modern has new data supporting the use of your COVID-19 vaccine Spikevax at a low dose in younger children under 6 years of age, and is moving forward with global regulatory filings.
Moderna will ask the FDA and the European Medicines Agency (EMA) “in the next few weeks” that Spikevax be authorized for children from 6 months to less than 6 years, the company said Wednesday. Simultaneously, modern initiated a delayed FDA submission for emergency use authorization of the mRNA vaccine. This in children from 6 to 11 yearsCEO Stéphane Bancel said in a statement.
For the age group under 6 years old, modern is using a two-dose regimen of 25 micrograms per injection. That’s half the strength you’re looking for population aged 6 to 11 and a quarter of that approved for primary vaccination in adults.
In a phase 2/3 trial called KidCOVE, two 25-microgram doses of Spikevax showed “a robust neutralizing antibody response.” In two age subgroups, along with a “favourable” safety profile, Moderna said.
Both in children from 6 months to 2 years and in children from 2 to 6 years, Spikevax elicited immune responses against coronavirus that were “similar to” the high dose in adults, the company said. Therefore, the trial met its primary objective in these age groups.
But when it comes to the efficacy against COVID-19 infectionSpikevax was only 43.7% effective in children 6 months to 2 years and 37.5% effective in children from 2 to less than 6 years old. The efficacy was “statistically significant but minor” compared to adult data, a sample that Moderna said was expected given the dominance of the omicron variant during the testing period. Existing vaccines are also known to be less potent against omicron in adults.
In spite of the reduced effectivenessno deaths, hospitalizations, or severe COVID were reported in any of the age groups.
Approval delayed due to risk of myocarditis
The KidCOVE trial also enrolled children from 6 to 12 years. Moderna had previously found that Spikevax works in that age group, and last month the EMA recommended approval of the vaccine in those older children. But modern previously decided to delay a filing for that age group in the US. This, after the FDA took the time to assess the risk of myocarditis. A condition of inflammation of the heart, for adolescents.
In younger children, the tolerability profile of Spikevax was “generally consistent with” that seen in older people, Moderna said.
Most of the side effects were mild or moderate. The trial recorded no deaths or myocarditis.
Thanks to an EUA in October, Pfizer and BioNTech’s rival mRNA injection, Comirnaty, is allowed in children as young as 5 years old. The company is also looking to tap into even younger children. In addition to a typical two-dose regimen, Pfizer and BioNTech are also pursuing a three-dose regimen for children under 5 years of age at 3 micrograms per dose. A tenth of the concentration for people over 12 years old.
In February, Pfizer and BioNTech extended their continuous delivery of Comirnaty in the age group of children under 5 years until April, with the hope of including the data of three doses. The companies believe that the three-dose regimen may provide a higher level of protection in this age group than the two doses.
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