In the United States, almost 400 million doses of the Pfizer and Moderna COVID vaccines have been given. The Emergency Use Authorization from the Food and Drug Administration (FDA) authorized this. The vaccines seem safe as well as effective at dramatically reducing the risk of hospitalization or dying due to COVID-19. The data showing vaccine safety was first collected back in December 2020. The question today is: why have the vaccines not been fully approved by the FDA by now?
Authorization may reduce vaccine hesitancy
So far, 190 million doses of the Pfizer shot and 138 million of the Moderna vaccine have been administered in the United States, and more abroad. It has been suggested that there has been more than enough time for a decision by the FDA. This is important given that nearly half of all Americans are still unvaccinated. The “emergency” nature of the authorization so far has left many people hesitant to have a shot. Approval from the FDA is very likely to boost vaccination rates.
The approval process has to be flawless
FDA approval takes a long time because, while millions of vaccine doses have been given, accessing follow-up information from vaccinated people across the country is hard. Instead, the FDA is looking at data from 40,000 people who participated in clinical trials. The FDA must also ensure that there are no flaws in the manufacturing process. Pfizer’s application for full approval was submitted May 7, 2021 and Moderna’s on June 1, 2021.
If vaccination is the key to ending the pandemic, then the FDA’s review must be clear and accurate. If shortcuts cause questions about the review, it would hurt public confidence. We should hear about approval very soon.