Should FDA approvals hinder you from getting your COVID-19 vaccine?

Updated 8/24/2021: The Pfizer COVID-19 vaccine has received full FDA approval for ages 16 and older.

According to the Kansas Department of Health & Environment (KDHE), there have been more than 331,000 cases of coronavirus (COVID-19) reported through the end of July 2021, with more than 5,200 cases reported during the last seven days of July. Kansas has reported over 5,300 COVID-19 related deaths since the start of the pandemic with 29 deaths in the last week of July. 

Even though reported cases of COVID-19 and related deaths are down dramatically from the peaks seen during the winter, hospitalizations and deaths across the nation and in Kansas have been on the rise over the past several weeks. The Centers for Disease Control and Prevention (CDC) reports that over 99% of the serious cases of COVID-19 resulting in hospitalizations and deaths have occurred in people who have not received a single dose of vaccine. This statistic has led to the description as the “pandemic of the unvaccinated.”

As of the end of July, 1.4 million Kansas have received at least one dose of a COVID-19 vaccine accounting for about 48% of the population. Many of the people that have not received a vaccine have concerns about the safety, given the Food and Drug Administration (FDA) has not approved vaccines. This raises the question; would FDA approval of the vaccines result in more people getting the vaccine?

The Pfizer and Moderna vaccines were granted emergency use authorization (EUA) in December and the Johnson & Johnson (J&J) vaccine was granted a EUA in February. The EUAs were granted to medicines, vaccines and diagnostic tests for use by the American public to fight the virus as soon as possible. Vaccines were required to follow a specific set of guidelines to provide the FDA with a minimum of two months of safety and effectiveness data versus six months of data that would be required for full approval. During the time the vaccines have been used under the EUA, the companies have closely monitored the effectiveness, safety and side effects that will be reported to the FDA after six months of use. 

What is the difference between FDA approval and a EUA?

It is one of scale. The FDA will review much more data, covering a longer period before granting full approval for the vaccines. The FDA will look at additional clinical trial data and consider the real-world data on effectiveness and safety. They will also inspect manufacturing facilities and make sure quality control is in place. It is an exhaustive and timely review. 

In order to effectively fight the COVID-19 pandemic, the vaccine was given an EUA. This allowed the FDA to take into account a small scale of data to turn an approval around faster. Emergency approval meant vaccines were able to be administered to Americans and decrease COVID-19 cases and deaths.

When might the vaccines be FDA approved?

On July 16 the FDA accepted Pfizer’s application under “priority review” – meaning it will move faster through the process than during a standard review, which typically takes at least 10 months. The FDA has reported that the decision is likely to come within two months. This is because the review of the vaccine data has been on-going throughout the EUA. At this time Moderna has not submitted their application and required data to the FDA for review.

Why have the vaccines not been approved faster?

Even though the vaccines were granted use under the EUA with two months of safety and efficiency data, no steps have been skipped in the investigation process. Under normal study and manufacturing review, this process would have typically taken several years. Because these vaccines have been undergoing constant review the approval process will likely be completed in less than one year.

It is important to remember that 340 million doses of vaccines have been administered, likely resulting in hundreds of thousands of lives saved. It is critical to protect yourself and others from COVID-19 by getting your vaccine. If you have concerns about receiving the COVID-19 vaccine or the side effects of the vaccine please talk with to a trusted healthcare provider. You can find more information about COVID-19 treatment, vaccine information and more at

Ken Mishler, PharmD, RPh
Chief Pharmacist

Leave a Reply