PANDEMIC PULSE

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FDA Authorizes Comirnaty for Children 5 to 11

On October 29, 2021, 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 allow children between the ages of five and eleven to receive a pediatric dose of the vaccine. The agency’s decision is based on the unanimous recommendation of the Vaccines and Related Biological Products Advisory Committee, which voted 17-0 to recommend authorizing use of the vaccine in this population at their meeting on October 26, 2021. The two-dose vaccination series showed 90.7 percent efficacy in preventing COVID-19 in children between the ages of five and eleven, which is similar to the vaccine’s performance in adults between the ages of 16 and 25. The vaccine formulation that was studied for children is a smaller dose (10 micrograms for children vs. 30 micrograms for adults) that was administered three weeks apart. Importantly, no serious side effects occurred in the vaccine’s safety study, which included approximately 3,100 children between the ages of five and eleven.

Following the FDA’s authorization, the U.S. Centers for Disease Control (CDC) is expected to meet in the next week to approve the use of the Pfizer-BioNTech vaccine in children If approved, children could receive the vaccine as soon as Wednesday, November 3, 2021.

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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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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