PANDEMIC PULSE

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Pfizer and BioNTech Submit Data to the FDA for Pediatric Use of Comirnaty

On September 28, 2021, Pfizer and BioNTech announced that they have submitted data to the U.S. Food and Drug Administration (FDA) to support an Emergency Use Authorization that would allow children between the ages of five and eleven to receive the Pfizer-BioNTech COVID-19 vaccine (labeled as Comirnaty). This information reviews the results of a Phase 2/3 clinical trial, which is the first to study the safety and efficacy of a two-dose regimen of Comirnaty in a pediatric population. Pfizer and BioNTech previously announced the encouraging results of the pediatric clinical trial in a press release on September 21, 2021 and the companies jointly stated that the results will be submitted to the regulatory authorities in the U.S. and abroad with urgency.

The pediatric dose of Comirnaty is one-third the size of the adult dose and consists of two doses given twenty-one days apart. The results of the clinical trial indicate that the pediatric dose is well-tolerated and it triggers an immune response that is comparable to the immune response that Comirnaty triggers in adults between the ages of 16 and 25 who received the adult dose. In an interview with MSNBC, Dr. Anthony Fauci expressed that he is hopeful that Comirnaty will be available to children by the end of October. After receiving the data from Pfizer, it will likely take the FDA several weeks to review it before deciding whether the safety and efficacy of Comirnaty satisfy the agency’s standards for granting Emergency Use Authorization for this population.

Separately, Moderna is collecting data on the safety and efficacy of their COVID-19 vaccine for the pediatric population in the KidCOVE Study. This study will take longer to complete because it is collecting data on three separate cohorts consisting of children between the ages of six months and twelve years. Johnson & Johnson has not yet announced the results of their Phase 2a clinical trial that is studying the use of their COVID-19 vaccine in adolescents and the company is also planning to study the safety and efficacy of their vaccine in children between the ages of six months and twelve years.

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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