The 18 million kids under 5 are the only group in the U.S. not yet eligible for COVID-19 vaccination.
Preliminary data suggested the three-dose series is 80% effective in preventing symptomatic COVID-19, the companies said, but they cautioned the calculation is based on just 10 cases diagnosed among study participants by the end of April. The study rules state that at least 21 cases are needed to formally determine effectiveness, and Pfizer promised an update as soon as more data is available.
“The study suggests that a low, 3-microgram dose of our vaccine, carefully selected based on tolerability data, provides young children with a high level of protection against the recent COVID-19 strains,” he said in a statement. The agency has set tentative dates next month for its scientific advisers to publicly debate data from each company.
Moderna submitted data to the Food and Drug Administration that it hopes will prove two low-dose shots can protect children under the age of 6.The FDA is expected to review Moderna's data on both the youngest age group, plus its study of teens and elementary-age children. Other countries already have expanded Moderna's shot to kids as young as 6.
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