An FDA approval might be granted in a matter of days. It would make Moderna’s vaccine available to children in the United States for the first time, and allow anyone still planning to vaccinate their children aged 6 and up against Covid-19 a second alternative.
The votes are important because children under 5 years are the last age group still ineligible for Covid-19 vaccination.The panel is made up of pediatricians, infectious-disease experts and other health specialists. It is a normal step leading up to an FDA decision on a vaccine application.
The FDA found that two doses of Moderna’s vaccine were about 93% effective at preventing symptomatic Covid-19 in adolescents 12 to 17 years in a study. That study was conducted when the original coronavirus strain and the Alpha variant were predominant.
As it normally does, the committee is expected to consider the assessment of FDA staff. They concluded Moderna’s vaccine was generally safe and effective in all childhood age groups studied, from 6 months through 17 years old.
The advisory council is set to vote on whether the benefits of immunising children in this age group outweigh the risks on Tuesday afternoon. The FDA will take the vote into account when deciding whether or not to approve the vaccine for children aged 6 and up.
The Tuesday vote by the Vaccines and Related Biological Products Advisory Committee won’t include the youngest children. The same panel will meet Wednesday to consider whether Moderna’s vaccine should be used in younger children, ages 6 months through 5 years old. At the same time, the panel will consider whether to expand use of the Pfizer-BioNTech vaccine to children ages 6 months through 4 years old.
Among children ages 6 to 11, two doses of Moderna’s vaccine were 77% effective in a study conducted when the Delta variant was predominant.
The vaccine used in the adolescent trial was in the same dosage as the vaccine for adults. The vaccine for the 6-to-11-year-old group was half that dose level.The FDA found no severe cases of Covid-19 in any of the children in the studies.
The agency said side effects among children receiving Moderna’s vaccine were mostly mild to moderate, and included injection-site pain and fever. The FDA said children 6 months to 11 years old had lower rates of side effects than adolescents and young adults, with the exception of fever, which was reported more frequently in the younger age groups.