FDA panel to review Moderna COVID-19 shot for ages 6 – 17
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An independent group of experts at the FDA is set to meet on Tuesday to decide whether to recommend the use of Moderna (NASDAQ:MRNA) COVID-19 shot for those aged 6 to 17 years.
The members of the FDAâs Vaccines and Related Biological Products Advisory Committee are expected to vote in the afternoon if the benefits of the vaccine outweigh the risks.
Already the age group has access to Pfizer (PFE)/BioNTech (BNTX) COVID-19 vaccine, while Moderna (MRNA) vaccine was available only for adults since late 2020.
The decisions of the agencyâs AdCom committees are non-binding. However, the regulator considers them before making a final decision on authorizations.
Ahead of the meeting, the FDA staffers backed the use of the Moderna (MRNA) vaccine for those aged 6 months through 17 years old.
The agencyâs reviewers found that two doses of the vaccine led to about 93% of effectiveness in the prevention of symptomatic COVID-19 in adolescents aged12 to 17 years. The study ran during a period dominated by the original coronavirus strain and the Alpha variant.
For those aged 6 to 11, the efficacy of the two-dose regimen was found to be 77% in a study conducted when the Delta variant was predominant.
The dose used in the adolescent trial was similar to that used in the adult vaccine, while the younger age group received half that level.
Last year, the FDA delayed a decision to expand the use of Moderna (MRNA) shot for adolescents citing the need to review data on the risk of heart inflammation linked to the vaccine.