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Former FDA chief says COVID-19 vaccine could be approved for kids ages 5 and up by October

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American children between the ages of 5 and 11 could be eligible for the COVID-19 vaccine at the end of October, according to the former head of the Food and Drug Administration.

Scott Gottlieb, who headed the FDA under former President Donald Trump, says the emergency approval process for vaccinating young children could be completed in weeks.

Gottlieb, who sits on Pfizer’s board of directors, says the pharmaceutical giant is expected to file paperwork with the federal government as early as September to seek permission to vaccinate children.

“At best, given the timeline they just set up, you could potentially have a vaccine available for kids ages 5 to 11 by Halloween,” Gottlieb said. CBS’s Face the Nation.

“If all goes well, Pfizer’s data package is in order and the FDA finally makes a positive decision, I have confidence in Pfizer in the data they have collected.

Scott Gottlieb, who headed the FDA under former President Donald Trump, says the emergency approval process for vaccinating young children could be completed in weeks

An air traveler undergoes COVID-19 testing before boarding an El Al flight to Israel at JFK International Airport in New York on Aug. 5

An air traveler undergoes COVID-19 testing before boarding an El Al flight to Israel at JFK International Airport in New York on Aug. 5

Gottlieb, who sits on Pfizer's board of directors, says the pharmaceutical giant is expected to file paperwork with the federal government as early as September to seek permission to vaccinate children.  Approval may come before Halloween

Gottlieb, who sits on Pfizer’s board of directors, says the pharmaceutical giant is expected to file paperwork with the federal government as early as September to seek permission to vaccinate children. Approval may come before Halloween

“But this is really up to the Food and Drug Administration to make an objective determination.”

PFIZER-BIONTECH VACCINE AGAINST COVID-19

  • 16 years and older – Full FDA approval granted
  • Ages 12 – 15 – Emergency use authorization granted
  • Ages 5 – 11 – Awaiting Emergency Use Authorization

Pfizer has conducted trials of its two-dose vaccine in children over two years of age.

Pfizer and BioNTech plan to seek approval soon for their COVID-19 vaccine in children ages five to 11.

Dr Özlem Türeci, chief physician of BioNTech, told the German news site of the mirror that the companies will soon release the results of their research in children under 12 and seek approval of the injection for emergency use from the FDA and other agencies.

“In the coming weeks, we will present the results of our study in the five-to-11-year-olds worldwide to authorities and apply for vaccine approval for this age group,” said Türeci.

She added that the vaccine formula is the same as that for adolescents and adults, but the dose is smaller.

Currently, the Pfizer vaccine is only approved for children ages 12 and older in both the US and the European Union.

Parents and doctors have debated whether or not to vaccinate children as they account for 0.1 percent of all Covid deaths in the US

As children return to school, vaccinating them is considered crucial to slowing the spread of COVID-19 and its highly contagious Delta variant.

A new report from the American Academy of Pediatrics finds that children are responsible for 26.8 percent of new weekly U.S. cases of COVID-19 — an unprecedented number since the pandemic began.

As of the week ending September 2, nearly 252,000 cases of COVID-19 in children were reported.

“Following a decline in early summer, childhood cases have increased exponentially, with more than 750,000 cases added between Aug. 5 and Sept. 2,” the AAP said.

While hospital admissions for pediatric COVID-19 are lower than for adults, they have risen sharply in recent weeks, reaching 0.41 per 100,000 children aged 0 to 17, compared to 0.31 per 100,000, the previous high in mid January, according to an August 13 report from the Centers for Disease Control and Prevention.

dr. Francis Collins, head of the National Institutes of Health, calls the spike in cases among children “very worrying.”

He noted that more than 400 American children have died from COVID-19 since the pandemic began.

Nevertheless, children are much less likely to have severe cases of COVID-19. In states reporting pediatric cases, children were responsible for less than a quarter of 1 percent of all COVID-19 deaths, according to National Public Radio.

Seven states reported no child deaths, while other states reported 0-0.03 percent of all COVID cases in children resulting in deaths.

The vaccine has already been approved for children between the ages of 12 and 15.

Gottlieb told Face the Nation he believes local public school districts will make the COVID-19 vaccine a requirement — as it has for other injections, including inoculation against measles and other infectious diseases.

“I think you’re going to see more local school districts and governors making recommendations,” he said.

“Ultimately, ACIP (the CDC’s advisory committee on immunization practices) is going to make a recommendation on whether this should be included in the childhood vaccination schedule.

“My guess is they are waiting for more of the vaccines to be fully approved to make those kinds of recommendations.

“But I would expect that eventually this will be necessary as part of the childhood vaccination schedule.”

When asked what he would say to parents who are hesitant to give their children a vaccine that has only received emergency use approval rather than full FDA approval, Gottlieb said it was not a “binary decision.”

“There are different ways to approach vaccination,” Gottlieb said.

“You could go with one dose for now. You may be able to wait for the lower-dose vaccine to become available, and some pediatricians may make that judgment.

“If your child has already had COVID, one dose may be enough. You could divide the doses more.’

He added, “So there’s a lot of discretion that pediatricians can exercise, largely off-label judgments, but exercise discretion in the context of what an individual child’s needs are, their risks, and what the parents’ concerns are.”

Gottlieb also predicted on Sunday that Johnson & Johnson will likely file a petition with the FDA for approval of a booster injection.

“They have very good data, also looking at boosters. They’ve responded well,” he said of Johnson & Johnson.

“And I think that vaccine could also be approved by the FDA in the near term.”

President Joe Biden last week called some Republican governors “cavalier” for opposing new federal vaccine requirements, which he hopes will include the soaring Delta variant.

Biden attended Brookland Middle School on Friday, just a short drive from the White House. He argued for new federal rules that could affect 100 million Americans.

All employers with more than 100 employees must be vaccinated or tested weekly for the virus, which affects approximately 80 million Americans.

About 17 million health facility workers who receive federal Medicare or Medicaid must also be fully vaccinated.

“I am so disappointed that some Republican governors in particular have been so arrogant with the health of these children, so arrogant with the health of their communities,” Biden said during the visit.

‘This is not a game’

Republicans and some union officials say he is exceeding his authority.

Asked about potential legal challenges to the new vaccine requirements, Biden replied, “Go ahead.”

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