Covid

Pfizer/BioNTech say 3 COVID shots produce a good response in under 5s

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Drugmakers Pfizer Inc and BioNTech SE announced Monday that three doses of their COVID-19 vaccine elicited a strong immune response in children under the age of five in their clinical trial.

The companies said the vaccine is safe and well-tolerated by children, and they plan to soon ask global regulators to approve the vaccine for the age group, children, who currently have no vaccine approved in most parts of the world.

They expect to complete their submission of data to the US Food and Drug Administration (FDA) this week, they said.

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Pfizer and BioNTech said three shots of a 3-microgram formulation of their vaccine in children ages six months to under five years elicited an immune response similar to that seen in 16- to 25-year-olds who received two doses of the 30-microgram formulation had the vaccine in a previous clinical trial.

“The study suggests that a low 3 microgram dose of our vaccine, carefully selected based on safety data, provides young children with a high level of protection against the recent strains of COVID-19,” said Ugur Sahin, BioNTech’s chief executive, in a statement.

The drugmakers said an early analysis of 10 symptomatic COVID cases identified through April 29 while the Omicron variant was dominant suggested a vaccine efficacy of 80.3% in the under-five age group. This analysis is inconclusive as the study protocol specified that efficacy should be calculated based on at least 21 cases.

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Pfizer and BioNTech said final efficacy data will be shared in the age group as it becomes available.

The drugmakers had previously tested two doses of the 3-microgram vaccine in the children. However, the two-dose study did not meet its primary endpoint after results showed a weaker immune response in 2- to 4-year-olds than in adults.

The 1,678 study participants received their third dose at least two months after their second injection. Pfizer said the vaccine was well tolerated, with most side effects being mild or moderate.

The Pfizer/BioNTech syringe is currently approved for use in all Americans five years and older. Children ages five to 11 are given two 10-mcg doses as initial treatment, while those 12 and older are given two 30-mcg doses.

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It is not clear how many US parents will vaccinate their children in the age group. Only 29% of five to eleven year olds in the country are fully vaccinated, and COVID is generally milder in children than in adults.

US regulators are already preparing to review data in younger children, as well as data submitted by rival vaccine maker Moderna Inc for children under the age of six. A committee of FDA external advisors is scheduled to meet June 8, 21, and 22 to review the use of the two vaccines in younger people.

Moderna released study data in March showing its vaccine was safe and elicited an immune response in young children similar to that in adults.

The company said two 25-microgram shots of its vaccine were about 37% effective in preventing infection in children aged two to five years and 51% in children aged six months to two years. (Reporting by Michael Erman; Editing by Kenneth Maxwell)

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