PANDEMIC PULSE

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mRNA Vaccine Manufacturers Request Authorization for Fourth Dose

On March 15, 2022, Pfizer and BioNTech submitted an amendment to the Emergency Use Authorization for their COVID-19 vaccine (marketed as Comirnaty). This amendment requested that the U.S. Food and Drug Administration (FDA) authorize Comirnaty for a fourth dose for adults 65 years of age and older who have already received one booster dose of any COVID-19 vaccine. Initial data cited by the vaccine manufacturers demonstrated that individuals who received the additional vaccine dose at least four months after receiving the first booster shot experienced a reduction in both confirmed infections and severe illness.

Similarly, on March 17, 2022, Moderna submitted an amendment to the Emergency Use Authorization for its COVID-19 vaccine (marketed as Spikevax). This amendment requested that the U.S. Food and Drug Administration (FDA) authorize Spikevax for a fourth dose for adults 18 years of age and older who have already received one booster dose of any COVID-19 vaccine. An important distinction between Pfizer-BioNTech and Moderna’s request is the target age group: Pfizer and BioNTech requested authorization for a fourth booster dose in adults 65 years of age and older, while Moderna requested authorization for a fourth dose in adults 18 years of age and older, which is a much larger population. However, Moderna has clarified that it made the broader request to allow the U.S. Centers for Disease Control and Prevention (CDC) and healthcare practitioners to determine when it is appropriate to administer a fourth dose of Spikevax. Notably, Moderna’s additional dose is not specific to the Omicron variant of COVID-19, but clinical trials are currently in progress to test the safety and efficacy of an Omicron-specific vaccine manufactured by Moderna.

Subsequently, on March 23, 2022, Moderna announced that interim data from its Phase 2/3 KidCOVE trial demonstrate that a 25 µg two-dose vaccine regimen for children between the ages of 6 months and 6 years is showing positive results. When provided to children in these age groups, Moderna’s vaccine is well-tolerated tih the majority of adverse events being mild-to-moderate, consistent with how the vaccine is tolerated by adults. Importantly, no new safety concerns were identified during the trial and the vaccine provided a similar level of immunity to the trial participants as demonstrated in adults between the ages of 18 and 25. Following the release of this data, Moderna announced that it will be pursuing regulatory authorization for the use of its vaccine in children between the ages of 6 months and 6 years.

On March 21, 2022, the FDA announced that it will be holding a virtual meeting for its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on April 6, 2022 to discuss future COVID-19 vaccine booster doses. Specifically, VRBPAC will discuss whether to update the composition of the COVID-19 vaccines to address specific variants of COVID-19 and the timing for certain populations to receive additional booster doses of the COVID-19 vaccine in the coming months. The meeting will be live-streamed on the agency’s YouTube channel.

With vaccine eligibility criteria changing so rapidly, you might be wondering if you are eligible to get vaccinated against COVID-19. Review our COVID-19 Vaccine Eligibility Guide to learn more.

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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