PANDEMIC PULSE

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FDA Authorizes Third Dose of mRNA Vaccine for Certain Patients

On August 12, 2021, the U.S. Food and Drug Administration (FDA) amended the Emergency Use Authorizations (EUA) for the Pfizer-BioNTech and Moderna COVID-19 vaccines to allow certain patients to receive an additional dose of those vaccines. The EUAs for these vaccines now allow solid organ transplant recipients and individuals who are equivalently immunocompromised to receive a third dose of either the Pfizer-BioNTech or Moderna mRNA vaccines. The agency stated that this patient population is at heightened risk for developing severe COVID-19 symptoms due to their compromised immune systems and that a third vaccine dose will help them maintain a strong antibody response against COVID-19. In addition to allowing patients with compromised immune systems to access a third dose of an mRNA vaccine as a preventive measure, the FDA also advised these patients to discuss monoclonal antibody treatment options with their health care provider if they have been exposed to the coronavirus.

If a patient with a compromised immune system receives a third dose of an mRNA vaccine, it should be the same vaccine that they received in their primary vaccination series and it should be administered at least 28 days after the prior dose. The FDA clarified that the agency is currently engaging in a rigorous process to evaluate whether fully vaccinated adults who are not immunocompromised will benefit from an additional dose of an mRNA vaccine.

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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