According to Dr. Anthony Fauci, the US Food and Drug Administration may approve the Covid-19 vaccines for children sometime this fall.
Fauci, the director of the National Institute of Allergy and Infectious Diseases, in his CNN interview said, “If you look at the studies that we at the (National Institutes of Health) are doing in collaboration with the pharmaceutical companies, there will be enough data to apply for an emergency use authorization both by Pfizer, a little bit later by Moderna.”
“I believe both of them — with Pfizer first — will very likely be able to have a situation where we’ll be able to vaccinate children. If the FDA judges the data sufficient enough, we could do it by the fall,” he added.
Pfizer CEO Albert Bourla said on Tuesday, that they will be submitting the data on how the company’s Covid-19 vaccine works in children between 5 and 11 to the FDA by the end of this month or the first week of October. Then, they’ll submit the vaccine data for younger children after that, he added.
At an event hosted by the ResearchAmerica Alliance, Bourla shared, “we are working also on younger kids actually all the way down to 6 months old, between 6 months all the way to 5 years old.
Those data will be available a month, month, and a half later. So it will be the end of October, beginning of November.”
FDA said they will review the data for the vaccine for 5 to 11-year-old children carefully once they receive it and they are prepared to speed up the review into weeks rather than months, according to the acting FDA Commissioner Dr. Janet Woodcock and Dr. Peter Marks, who is currently heading the FDA’s vaccine division.
However, “the agency’s ability to review these submissions rapidly will depend in part on the quality and timeliness of the submissions by manufacturers,” they added.
Keeping Your Children Safe
Over the past week, the Covid-19 cases in the US have averaged 171,394 daily. This data from John Hopkins University shows that there is a 33% increase from last month.
In addition, the same data shows an average of 1,843 American lives were lost daily from Covid-19. That is three times more than the daily average from last month.
There has been a Covid-19 surge among children, too, since students are back to school and some have no rules on masking.
According to the latest weekly count of new cases in children, a 240% increase was observed since July with the 243,373 new cases according to the American Academy of Pediatrics.
Fauci said on Wednesday that the reopening of schools without masking mandates has likely caused this increase.
“Also, we’ve got to realize that this is happening in the context of the Delta variant, which is remarkably more transmissible, so we’re getting more cases in everyone,” Fauci added.
“When you get a highly transmissible virus that’s going around the community, you’re going to see a lot more children get infected.”
He reiterated that masks and vaccines are key to keeping children safe in schools.
“If you surround the kids with vaccinated people and you have everybody wear a mask, you can get a situation where the children will be relatively safe in school,” Fauci said.
However, implementing mask mandates in schools continues to be a heavily debated issue.
Two Long Island public school districts in New York are filing a case against the governor and state health commissioner for imposing a mask mandate in schools statewide before the start of the school year.
Children’s hospitals in Ohio are overwhelmed with the rise in Covid and respiratory cases, according to Gov. Mike DeWine on Tuesday. He encouraged schools to implement masking.
Currently, only 54% of the state’s public schools have imposed mask mandates. The governor added that a full statewide mask mandate implementation is not yet done because according to the state’s legislature, they will “take it off” and create further confusion.
“Reasonable people may disagree about a lot, but we can all agree that we must keep our children in the classroom,” DeWine said.
On Monday, a federal judge in Iowa issued a temporary restraining order allowing the state’s school districts to implement masking rules in classrooms. Gov. Kim Reynolds, who signed a law banning local entities and school districts from issuing their own mask mandates in May, said the state will appeal.
“Today, a federal judge unilaterally overturned a state law, ignored the decision by our elected legislature, and took away parents’ ability to decide what’s best for their child,” Reynolds said.
Thomas Ahart, Des Moines Public Schools Superintendent, called the court’s decision “welcome news.”
In Des Moines schools, students, staff, and visitors will be required to wear masks effective Wednesday, according to the district’s new release.
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The Conflict Between Local Leaders and Mandates
Vaccine and masking mandates have caused some tension in different states.
Despite Texas Gov. Greg Abbott’s restrictions on who can mandate vaccinations, The San Antonio Independent School District has mandated vaccination among its district employees, despite the restrictions of Texas Gov, Greg Abbott on who can mandate vaccinations.
On Monday, Texas Attorney General Ken Paxton filed a lawsuit against the district and Superintendent Pedro Martinez because of this action.
In a news release, Paxton said, “The decision to openly violate state law and devote district resources to defending Superintendent Martinez’s unlawful actions is irresponsible.”
“But if school districts decide to use their limited funding to try to get away with breaking the law, my office will oppose them and uphold the rule of law in Texas.”
Despite President Joe Biden’s announcement for requiring workforce vaccination and regular testing of employees for businesses of more than 100 staff, Florida Gov. Ron DeSantis said that Florida cities and counties asking employees for proof of vaccination or post-infection recovery will be fined $5,000 per instance.
Orange County, Florida’s mayor said that despite the costly consequences, the county will not overlook its community’s well-being.
At a news conference, Mayor Jerry Demings in reference to the fines said, “It could be a lot of money. There is no question about it. At the end of the day, it is all of our goals to protect the greater collective of the people in our community, to keep them safe. That’s the fundamental role of government.”
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The Booster Doses Discourse
There is also a discussion on booster doses, when they should be given, and who needs them.
An announcement was made by the Biden administration that they are planning to roll out third doses as early as next week depending on FDA’s approval. However, according to some experts, it may not be needed yet.
However, an international group of vaccine scientists together with some members of the US FDA and the World Health Organization, published a paper in The Lancet on Monday that the general public may not need booster shots according to the current evidence.
Dr. Philip Krause and Marion Gruber, two senior FDA vaccine leaders stepping down in October and November, took part in writing the paper.
On the other hand, the dean of the National School of Tropical Medicine at the Baylor College of Medicine, Dr. Peter Hotez said he found some evidence that boosters may “keep people out of the hospital, prevent long Covid … and could restore interrupting asymptomatic transmissions.”
“From the data from Israel, I come out strongly in favor of the boosters,” Hotez said.
FDA is set to discuss boosters on Friday, but the agency has been late in gathering data from its panel of outside vaccine experts.
Stephanie Caccamo, the FDA spokesperson, informed CNN that the Committee members will get the materials before the meeting.
“Our vaccine team is working around the clock on many priorities, including preparing for Friday’s (Vaccines and Related Biological Products Advisory Committee) meeting,” she said.