FDA officials are reviewing the Pfizer/BioNTech application seeking authorization of its 2-dose vaccine for younger children, with its panel of outside advisers scheduled to weigh in on Oct. 26.
The Biden administration on Wednesday outlined its plan to vaccinate millions of US children ages 5 to 11 as soon as the Covid-19 shot is authorized for them, readying doses and preparing locations ahead of the busy holiday season.
Unlike the mass vaccination centers used in the initial Covid-19 vaccine rollout, the White House said it is working to set up clinics in more than 100 children’s hospital systems nationwide as well as doctor’s offices, pharmacies and potentially schools.
If Pfizer Inc and BioNTech SE’s vaccine wins wider authorization from the US Food and Drug Administration, the plan aims to ensure quick and equitable distribution, the White House said.
FDA officials are reviewing the Pfizer/BioNTech application seeking authorization of its 2-dose vaccine for younger children, with its panel of outside advisers scheduled to weigh in on Oct. 26. The FDA typically follows the advice of its panel but is not required to do so.
Advisers to the US Centers for Disease Control and Prevention (CDC) will weigh in on recommendations for the vaccine at a meeting on Nov. 2 and Nov. 3, helping to inform a final decision by its director.
“Should the FDA and CDC authorize the vaccine, we will be ready to get shots in arms,” White House COVID response coordinator Jeff Zients told reporters, adding that the government had 15 million doses set to ship nationwide, with millions more going out in the weeks to follow.
Once authorized, roughly 28 million more children in the United States would be eligible to receive what would be the first US Covid-19 vaccine for younger kids. The Pfizer/BioNTech shot is already available to those ages 12-17, and the companies are still studying it for children younger than 5.
Zients said the administration had worked with Pfizer to modify the packaging of the pediatric doses to make it easier to administer to children, including providing smaller needles.
While children have a lower rate of death from Covid-19, many face illness and long-term symptoms that are still being studied. Many adults who have been hesitant or opposed to the Covid-19 vaccine, and even some who did not oppose the vaccine for themselves, are expected to resist giving the shot to their children.
CDC Director Dr. Rochelle Walensky told reporters that the agency would continue to recommend mask wearing in schools even as the vaccine is rolled out for children.
Walensky said the seven-day average of Covid-19 cases in the United States was down about 16% to some 75,500 cases per day. The seven-day average for hospitalizations was down about 11% to around 6,000 per day, and that the seven-day average for daily deaths was down about 3% to 1,200.
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