It’s safe to vaccinate 5–11-year-olds!
This past October 29th, the Food and Drug Administration (FDA) authorized the Pfizer-BioNTech COVID-19 vaccine for emergency use in children from 5 to 11 years old. In a press release, Acting FDA Commissioner, Janet Woodcock M.D. said, “Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy.” The COVID-19 vaccine is one of the greatest scientific achievements of our time and is essential to mitigate the pandemic. However, it’s perfectly normal to have doubts regarding how safe it is. That’s why, in this article, we will tell you about the process used to determine the safety of the vaccine for children age 5 to 11.
To begin, it’s important to distinguish between the meaning of an Emergency Use Authorization (EUA) and an Approval in the FDA context. They both are certifications that allow the usage of a medical product after demonstrating its effectiveness and safety. Some critics argue that the lack of approval shows that the vaccine is not safe. This is not the case, the Approval and EUA are different mechanisms. Both require rigorous scrutiny of scientific data that proves that a product is safe and effective. The fact that a product has a EUA doesn’t mean it’s not safe. The difference is not about the rigor of the studies, but rather their size.
The studies that back a EUA tend to be smaller, but, just like an approval, they need to demonstrate that, in the case of the vaccine, the benefits of vaccinating outweigh the risks. To verify the effectiveness, the FDA analyzed an international study of 4,700 participants. The vaccine showed a 90% effectiveness rate protecting kids 5-11 from a COVID-19 infection. In addition, the participants showed a similar immune response to vaccinated 16-25-year-olds.
The safety of the vaccine is being tested in a separate study of 4,600 children in which, according to available data, there haven’t been any dangerous side effects. The FDA did detect a higher risk of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the outer lining of the heart) in 12 to 17-year-old males. But, according to their statistical models, the benefits of the vaccine still outweigh the risks. Furthermore, the studies and monitoring continue to detect and rapidly act if there were to be dangerous side effects perceived.
After the FDA consulted with an independent advisory expert committee, and they both agreed that the benefits of the vaccine outweigh known and unknown risks, it granted the Emergency Use Authorization. According to the existing rigorous procedures, the COVID-19 vaccine for 5-11-year-olds is safe, helps lower transmissions, the development of variants, and takes us one step closer to a normal life.