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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 by 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 and now sits on the board of directors at Pfizer, says that the emergency use approval process for vaccinating young children could be done in a matter of weeks.

Gottlieb says the pharmaceutical giant is expected to file the paperwork with the federal government requesting authorization to vaccinate kids as early as September.

‘In a best-case scenario, given that timeline they’ve just laid out, you could potentially have a vaccine available to children aged 5 to 11 by Halloween,’ Gottlieb told CBS’s Face the Nation.

‘If everything goes well, the Pfizer data package is in order, and FDA ultimately makes a positive determination, I have confidence in Pfizer in terms of the data that they’ve collected.

The vaccine has already been granted emergency use approval for children between the ages of 12 and 15. 

Children are far less likely to have severe cases of COVID-19. In states reporting pediatric cases, children accounted for fewer than one-quarter of 1 percent of all COVID-19 deaths, according to National Public Radio

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

Scott Gottlieb, who headed the FDA under former President Donald Trump, says that the emergency use approval process for vaccinating young children could be done in a matter of weeks

Scott Gottlieb, who headed the FDA under former President Donald Trump, says that the emergency use approval process for vaccinating young children could be done in a matter of weeks

An air traveler takes a COVID-19 test before boarding an El Al flight to Israel at JFK International Airport in New York on August 5

An air traveler takes a COVID-19 test before boarding an El Al flight to Israel at JFK International Airport in New York on August 5

Gottlieb, who sits on the board of directors for Pfizer, says the pharmaceutical giant is expected to file the paperwork with the federal government requesting authorization to vaccinate kids as early as September. Approval could come before Halloween

Gottlieb, who sits on the board of directors for Pfizer, says the pharmaceutical giant is expected to file the paperwork with the federal government requesting authorization to vaccinate kids as early as September. Approval could come before Halloween

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

Who is the Pfizer Covid vaccine approved for?

  • Ages 16 and up – Full FDA approval granted
  • Ages 12 – 15 – Emergency use authorization granted 
  • Ages 5 – 11 – Pending request for emergency use authorization, could be approved by late next month

Pfizer has been conducting trials of its two-dose vaccine in children over the age of two.

Pfizer and BioNTech are soon planning to seek approval for their COVID-19 vaccine in children aged five to 11.

Dr Özlem Türeci, chief physician for BioNTech, told German news site Der Spiegel that the companies are set to shortly release results from their study in kids under age 12 and will ask for the shot to be approved for emergency use authorization by the FDA and other agencies.

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

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

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

Parents and doctors have been debating about whether or not to inoculate children because they make up 0.1 percent of all Covid deaths in the U.S.  

The US government says that is it essential to vaccinate children to slow the spread of COVID-19 and its contagious Delta variant.

A new report by the American Academy of Pediatrics (AAP) shows that children accounted for 26.8 percent of new weekly US cases of COVID-19 – an unprecedented number since the start of the pandemic.

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

But hospitalization and death rates for children are significantly lower than those for adults.

In recent weeks, 0.41 per 100,000 children ages 0 to 17 Have been hospitalized with COVID. 

This is a high, with the previous peak set in mid-January at 0.31 per 100,000, 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 recent spike in cases among children ‘very worrisome. He noted that over 400 US children have died of COVID-19 since the pandemic began.

‘After declining in early summer, child cases have increased exponentially, with over 750,000 cases added between August 5 and September 2,’ the AAP said.

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

‘I think you’re going to see more local school districts and governors make those recommendations,’ he said.

‘Eventually ACIP (the CDC’s Advisory committee on Immunization Practices) is going to make a recommendation about whether this should be included in the childhood immunization schedule.

‘My guess is they’re waiting for more of the vaccines to be fully licensed to make that kind of a recommendation.

‘But I would expect this eventually to be required as part of the childhood immunization schedule.’

When asked what he would say to parents who are hesitant to give their children a vaccine that has only been given emergency use authorization rather than full-fledged FDA approval, Gottlieb said it wasn’t a ‘binary decision.’

‘There’s different ways to approach vaccination,’ Gottlieb said.

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

‘If your child’s already had COVID, one dose may be sufficient. You could space the doses out more.’

He added: ‘So, there’s a lot of discretion that pediatricians can exercise, making largely off-label judgments, but exercising discretion within the context of what an individual child’s needs are, their risk is, and what the parents’ concerns are.’

Gottlieb also predicted on Sunday that Johnson & Johnson is likely to file a request with the FDA for approval of a booster shot.

‘They have very good data also looking at boosters. They’ve showed a good response,’ he said of Johnson & Johnson.

‘And I think that vaccine also could be in a position to get authorized by FDA in short order.’ 

President Joe Biden last week called some Republican governors ‘cavalier’ for resisting new federal vaccine requirements he hopes will contain the surging Delta variant.

Biden visited Brookland Middle School on Friday, just a short drive from the White House. He was making the case for new federal rules that could impact 100 million Americans.

All employers with more than 100 workers must be vaccinated or tested weekly for the virus, affecting about 80 million Americans. 

About 17 million workers at health facilities that receive federal Medicare or Medicaid also must be fully vaccinated.

‘I am so disappointed that particularly some Republican governors have been so cavalier with the health of these kids, so cavalier with the health of their communities,’ Biden said during the visit. 

‘This isn’t a game’

Republicans and some union officials say he’s overreaching his authority. 

Asked about potential legal challenges to the new vaccine requirements, Biden responded, ‘Have at it.’ 

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