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June 17, 2022 – FDA Authorizes Pfizer and Moderna COVID-19 Vaccines for Children

On June 17, 2022, the U.S. Food and Drug Administration (FDA) amended the Emergency Use Authorizations (EUA) for the Pfizer and Moderna vaccines (marketed as Comirnaty and Spikevax) to allow children as young as six months to get vaccinated against COVID-19. In making this decision, the FDA concluded that the vaccines are safe and effective for use in this population and that the benefits of vaccination outweigh the potential risks.

The data underlying the FDA’s decision revealed that both Pfizer and Moderna’s vaccine effectiveness in younger individuals was comparable to its effectiveness for adults. The most commonly reported side effects include pain, redness and swelling at the injection site, fever, swelling in the underarm or groin, tenderness of lymph nodes, irritability, crying, sleepiness, loss of appetite, fatigue, headache, muscle ache, chills, nausea/vomiting and joint stiffness. The FDA, the Centers for Disease Control & Prevention (CDC), Pfizer, and Moderna have all committed to conducting ongoing safety monitoring of the COVID-19 vaccines to ensure that all serious adverse events are identified and reported.

Today’s long-awaited action by the FDA ensures robust availability of the COVID-19 vaccines for adults and children of all ages. Furthermore, the expanded availability of these vaccines will provide an extra layer of protection for children who have, up until this point, been unable to get vaccinated against COVID-19.

The updated EUAs for the Moderna and Pfizer COVID-19 vaccines are now reflected on our COVID-19 Vaccine Eligibility Guide, which you can review here.

FDA Authorizes First Vaccine Booster for Children 5-11

On May 17, 2022, the U.S. Food and Drug Administration (FDA) amended the Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine (marketed as Comirnaty) to authorize the use of a single booster dose for children between the ages of five and eleven. The FDA authorized the administration of this booster at least five months after the completion of the primary vaccination series with the same vaccine.

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R.T. Asked: When Can I Get the COVID-19 Booster After Receiving Monoclonal Antibodies?

“When should immunocompromised patients get their second COVID-19 vaccine booster after receiving monoclonal antibodies? We are getting conflicting information from doctors, the news, medical literature, and hospitals on whether it is safe to receive a COVID-19 vaccine or vaccine booster after receiving monoclonal antibodies and whether doing this will reduce the efficacy of the vaccine. We are in a quandary, not knowing what to do.”

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