New York-based Pfizer Inc. submitted the required Briefing Document to obtain authorization for its COVID-19 vaccine, known globally as Comirnaty, to be used with children to the U.S. Food and Drug Administration (FDA) on October 23, 2021.
The FDA and its Vaccines and Related Biological Products Advisory Committee (VRBPAC) will evaluate the information regarding the safety and efficacy of the Pfizer-BioNTech Comirnaty vaccine for children 5 to 11 in a meeting scheduled for October 26, 2021.
Pfizer's document says 'the benefits of reducing the risk of severe COVID-19 and death generally outweighed the risks of possible side effects in that age group.'
Although the mortality rate for COVID-19 in children is substantially lower than that in adults, COVID-19 was among the top 10 leading causes of death for children in the U.S.
As of October 20, 2021, the U.S. CDC reported 542 deaths attributed to COVID-19 (comorbidity status undisclosed) in people under 18 since January 2020, when the pandemic began in the U.S.
Additionally, there have been 138 deaths related to the combination of COVID-19 and pneumonia in the 18 and under age group.
However, the CDC reports pneumonia morbidity alone (1,043) is far more prevalent in these young people.
While mRNA vaccines have significantly reduced the health impact of severe COVID-19, they are not 100% protective.
The CDC reported deaths of fully-vaccinated Breakthrough Cases reached 10,857 as of October 18, 2021.
Pfizer-BioNTech are seeking authorization of a 10-µg dose level of COVID-19 vaccine as a two-dose primary series given three weeks apart.
The modified formulation improves vaccine stability and simplifies vaccine administration. Adults receive 30-ug dose levels.
The 10-µg dose level was selected as the optimal dose for this age group based on the favorable reactogenicity profile and robust immunogenicity results from Phase 1 dose level finding evaluation (Study C4591007).
Overall, the safety and tolerability profile of this COVID-19 vaccine, administered as a two-dose ten µg primary series given three weeks apart to approximately 1,500 children 5 to <12 years of age who had at least two months of follow-up since their second dose, reflects age-appropriate events that are consistent with a general pediatric population and the known reactogenicity profile of the Pfizer-BioNTech vaccine, says the document.
Furthermore, no myocarditis/pericarditis (heart) cases were observed during the vaccination period through approximately three months of follow-up post-Dose 2 in the 5 to <12 years of age group in the Study.
Interested persons may present data, information, or views on issues pending before the committee, orally or in writing. In addition, the FDA established a docket (FDA-2021-N-1088) for public comment on this meeting.