Washington – Pfizer has submitted research on the effectiveness of its COVID-19 vaccine in children to the US Food and Drug Administration, but the shots may not be available until November.
The company said Tuesday that it has provided health regulators with data from a recent study of its vaccine in children between the ages of 5 and 11. Officials previously said they would file an application with the FDA to authorize use in the coming weeks, with public health experts and parents expecting the dose to be available by the end of October.
But instead of Halloween, it may fall until the close of Thanksgiving, according to a person familiar with the process but not authorized to discuss it publicly. But it is possible that, depending on how quickly the FDA grants approval, the shots could become available earlier in November, the person said.
The drugmaker and its partner, Germany’s BioNTech, say they expect to request emergency use authorization of their vaccine in children aged 5 to 11 in the coming weeks. The companies also plan to submit the data to the European Medicines Agency and other regulators.
The two-shot Pfizer vaccine is currently available for people 12 years of age and older. According to the Centers for Disease Control and Prevention, an estimated 100 million people in the US have been fully vaccinated.
Pfizer tested low doses of the shots in children. drug maker said last week Researchers found that the vaccine developed coronavirus-fighting antibody levels in children that were as strong as those of teens and young adults receiving regular-strength doses.
Earlier this month, FDA chief Dr. Peter Marks AP. told That once Pfizer changes the results of its study, its agency will evaluate the data “hopefully within a few weeks” to determine if the shots are safe and effective for young children. Or not.
Pfizer’s updated timetable was first reported by The Wall Street Journal.
Another US vaccine maker, Moderna, is also studying its shots in elementary school-aged children. Results are expected later in the year.