Safety of Pfizer vaccine for children under five years

 Covid-19. Pfizer says its vaccine is safe and effective for children under five years of age with three doses

The Covid vaccine formulation for younger children is well tolerated and produces a strong immune response," said Pfizer's CEO.

The Covid vaccine from the Pfizer-BioNTech alliance is safe and effective for children aged six months to five years with a three-dose injection, the two companies said in a statement on Monday.

Pfizer-BioNTech said it had tested three doses of three micrograms each in a clinical trial and found that the vaccine elicited a strong immune response. Side effects were similar in the vaccine and placebo groups.

Efficacy was 80.3%, according to a preliminary estimate.

"We are pleased that our formulation for young children, which we carefully measured at one-tenth the dose for adults, was well tolerated and produced a strong immune response," Albert Bourla, Pfizer's chief executive, said in a statement.

Children under five still cannot be vaccinated in many countries

The announcement comes at a time when the U.S. Food and Drug Administration (FDA) has scheduled three meetings in June to review the approval of Pfizer's vaccine for children under five and Moderna's vaccine for children under six.

The FDA initially planned to evaluate Pfizer's two-dose vaccine in February, but data showed that the vaccine was not strong enough to elicit an immune response in children aged two to four years. It then asked for data from a third injection.

The Pfizer-BioNTech alliance's Covid vaccine is safe and effective for children aged six months to five years with three doses, the two companies said Monday in a statement.

Pfizer-BioNTech said it had tested three doses of three micrograms each in a clinical trial and found that the vaccine elicited a strong immune response. Side effects were similar in the vaccine and placebo groups.

Younger children are the only age group that cannot yet be vaccinated against the coronavirus in most countries.

A serious health condition associated with Covid-19 is very rare in children under five. In the United States, 477 deaths in this age group have been reported since the beginning of the pandemic, representing about 0.1% of all deaths.

In addition, like adults, some children infected with the coronavirus may develop long-term Covid, with new, ongoing, or recurring symptoms, such as mental confusion and fatigue.