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COVID-19 Vaccines: FDA Authorizes Moderna & Pfizer-BioNTech for Children Aged 6 Months and Above

  • June 27, 2022
  • 2 mins read

On June 17, 2022, the US Food and Drug Administration (FDA) authorized emergency use of COVID-19 vaccines named Moderna and Pfizer-BioNTech to include use in children aged 6 months and above.

This announcement typically takes place days after the FDA VRBPAC voted unanimously to recommend EUA of the Pfizer-BioNTech COVID-19 vaccine for those children who are aged 6 months to 4 years and recommended dividing the vote into two age groups of the Moderna COVID-19 vaccine because of the dosing differences.

With the FDA authorization, the Moderna COVID-19 Vaccine EUA is now amended to include use of jab in individuals aged 6 months through 17 years. Prior to this amendment, the vaccine had only been authorized for use in adults aged 18 years and older.

The Pfizer-BioNTech COVID-19 Vaccine will now include indications for those individuals who are aged 6 months through 4 years. Earlier, the vaccine had only been authorized for those aged 5 years and older.

The Moderna COVID-19 Vaccine is administered as a primary series of 2-doses, 30 days apart, to individuals aged 6 months through 17 years. The vaccine is also authorized in order to provide a 3’rd primary series dose at least 30 days following the 2’nd dose for individuals in this age group who have been determined to have certain sorts of immunocompromise.

The Pfizer-BioNTech COVID-19 Vaccine is administered as a primary series of 3-doses in which the initial 2-doses are administered 3 weeks apart followed by a 3’rd dose administered at least 8 weeks after the 2’nd dose in individuals aged 6 months through 4 years.

According to the FDA commissioner Robert M. Califf, MD, “Zillions of parents, caregivers and health specialists have been waiting for a COVID-19 vaccine for the younger kids and this effort will help protect those aged 6 months and above. As we have noticed with older age populations, we hope that the COVID-19 vaccines for younger children will confer safety from the most severe outcomes of the COVID-19, like hospitalization and death. Those who are trusted with the care of children can have confidence in the safety and effectiveness of these COVID-19 vaccines and can be assured that the agency was thorough in its assessment of the data.”

Key points the FDA assessed prior to its authorization of the two vaccines included a rigorous and comprehensive analysis of safety, effectiveness, and manufacturing data. The administration also concluded that the known and potential benefits of both vaccines (Moderna & Pfizer-BioNTech) outweigh the risks in pediatric groups now authorized for use.

The Food and Drug Administration noted that the VRBPAC recommendation also came into account when making the decision. Historically, both the Food and Drug Administration and the Centers for Disease Control and Prevention have followed VRBPAC endorsements for vaccine authorizations.

“As with all other vaccines for any age group/population, when authorizing COVID-19 vaccines intended for the pediatric age group, the FDA secures that our assessment and analysis of the finding is rigorous and thorough,” uttered Peter Marks, MD, Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, in the press release. Furthermore, to make certain the finding for these COVID-19 vaccines met the rigorous standards of the FDA, the agency’s convening of an advisory committee was part of a transparent process to help the public have a clear understanding of safety as well as effective findings supporting the authorization of Moderna and Pfizer-BioNTech COVID-19 vaccines for the pediatric populations.”