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Pfizer says its COVID-19 vaccine works for children ages 5 to 11 and that it will seek US approval for this age group soon – a key step toward beginning vaccinations for youngsters.
The vaccine made by Pfizer and its German partner BioNTech already is available for anyone 12 and older. But with kids now back in school and the extra-contagious Delta variant causing a huge jump in pediatric infections, many parents are anxiously awaiting vaccinations for their younger children.
Pfizer tested a much lower dose, a third of the amount that is in each shot given now, in young children.Credit:AP
For primary school-aged kids, Pfizer tested a much lower dose – a third of the amount that is in each shot given now. Yet after their second dose, children ages 5 to 11 developed coronavirus-fighting antibody levels just as strong as teenagers and young adults, Dr Bill Gruber, a Pfizer senior vice-president, told The Associated Press.
The kid dosage also proved safe, with similar or fewer temporary side effects – such as sore arms, fever or achiness – that teens experience, he said.
“I think we really hit the sweet spot,” said Dr Gruber, who is also a paediatrician.
He said the companies aim to apply to the Food and Drug Administration by the end of the month for emergency use in this age group, followed shortly afterward with applications to European and British regulators.
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 enough 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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