Pharmaceutical manufacturers Pfizer Inc and BioNTech SE said Monday that three doses of their COVID-19 vaccine have developed a strong immunity in children under 5 years of age and are safe and well tolerated in their clinical trials.
The companies say they plan to ask regulators around the world to approve shots for age, for children for whom no vaccine is currently approved in most countries around the world. They said they expect to complete the task of submitting their information to the US Food and Drug Administration (FDA) this week.
The clinical trial involved administering smaller doses of the vaccine to 1,678 children aged 6 months to 5 years than to older children and adults. Pfizer and Bioentech said three shots of a 3 microgram formulation of their vaccine produced similar immunity in those ages as those aged 16 to 25 who received two doses of the previous clinical 30 microgram formulation. Judgment
Ugur Sahin, chief executive of Bioentech, said in a statement: “Research suggests that our low-3-microgram dose of vaccine, carefully selected based on tolerance data, provides a high level of protection against the recent COVID-19 strain in young children.”
Rival vaccine maker Moderna Inc. released trial data in March showing that its vaccine is safe and develops similar immunity in young children as in adults.
New York-based Pfizer Inc. and Germany-based Bioentech said a preliminary analysis of 10 symptomatic COVID-19 cases identified as of April 29, where the Omicron variant was dominant, suggested 80.3% vaccine efficacy in the under-5 age group. This analysis was not final, as the trial protocol specified that efficacy should be calculated based on at least 21 fields.
Pfizer and BioNTech have stated that the final age data will be made public once it becomes available.
The drug makers had previously tested two doses of the 3 microgram vaccine in children. But the two-dose trial failed to meet its initial end point after results for children 2 to 4 years of age showed weaker resistance than in adults.
Trial participants received their third dose at least two months after their second shot. Pfizer says the vaccine is well tolerated, with most adverse side effects mild or moderate.
Pfizer / BioNTech shots are currently approved for use by all Americans 5 years of age or older. Children 5 to 11 years of age receive two 10 microgram doses as their primary course, while people 12 years of age or older receive two 30 microgram doses.
It was not clear how many American parents would vaccinate children their age. Only 29% of American children ages 5 to 11 are fully vaccinated, and COVID-19 is generally milder in children than in adults.
U.S. regulators are already preparing to review information submitted by Modern for young children as well as children under 6 years of age. The FDA said Monday that a committee of external advisers will meet on June 15. Two vaccines for young children.
Moderna said two 25-microgram shots of her vaccine were 37% effective in preventing infections in children aged 2 to 5 years and 51% in children aged 6 months to 2 years.
(Reporting by Michael Erman; Editing by Will Dunham and Kenneth Maxwell)