On May 10, the U.S. Food and Drug Administration granted emergency use authorization for the Pfizer COVID-19 vaccine to be given to adolescents aged 12 – 15 years. Pharmacies, doctor offices and other sites have already started to vaccinate kids in this age group. You may be wondering how the FDA could evaluate the safety of the vaccine for this age group, or what data the FDA used to make their authorization decision.
How were the vaccines tested in adolescents?
- First, the vaccine was tested on a small number of volunteers in a particular age group. Some volunteers were given the vaccine and others were given a placebo (saline), but the volunteers did not know which one they got. Researchers watched for side effects, looked at dose size, and checked efficacy.
- Then the vaccine was tested on a larger group of volunteers in the same age group. Again, the research was “blinded,” so the participants don’t know if they were getting the vaccine or a placebo. Researchers tracked any side effects and tested the efficacy of the vaccine through blood tests that look for appropriate immune markers.
Because the vaccine was already tested in adults, it did not take as long to then test the vaccine in a younger age group. The FDA had already found that the vaccine is safe and effective in humans. In fact, the adult vaccine trials included an additional phase which tested the vaccine on tens of thousands of people. The vaccine was tested in more than 2,000 kids over age 12, and the FDA concluded that the vaccine provides excellent protection against COVID. The Pfizer vaccine was shown to be nearly 100% effective in protecting against COVID. Participants will continue to be monitored for two years.
What does “Emergency Use Authorization” mean?
An emergency use authorization (EUA) is a valid, tested authorization by the FDA. It is a way to make medications and vaccines quickly available in a public health emergency. Before the FDA would grant an EUA, the vaccine had to meet a set of criteria, including showing that there are no other adequate, approved and available alternatives. Then, the FDA evaluated the vaccine based on findings from the clinical trials. The vaccines met FDA standards for quality, safety and effectiveness. The FDA used the same clinical standards as they do when granting a standard authorization. The emergency use authorization enables faster coordination of various government and nongovernment agencies and organizations to manufacture and distribute the vaccine.