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. Because the effectiveness of the COVID-19 vaccines diminishes over time, a booster dose is necessary to maintain robust protection against COVID-19. 

In the agency’s assessment of the booster dose’s safety and efficacy, the FDA found that few negative side effects were experienced by the study group and the booster dose generates a strong antibody response one month after administration. The most common side effects were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, and chills and fever.

Are you uncertain about your eligibility for the COVID-19 vaccine or a vaccine booster? Review our Vaccine Eligibility Guide to learn more. If you have not yet been vaccinated against COVID-19, Pandemic Patients recommends consulting with your health care provider as soon as possible to discuss getting vaccinated against COVID-19.

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FDA Grants EUA to Novavax COVID-19 Vaccine

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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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.

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