U.S. children ages 5 to 11 could opt for the COVID-19 vaccine in late 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 process for approving emergency use to vaccinate young children could be done in a matter of weeks.
Gottlieb, who is on Pfizer’s board of directors, says the pharmaceutical giant is expected to file formalities with the federal government seeking permission to vaccinate the children as early as September.
“At best, given the timeline they just defined, you might have a vaccine available for kids ages 5 to 11 for Halloween,” Gottlieb told CBS’s Face the Nation.
“If all goes well, the Pfizer data package is in order and ultimately the FDA makes a positive determination, I have confidence in Pfizer in terms of the data they have collected.
Scott Gottlieb, who headed the FDA under former President Donald Trump, says the process of approving emergency use to vaccinate young children could be done in a matter of weeks
An air traveler takes a COVID-19 test before boarding a flight from El Al to Israel at New York’s JFK International Airport on August 5
Gottlieb, who is on Pfizer’s board of directors, says the pharmaceutical giant is expected to file formalities with the federal government seeking permission to vaccinate the children as early as September. Approval could arrive before Halloween
“But it’s really up to the Food and Drug Administration to make an objective determination.”
Pfizer has conducted trials of its two-dose vaccine in children older than two years.
Pfizer and BioNTech are soon planning to apply for the COVID-19 vaccine in children ages five to 11.
Dr. Özlem Türeci, chief physician of BioNTech, told the German news site Der Spiegel that the companies will publish the results of their study in children under 12 and that they will ask the FDA and others to authorize the shooting for the emergency use authorization. agencies.
“In the coming weeks we will present the results of our study on children aged five to 11 around the world to the authorities and request the approval of the vaccine for this age group,” Türeci said.
He added that the formula of the vaccine 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 12 years of age and older in the United States and the European Union.
Parents and doctors have debated whether or not to inoculate children because they account for 0.1 percent of all covetous deaths in the U.S.
When children return to school, vaccinating them is considered crucial to curb 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 cases of COVID-19 in the United States, an unprecedented number since the start of the pandemic.
In the week ending Sept. 2, nearly 252,000 childhood cases of 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.
Although COVID-19 pediatric hospitalization rates are lower than those of adults, they have increased in recent weeks to 0.41 per 100,000 children aged 0 to 17 years, compared with 0.31 per 100,000. , the previous maximum set in mid-January, according to a month of August. 13 report of the Centers for Disease Control and Prevention.
Dr. Francis Collins, head of the National Institutes of Health, considers the rise in cases among children to be “very worrying.”
He noted that more than 400 U.S. children have died of COVID-19 since the pandemic began.
However, children are much less likely to have severe cases of COVID-19. In states that reported pediatric cases, children accounted for less than a quarter of 1 percent of all deaths from COVID-19, according to National Public Radio.
Seven states did not report infant deaths, while other states reported 0-0.03 percent of all COVID cases in children that caused the death.
The vaccine is already authorized for children between 12 and 15 years old.
Gottlieb told Face the Nation that he believes local public school districts will make the COVID-19 vaccine a requirement, as he has done for other traits, including inoculation against measles and other infectious diseases.
“I think you’ll see more local school districts and governors make those recommendations,” he said.
“Finally, ACIP (the CDC Advisory Committee on Immunization Practices) will make a recommendation on whether it should be included in the childhood vaccination program.
“I guess they are waiting for more vaccine licenses to get that kind of recommendation.
“But I would like to hope that it will eventually be required as part of the childhood vaccination program.”
When asked what he would say to parents who are hesitant to give their children a vaccine that has only received emergency use authorization instead of full FDA approval, Gottlieb said it was not a ” binary decision “.
“There are different ways to approach vaccination,” Gottlieb said.
“You can go with a dose for now. You could expect the vaccine with lower doses to be available and some pediatricians can make that judgment.
“If your child already had COVID, one dose may be enough. Doses may be more spaced.
He added: “Thus, there is a lot of discretion that can be exercised by pediatricians, making judgments largely off-label, but exercising discretion in the context of an individual child’s needs, risk, and parental concerns. “.
Gottlieb also predicted Sunday that Johnson & Johnson is likely to file an application with the FDA for approval of a booster shot.
‘They have very good data on the drivers as well. They have shown a good response, ‘he said of Johnson & Johnson.
“And I think the vaccine could also be in a position to be authorized by the FDA in the short term.”
President Joe Biden last week called on some Republican governors as “gentlemen” to resist the new federal vaccine requirements he hopes to contain the growing Delta variant.
Biden visited Brookland Middle School on Friday, a short drive from the White House. He was advocating for new federal rules that could affect 100 million Americans.
All employers with more than 100 workers must be vaccinated or tested weekly to detect the virus, affecting about 80 million Americans.
About 17 million health care workers receiving Medicare or federal Medicaid must also be fully vaccinated.
“I am so disappointed that particularly some Republican governors have been so gentlemen with the health of these children, so gentlemen with the health of their communities,” Biden said during the visit.
“This is not a game”
Republicans and some union officials say he is overstepping his authority.
Asked about possible legal challenges for the new vaccine requirements, Biden replied, “Be aware of that.”