by Jonathan Lemire
WASHINGTON (AP) – 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 aged 5 to 11. Officials previously said they would file an application with the FDA to authorize use in the coming weeks.
Once the company files its application, US regulatory and public health officials will review the evidence and consult with their advisory committees at public meetings to determine whether the shots are safe and sufficient to recommend use. are effective.
That process could mean that shots may not be available until close to Thanksgiving, according to a person familiar with the process but not authorized to discuss it publicly. But it’s possible that, depending on how quickly the FDA acts, the shots could become available earlier in November, the person said.
The drugmaker and its affiliate, 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. The drugmaker said last week that researchers found the vaccine developed levels of coronavirus-fighting antibodies in children that were as strong as those found in teens and young adults at regular-strength doses.
Earlier this month, FDA chief Dr. Peter Marks told the AP that once Pfizer changes the results of its study, its agency will evaluate the data “hopefully in a few weeks” to decide in order to decide whether the shots are safe and effective for young children.
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.