WASHINGTON (AP) – Pfizer has submitted to the U.S. Food and Drug Administration (FDA) its research on the effectiveness of its COVID-19 vaccine in children, but doses will be available until November.
The company announced Tuesday that it provided health regulators with data from a recent study of its vaccine in children ages 5 to 11. Officials had previously said they would ask the FDA to authorize its use in the coming weeks.
Once the company submits its application, federal regulators and public health authorities will review the evidence and consult with their advisory committees in public meetings to determine if the vaccines are safe and effective enough to recommend their use.
The process could mean that doses would not be available until Thanksgiving, according to a person familiar with the process who is not authorized to discuss the issue publicly. But depending on how quickly the FDA acts, the doses may be available as early as the first weeks of November, the source said.
The pharmaceutical company and its German partner, BioNTech, indicated that they plan to request authorization for the emergency use of their vaccine in children aged 5 to 11 years “in the coming weeks.” The companies also plan to hand over the data to the European Medicines Agency and other regulators.
Currently, Pfizer’s two-dose vaccine is available for children 12 years and older. About 100 million people in the United States count on both doses of Pfizer, according to the Centers for Disease Control and Prevention (CDC).
Pfizer tested a lower dose of the vaccine for children. The drugmaker said last week that researchers found that the levels of antibodies against the coronavirus developed by the vaccine in children were as strong as those found in adolescents and young adults receiving the regular dose.
Earlier this month, FDA Director Dr. Peter Marks told The Associated Press that once Pfizer released the results of its study, his agency would evaluate the data “hopefully in a matter of weeks” to decide whether the Vaccines are safe and effective enough for little ones.
The update to Pfizer’s calendar was first reported by The Wall Street Journal.
Meanwhile, Moderna, another pharmacist that developed a vaccine against COVID-19, also conducts studies on the effects of its dose in primary school children. The results are expected to be ready towards the end of the year.
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