Did you know that immunizations prevent 2 to 3 million deaths every year from more than 20 different diseases? In June 2020, the U.S. Food and Drug Administration (FDA) released guidelines to assist those interested in developing a COVID-19 vaccine in the clinical development and licensure of COVID-19 vaccines. The methodology behind vaccination safety and approval is the result of years of refinement of the testing process, which relies heavily on science.
According to the Worldwide Health Organization (WHO), once a vaccine has been selected, it undergoes rigorous laboratory testing to ensure its safety and efficacy. This testing falls under the responsibility of the FDA Center for Biologics Evaluation and Research (CBER). In June 2020, the FDA released guidelines to help companies and researchers in developing a COVID-19 vaccine. After a vaccine meets all of the proper requirements, it is then ready for clinical trials.
But what happens when the world finds itself in the midst of a pandemic such as COVID-19? In emergency situations, the FDA may choose to utilize Emergency Use Authorization (EUA) authority in order to provide more timely access to drugs, medical tests, or other critical medical products that may help during the emergency. The EUA process is different from full approval of these products, because in some emergency situations there is a more urgent need, and there may not be time for full FDA approval. This does not mean the vaccine isn’t safe or that shortcuts were taken during the clinical trials. If the available evidence shows the benefits of these products outweigh the risks, the FDA will give approval for them to be used during the emergency under an EUA. EUAs have been issued in the past, such as in 2009 during the H1N1 pandemic, when EUAs made possible the distribution of medications not specifically designed to treat H1N1 but which showed promising benefits for people suffering from this illness, while a vaccine for H1N1 was still being developed.
We have the gold standard of safety and effectiveness for all medical products. The FDA, along with all of our sponsors have top of mind the safety of all vaccines. We will not cut corners in terms of our assessment of FDA, of that gold standard of safety and effectiveness.Dr.Stephen M. Hahn, Commissioner of Food and Drugs, U.S. Food and Drug Administration (FDA) about the FDA approval process for COVID-19 vaccinations.
EUAs allow the FDA to provide important medical tools quicker than it normally would to healthcare providers and the public. EUAs have been authorized throughout the pandemic for different kinds of COVID-19 tests, including PCR, antigen, and antibody tests. This same process is being used for COVID-19 vaccines.
It is important to understand any side effects the vaccine may have. During clinical trials, great care is taken by scientists to document any side effects, even if they are mild. Before a vaccine can receive approval and be distributed, this information is put into a document called a Vaccine Information Statement (VIS). This statement is legally required to be given to you before you get a vaccine so you can make an informed choice about receiving a vaccination. The VIS includes information on potential side effects of the vaccine which participants in the clinical trials reported. In the case of a COVID-19 vaccine, the FDA will require two months of safety information following a final dose of a vaccine before authorizing an EUA; generally, the time required by the FDA for vaccine development during times of non-emergency is considerably longer.
After the vaccine is distributed, scientists will continue to monitor the COVID-19 vaccine. The Vaccine Adverse Event Reporting System (VAERS), a national vaccine safety surveillance program co-sponsored by the FDA and the CDC, collects and analyzes information from reports of potential, rare side effects that occur after the administration of approved vaccines.
There are currently more than 100 COVID-19 vaccine candidates under development. Pfizer and Moderna began limited distribution of their COVID-19 vaccines in December. These first vaccine doses are limited to frontline healthcare workers who are treating COVID-19 patients.
Until everyone has access to a vaccine, we must continue to wear masks, physical distance, wash our hands frequently, and stay home when we have symptoms of COVID-19 in order to further prevent the spread of COVID-19.