FDA Advisors Approve Emergency Use of Pfizer COVID Vaccine in Kids 5 to 11
A U.S. Food and Drug Administration advisory panel voted Tuesday to recommend emergency use of a smaller dose of Pfizer's coronavirus vaccine for children aged 5 to 11, advancing plans to offer the shots to 28 million young kids across the United States.
The vote was nearly unanimous at 17-0, with one abstention, and the FDA is expected to make a final ruling in a matter of days.
Despite the vote count, some panel members noted they struggled with the decision.
"This is a much tougher one, I think, than we had expected coming into it," panel member Dr. Eric Rubin, editor-in-chief of the New England Journal of Medicine, said during the meeting, NBC News reported. "The data show that the vaccine works and it's pretty safe, ... [yet] we're worried about a side effect that we can't measure yet," he said, referring to a heart condition called myocarditis that has cropped up in rare cases in some younger recipients of COVID vaccines.
Another panel member questioned whether the vaccinations were needed at all for these youngest Americans.
"It just seems to me that in some ways, we're vaccinating children to protect the adults, and it should be the other way around," said committee member Dr. James Hildreth, president and CEO of Meharry Medical College in Tennessee. "I do believe that children at highest risk do need to be vaccinated. But vaccinating all of the children ... that seems a bit that much for me."
Panel member Dr. Paul Offit, a vaccine researcher at Children's Hospital of Philadelphia said that, "It's always nerve-racking, I think, when you're asked to make a decision for millions of children based on studies of only a few thousand children."
But he stressed that the potential threat from a pediatric infection with COVID-19 is real.
"The question is, when do you know enough?" Offit added. "And I think we certainly know that there are many children between five and 11 years of age who are susceptible to this disease who could very well be sick and are hospitalized or die from it."
Panel member Dr. Amanda Cohn, chief medical officer at the U.S. Centers for Disease Control and Prevention, saw the decision similarly.
"When I look at this question, it is pretty clear to me that the benefits do outweigh the risk, when I hear about children who are being put in the ICU, who are having long term outcomes after their COVID, and children are dying," Cohn said. "We vaccinate routinely against a couple of vaccine-preventable diseases for which far fewer deaths and hospitalizations and ICU admissions occur."
In fact, more than 1.9 million children aged 5 to 11 have tested positive for the coronavirus over the course of the pandemic, and more than 8,400 have been hospitalized, said Dr. Fiona Havers, a medical officer with the CDC, NBC News reported. And when hospitalized with COVID-19, children are more likely to be admitted to the intensive care and more likely to need a ventilator than children hospitalized with the flu are, she added.
Children who contract COVID-19 are also at risk for a rare inflammatory condition called multisystem inflammatory syndrome (MIS-C). As of Oct. 4, just over 5,200 children of all ages have developed MIS-C, and 46 have died, Havers said, adding that the condition was most common in younger children.
If approved by the FDA and then the CDC, Pfizer's pediatric vaccine would involve a two-dose series of 10-microgram shots, about one-third of the dosage administered to adults and kids aged 12 or older. Two doses of the Pfizer vaccine is nearly 91% effective in preventing symptomatic illness in young children and brings no unexpected safety issues, according to a study posted Friday by the FDA.
"Overall, it is very promising news that the FDA [panel] has decided to approve the vaccine, allowing parents to collectively breathe a sigh of relief. The bottom line is that they can now extend this much needed protection to their children and families as a whole," said Dr. Robert Glatter, an emergency medicine physician with Lenox Hill Hospital in New York City.
However, Glatter acknowledged there's still a lot of work ahead.
The U.S. Centers for Disease Control and Prevention's vaccination advisors are now set to meet Nov. 2 to weigh in on the pediatric vaccine. Once they have spoken, CDC Director Dr. Rochelle Walensky is expected to sign off on the panel's recommendation.
After that comes the Biden administration's plans to roll out the vaccine through pediatricians' offices, community clinics and pharmacies, hoping to reassure hesitant parents that the jab will protect their kids from COVID-19.
"For those parents who decide to wait on the sidelines, convincing them that protecting their children means vaccinating them will be an ongoing challenge," Glatter said.
The White House has decided that pediatric COVID-19 shots will be delivered in settings that parents know and trust, rather than mass vaccination sites.
More than 25,000 pediatric and family doctor clinics will provide vaccinations to children, along with tens of thousands of pharmacies, children's hospitals and community health centers, according to the White House plan.
"Our planning efforts mean that we will be ready to begin getting shots in arms in the days following a final CDC recommendation," a White House statement on the plan said. "These steps will be critical in ensuring that we are staying ahead of the virus by keeping kids and families safe, especially those at highest risk."
The federal government has already bought enough vaccine to fully cover all 28 million American kids aged 5 to 11, and it will be distributed in smaller packages of about 100 doses each, to make things more manageable for doctors' offices and community health centers, the White House added.
Two-thirds of U.S. parents of kids aged 5 to 11 plan to get their children vaccinated once the shots are approved, according to a recent poll by the COVID-19 Vaccine Education and Equity Project.
"While we're encouraged to see that a majority of parents intend to vaccinate their children against COVID-19 once they are eligible, there is clearly more work to be done to help address parents' questions and ease concerns about the vaccines," said Beth Battaglino, CEO of HealthyWomen and an organizer with the COVID-19 Vaccine Education and Equity Project.
The U.S. Centers for Disease Control and Prevention has more about COVID vaccination for children aged 5 to 11.
SOURCES: Robert Glatter, MD, emergency medicine physician, Lenox Hill Hospital, New York City; White House, statement, Oct. 20, 2021; COVID-19 Vaccine Education and Equity Project, news release, Oct. 14, 2021