Pfizer and BioNTech, after revealing positive data from a COVID-19 vaccine booster trial in young children, plan to complete their rolling FDA submission this week.
The companies said that the safety, immunogenicity and vaccine efficacy data for the three-dose regimen were consistent with the data seen in adults. Efficacy reached 80.3% in the booster trial.
Previously, a two-dose regimen failed to work in young children. The age group is the only one not yet cleared for a COVID-19 vaccine.
The shots are one-tenth of the dose strength for adults. In the trial, 1,678 children received a third dose at a time when omicron was the dominant COVID-19 variant.
The partners last week received an emergency use authorization for a booster in the 5 to 11 age group. More than 8 million U.S. children in this age group have already received the primary two-dose course.
Meanwhile, Moderna is waiting on an FDA decision for its two-dose vaccine course in children under 5. This weekend, White House COVID-19 response coordinator Dr. Ashish Jha said the FDA's decision is expected in the coming weeks.
Pfizer forecasts COVID-19 vaccine sales of $32 billion this year, while BioNTech expects between €13 billion ($13.68 billion) and €17 billion ($17.89 billion) for the year. Moderna is expecting $21 billion from its mRNA shot.