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Pfizer will ask US FDA for approval of its vaccines in 5-11 year-olds ‘in days’

We’ve not yet finished debating the vaccination of 12-15 year-olds. But Pfizer’s CEO, who hinted at “annual re-vaccinations” against COVID over the weekend, is already looking to go one step further by asking the US Food and Drug Administration (FDA) to authorise the use of its vaccine in even younger children “within days”. MailOnline has the story.

On Sunday, in an appearance on ABC’s This Week, Albert Bourla was asked when the country should expect the shots to be approved in kids between ages five and 11.

The New York-based firm, along with its German partner BioNTech, recently released data that it said showed the vaccine was safe and effective in a smaller doses in elementary schoolers.

“I think we are going to submit this data pretty soon,” Bourla told host George Stephanopoulos.

“It’s a question of days, not weeks, and then it is up to FDA to be able to review the data and come to their conclusions and approve it or not.”

According to clinicaltrials.gov, Pfizer’s study in younger children worked similarly to the way it did in older children and adults.

A total of 4,500 younger kids from ages six months to 11 years were enrolled at nearly 100 clinical trial sites in 26 U.S. states, Finland, Poland and Spain

About half of the ages five-to-11 group were given two doses 21 days apart and the other half were given placebo shots.

The team then tested the safety, tolerability and immune response generated by the vaccine by measuring antibody levels in the young subjects.

Pfizer said it had selected lower doses for COVID vaccine trials in children than are given to teenagers and adults.

Those aged 12 and older receive two 30 microgram (μg) doses of the vaccine.

However, children between ages five and 11 were given 10 μg doses and kids from six months to four years old will receive three μg doses.

Bourla assured that Pfizer would be ready to ship these smaller doses across the country if the FDA authorises the shot in younger children.

‘If they approve it, we will be ready with our manufacturing to provide this new formulation of the vaccine,’ he told This Week.

‘Because the vaccine that the kids will receive…it’s a different formulation. It’s one-third of the dose we are giving to the rest of the population.’

Unlike the larger clinical trial conducted in adults, the pediatric trial did not measure efficacy by comparing the number of COVID cases among the vaccine group to the number in the placebo group.

Instead, scientists looked at levels of neutralizing antibodies in young vaccine recipients and compared the levels to those seen in adults.

The companies expect data on how well the vaccine works in children between ages two and five and between six months and two years of age by the end of the year.

Recently, pediatric cases also increased from 71,726 per week at the beginning of August to more than 243,000 earlier this month, fueled by the Delta variant.

However, they now appear to be trending downward with 225,000 reported last week, according to the American Academy of Pediatrics.

There have also been 480 pediatric deaths since the start of the pandemic, indicating children make up less than 0.1 percent of all deaths.

Currently, no evidence suggests the Delta variant is more dangerous in kids than previous strains of the virus.

Because of this low risk of severe illness, polls have shown that many parents are not inclined to vaccinate their children.

In an April 2021 poll, conducted by the Kaiser Family Foundation, parents were asked if they would get their child immunized once a COVID-19 vaccine is authorized and available for their child’s age group.

Among parents of those between ages five and 11, 27 percent said they would get their child vaccinated ‘right away’ and 32 percent said they would wait and see how it’s working.

Nineteen percent said they only plan to vaccinate their children if their school requires it and an additional 19 percent said their child will definitely not be getting vaccinated.

A July 2021 survey, conducted by CS Mott Children’s Hospital National Poll on Children’s Health at Michigan Medicine found similar results.

Among parents of children from ages three to 11, 49 percent said it was likely their kids would be getting a vaccine and 51 percent said it was unlikely.

Source: Michael Curzon – The Daily Sceptic