The FDA’s approval is just one step in a longer journey

Austin Zhuang ’22

On August 23, 2021, the Food and Drug Administration fully approved the first COVID-19 vaccine for all individuals sixteen years of age or older, an important milestone in the ongoing fight against the virus. The Pfizer-BioNTech COVID-19 vaccine, now marketed as Comirnaty, is still available under emergency use authorization (EUA) for individuals ages twelve through fifteen and for the administration of a third dose for certain immunocompromised individuals, among others.

     While Comirnaty and the EUA vaccine have the same formulation, changing its status from emergency use to fully approved has legal consequences. The Defense Department has already required all service members to get the vaccine, something they could not have done before the approval without a presidential waiver. More and more universities, public school districts, and states have also started issuing vaccine mandates.

     This flood of requirements is largely due to the removal of legal challenges. Most university and state vaccine mandates like those for measles, mumps, and rubella are in place because of FDA approval, so requiring the COVID-19 vaccine is legal. Despite this, many are still refusing to follow mandates and become fully vaccinated. Reasons for their decision include potential negative side effects and too quick of an approval process, the majority of which public health officials have disproved.

If infections are not in control by winter, schools could face another forced shutdown like the one Haverford experienced in December of 2020.

     The continuing hesitation to get “the jab” after legal and safety concerns is threatening; the recent Delta surge has left thousands hospitalized. If infections are not in control by winter, schools could face another forced shutdown like the one Haverford experienced in December of 2020.

A Shipley student getting the Pfizer vaccine at a Baldwin School vaccination clinic, April 22, 2021 – Index Staff

The surefire way to prevent deaths, cases, and another shutdown is to expand vaccine coverage. Data continues to show that COVID-19 vaccines effectively prevent hospitalization as most severe infections are in unvaccinated individuals. The more people that have the vaccine, the more chance for an uninterrupted academic year.

     “Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.” That’s what Acting FDA Commissioner Janet Woodcock, M.D., claimed the day the FDA approved the Pfizer vaccine.  Her words capture the essence of what is to come.

As vaccination rates rise and the public gradually accepts the effectiveness of vaccines, the pandemic finish line grows closer. But as long as a significant portion of the population continues to find reasons to not take the shot despite mandates and government support, COVID-19 will remain a threat to health and safety and to the relative normalcy we just got back.