Pfizer requests FDA approval for COVID vaccine for children

Drug giant Pfizer has submitted its research papers regarding the effectiveness of its COVID-19 vaccine in children to the US Food and Drug Administration on Tuesday for the agency’s authorisation but the vaccine may only be available in or after November.

The company on Tuesday that it has provided the data from a recent study of its vaccine in children 5 to 11 years old to health regulators.

Once the company files its application, US regulators and public health officials will review the evidence and consult with their advisory committees in public meetings to determine if the shots are safe and effective enough to recommend use.

That process may mean the shots may not be available until closer to Thanksgiving, the Associated Press reported quoting an unnamed source. But it is possible that, depending on how quickly the FDA acts, the shots could become available earlier in November, the source said.

The drugmaker and its partner, Germany’s BioNTech, say they expect to request emergency use authorization of their vaccine in children ages 5 to 11 “in the coming weeks.” The companies also plan to submit data to the European Medicines Agency and other regulators.

The two-shot Pfizer vaccine is currently available for those 12 and older. An estimated 100 million people in the US have been fully vaccinated with it, according to the Centers for Disease Control and Prevention.

Pfizer tested a lower dose of the shots in children. The drugmaker said last week that researchers found the vaccine developed coronavirus-fighting antibody levels in children that were just as strong as those found in teenagers and young adults getting regular-strength doses.