But parents hoping for clear guidance on the safety and effectiveness of the vaccine for children between the ages of 5 and 11 might not have been reassured by what they heard last week: Members of a vaccine advisory panel to the Food and Drug Administration expressed reservations about the vaccine for all children in this age group.
“I do think it’s a relatively close call,” said adviser Dr. Eric Rubin, an infectious diseases expert at the Harvard T.H. Chan School of Public Health. “... But we’re never going to learn about how safe this vaccine is unless we start giving it.”
An FDA researcher said that models comparing the benefits and risks of the vaccine for ages 5-11 were highly dependent on how much COVID-19 was spreading in the community. And for now, the spread has slowed considerably with new infections plunging more than 80% since the delta-fueled surge in August.
Last week, federal regulators and scientists made their case for an emergency authorization of the vaccine: 8,300 children between ages 5 and 11 have been hospitalized with COVID-19 and 94 have died over the course of the pandemic, according to CDC data.
Clinical trials Pfizer conducted in children ages 5-11, which used a third of the dose used for adults and older children, found the vaccine to be 90.7% effective in preventing symptomatic COVID-19.
While children who catch the coronavirus tend to have milder symptoms than adults, in rare instances they can have severe complications, including a rare inflammatory condition called MIS-C, or multisystem inflammatory syndrome in children. As of Oct. 4, as many as 5,217 children of all ages have developed MIS-C, and 46 have died, according to the CDC. The condition is also most common in children ages 5 to 11. Children can also suffer from the lingering symptoms of long COVID.
Limited safety data
During a heated discussion on the FDA’s vaccine advisory committee last week, some members questioned whether every child in this age group really needed the vaccine or whether it should be limited to those at high risk of severe COVID-19 — children with underlying conditions such as asthma, obesity or chronic lung disease.
“If the trends continue the way they’re going, the emergency for children is not what we think it might be,” said committee member Dr. James Hildreth, an immunologist and president and chief executive of Meharry Medical College, at the meeting. After multiple waves of infections, the virus appears to be in retreat, and Hildreth said many children have caught the virus and have gained some immunity.
Many advisory committee members also expressed concern about limited safety data on the vaccine in 5- to 11-year-olds. They discussed the risk of myocarditis, a rare condition involving inflammation of the heart muscle.
No cases of myocarditis were found in Pfizer’s trial involving 2,268 children in that age group submitted to the FDA. But Dr. Leslie Ball, a medical officer at the FDA, said the studies were not large enough to necessarily pick up an uncommon side effect like myocarditis.
Among 16- to 17-year-olds, who have received 2.3 million doses, there have been 79 cases of myocarditis or pericarditis reported. Based on the normal frequency of myocarditis and pericarditis in those ages, there would have been an expected two to 19 cases in that group. Most of the cases were mild and the young people have fully recovered, according to the CDC.
Myocarditis also is playing into a delay for Moderna’s vaccine for children ages 12 to 17. Moderna announced Sunday the FDA will need more time to complete its assessment of the risk of myocarditis in kids. Moderna said the review may not be completed before January 2022.
Longmire, mom to 7-year-old Neely and 11-year-old Wyatt, said she already was leaning no on having them vaccinated, but hearing reservations raised by FDA panel members solidified her position.
“The safety data is not really complete. We are just not there yet. I am not saying not ever, just not now,” said Longmire who emphasized she would never discourage other parents from vaccinating their kids. “I just think everyone has to make their own personal decision.”
Giving parents a choice
While children are at lower risk of severe COVID-19 than older people, many panelists ultimately decided it’s important to give parents the choice to vaccinate their children — especially those at high risk of getting seriously ill, and they pointed to other benefits such as helping kids stay in school. The FDA advisory committee voted unanimously, with one abstention, that the vaccine’s benefits in preventing COVID-19 in ages 5 to 11 outweigh any potential risks.
Before the vote, some committee members discussed their hope the CDC’s committee will consider whether to limit the emergency use authorization of vaccine to children with underlying health conditions.
Dr. Amanda Cohn, a physician and medical officer with the CDC and also a voting member of the FDA committee, said she believed the benefits of the vaccine clearly outweigh the risks and that the surveillance in place for detecting rare side effects in children will continue.
“To me, the question is pretty clear,” said Cohn said right before the vote. “We don’t want children to be dying from COVID, even if it is far fewer children than adults, and we don’t want them in the ICU.”
Stephen Thacker, director of pediatric infectious diseases at Savannah’s Memorial Health University Medical Center, said the panel raised important questions during its debate. He believes the benefits of the vaccine far exceed the risks. He stressed the risk of myocarditis is far higher from a COVID-19 illness than a vaccine.
“During this delta surge, like other children’s hospitals, we felt this a lot more than prior surges. We had more children hospitalized and more children had the need for intensive care and there were lives lost. Any time you have lives lost to what is largely a vaccine-preventable disease, that shouldn’t be taken as an acceptable risk,” he said.
And for children who spent much of the last two years facing disrupted school and social lives, many see vaccination as a step toward normalcy. Thacker, also a father to three children said his oldest, who is 13, is fully vaccinated and he plans to get his younger children, ages 5 and 10, vaccinated as soon as they are eligible.
While the clinical trial on the vaccine for ages 5 to 11 was relatively small, Thacker said we have “real-world data” from millions of children who are 12 and older already vaccinated showing the vaccine is safe and effective, with serious adverse events rare.
Erin Brooks of Avondale Estates said she’s counting down the days before her younger daughter, Abby, can get vaccinated.
She said vaccinating her 9-year-old is a way to add another layer of protection for her family, which includes an older daughter with asthma and her parents in their 70s. Vaccinating her younger daughter would bring her family one step closer to normalcy. She said she also looks forward to the little things, like going to a restaurant and eating inside.
“I don’t take it for granted how incredibly fortunate we are to have ready access to vaccines which are basically modern miracles,” she said.