Pfizer says its COVID-19 vaccine is safe and effective in children aged 5 to 11 – .

Pfizer says its COVID-19 vaccine is safe and effective in children aged 5 to 11 – .

Pfizer said on Monday that its COVID-19 vaccine works for children aged 5 to 11, and that it will seek US 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 kids 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. 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 Associated Press. 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 – that teens experience, 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 Dr Scott Gottlieb – who is now a Pfizer board member – told “CBS Mornings” on Monday that if all goes well, the green light from the government could come “soon. Halloween – maybe a little later ”.

Earlier this month, senior FDA vaccine official Dr Peter Marks told the AP 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 younger children. kids.

“CBS Mornings” spoke to an 8-year-old boy who participated in the trial. “I think everyone should get the shot to get things back to normal,” Joshua Chung said.

His older brother, Caleb, had been involved in a vaccine trial for children 12 and older.

“I wanted to participate in the trial to help motivate other kids to get the vaccine once it becomes available,” Caleb said.

While children are at lower risk of serious illness or death than the elderly, more than 5 million children in the United States have tested positive for COVID-19[feminine[feminine since the start of the pandemic and at least 460 people have died, according to the American Academy of Pediatrics. Cases in children have dramatically increased 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 get their children back to normal life. “

Joshua and Caleb’s father, Dr Richard Chung, an adolescent medicine specialist at Duke Health in Durham, North Carolina, said he was proud of his sons’ participation in the trials.

“Watching them take this step with courage and enthusiasm has been a remarkable experience, not only as a pediatrician, but certainly as a father,” he said.

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.


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