FDA advisory panel backs Covid-19 vaccines for children under 5


US government advisers have recommended administering Covid-19 vaccines to babies and toddlers, paving the way for the nationwide rollout of jabs from as early as next week.

Scientists on a Food and Drug Administration advisory panel on Wednesday voted unanimously in favor of the “child-sized” shots developed by Moderna and BioNTech / Pfizer for about 20mn children in the last age group that lacks access to Covid jabs.

The Biden administration is gearing up to begin vaccinations for young children next week and is making 10mn doses available for distribution, pending a final recommendation in favor by the Centers for Disease Control and Prevention expected later this week.

If US regulators greenlight the jabs, it would mark the first time a big western nation has extended the Covid vaccine rollout to children between the ages of six months and five years. So far only China and a handful of other countries have offered Covid shots to this age group using alternatives to Moderna and Pfizer.

Moderna’s shot is about a quarter of the size of an adult dose and is targeted at children under six years in a two dose regimen. Meanwhile, the Pfizer vaccine is about a tenth of the size of an adult dose and aimed at children under five years in a three dose regimen.

Both were deemed safe and effective, according to FDA briefing documents prepared for the advisory panel.

Some panel members raised questions about the limited trial data available to them and the limited efficacy against infection provided by the shots, particularly Pfizer’s “child-sized” vaccine. Pfizer said its clinical study shows three doses can provide protection for the circulating Omicron variants.

Paul Offit, a professor of pediatrics at Children’s Hospital of Philadelphia, said he was concerned two doses of Pfizer’s vaccine provided low levels of protection. “I fear that they may have underdosed.”

However, panel members were unanimous that the benefits of both vaccines to infants outweighed any risks.

There have been 442 Covid-related deaths in children under the age of five, according to CDC figures, a fraction of the more than 1mn US adult deaths.

But Dr Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, told the advisory panel there had been a “quite troubling surge” in hospitalisations during the recent wave of infections caused by the Omicron variant.

“I think we have to be careful that we don’t become numb to the number of pediatric deaths because of the overwhelming number of older deaths here. Every life is important, ”he said.

Experts said persuading parents to get their children inoculated could be challenging, noting that less than a third of the five- to 11-years-olds have been vaccinated in the US, nearly eight months after jabs were approved for this age group.

Dr Sonja Rasmussen, a pediatrician at the University of Florida, said there are some families anxiously awaiting the opportunity to vaccinate their children but, as with older age groups, there will be some parents who want to “wait and see” and others who don ‘t want theirs to be vaccinated.

“Although young children are at lower risk for severe Covid-19, they’re not at risk – many children under the age of five have been hospitalized and some have died of Covid-19. If you have a safe vaccine that works, it makes sense to do what you can to reduce that risk of hospitalization and death. ”



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