Pfizer and BioNTech said on Monday that preliminary findings of a clinical trial of children younger than five showed three doses of their coronaviruses vaccine produced a strong enough immune response to meet the criteria for regulatory authorization.
The companies said in a news release that the three-dose regimen had been 80 percent effective in preventing infections in children. The companies did not say how many children were in the subset. The results of the trial will be disclosed next month.
Pfizer and Moderna are trying to get permission to give the vaccine to the nation's youngest children. 18 million children under the age of 5 are not yet eligible for vaccine against the coronaviruses, and parents have had their expectations dashed many times.
The number of children who fell ill with Covid was too small to make a conclusive statement about efficacy, according to Pfizer and BioNTech. The vaccine group became ill with Covid after being given the third dose. At least 21 Covid cases are required for analysis of vaccine efficacy in the clinical trial protocol. Once available, the companies said that final data on efficacy would be shared.
The Biden administration wanted to give vaccine to children under 5 in February. Pfizer was pressed by the FDA to submit data on how well two doses worked for young children, but pulled back after they said two doses were not effective in preventing Omicron variant infections.
Pfizer said that the new results showed that three doses, with the third given at least two months after the second, stimulated the immune system to protect against the virus, with no safety concerns. One month after the third dose, the immune response of the subset of trial participants was better than that of people who received two doses.
We are pleased that our formula for the youngest children, which we carefully selected to be one-tenth of the dose strength for adults, was well tolerated and produced a strong immune response. The companies will complete their application for emergency authorization of the vaccine this week, according to Dr. Ugur Sahin.
Moderna and Pfizer are competing to produce the best vaccine for the youngest Americans. Moderna is suggesting a two-dose regimen for children younger than 6. The company hasn't submitted any data to the government about the need for a third dose as a booster shot.
The question of which vaccine works better will be put to a committee of outside advisers to the F.D.A. The committee could sway regulators on which vaccine should be authorized, or whether both deserve clearance, if Pfizer and Moderna proposed different vaccine regimes for the youngest children.
Moderna sought emergency authorization for its vaccine after interim results showed that clinical trial participants had a similar immune response to young adults when given a dose one-fourth as strong.
The firm said its results met the criteria for success. According to Moderna, its vaccine appeared to be effective against infections in children younger than 2 and older than 2.
Moderna's efficacy would be better if Pfizer's results were followed by subsequent data. Both companies say their vaccines have the same side effects.
Adeel gave reporting.
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