US FDA says benefits of Pfizer Covid-19 vaccine for young children outweigh risks

The jab’s capacity to prevent hospitalisation and deaths likely exceed the risk of adverse outcomes such as the heart condition myocarditis

A hearing is scheduled for October 26 where an advisory panel will debate whether the vaccine should be cleared for young children

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Pfizer earlier this month asked the FDA to grant an emergency authorisation for children age 5 to 11 to receive its vaccine. Photo: AFP

Published: 1:00pm, 23 Oct 2021

The staff of the Food and Drug Administration said the benefits of Pfizer and BioNTech’s Covid-19 vaccine for young children likely outweigh its risks, ahead of a meeting next week where experts will weigh whether the shot should be cleared for use.

According to the staff report, which was posted on the FDA website late Friday, the vaccine’s capacity to prevent hospitalisation and deaths likely exceed the risk of adverse outcomes such as the heart condition myocarditis, which has been reported in some younger males who have received messenger RNA shots for Covid-19.

Pfizer and BioNTech earlier this month asked the FDA to grant an emergency authorisation for children age 5 to 11 to receive its vaccine. The formulation for young kids is one-third the dose of the adult shot.

The FDA’s Vaccines and Related Biological Products Advisory Committee will meet on Tuesday to evaluate the data and hear presentations from the company and health officials. The group, made up of outside scientific experts, will then make a recommendation on whether to grant an authorisation.

The staff report made no explicit recommendation as to whether the advisers should support authorisation. If the panel votes to back a clearance and the FDA agrees, it could pave the way for kids to begin getting shots by early to mid-November.

Clearing a vaccine for junior school age children would mark a major milestone in the pandemic. It is likely to provide peace of mind for many concerned parents and for kids themselves, and could open the door to resume activities that have been on hold since Covid-19 first began to spread in the US.