Pfizer-BioNTech's Covid-19 vaccine is safe and effective for children 6 months to 5 years old with three doses, the two companies say.
Specifically, the announcement comes as the US Food and Drug Administration, the FDA, intends in the coming weeks to consider approving Covid vaccines for children under the age of 5, the only age category for which there is no vaccine approval in most countries.
According to clinical trial results published Monday by the two companies, three doses of the vaccine, making it 80% effective in preventing the disease at these ages
Specifically, the third dose elicited a strong immune response and was well tolerated by children with the majority of side effects being mild to moderate.
BioNTech's CEO, Ugur Shahin, said the companies plan this week to complete their application asking the Food and Drug Administration (FDA) to approve the vaccine. Pfizer chief executive Albert Burla said he hopes the vaccine will be available to younger children as soon as possible.
The safety data is based on trials in 1,678 children under the age of 5 who received a third dose at least two months after the second, when Omicron was the main variant marketed.
The announcement comes as the US Food and Drug Administration, the FDA, intends in the coming weeks to review the approval of Covid vaccines for children under 5 years of age, the only age category for which there is no vaccine approval in most countries.
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