PANDEMIC PULSE

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FDA Grants Full Approval to the Pfizer-BioNTech COVID-19 Vaccine

On August 23, 2021, the U.S. Food and Drug Administration (FDA) announced that the agency has granted full approval to the Pfizer-BioNTech COVID-19 vaccine for adults sixteen years of age and older. This vaccine is the first COVID-19 vaccine to be fully approved by the FDA and it will be labeled and marketed as “Comirnaty.” While the agency’s full approval of Comirnaty applies to adults, the use of the vaccine by individuals between the ages of twelve and fifteen remains subject to the FDA’s Emergency Use Authorization (EUA) and is not yet available to children under the age of twelve. In addition to granting approval for Comirnaty, the FDA is requiring Pfizer-BioNTech to conduct ongoing safety monitoring of the product to study the risk of individuals developing myocarditis and pericarditis following vaccination, including collecting data on long-term health outcomes of individuals who develop myocarditis following vaccination. On their own initiative, Pfizer-BioNTech have committed to conduct a pregnancy registry study to assess the health outcomes of pregnant women and infants following vaccination with Comirnaty during pregnancy.

The vaccines offered by Moderna and Johnson & Johnson are both still subject to their original EUA and not yet fully approved by the FDA. However, the original Emergency Use Authorizations for these vaccines were granted after the EUA for the Pfizer-BioNTech vaccine, which suggests that full approval for these vaccines will be granted soon.

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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