PANDEMIC PULSE

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FDA Extends COVID-19 Vaccine Booster Eligibility to All Adults

On November 19, 2021, the U.S. Food and Drug Administration (FDA) amended the Emergency Use Authorizations (EUA) for the Moderna and Pfizer-BioNTech COVID-19 vaccines to authorize a single dose booster for all adults 18 years of age and older. The FDA had previously authorized booster doses for individuals between the ages of 18 and 64 only if they are at heightened risk of severe COVID-19 or if they have frequent institutional or occupational exposure to COVID-19. Boosters doses of the mRNA vaccines are provided after completion of the primary vaccination series, regardless of the vaccine used in the primary series. To support the FDA’s decision to amend the EUAs for these vaccines, the agency referenced an analysis of original clinical trial participants who received a booster dose of an mRNA vaccine six months after completing their primary vaccination series. Data gathered from these participants approximately one month after receiving the booster dose demonstrated an effective booster response. The amended authorization also includes the agency’s assessment of the safety risks of receiving a booster dose of an mRNA vaccine, where the FDA concludes that the benefits of receiving a booster dose outweigh the heightened risk of recipients developing myocarditis or pericarditis after receiving the booster. To address this risk, the vaccine manufacturers and continuing to conduct post-marketing studies to assess known serious risks of myocarditis and pericarditis. Additionally, the FDA and U.S. Centers for Disease Control and Prevention (CDC) are continuing to monitor the safety of COVID-19 vaccines and respond to any safety concerns that arise. Regarding side effects of an mRNA vaccine booster dose, the agency states the following:

“The most commonly reported side effects by individuals who received a booster dose of the vaccines were pain, redness and swelling at the injection site, as well as fatigue, headache, muscle or joint pain and chills. Of note, swollen lymph nodes in the underarm were observed more frequently following the booster dose than after the primary two-dose series.”

Following the FDA’s action to amend the EUAs for these vaccines, the CDC is meeting to discuss clinical recommendations for COVID-19 vaccine boosters.

 

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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