COVID mRNA Vaccines Safe, Effective for Babies and Toddlers, Says FDA Staff

News

Moderna and Pfizer/BioNTech’s COVID-19 vaccines proved safe and effective for kids under 5 years of age, paving the way for immunization of the only age group still awaiting access, according to FDA briefing documents released ahead of 2 days of advisory meetings.

On Tuesday, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet to discuss Moderna’s request for emergency use authorization (EUA) of its COVID-19 vaccine (Spikevax) in children ages 6 years to 17 years.

And on Wednesday, the agency’s vaccine advisers will discuss whether the benefits of the mRNA COVID-19 vaccines outweigh the risks in the country’s youngest patients: those ages 6 months to 4 years for Pfizer/BioNTech’s EUA request and those ages 6 months to 5 years for Moderna’s request.

Moderna’s EUA Requests

Over the 2-day session, VRBPAC will discuss whether a two-dose regimen of the Moderna mRNA vaccine is safe and effective to prevent COVID-19 in kids ages 6 months to 17 years.

Moderna’s COVID vaccine is currently approved in adults 18 and over. The company has submitted EUA requests to the FDA for three pediatric age groups: ages 12 to 17 years, ages 6 to 11 years, and ages 6 months to 5 years. The proposed two-dose primary series for each age group are 100 μg, 50 μg, and 25 μg per dose, respectively. Currently, only the Pfizer/BioNTech formula (Comirnaty) is authorized for use among children ages 5 to 17 years.

In phase II/III trials including more than 14,000 participants ages 6 months to 17 years, a two-dose regimen of Moderna vaccine met immunobridging success criteria in all age groups, the FDA briefing document stated. Data were analyzed from clinical trials among teens, those ages 6 to 11 years, and those ages 6 months to 5 years. In each pediatric age-group, the studies compared amounts of neutralizing antibodies to that of participants ages 18 to 25 years.

Vaccine efficacy (VE) for Moderna’s shot was 36.8% (95% CI 12.5-54.0) for those ages 2 to 5 years, and 50.6% (95% CI 21.4-68.6) for those ages 6 to 23 months, during an evaluation period when the Omicron variant was predominant, according to the briefing document.

Among participants ages 12 to 17 years, VE was 93.3% (95% CI 47.9-99.9) during a time when the ancestral and Alpha strains were predominant. VE was 76.8% (95% CI -37.3 to 96.6) among those ages 6 to 11 years during a period when Delta was the most prevalent.

Overall, younger kids (ages 6 months to 11 years) experienced fewer adverse events (AE) than teens, with the exception of fevers, the FDA briefing document noted. Rates of fever among the youngest age group were 21-26%, with a high fever (over 104°F) reported in less than 0.4% of children in this cohort. The most common AE reported by all pediatric participants was pain at the injection site, occurring in 58-98% of the study population. There were no confirmed cases of myocarditis or pericarditis among those ages 6 months to 17 years.

Pfizer’s EUA Request

VRBPAC will also review the Pfizer/BioNTech COVID-19 vaccine on Wednesday for the youngest kids. The Pfizer EUA request included data from a phase II/III clinical trial of approximately 1,200 vaccine recipients and 568 placebo recipients (ages 6 to 23 months), as well as 1,835 vaccine recipients and 915 placebo recipients (ages 2 to 4 years).

In a three-dose series of 3-µg mRNA per dose, administered 3 weeks apart, the vaccine met immunobridging success criteria in those ages 6 to 23 months, and in those ages 2 to 4 years, according to a separate briefing document. Previous data showed that the vaccine was safe and effective in these age groups.

The VE for Pfizer’s shot among all kids was 80.4% (95% CI 14.1-96.7):

  • 6 to 23 months: VE 75.6% (95% CI -369.1 to 99.6)
  • 2 to 4 years: VE 82.4% (95% CI -7.6 to 98.3)

Overall, three COVID-19 cases were reported in participants who received the vaccine versus seven in the placebo group.

AE rates were similar among the vaccine and placebo groups. Once again, there were no reports of myocarditis or pericarditis in this group.

  • Amanda D’Ambrosio is a reporter on MedPage Today’s enterprise & investigative team. She covers obstetrics-gynecology and other clinical news, and writes features about the U.S. healthcare system. Follow

Articles You May Like

5 top tips on how to talk to your employer about ADHD and get the right support
New COVID-19 Variants Dodge Vaccine Antibodies, New Study Reveals
Mother’s gut microbes can aid in the healthy development of baby, finds study
How to find positivity on social media
Some states move quickly to ban abortion after Supreme Court ruling

Leave a Reply

Your email address will not be published.