The companies said in a statement that Pfizer Inc. and BioNTech SE plan to study three-dose doses of their COVID-19 vaccine in young children aged 6 months to 4 years.
Vaccine partners revised their clinical trial protocols after a request from an external, independent data monitoring committee, which found that the two-dose regimen showed a significant increase in blood tests in people aged 2 to 5 years. Did not indicate strong immune response. No safety concerns were identified across the age group.
If the three doses prove successful, Pfizer and BioNTech will approach the US Food and Drug Administration for emergency use authorization for the regimen in that age group in the first half of 2022.
The additional shot would be a dose of 3 micrograms. “This change reflects the companies’ commitment to carefully selecting the right dosage to maximize the risk-benefit profile,” the companies said in a statement.
Pfizer and BioNTech also plan to trial a third dose, but on a 10 microgram formulation, in children between the ages of 5 and 12, they said in the statement.
“Control of Omicron may only be possible with three or more doses,” said Katherine Jensen, Pfizer’s head of vaccine research and development, at an investor event Friday.
Pfizer fell 2.6% in pre-market trading in New York, while BioNTech’s US depository receipts fell 2.9%.
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