Cambridge-based Moderna announced Wednesday “good news for parents of children under 6 years of age.”The company reported successful results from the trial of its lower-dose COVID-19 vaccine in babies and young children. Approximately 6,700 children were involved in the research. According to the announcement, the trial found “a robust neutralizing antibody response” in both children ages 6 months to under 2 years and from 2 years to under 6 years. They plan to request authorization for the two-dose vaccination series within weeks. Once Moderna submits the data to the FDA, regulators will debate whether to authorize emergency use of the small doses for tots. If so, the Centers for Disease Control and Prevention then will decide whether to recommend them.”Given the need for a vaccine against COVID-19 in infants and young children, we are working with the U.S. FDA and regulators globally to submit these data as soon as possible,” said Stéphane Bancel, Chief Executive Officer of Moderna. “Additionally, after consultation with the U.S. FDA, we have initiated a submission for emergency use authorization of our COVID-19 vaccine in children ages 6 to 11 years old and are updating our submission to the FDA for emergency use authorization of mRNA-1273 in adolescents ages 12 to 17 years with additional follow-up data. We remain committed to helping to end the COVID-19 pandemic with a vaccine for children of all ages.”Moderna said the small doses were safe, and the main side effects were mild fevers like those associated with other commonly used pediatric vaccines.The company also is seeking to have larger-dose shots cleared for older children and teens in the U.S.The nation’s 18 million children under 5 are the only age group not yet eligible for vaccination. Competitor Pfizer currently offers kid-sized doses for school-age children and full-strength shots for those 12 and older. Pfizer is testing even smaller doses for children under 5 but had to add a third shot to its study when two didn’t prove strong enough. Those results are expected by early April.Moderna received full approval for the COVID-19 vaccine in adults from U.S. regulators in January. The Associated Press contributed to this report.
Cambridge-based Moderna announced Wednesday “good news for parents of children under 6 years of age.”
The company reported successful results from the trial of its lower-dose COVID-19 vaccine in babies and young children. Approximately 6,700 children were involved in the research.
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According to the announcement, the trial found “a robust neutralizing antibody response” in both children ages 6 months to under 2 years and from 2 years to under 6 years. They plan to request authorization for the two-dose vaccination series within weeks.
Once Moderna submits the data to the FDA, regulators will debate whether to authorize emergency use of the small doses for tots. If so, the Centers for Disease Control and Prevention then will decide whether to recommend them.
“Given the need for a vaccine against COVID-19 in infants and young children, we are working with the U.S. FDA and regulators globally to submit these data as soon as possible,” said Stéphane Bancel, Chief Executive Officer of Moderna. “Additionally, after consultation with the U.S. FDA, we have initiated a submission for emergency use authorization of our COVID-19 vaccine in children ages 6 to 11 years old and are updating our submission to the FDA for emergency use authorization of mRNA-1273 in adolescents ages 12 to 17 years with additional follow-up data. We remain committed to helping to end the COVID-19 pandemic with a vaccine for children of all ages.”
Moderna said the small doses were safe, and the main side effects were mild fevers like those associated with other commonly used pediatric vaccines.
The company also is seeking to have larger-dose shots cleared for older children and teens in the U.S.
The nation’s 18 million children under 5 are the only age group not yet eligible for vaccination. Competitor Pfizer currently offers kid-sized doses for school-age children and full-strength shots for those 12 and older.
Pfizer is testing even smaller doses for children under 5 but had to add a third shot to its study when two didn’t prove strong enough. Those results are expected by early April.
Moderna received full approval for the COVID-19 vaccine in adults from U.S. regulators in January.
The Associated Press contributed to this report.