Former FDA chief says COVID-19 vaccine could be approved for children 5 and older by October

American children aged 5 to 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 led the FDA under former President Donald Trump, said the emergency use approval process for immunizing young children could be completed in a matter of weeks.

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

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

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

“But it’s really up to the Food and Drug Administration to make an objective decision.”

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

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

Dr Özlem Türeci, chief medical officer of BioNTech, told German news site Der Spiegel that the companies are expected to publish the results of their study in children under 12 shortly and ask for the vaccine to be approved for use. emergency use authorization by the FDA and other agencies.

“In the coming weeks, we will present the results of our study on 5-11 year olds around the world to the authorities and seek vaccine approval for this age group,” Türeci said.

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

Currently, the Pfizer vaccine is only approved for children 12 years of age and older in the United States and the European Union.

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

With the children back to school, their vaccination is considered crucial in slowing the spread of COVID-19 and its highly contagious Delta variant.

A new report from the American Academy of Pediatrics shows that children accounted for 26.8% of new weekly COVID-19 cases in the United States – an unprecedented number since the start of the pandemic.

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

“After declining in early summer, children’s cases have increased exponentially, with more than 750,000 cases added between August 5 and September 2,” the AAP said.

While COVID-19 pediatric hospitalization rates are lower than adults, they have increased in recent weeks, reaching 0.41 per 100,000 children aged 0 to 17, from 0.31 per 100,000, the previous record set in mid-January, according to an August report. 13 Centers for Disease Control and Prevention report.

Dr Francis Collins, director of the National Institutes of Health, calls the spike in cases in children “very worrying.”

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

Nonetheless, children are much less likely to have severe cases of COVID-19. In states reporting pediatric cases, children accounted for less than a quarter of 1% of all deaths from COVID-19, according to National Public Radio.

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

The vaccine has already been licensed for children aged 12 to 15.

Gottlieb told Face the Nation he believes local public school districts will make the COVID-19 vaccine mandatory – as he has done for other vaccines, including inoculation against measles and other diseases infectious.

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

“Ultimately, ACIP (the CDC’s Advisory Committee on Immunization Practices) will make a recommendation as to whether this should be included in the childhood immunization schedule.

“I guess they wait until more vaccines are fully licensed to make that kind of recommendation.

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

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

“There are different ways of approaching vaccination,” Gottlieb said.

“You can take a dose right now. You could potentially wait until the lower dose vaccine is available, and some pediatricians can make that judgment.

“If your child has had COVID before, one dose may be enough. You may want to space the doses further apart.

He added: “So pediatricians can exercise a great deal of discretion, making judgments largely off-label, but exercising discretion in the context of a child’s needs, risk and parental concerns. . “

Gottlieb also predicted on Sunday that Johnson & Johnson would likely file with the FDA for approval of a recall.

“They have very good data regarding boosters as well. They showed a good response, ”he said of Johnson & Johnson.

“And I think this vaccine might also be able to be cleared by the FDA as soon as possible.”

President Joe Biden last week called some Republican governors “horsemen” for resisting new federal vaccine requirements that he hopes will contain the burgeoning Delta variant.

Biden visited Brookland Middle School on Friday, a short drive from the White House. He advocated 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 an estimated 80 million Americans.

About 17 million workers in healthcare facilities who receive federal Medicare or Medicaid also need to be fully immunized.

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

“It’s not a game”

Republicans and some union officials say he oversteps his authority.

Asked about the potential legal challenges associated with the new vaccine requirements, Biden replied, “Hang on.”