Updated: 14 Sep 21 18:22 ET
By Madeline Holcombe, Holly Yan and Christina Maxouris, CNN
(CNN) – A COVID-19 vaccine for children ages 5 to 11 could get a green light from the US Food and Drug Administration sometime this fall, Dr. Anthony Fauci said.
“If you look at the studies that we’re doing in collaboration with the (National Institutes of Health) pharmaceutical companies, there will be enough data to apply for emergency use authorization by Pfizer, a little later by Moderna.” Fauci, director of the National Institute of Allergy and Infectious Diseases, told CNN’s Jake Tapper on Tuesday.
“I believe that both of them – first with Pfizer – will be able to be in a situation where we will be able to vaccinate children. If the FDA adequately judges the data, we can do it by the fall. are,” he said.
Also on Tuesday, Pfizer CEO Albert Boerla said that data on how the company’s Kovid-19 vaccine works in children aged 5 to 11 should be submitted to the FDA by the end of this month or the first week of October. . Vaccine data for young children will soon follow, he added.
“We’re also working on really young children as young as 6 months old, 6 months to 5 years old,” Borla said at an event organized by the ResearchAmerica Alliance. “Those data will be available after a month, a month and a half. So it will be the end of October, the beginning of November.”
FDA Acting Commissioners Dr. Janet Woodcock and Dr. Peter Marks, who heads the FDA’s vaccine division, said in a statement Friday that the agency will carefully review vaccine data for children 5 to 11 as it becomes available and “Ready to complete its review” as soon as possible, likely in a matter of weeks rather than months. “
But “the agency’s ability to rapidly review these submissions will depend on the quality and timeliness of submissions by producers,” he said.
how to keep kids safe
The United States has recorded an average of 171,394 new Covid-19 cases every day over the past week, according to data from Johns Hopkins University. This is 33% more than a month ago.
And over the past week, an average of 1,843 Americans have died from Covid-19 every day, according to data from Johns Hopkins. This is almost triple the average daily death rate a month ago.
Covid-19 cases are also increasing among children, as schools have welcomed back students – in many cases without masks. The American Academy of Pediatrics said on Monday that the latest weekly count of new pediatric cases — 243,373 — is a nearly 240% increase since July.
Fauci said Wednesday that factors, including school reopenings without proper masking, have contributed to the increase.
“Also, we’ve realized that this is happening in the context of the delta version, which is remarkably more transmissible, so we’re getting more cases in everyone,” Fauci said. “When you get a highly contagious virus that’s circulating around the community, you’ll see a lot more kids get infected.
He said that masks and vaccines are important to keep children safe in schools.
“If you surround kids with vaccinated people and you make everyone wear masks, you can get into a situation where kids will be relatively safe at school,” Fauci said.
But the wearing of masks in schools remains a subject of much debate. In New York, two Long Island public school districts are suing the governor and the state health commissioner over a statewide school mask mandate imposed before the start of the school year.
In Ohio, Governor Mike Devin said Tuesday that children’s hospitals are overwhelmed with COVID and respiratory cases and encouraged schools to issue mask mandates. More than 54% of the state’s public school students are subject to the mask requirement. The governor said he had not implemented the statewide mandate because the state legislature had made it clear that he would “remove it” and create further confusion.
“Reasonable people may disagree with many, but we can all agree that we should put our kids in the classroom,” Devin said.
In Iowa, a federal judge on Monday issued a temporary restraining order that would allow state school districts to make masks mandatory in classrooms. The state government will appeal, said Kim Reynolds, who in May signed a law that prohibits local entities and school districts from issuing their own mask mandates.
Reynolds said, “Today, a federal judge unilaterally overturned a state law, ignored the decision of our elected legislature and took away a parent’s ability to decide what is best for their child.” What’s good.”
Des Moines Public School superintendent Thomas Ahart called the court’s decision “welcome news.” Effective Wednesday, students, staff and visitors will be required to wear masks at Des Moines schools, the district said in a news release.
Local leaders protesting against the mandate
There is tension in various states over the mandate for both vaccines and masking.
Despite Texas Gov. Greg Abbott’s restrictions on who can make vaccinations mandatory, the San Antonio Independent School District requires district employees to be vaccinated against the virus. Texas Attorney General Ken Paxton filed a lawsuit Monday against the district and Superintendent Pedro Martinez over the mandate.
“The decision to dedicate district resources to openly violating state law and defending Superintendent Martinez’s illegal actions is irresponsible,” Paxton said in a news release. “But if school districts decide to use their limited funds to avoid breaking the law, my office will oppose them and uphold the rule of law in Texas.”
Following President Joe Biden’s announcement that businesses with more than 100 employees would require their employees to be vaccinated or tested regularly, Florida Gov. The latter will be required to show proof of recovery, with a $5,000 fine per violation.
The mayor of Orange County, Florida, said that although the consequences could be costly, the county would not ignore the well-being of its community.
“That could be a lot of money. There’s no question about it,” Mayor Jerry Demings said at a news conference in reference to the fine. “At the end of the day, protecting a large group of people in our community, It is our goal to keep them safe. That is the fundamental role of the government.”
The debate over booster doses
The need and timing of vaccine booster doses is also being debated.
The Biden administration announced plans to introduce a third dose early next week, pending FDA approval, but some experts say it’s not needed yet.
But an international group of vaccine scientists, including some from the US Food and Drug Administration and the World Health Organization, published a paper in The Lancet on Monday saying current evidence does not support the need for booster shots in the general public. .
The paper’s authors include two senior FDA vaccine leaders, Dr. Philip Krauss and Marion Gruber, who will step down in October and November, the FDA announced late last month.
Dean of the National School of Tropical Medicine at Baylor College of Medicine, Dr. Peter Hotez said he has seen evidence that boosters can “keep people out of hospital, prevent long-term COVID … and disrupt asymptomatic transmission.”
“From Israel’s data, I stand strongly in favor of the booster,” Hotez said.
The FDA is due to meet on Friday about the booster, although the agency has been late in getting the data to its panel of outside vaccine experts, two sources told CNN.
FDA spokeswoman Stephanie Cacomo told CNN that committee members will receive the materials before the meeting.
“Our vaccine team is working round the clock on several priorities, including preparing for Friday’s (Vaccine and Related Biological Products Advisory Committee) meeting,” she said.
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