The US Food and Drug Administration issued emergency use authorization on Friday for Pfizer’s Covid-19 vaccine for children 5 to 11. This is the first Covid-19 vaccine authorized in the United States for younger children.
The FDA’s vaccine advisers voted 17-0 with one abstention on Tuesday to recommend EUA for the vaccine, which is formulated at one-third the dose of the vaccine used for people 12 and older.
Pfizer says a clinical trial showed its vaccine provides more than 90% protection against symptomatic disease among children, even at one-third the dose, and the company hopes the lower dose will reduce the risk of any side effects.
Shots can’t be administered yet – the question now goes to the US Centers for Disease Control and Prevention. The CDC’s vaccine advisers, the Advisory Committee on Immunization Practices, meet November 2 to discuss whether to recommend use of the vaccine among US children. Then the CDC director, Dr. Rochelle Walensky, makes the final decision on use of the vaccine.
The White House says it has a plan already in place for distributing vaccines to children. Vaccines could be administered as soon as the CDC signs off.
Pfizer’s Covid-19 vaccine was previously authorized for children ages 12 to 15. The vaccine is approved for people age 16 and older.
The American Academy of Pediatrics welcomed the decision.
“Authorization of the vaccine for younger children is an important step in keeping them healthy and providing their families with peace of mind. The vaccine will make it safe for children to visit friends and family members, celebrate holiday gatherings, and to resume the normal childhood activities that they’ve missed during the pandemic,” Dr. Lee Savio Beers, president of the organization, said in a statement.
“Pediatricians are standing by to talk with families about the vaccine and to administer the vaccine to children as soon as possible.”
“As a mother and a physician, I know that parents, caregivers, school staff, and children have been waiting for today’s authorization. Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy,” Acting FDA Commissioner Dr. Janet Woodcock said in a statement.
“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.”
The FDA said those ages 5 to 11 account for 39% of Covid-19 cases in children.
“The FDA is committed to making decisions that are guided by science that the public and healthcare community can trust,” Dr. Peter Marks, who heads the FDA’s vaccine arm, the Center for Biologics Evaluation and Research, said in a statement.
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“We are confident in the safety, effectiveness and manufacturing data behind this authorization. As part of our commitment to transparency around our decision-making, which included our public advisory committee meeting earlier this week, we have posted documents today supporting our decision and additional information detailing our evaluation of the data will be posted soon. We hope this information helps build confidence of parents who are deciding whether to have their children vaccinated,” he added.
Pfizer said it would start shipping the orange-topped pediatric doses of the vaccine immediately.
FDA officials urged parents to vaccinate their children if the CDC signs off.
“While we have heard from some parents that their children have had Covid-19 and their symptoms were mild or hardly noticeable, it’s important to note the data from the CDC show that among children 5 to less than 12 years of age, there have been about 1.9 million reported cases of Covid-19,” Woodcock told a news conference.
“This includes more than 8,300 Covid-19-related hospitalizations through September of this year in this age group,” she added. “Tragically, Covid-19 was among the top 10 leading causes of death for children 5 through 11 years of age in the US,” Woodcock said.
According to the US Centers for Disease Control and Prevention, 170 children 5-11 have died of Covid-19.
“These are really starting statistics,” Woodcock said.