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January 31, 2022 – 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 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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R.T. Asked: When Can I Get the COVID-19 Booster After Receiving Monoclonal Antibodies?

“When should immunocompromised patients get their second COVID-19 vaccine booster after receiving monoclonal antibodies? We are getting conflicting information from doctors, the news, medical literature, and hospitals on whether it is safe to receive a COVID-19 vaccine or vaccine booster after receiving monoclonal antibodies and whether doing this will reduce the efficacy of the vaccine. We are in a quandary, not knowing what to do.”

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