Cambridge-based Moderna is announcing the company has asked the FDA to authorize a low-dose version of its COVID-19 vaccine as the first vaccine for children younger than age 5:
Moderna says its vaccine appears to be about 51 percent effective for children ages 6 months to less than 2 years, and 37 percent effective for those ages 2 to less than 6 years.
"We are proud to share that we have submitted for authorization for our COVID-19 vaccine for young children," said Stéphane Bancel, Moderna's chief executive officer, in a statement."We believe [the vaccine] will be able to safely protect these children against SARS-CoV-2, which is so important in our continued fight against COVID-19, and will be especially welcomed by parents and caregivers.
While that level of effectiveness is lower than many had hoped, it's not surprising given the study was conducted when omicron was the dominant variant, company officials and others say. Omicron can evade immunity better than previous variants, resulting in more"breakthrough" infections among vaccinated older children and adults.
While officials had hoped to make a vaccine available for this age group by the end of April, the FDA is now expecting to consider it in June once all the data have been submitted, according to an official familiar with the issue who is not authorized to speak publicly.
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