Covid

Third Covid vaccine for children under 5 years old is 80% effective against Omicron, according to Pfizer

A healthcare worker administers a Pfizer-BioNTech Covid-19 vaccine to a child at a vaccination center in San Francisco, California, Monday, January 10, 2022.

David Paul Morris | Bloomberg | Getty Images

Pfizer and BioNTech’s three-dose Covid vaccine for children ages six months to five years was 80% effective in preventing disease during the Omicron wave, according to clinical trial results released Monday.

A third dose of the vaccine elicited a strong immune response and was well tolerated by the children, with most side effects being mild to moderate, according to the companies.

BioNTech CEO Ugur Sahin said the companies plan to finalize their application to the Food and Drug Administration for approval of the vaccine this week. Pfizer CEO Albert Bourla said he hopes the vaccine will be available to younger children as soon as possible.

The safety data is based on 1,678 children under the age of 5 who received a third injection at least two months after the second dose when omicron was the main variant in circulation. Pfizer studied a subset of children to determine the immune response of children under the age of 5.

Children under the age of 5 are given 3 microgram shots, one-tenth the adult dosage.

Pfizer and the Food and Drug Administration originally tried to expedite approval of the first two doses in February so parents could start vaccinating their children while clinical trial results from the third vaccine were pending.

However, Pfizer delayed its request to await data from the third dose after the first two shots were only 30% to 40% effective, Bourla said in a podcast interview last month.

Children under the age of 5 are the only group in the United States who are not yet eligible for vaccination. Parents have waited months for the FDA to approve the recordings.

During the winter’s massive wave of Omicron infections, children under the age of 5 were hospitalized with Covid at five times the rate of the peak of the pandemic, according to the Centers for Disease Control and Prevention. About 75% of children under the age of 11 were infected with Covid in February, according to CDC data.

Moderna has also asked the FDA to approve its two-dose vaccine for children under the age of 6. His vaccine was about 51% effective against infections caused by Omicron in children under 2 years of age and about 37% effective in children aged 2 to under 6-years-old. However, Moderna said the antibody levels induced by the vaccine should result in a high level of protection against serious diseases.

The FDA’s Committee of Independent Vaccine Experts plans to meet in June to review Pfizer and Moderna’s applications, with tentative dates set for June 8, 21, and 22. Bourla said he hopes Pfizer’s vaccine for children under 5 will receive approval in June.

CNBC Health & Science

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