Pfizer and BioNTech's three-dose COVID-19 vaccine for children ages six months to under 5 years produced a strong immune response, the companies said on Monday.
The vaccine for younger kids has an efficacy of just over 80%, according to a preliminary analysis. The results are based on clinical trials in which children got 3-microgram doses -- one-tenth of the dose for adults -- of the COVID-19 vaccine. Following a third dose, the companies said the vaccine elicited a strong immune response with only mild to moderate side effects.
"The study suggests that a low 3-µg 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," said Dr. Ugur Sahin, CEO and co-founder of BioNTech, in a release. "We are preparing the relevant documents and expect completing the submission process to the FDA this week, with submissions to EMA and other regulatory agencies to follow within the coming weeks."
While the US Centers for Disease Control and Prevention last week signed off on a booster shot of the COVID-19 vaccine for children ages 5 to 11, parents have been waiting for a vaccine to get authorized for this younger age group.
Pfizer initially submitted data to the Food and Drug Administration in February for emergency use authorization of its vaccine for babies, toddlers and children under age 5, but postponed the official application and authorization process to wait for additional data on a third dose. Moderna and Pfizer have both asked the FDA to authorize low-dose vaccines for the youngest age group, and the agency has a tentative schedule in June to go over data on both companies' vaccines.
Last week, the US crossed the grim milestone of 1 million deaths from COVID-19, and cases and hospitalization rates have been rising across the country. New, more contagious versions of the omicron variant are responsible. While numbers are lower than the surge this past winter, the rise threatens the relaxation of some safety measures, like dropped mask mandates.