Pfizer-BioNTech to submit children COVID-19 vaccine data in ‘days’ for approval

Pfizer’s CEO says "it’s a question of days, not weeks" before the company and German partner BioNTech submit data to U.S. regulators for federal authorization of a COVID-19 vaccine for children age 5 to 11.

That would be an important step toward starting vaccinations for those youngsters, especially with kids now back in school and the delta variant resulting in a big jump in pediatric infections.

Pfizer said last week that its vaccine works for that age group and that it tested a much lower dose of the vaccine that’s already available for anyone 12 and older. The company said that after children age 5 to 11 got their second dose during testing, they developed coronavirus-fighting antibody levels just as strong as teenagers and young adults getting the regular-strength shots.

RELATED: Moderna to add more children to COVID-19 vaccine studies at FDA’s request

Pfizer CEO Albert Bourla said Sunday that if the Food and Drug Administration approves the company’s application, "we will be ready with our manufacturing to provide this new formulation of the vaccine."

And when it comes to the coronavirus pandemic, he told ABC’s "This Week" that within a year, "I think we will be able to come back to normal life. I don’t think that this means that variants will not be continuing coming. And I don’t think that this means that we should be able to live our lives … without having vaccinations, basically."

Bourla also said "we will have vaccines that … will last at least a year’’ and that "the most likely scenario, it is annual revaccinations."

Meanwhile, Moderna said it hopes to have authorization for the COVID-19 vaccine in younger children by late 2021 or early 2022.

A recent report shows more than one in four coronavirus cases are among children — the highest ratio since the pandemic began, raising more questions about how best to keep kids safe as the highly infectious delta variant continues to surge.

According to the report by the American Academy of Pediatrics (AAP), children typically represent around 15% of total cumulated cases since the pandemic began.

This news comes as the delta variant continues to affect many people — mainly among the unvaccinated — including children under 12 who are too young to be vaccinated.

RELATED: COVID-19 cases higher in schools without mask policies, CDC studies show

The U.S. Centers for Disease Control and Prevention released three studies highlighting the importance of using layered prevention strategies including universal masking to stop the spread of the novel coronavirus in schools.

The studies, published in the site’s "Morbidity and Mortality Weekly Report," found that school districts without a universal masking policy in place were more likely to have COVID-19 outbreaks. Nationwide, counties without masking requirements saw the number of pediatric COVID-19 cases increase nearly twice as quickly during this same period.

In late July, the AAP recommended universal masking in schools, even for those who are vaccinated against the virus that causes COVID-19.

But that has become a point of division among some school districts.

A Florida judge ruled this month that the state cannot enforce a ban on public schools mandating the use of masks to guard against the coronavirus, while an appeals court sorts out whether the ban is ultimately legal. Leon County Circuit Judge John C. Cooper lifted an automatic stay of his decision last week that Republican Gov. Ron DeSantis and state education officials exceeded their authority by imposing the blanket ban through executive order and tagging defiant pro-mask local school boards with financial penalties.

RELATED: Children participating in Moderna's COVID-19 vaccine trial talk to FOX 5 about their experience

A group of parents is suing a southwest Illinois school district over its mask mandate, asking a judge to allow their children to attend school without a mask. An attorney filed the suit on behalf of three parents who have nine children enrolled in Triad Community Unit School District 2, which imposed a mask mandate after Gov. J.B. Pritzker issued a coronavirus executive order over the summer requiring universal masking in Illinois schools.

The parents’ lawsuit asks a Madison County judge to approve temporary restraining orders that would allow their children to attend school without a mask, at least in the short term.

According to the CDC, people infected with the COVID-19 virus may be asymptomatic but still able to spread the virus to others.

Stephanie Weaver and The Associated Press contributed to this report. This story was reported from Los Angeles.
 

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