US FDA advisers weigh COVID vaccines for infants, young children

Advisers to the US Food and Drug Administration are meeting on Wednesday to decide whether to recommend the authorisation of two COVID-19 vaccines for the millions of children ages five years and under, an important step toward immunising a group that has not been eligible for the shots during the pandemic.

The US government is planning for a Jun 21 start to its under-5 vaccination campaign should the vaccines from Moderna Inc and Pfizer/BioNTech receive FDA authorisation, White House COVID-19 response coordinator Ashish Jha said last week.

The panel members will make separate recommendations on each of the vaccines, with votes roughly an hour apart.

Once the FDA authorises the vaccines for the age group - 6 months to 4 years old for Pfizer/BioNTech and 6 months to 5 years old for Moderna - the US Centers for Disease Control and Prevention (CDC) will make its recommendations on use of the shots in young children.

Public health officials and experts say that even though a large portion of small children were infected during the winter surge in cases driven by the omicron variant of the coronavirus, natural immunity wanes over time and vaccinations should help prevent hospitalisations and deaths when cases rise again.

FDA officials told the panel that the number of US COVID-19 deaths so far in small children - roughly 442 under age 5 - "compared terribly" to the 78 deaths reported during the swine flu pandemic of 2019-2010.

"I think we have to be careful that we don't become numb to the number of paediatric deaths because of the overwhelming number of older deaths," FDA official Peter Marks told the panel.

The companies have presented data showing their vaccines are safe and generate a strong immune response in younger children, but it remains unclear how many parents will decide to vaccinate them.

The Pfizer/BioNTech vaccine was authorised for children ages 5 to 11 in October, but only about 29% of that group is fully vaccinated. About 76% of US adults are fully vaccinated, lagging most Western nations.

"This 19 million person group is the last one that can’t access a vaccine," Andy Slavitt, former senior pandemic adviser to US President Joe Biden said on Twitter this week. "It will be a watershed moment that within a week vaccines will be approved for all ages."