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The vaccine made by Pfizer and its German partner BioNTech already is available for anyone 12 and older.Credit:Eddie Jim

Earlier this month,FDA chief Dr Peter Marks said once Pfizer turns over its study results,his agency would evaluate the data “hopefully in a matter of weeks” to decide if the shots are safe and effective for younger kids.

Many Western countries so far have vaccinated no younger than age 12,awaiting evidence of what is the right dose and that it works safely in smaller tots. But Cuba last week began immunising children as young as two with its homegrown vaccines and Chinese regulators have cleared two of its brands down to age three.

While kids are at lower risk of severe illness or death than older people,more than 5 million children in the US have tested positive for COVID-19 since the pandemic began and at least 460 have died,according to the American Academy of Pediatrics. Cases in children have risen dramatically as the Delta variant swept through the country.

Dr Gruber said he felt “a great sense of urgency” in making the vaccine available to children under 12. “There’s pent-up demand for parents to be able to have their children returned to a normal life,” he added.

Pfizer said it studied the lower dose in 2268 kindergarten students and primary school-aged kids. The FDA required what is called an immune “bridging” study:evidence that the younger children developed antibody levels already proven to be protective in teens and adults. That’s what Pfizer reported in a press release,not a scientific publication. The study still is ongoing,and there haven’t yet been enough COVID-19 cases to compare rates between the vaccinated and those given a placebo – something that might offer additional evidence.

The study isn’t large enough to detect any extremely rare side effects,such as the heart inflammation that sometimes occurs after the second dose,mostly in young men. Dr Marks said the paediatric studies should be large enough to rule out any higher risk to young children. Dr Gruber said once the vaccine is authorised for younger children,they’ll be carefully monitored for rare risks just like everyone else.

A second US vaccine maker,Moderna,also is studying its shots in primary school-aged children. Pfizer and Moderna are studying even younger toddlers as well,down to six-month-olds. Results are expected later in the year.

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