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FDA decision expected on Pfizer vaccine for 5- to 11-year-olds

Pfizer shows off kid-size doses of its COVID-19

Pfizer shows off kid-size doses of its COVID-19 vaccine in Puurs, Belgium. The vaccine appear safe and nearly 91% effective at preventing symptomatic infections in 5- to 11-year-olds, according to study details released Friday. Credit: AP

The first COVID-19 vaccine approval for children ages 5 to 11 could take a major step forward on Tuesday when an FDA advisory committee meets to discuss the request by Pfizer-BioNTech and make a recommendation.

The committee is expected to approve the request, and shots could be going into the arms of elementary school-age children as early as the first weeks of November, according to officials including the nation’s top infectious disease expert, Dr. Anthony Fauci.

Dr. Mundeep Kainth, who specializes in pediatric infectious diseases at Cohen Children’s Hospital in New Hyde Park, said the pending approval is a "big deal" that could soon trigger "thunderous applause" among medical experts.

"I think it’s another step forward in this cascade of paperwork that needs to be done for authorization," she said of Tuesday’s committee meeting. Approval is "kind of expected at this point because we have all seen the data that’s come out."

What to know

An FDA advisory committee is meeting on Tuesday to discuss a request by Pfizer-BioNTech to authorize the company's COVID-19 vaccine for children ages 5-11.

The next steps in the process are a decision by the FDA, informed by the advisory committee, and then a referral to the CDC for final say.

If the regulatory hurdles are cleared, as expected, Dr. Anthony Fauci and other top medical officials expect the vaccine to begin rolling out for the age group in the first and second weeks of November.

The Food and Drug Administration will forward its recommendation to the Centers for Disease Control and Prevention. The CDC should receive the FDA's decision by Nov. 2 or 3, Fauci said. The CDC has the final say on approval.

"So, if all goes well … it’s entirely possible, if not very likely" that vaccines will be available to that age group "within the first week or two of November," Fauci said Sunday on ABC News’ "This Week."

"You never want to get ahead of the FDA and their regulatory decisions," he said. But, he added, "The data look good as to the efficacy and the safety" of the vaccine for children.

A significant moment in the COVID-19 fight

The approval would mean 28 million more people will be eligible for the vaccine as the United States strives to shut down the virus by getting as many people vaccinated as possible. The virus has killed more than 700,000 people — the most of any country.

The two-dose regimen of Pfizer shots about a month apart means millions of schoolchildren could be fully vaccinated by the Christmas holiday season.

The Pfizer shots would be 10-microgram doses, a third of the amount given to adults. The vaccine is nearly 91% effective for children between 5 and 11, according to the pharmaceutical company's study released Friday. The benefits of the vaccine in that age group outweighed the risks of not getting vaccinated, according to the FDA.

Some parents have been clamoring for weeks for the shots to be approved for that age group, as school resumed, the delta variant spread, and case numbers, hospitalizations and deaths from COVID-19 spiraled upward.

But many parents also are hesitant to get young children vaccinated, despite medical experts’ assertions that the shots are safe. Just over half of parents with kids under age 12 say they would vaccinate their child, according to a Gallup Poll released late last month.

Medical experts say vaccines are necessary for children because, while they often are not as severely affected as adults by COVID-19, substantial numbers do get infected, and some are hospitalized or even die from the virus.

As of Oct. 21, nearly 6.3 million children have tested positive for COVID-19 since the onset of the pandemic, according to the American Academy of Pediatrics. While the number of new weekly cases has dropped from a pandemic high of 252,000 the week of Sept. 2, this past week still saw 118,000 new cases, the academy said, calling it "an extremely high number of newly diagnosed children."

More than 1 million child cases were added over the past six weeks, the academy said.

Children 12 to 17 have been eligible for vaccination since May, though vaccination rates in that age group have lagged behind adults.

Moderna said Monday that a low dose of its COVID-19 vaccine is safe and appears to work in 6- to 11-year-olds, as that manufacturer also moved toward expanding shots to children.

Dr. Rochelle Walensky, the director of the CDC, indicated on Sunday that the decisions on the Pfizer vaccine would not be delayed.

"We know how many parents are interested in getting their children vaccinated, and we intend to work as quickly as you can," Walensky said on "Fox News Sunday."

How the vaccine rollout could work

The federal government is already preparing to dole out up to 20 million doses of the Pfizer pediatric vaccine if it is approved. The Biden administration says it expects to ship out millions of doses, along with smaller needles used for vaccinating children, within a week of approval.

The rollout of the vaccine will look different than the process for adults and teenagers. Medical experts expect pediatricians working in their offices to play a key role, rather than mass vaccination sites run by government workers.

"It’s mostly going to be pediatrician-driven because pediatricians are just vaccine experts," Kainth said. "That’s their bread and butter. That’s what we do all the time."

She added that "this is a great venue to actually have a conversation," including with parents who may be reluctant to give their children the shot.

Gov. Kathy Hochul also has floated the idea of using schools as vehicles for vaccinating children. Kainth said doctors may also set up "clinics" with specified times when families can come in to get their children inoculated. Local pharmacies and community clinics also will be used as officials rely on trusted messengers to encourage vaccinations and combat hesitancy.

Meanwhile, the virus continued to persist on Long Island and throughout the state, according to state data released Monday.

The seven-day average for positivity in testing for the virus continued a slow general decline, hitting 2.19% in test results from Sunday. The statewide average was 2.10%.

Nassau County registered 155 new daily cases on Sunday, while Suffolk tallied 224, for a total of 399. New York City logged 699.

Across the state, 28 people died on Sunday of COVID-19-related causes, including three in Suffolk.

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