PANDEMIC PULSE

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FDA Grants Full Approval to Moderna's COVID-19 Vaccine

On January 31, 2022, the U.S. Food and Drug Administration (FDA) granted full approval to Moderna’s COVID-19 vaccine for individuals 18 years of age and over. This vaccine will be marketed as “Spikevax,” and is the second COVID-19 vaccine to receive full approval from the FDA following the agency’s approval for Pfizer’s Comirnaty in 2021. Full approval of this vaccine signals that the product has satisfied the agency’s strict standards for safety, efficacy, and manufacturing quality. The FDA’s approval for Spikevax follows the publication of a study in the New England Journal of Medicine that demonstrates how a booster dose of the Moderna vaccine creates a strong and durable antibody response against the Omicron variant. This is a welcome development as the Omicron variant is overwhelming the U.S. health care system and a concerning subvariant of Omicron, known as BA.2 or “stealth Omicron,” has already been detected in several states.

Pandemic Patients encourages all Americans to get fully vaccinated against COVID-19 to reduce the transmissibility of the virus and to reduce overall mortality. If you have not yet been vaccinated against COVID-19, we encourage you to meet with your health care provider to discuss getting vaccinated as soon as possible.

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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