Sept. 28, 2021 – 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 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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