US approves Pfizer and Moderna vaccines for youngest children

In this file photo taken in 2021 a six-year-old child receives the Pfizer-BioNTech Covid-19 vaccine

The US Food and Drug Administration granted emergency authorization Friday for the use of Pfizer and Moderna Covid-19 vaccines in the youngest children, the final age group awaiting immunization in most countries.

The agency, whose approval is considered the global gold standard, authorized Moderna's two-dose vaccine for children aged six months to five years, and three doses of Pfizer's shots for those between six months and four years old.

FDA chief Rober Califf similarly hailed the decision, saying "vaccines for younger children will provide protection from the most severe outcomes of Covid-19, such as hospitalization and death."

"Parents in the US now have the option to vaccinate their children under 5 years of age, and we are working to ensure that other countries worldwide will follow,” said Ugur Sahin, CEO and co-founder of Germany's BioNTech, which developed the vaccine together with Pfizer.

But the government has said that as soon as the FDA decision was made, 10 million doses could immediately be sent around the country, followed by millions more in subsequent weeks.

Both vaccines are based on messenger RNA, which delivers genetic code for the coronavirus spike 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 Covid vaccination platform.

Efficacy against infection was higher for Pfizer, with the company placing it at 80 percent, compared to Moderna's estimates of 51 percent for children aged six-months to two years old and 37 percent for those aged two to five years.

Moderna's vaccine should provide strong protection against severe disease after two doses, given four weeks apart, and the company is studying adding a booster that would raise efficacy levels against mild disease.

"We are thrilled that the FDA has granted Emergency Use Authorization of Moderna's Covid-19 vaccine for children and adolescents, particularly for our vulnerable, youngest children," said Moderna CEO Stephane Bancel.

The United States, home to 20 million children four years and under, has recorded 480 Covid deaths in that group in the pandemic -- far higher than even a bad flu season, according to the FDA.

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Originally published as US approves Pfizer and Moderna vaccines for youngest children