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American coronavirus: vaccines for young children could be authorized this fall, according to Fauci

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“If you look at the studies that we (National Institutes of Health) are doing in conjunction with pharmaceutical companies, there will be enough data to apply for emergency use authorization both by Pfizer, later by Moderna. “Fauci, director of the National Institute of Allergy and Infectious Diseases, told CNN’s Jake Tapper Tuesday.

“I think both – with Pfizer first – will most likely be able to have a situation where we can vaccinate children. If the FDA deems the data sufficient enough, we could do so by fall.” , he added.

Also on Tuesday, Pfizer CEO Albert Bourla said data on how the company’s Covid-19 vaccine works in children ages 5 to 11 is expected to be submitted to the FDA by the end of this month or so. the first week of October. Data on vaccines for young children will follow soon, he added.

“We are also working with younger children up to the age of 6 months, between 6 months and 5 years old,” Bourla said at an event organized by the ResearchAmerica Alliance. “This data will be available a month, a month and a half later. So it will be late October, early November.”

Acting FDA Commissioner Dr Janet Woodcock and Dr Peter Marks, who heads the FDA’s vaccines division, said in a statement on Friday that the agency would carefully review data from a vaccine for children of 5 to 11 years once he was available and she was “ready to complete her exam as quickly as possible, probably within weeks rather than months.”

But “the agency’s ability to quickly review these submissions will depend in part on the quality and timeliness of submissions by the manufacturers,” they added.

How to keep children safe

The United States has recorded an average of 171,394 new cases of Covid-19 every day over the past week, according to data from Johns Hopkins University. This is a 33% increase from a month ago.

And over the past week, an average of 1,843 Americans have died each day from Covid-19, according to data from Johns Hopkins. That’s almost triple the average daily death rate from a month ago.

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Cases of Covid-19 are also increasing among children, as schools have taken in students again – in many cases without a mask warrant. The latest weekly tally of new pediatric cases – 243,373 – marks an increase of about 240% since July, the American Academy of Pediatrics said Monday.

Factors such as the reopening of schools without proper masking likely contributed to the increase, Fauci said on Wednesday.

“Also, we have to realize that this is happening in the context of the Delta variant, which is remarkably more transmissible, so we are getting more cases for everyone,” Fauci said. “When you catch a highly transmissible virus that is circulating in the community, you will see many more children getting infected.

Masks and vaccines are essential to keep children safe in schools, he added.

“If you surround the children with vaccinated people and everyone wears a mask, you can achieve a situation where the children will be relatively safe in school,” Fauci said.

But putting on compulsory masks in schools remains a hotly debated subject. In New York City, two Long Island public school districts are suing the state governor and health commissioner over a statewide school mask mandate before the start of the school year.

In Ohio, Governor Mike DeWine said Tuesday children’s hospitals are inundated with Covid and respiratory cases and encouraged schools to issue mask warrants. Just over 54% of students in public schools across the state have a mask requirement. The governor said he had not implemented a statewide mandate because the state legislature made it clear that it would “withdraw” and create further confusion.

“Reasonable people can disagree on a lot of things, but we can all agree that we need to keep our kids in the classroom,” DeWine said.

In Iowa, a federal judge on Monday issued a temporary restraining order that will allow school districts across the state to impose masks in classrooms. The state will appeal, said Gov. Kim Reynolds, who signed a law in May prohibiting local entities and school districts from issuing their own mask warrants.

“Today a federal judge unilaterally struck down a state law, ignored the decision of our elected legislature and deprived parents of the ability to decide what is best for their child,” Reynolds said.

Des Moines Public Schools Superintendent Thomas Ahart called the court’s decision “good news.” Starting Wednesday, students, staff and visitors will be required to wear masks in schools in Des Moines, the district said. Press release.
A healthcare worker vaccinates a teenager at West Philadelphia High School in Philadelphia.

Local leaders disagree over mandates

There have been tensions in various states over warrants for vaccines and masking.

Florida Governor Ron DeSantis threatens to fine counties and cities in states for vaccination warrants

Despite Texas Governor Greg Abbott’s restrictions on who can be vaccinated, the San Antonio Independent School District has demanded that district employees be vaccinated against the virus. Texas Attorney General Ken Paxton filed a lawsuit Monday against the district and Superintendent Pedro Martinez over the warrant.

“The decision to openly violate state law and devote district resources to defending Superintendent Martinez’s unlawful actions is irresponsible,” Paxton said in a press release. “But if school districts decide to use their limited funding to try to break the law, my office will stand against them and uphold the rule of law in Texas.”

Following President Joe Biden’s announcement that companies with more than 100 employees must require their staff to be vaccinated or tested regularly, Florida Gov. Ron DeSantis said cities and counties in Florida requiring employees to show proof of vaccination or post-infection recovery will face $ 5,000 in fines per violation.
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The mayor of Orange County, Florida has said that while the consequences can be costly, the county will not neglect the well-being of its community.

“It could be a lot of money. There is no doubt about it,” Mayor Jerry Demings said at a press conference in reference to the fines. “At the end of the day, our goal is to protect all of the people in our community, to keep them safe. This is the fundamental role of government.

Debate on booster doses

There is also debate about the need and timing of booster doses of the vaccine.

The Biden administration had announced plans to roll out a third dose as early as next week, pending FDA approval, but some experts say it is not yet necessary.

But an international group of vaccine scientists, including some from the United States Food and Drug Administration and the World Health Organization, published an article in The Lancet on Monday claiming that current evidence does not appear to support the claim. need for booster vaccines in the general public at this time. .

Two early FDA leaders among scientists who say Covid-19 vaccines

The authors of the article include two senior FDA vaccine officials, Dr Philip Krause and Marion Gruber, who will step down in October and November, the FDA announced late last month.

Dr Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine, said he had seen evidence that boosters could “keep people out of hospital, prevent long Covid … and could re-establish the interruption of asymptomatic transmissions “.

“From Israel’s data, I am strongly in favor of boosters,” Hotez said.

The FDA is due to meet on the recalls on Friday, although the agency has been slow to provide data to its panel of outside vaccine experts, two sources told CNN.

Committee members will receive documents ahead of the meeting, FDA spokeswoman Stephanie Caccomo told CNN.

“Our immunization team is working tirelessly on many priorities, including preparation for Friday’s meeting (Advisory Committee on Vaccines and Related Biologics),” she said.

CNN’s Deidre McPhillips, Jen Christensen, Virginia Langmaid, Raja Razek, Lauren Clabby Moore, Leyla Santiago, Amy Simonson and Laine Mackey contributed to this report.

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2/ https://www.cnn.com/2021/09/14/health/us-coronavirus-tuesday/index.html

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