Moderna announced today that its COVID-19 vaccine produces “robust” levels of antibodies among children six months to six years old similar to those generated by adults vaccinated with the shot.
The results are part of the company’s KidCOVE study and will be submitted to the Food and Drug Administration (FDA) for emergency use authorization in this youngest, and last group of children to be eligible for COVID-19 vaccination, Moderna said in a statement.
In the study, nearly 7,000 children six months to six years old were randomly assigned to receive two doses of Moderna’s mRNA-based COVID-19 vaccine, or two doses of placebo. The dosage for this age group is one-quarter of that currently approved for adults. Children vaccinated with the shot produced antibodies against SARS-CoV-2 at similar levels to those that adults made after being vaccinated at higher doses, likely reflecting children’s more active and efficient immune systems. Those antibodies led to an efficacy of 43.7% in protecting children six months to two years old from getting infected with the Omicron variant of the COVID-19 virus, and 37.5% among those aged two to six. None of the children in the study who became infected experienced severe disease, were hospitalized, or died.
Currently, Moderna’s vaccine is only approved for those over 18 years old, while Pfizer-BioNTech’s is approved for adults and has emergency use authorization for those between ages five and 18. But these results could put Moderna ahead of Pfizer-BioNTech in receiving authorization to distribute its vaccine to younger children. In addition to seeking authorization for its vaccine to be used for children between six months and six years of age, Moderna is also asking the FDA to authorize two doses of its mRNA vaccine in children six to 12 years old, based on data provided to the agency the shots are safe and effective in that age group.
While Pfizer-BioNTech had submitted a request in February for FDA authorization of its vaccine for the youngest age group, the companies and the agency decided to delay reviewing the application until April, when additional data among children given an additional, third dose of the vaccine will be available. The two-dose regimen didn’t prove as efficacious in protecting the youngest children from infection and disease, especially against the Omicron variant, as health officials had hoped.
Children under six are the last group to be vaccinated against COVID-19, and ensuring the shots for them are both safe and effective is critical as the new Omicron subvariant, BA.2, continues to cause more new infections, and virus control measures like mask-wearing are being dropped in schools and other public places throughout the U.S.
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