The US Food and Drug Administration granted emergency authorization on Friday for the use of the Pfizer and Moderna COVID-19 vaccines in the youngest children, who are the last age groups awaiting vaccination in most countries.
The agency authorized two doses of Moderna’s vaccine for children aged six months to five years, and three doses of Pfizer’s shots for children aged six months to four years.
Robert Califf, chief of the Food and Drug Administration, said in a statement, “Many parents, caregivers and physicians are waiting for a vaccine for young children and this action to help protect children under six months of age.” will help.”
“We expect that vaccines for young children will provide protection against the most serious consequences of COVID-19, such as hospitalization and death.”
The Centers for Disease Control and Prevention (CDC) must now recommend vaccines before they are put into use – a final green light to be given after an advisory committee meeting of experts is expected to be held shortly.
But the US government has said that as soon as the FDA decides, 10 million doses could be shipped nationwide immediately, with millions more to be sent in the weeks that followed.
Both vaccines are based on messenger RNA, which provides the genetic code for coronavirus Spike the protein to human cells which then grow it on their surface, training the immune system to be ready. The technology is now considered to be the leading COVID vaccination platform.
The vaccines were tested in trials involving thousands of children. They were found to cause similar levels of mild side effects as older age groups and trigger similar levels of antibodies.
Efficacy against infections was higher for Pfizer, with the company putting it at 80 percent, compared to Moderna’s estimate of 51 percent for children between the ages of six months and two and 37 percent for children between the ages of two and five. .
But Pfizer’s figure is based on a small number of cases and is therefore considered preliminary. It also takes three doses to achieve its protection, with the third shot given eight weeks after the second, three weeks after the first.
Moderna’s vaccine should provide strong protection against severe disease after two doses, four weeks apart, and the company is studying adding a booster that would increase the level of efficacy against mild disease.
However, Moderna’s decision to go with a higher dosage is associated with higher levels of fever in response to the vaccine than Pfizer.
There are about 20 million children in the United States aged four and under.
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