Drug manufacturers say coronavirus vaccines may be available for US children under 6 months old. Pfizer and Moderna are testing their vaccines in children under 12, and expect to have results on hand for children ages 5 to 11 by September.
Compared to adults, children are much less likely to develop serious illness after infection with the coronavirus. But nearly four million children in the United States have tested positive for the virus since the start of the pandemic, according to American Academy of Pediatrics.
Rare cases of doctors are seen Multisystem Inflammatory Syndrome in Children, a condition linked to COVID-19 that can affect multiple organs, including the heart. Vaccinated children should contribute further to virus prevention by reducing its spread in communities.
Pfizer announced Tuesday that it is moving to test its vaccine in children ages 5 to 12. It will start testing the vaccine in six-month-old babies in the next few weeks.
company expected to apply to the Food and Drug Administration in September for emergency authorization of the vaccine for children ages 5 to 11, according to Pfizer spokesman Kit Longley. Results for children in the age group of 2 to 5 years may be available soon.
Mr Longley said data from the trial for children aged 6 months to 2 years could come in October or November, with the potential to be submitted to the FDA after that.
The Pfizer-BioEntech vaccine was authorized last month for use in children aged 12 to 15 years.
Based on data from an earlier study assessing safety, Pfizer will give two doses of 10 micrograms — a third of the dose given to adolescents and adults — to children ages 5 to 11, and each to 6 children. Give two doses of three micrograms. Months to 5 years.
“We take a deliberate and careful approach to help understand safety and how well the vaccine can be tolerated in young children,” said Dr Bill Gruber, a senior vice president at Pfizer.
The study will enroll 4,500 children at more than 90 clinical sites in the United States, Finland, Poland and Spain. Researchers at Pfizer plan to submit complete data from the trial this summer for publication in a peer-reviewed journal.
In March, Moderna began testing individual doses of its vaccine. little kids. The purpose of that trial was to enroll 6,750 healthy children in the United States and Canada. Results are not expected until the end of the summer, and the vaccine’s authorization by the FDA will take longer.
“I think it’s going to fall quickly, simply because we have to go down the age very slowly and carefully,” Moderna chief executive Stephen Bunsell said on Monday.
The company announced late last month that its vaccine was potently effective in 12 to 17-year-olds, and plans to apply to the FDA for authorization in that age group. Last week, Moderna also asked the agency for full approval of its vaccine, not the emergency use for which it is currently authorized.
The United States will not be the first country in the world to authorize a coronavirus vaccine for young children. China has approved Sinovac vaccine for children According to the president of the company, as of 3 years old. The approval has not been officially announced.