US regulators are urging drugmaker Pfizer to apply for emergency approval for a two-dose regimen of its COVID-19 vaccine for children aged 6 months to 5 years old while waiting for data on a three-dose course, with the goal of clearing the way for the shots as soon as late February, to a person familiar with the matter reported.
The application was scheduled to be submitted as early as Tuesday.
Early Pfizer results indicate that the vaccine, which is given to younger children at one-tenth the potency of an adult shot, is safe and elicits an immunological response. However, Pfizer announced last year that the two-dose shot was less effective at preventing COVID-19 in children aged 2 to 5, and regulators encouraged the company to add a third dose to the study in the hope that another dose would boost the vaccine’s effectiveness, similar to how booster doses do in adults.
The FDA is now pushing the company to submit its application based on the two-dose data for potential approval in February, and then to return for additional authorization once the data from the third dose study is available, which is expected in March, according to a person familiar with the matter. If the FDA and the Centers for Disease Control and Prevention approve the shots in two steps, young children could be vaccinated more than a month earlier than previously estimated.
The individual talked on the condition of anonymity in order to discuss sensitive regulatory matters. Given the development of the highly transmissible omicron strain of COVID-19, the source stated the lower efficiency of the two-dose vaccine was not surprising. Allowing young children to be vaccinated with a two-dose shot sooner would hasten the time when they may receive the expected better protection from a third dose.
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