Coronavirus vaccines could be available to U.S. children 6 months and older this fall, drug makers say. Pfizer and Moderna are testing their vaccines on children under the age of 12 and are expected to have results for children ages 5 to 11 by September.
Compared to adults, children are significantly less likely to develop serious illnesses after being infected with the coronavirus. However, according to the American Academy of Pediatrics, nearly four million children in the United States have tested positive for the virus since the pandemic began.
Doctors continue to see rare cases of multisystem inflammatory syndrome in children, a Covid-19-related disease that can affect multiple organs, including the heart. Vaccinating children should further help contain the virus by reducing its spread in communities.
Pfizer announced Tuesday that it would test its vaccine on children ages 5 to 12. It will begin testing the vaccine in infants six months of age over the next few weeks.
The company hopes to apply to the Food and Drug Administration for emergency approval of the vaccine for children ages 5-11 in September. Kit Longley, a spokesman for Pfizer, could soon have results for children ages 2-5.
Data from the study for children 6 months to 2 years old could arrive in October or November, followed by a possible filing with the FDA soon after, Longley added.
The Pfizer BioNTech vaccine was approved for use in children between the ages of 12 and 15 last month.
Based on data from a previous safety assessment study, Pfizer will give two doses of 10 micrograms each to children aged 5 to 11 years – one-third of the dose given to adolescents and adults – and to children of 6 years of age two doses of each three micrograms give months to 5 years.
“We are taking a conscious and careful approach to understanding the safety and tolerability of the vaccine in younger children,” said Dr. Bill Gruber, Senior Vice President at Pfizer.
The study will enroll up to 4,500 children at more than 90 clinical centers in the United States, Finland, Poland and Spain. Pfizer researchers plan to submit full data from the studies for publication in a peer-reviewed journal this summer.
In March, Moderna began testing different doses of its vaccine in younger children. This study aimed to enroll 6,750 healthy children in the United States and Canada. Results are not expected before the end of summer, and FDA approval of the vaccine will take longer.
“I think it will be early autumn just because we have to age very slowly and carefully,” said Moderna boss Stéphane Bancel on Monday.
The company announced late last month that its vaccine was highly effective in 12-17 year olds and plans to apply to the FDA for approval in that age group. Last week, Moderna also asked the agency for full approval of its vaccine rather than the emergency use it is currently approved for.
The US won’t be the first country in the world to approve a coronavirus vaccine for young children. China has approved Sinovac’s vaccine for children 3 years and older, the company’s chairman said. The approval was not officially announced.