer booster shot. The FDA council decided to reject this provision, with a caveat that those over the age of 65 or with severely compromised immune systems may proceed with getting a booster shot.


However, the Pfizer booster shot is not utilizing new technology or being adapted to combat the Delta variant of the virus. It is a third dose of the vaccine individuals have already taken twice, if they chose Pfizer as their vaccine provider.


Two senior members of the FDA, Dr. Phil Krause and Dr. Marion Gruber, assisted in writing an academic article for a medical journal “The Lancet” along with 16 of their peers in the vaccine research field. In this article, it states, “Current evidence does not, therefore, appear to show a need for boosting in the general population, in which efficacy against severe disease remains high.” The scholars raised concerns regarding the severity of side effects in receiving a third dose, which in turn could lead to greater vaccine hesitancy among global populations.


What this group did make clear was the effectiveness of the initial one or two doses of vaccines offered by the various providers. Krause, Gruber and their peers argue that governments should focus on vaccinating the rest of their populations and assist in distribution to developing nations.


The World Health Organization has also recommended a moratorium on booster production, in order to assist struggling developing nations in their battle against COVID-19.


Reports such as these led to hesitancy in the FDA. The Federal agency released a report that did not seem to show any signs of a speedy approval of Pfizer’s plan for a third dose, citing a concern for side effects such as myocarditis and pericarditis.


Currently, third doses of the Pfizer vaccine have started to be administered to those with severely compromised immune systems. These measures have not been approved by the FDA, just as the initial COVID-19 vaccines were not federally approved until last summer.



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