Tag: Vaccine

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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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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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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.

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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.

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FDA Expands Vaccine Booster Eligibility to 16 Years and Older

On December 9, 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). The amended EUA now allows individuals 16 and 17 years of age to receive a booster dose of the Pfizer-BioNTech vaccine at least six months after completion of the primary vaccination series with the same vaccine.

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