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Pfizer vaccine for young kids gets FDA approval, leaving one last step

Passing the baton to the CDC, the FDA granted Pfizer’s request to extend emergency-use authorization of its children’s vaccine to kids ages 5 to 11.

WASHINGTON (CN) — Getting permission to administer kid-sized doses from the Food and Drug Administration, Pfizer’s Covid-19 vaccine for children between ages 5 and 11 cleared another hurdle Friday in its race toward U.S. authorization.

Acknowledging parents and teachers across the country are eagerly awaiting a vaccine for children, acting FDA Commissioner Janet Woodcock issued a statement on the agency’s decision Friday on Pfizer’s request to modify its emergency use application. Its vaccine was previously allowed for emergency use only in kids ages 12 and up.

“Vaccinating younger children against Covid-19 will bring us closer to returning to a sense of normalcy,” Woodcock said. “Our comprehensive and rigorous evaluation of the data pertaining to the vaccine’s safety and effectiveness should help assure parents and guardians that this vaccine meets our high standards.”

Peter Marks, who heads the FDA’s Center for Biologics Evaluation and Research, emphasized that the decision was based on science. 

“We are confident in the safety, effectiveness and manufacturing data behind this authorization,” Marks said.

Pfizer is now just waiting for approval from the Centers for Disease Control and Prevention to begin distributing doses to up to 28 million elementary-age Americans. The agency’s advisers are scheduled to meet Tuesday to discuss the children’s vaccine and determine which subsets of the 5-to-11 population should receive it. A decision by CDC Director Rochelle Walensky is expected after the meeting.

Assuming the CDC approves the jab for youngsters, Dr. Anthony Fauci, the nation’s top infectious disease specialist, has said the shots could be available early next month.

“If all goes well, and we get the regulatory approval and the recommendation from the CDC, it's entirely possible if not very likely that vaccines will be available for children from 5 to 11 within the first week or two of November,” Fauci said on ABC's "This Week" on Sunday.

Like adults, children will receive two shots, three weeks apart. The kid-size dose is one-third of the adult dose.

Pfizer and its partner BioNTech reported earlier this month that trial results show its vaccine is more than 90% effective in 5- to 11-year-olds, based on a study of more than 2,200 children.

In anticipation of approval, White House officials have indicated they are logistically ready to hit the ground running

“Should the FDA and CDC authorize the vaccine, we will be ready to get shots in arms,” White House coronavirus response coordinator Jeff Zients said during a news briefing last week. Zients emphasized the administration’s forward planning, ahead of regulatory approval, was an effort to be ready immediately operationally when a decision is made, in stark contrast to the lagging response time when adult vaccines were rolled out under former President Donald Trump late last year. 

The U.S. has enough doses to cover the millions of kids in the younger age group, federal officials said, and will deploy supplies like smaller needles to the doctors and community health centers that need them. 

The vials of the diluted doses for children will have an orange cap to differentiate them from the adults’ purple-capped vials, Pfizer representatives told the FDA advisory panel on Tuesday, and the shipping containers will also be distinct. 

Following the anticipated authorization by regulators, schools will face a decision on whether to make vaccines for kids mandatory. Children ages 5 to 11 years old account for 40% of all pediatric Covid-19 cases, and 9% of overall cases. Experts who addressed the FDA panel weighing approval of the children’s vaccine pointed out that, since kids are less likely to show symptoms of Covid-19, their rates of contracting the illness are probably underreported. 

Vaccine mandates for adults — including teachers, health care workers and public employees — have been the target of numerous lawsuits continuing to play out in federal court. 

In New York City, a group of teachers’ attempt to take down the city’s mandatory vaccine policy flopped at the Second Circuit.

While some parents are expected to be eager to vaccinate their children before holiday gatherings and cold and flu season, polling has indicated that others may not be in any rush—or even interested. Survey results published Thursday by the Kaiser Family Foundation found that about 25% of parents polled in October would vaccinate their children “right away,” while the rest were divvied up between waiting to see how the vaccine works and “definitely” not getting their children vaccinated.

Moderna’s vaccine is currently still being studied in young children while both Pfizer and Moderna continue trials of shots for babies and children under 5.

Other countries like China have already begun vaccinating children under 12. European regulators are also currently contemplating Pfizer and BioNTech’s kid-sized doses and will no doubt be watching the U.S.’s decision.

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