WASHINGTON: The U.S. Food and Drug Administration on Friday gave emergency approval for the use of Pfizer and Moderna against COVID-19 in the youngest children, the last age group awaiting immunization in most countries.
The agency approved Modern’s two-dose vaccine for children aged six months to five years, and three doses of Pfizer injections for children between six months and four years of age.
“Many parents, carers and clinicians have been waiting for the vaccine for younger children and this action will help protect those up to six months of age,” Food and Drug Administration chief Robert Califf said in a statement.
“We expect vaccines for younger children to provide protection against the most severe outcomes of COVID-19, such as hospitalization and death.”
The Centers for Disease Control and Prevention (CDC) must also recommend vaccines before they are put into use – a final green light to be given after a meeting of the expert advisory board expected soon.
But the U.S. government has said that as soon as an FDA decision is made, 10 million doses can be sent immediately across the country, followed by millions in the coming weeks.
Both vaccines are based on messenger RNA, which delivers the genetic code for the coronavirus protein to human cells that then grow it on their surface, training the immune system to be ready. The technology is now considered the leading vaccination platform against COVID.
Vaccines have been tested in experiments on thousands of children. They have been found to cause similar levels of mild side effects as in older age groups and trigger similar levels of antibodies.
Efficacy against infection was higher for Pfizer, and the company estimated it at 80 percent, compared to Modern’s estimates of 51 percent for children aged six months to two years and 37 percent for children aged two to five years.
But the Pfizer figure is based on a very small number of cases and is therefore considered preliminary. Three doses are also needed to achieve its protection, with the third injection being given eight weeks after the second, which is given three weeks after the first.
Modern’s vaccine should provide strong protection against severe illness after two doses, four weeks apart, and the company is studying the addition of an enhancer that would raise the level of effectiveness against mild illness.
However, Modern’s decision to go with a higher dose is associated with higher fever levels in response to the vaccine compared to Pfizer.
There are about 20 million children in the United States aged four and under.