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.

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On July 13, 2022, the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) to Novavax’s COVID-19 vaccine. The FDA’s authorization of this vaccine provides an additional option for individuals who wish to get vaccinated against COVID-19.

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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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