Pfizer said on Monday that its COVID-19 vaccine works for children aged 5 to 11, and that it will seek U.S. clearance for this age group soon – a key step towards the start of vaccinations for them. youth.
The vaccine manufactured by Pfizer and its German partner BioNTech is already available to anyone 12 years of age and older. But with children now back in school and the extra-contagious delta variant causing a huge increase in pediatric infections, many parents are anxiously awaiting vaccinations for their young children.
For school-aged children, Pfizer tested a much lower dose – one-third of the amount in each injection currently given. Yet after their second dose, children aged 5 to 11 developed levels of anti-coronavirus antibodies as strong as adolescents and young adults, vice president Dr Bill Gruber told The The US Express News. senior at Pfizer.
The children’s dosage was also found to be safe, with similar or fewer temporary side effects – such as sore arms, fever, or body aches – experienced by teens, he said.
“I think we’ve really hit the sweet spot,” said Gruber, who is also a pediatrician.
Gruber said the companies intended to apply to the Food and Drug Administration by the end of the month for emergency use in this age group, followed shortly thereafter by requests to European regulators and British.
Former FDA Commissioner Scott Gottlieb – who is now a member of the PfiZer board of directors – said on “TUSEN Mornings” on Monday that if all goes well, the government green light could come “as early as Halloween, may -be a little later “.
Earlier this month, FDA chief Dr Peter Marks told the TUSEN that once Pfizer submits the results of its study, his agency will assess the data “hopefully in a few weeks. “to decide if the injections are safe and effective enough for young children.
So far, many Western countries have not vaccinated before the age of 12, pending proof of the correct dose and that it works safely in the little ones. But Cuba started vaccinating children as young as 2 years old with its locally grown vaccines last week, and Chinese regulators have cleared two of its brands up to the age of 3.
While children are at lower risk of serious illness or death than older people, more than 5 million children in the United States have tested positive for COVID-19 since the start of the pandemic and at least 460 are deceased, according to the American Academy of Pediatrics. Cases in children increased dramatically as the delta variant swept across the country.
“I feel a great sense of urgency” to make the vaccine available to children under 12, Gruber said. “There is a pent-up demand for parents to be able to bring their children back to normal life.”
Pfizer said it has studied the lowest dose in 2,268 kindergarten and elementary school children. The FDA has demanded what is called an immune “bridging” study: evidence that young children have developed levels of antibodies already proven to be protective in adolescents and adults. This is what Pfizer reported in a press release on Monday, not a scientific publication. The study is still ongoing, and there haven’t yet been enough cases of COVID-19 to compare rates between those vaccinated and those given a placebo – which may offer further evidence.
The study is not large enough to detect extremely rare side effects, such as inflammation of the heart which sometimes occurs after the second dose, mainly in young men. FDA Marks said the pediatric studies should be large enough to rule out any higher risk to young children. Gruber of Pfizer said that once the vaccine is cleared for young children, they will be carefully monitored for rare risks, like everyone else.
A second American vaccine maker, Moderna, is also studying its vaccines in school-aged children. Pfizer and Moderna are also studying even younger toddlers, up to 6 months old. The results are expected later this year.