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. This dosage is only one quarter of the adult dose. 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. These antibodies resulted in a protection rate of 43.7% for children 6 months-to-two years of age from contracting the Omicron variation of COVID-19 virus. It was 37.5% for those two to six years of age. No children who were infected with the Omicron variant of COVID-19 virus died, nor did they experience severe diseases.
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. Moderna could be able to get authorization for its vaccine distribution to younger children thanks to these findings. Moderna has asked the FDA for authorization to use its vaccine for children aged 6 months to 6 years. Based on the data, Moderna also wants FDA approval to allow two doses for children 6 to 12 years.
Pfizer BioNTech submitted in February a request for FDA approval of the vaccine it had developed for children under the age of 3. However, both companies and FDA decided to defer reviewing the application until April when more data will become available from the additional doses of vaccine given to the kids. 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.
COVID-19 vaccinations for children younger than six years old are not required. It is important to ensure they get the shot as soon as possible. The new Omicron subvariant BA.2, which continues to spread new infections to the body, has been found to have a greater impact on the lives of young people. This means that measures such a mask-wearing in public areas and schools across the U.S. are becoming less effective.
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