Vaccine advisers to the US Food and Drug Administration debated what kind of detailed information the agency would need to consider authorizing the use of coronavirus vaccines in children younger than 12 on Thursday.
While a few advisers said it’s too soon to rush the use of vaccines in children because kids are at such low risk from the virus, most argued that it’s important to have authorizations on hand should there be a resurgence of the virus in the fall and winter.
And a top FDA official reminded committee members that Covid-19 can and does kill children.
The members of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) were not asked to provide specific advice or a vote. The FDA will advise companies on what kinds of clinical trials and data it would like to see to consider extending use of authorized vaccines to children, and it’s up to the companies to ask FDA to extend authorization – or full approval – to new age groups.
Pfizer/BioNTech’s vaccine is authorized for use in people as young as age 12. Moderna’s vaccine is authorized for people 18 and older, although the company has asked FDA to authorize its use in children as young as 12. Johnson & Johnson’s vaccine is authorized in people 18 and older.
While the vaccines have been shown to be highly safe and effective in older age groups, VRBPAC members expressed concern about fresh but preliminary reports of an inflammatory heart condition called myocarditis that could potentially be linked to the vaccine.
Dr. Cody Meissner, director of pediatric infectious diseases at Tufts University School of Medicine, said children are at low risk of severe disease from the virus and more study is needed about safety in younger age groups.
“Before we start vaccinating millions of adolescents and children, it’s important to find out what the consequences are,” Meissner said, noting a low Covid-19 hospitalization rate among children.
“As more people are immunized and become immune from infection, I think it’s likely that we are going to get this pandemic under pretty good control,” he said.
“I do not feel we can justify an EUA. The burden of disease is so small and the risks are just not clear.”
But other members of the committee sharply disagreed.
“I think we need these vaccines sooner rather than later in children,” said Dr. Mark Sawyer, a pediatrics professor at the University of California San Diego School of Medicine.
Dr. Eric Rubin, editor in chief of The New England Journal of Medicine and an adjunct professor at the Harvard T.H. Chan School of Public Health, noted the situation doesn’t look bad at present, but that could change.
“There’s not much disease right now,” he said.
“We don’t know what’s going to happen. I think that’s precisely the reason why we want to have these in our arsenal. Because we give an EUA to the vaccine doesn’t mean we have to use it and I think we’d have to think hard how to use it, given all the concern that’s been raised,” Rubin added.
And Marion Gruber, director of the FDA’s Office of Vaccines Research, expressed some frustration.
“We are hearing that we need the vaccines soon and we need them soon in children because we do not know what the virus will be doing in fall and kids are back in school and indoors,” she said.
“If we wait too long and do these clinical trials with large numbers of pediatric subjects, we may not be ready to have these tools available when we need them.”
“I think that we need to have EUA ready to go if we start to see an upsurge of cases in the fall,” said Dr. Stanley Perlman, a professor of pediatrics at the University of Iowa.
“Achieving consensus, as people can see, may be a little bit challenging,” noted Dr. Peter Marks, who heads the FDA’s division that evaluates vaccines.
Risks of heart inflammation
Meissner and others said they were worried about the reports of heart inflammation.
There are “very few” reports of myocarditis or pericarditis in 12-15-year olds who have been given coronavirus vaccines, Dr. Tom Shimabukuro, deputy director of the US Centers for Disease Control and Prevention’s Immunization Safety Office, told the meeting.
The data show that there has been a higher-than-expected number of cases of heart inflammation among young people who have recently received their second doses of the Pfizer/BioNTech and Moderna coronavirus vaccines - but mostly among older youths.
Among 16- and 17-year-olds, through May 31, nearly 2.3 million doses of the vaccines were administered and 79 cases of myocarditis and pericarditis were reported. The expected rate – the rate that is typical among people this age – is between two and 19 cases, Shimabukuro showed in his presentation.
The CDC data also showed that among 18- to 24-year-olds, nearly 9.8 million doses were administered, and there were 196 reports of myocarditis and pericarditis. The expected rate is between eight and 83 cases.
The CDC’s Advisory Committee on Immunization Practices scheduled an emergency meeting for next week to update data and further evaluate myocarditis following vaccination with the Pfizer/BioNTech or Moderna vaccines.
VRBPAC members discussed whether it’s more important to consider risks and benefits to children as individuals, or the benefits to society as a whole of vaccinating a group that might be vectors for spread.
Marks chided committee members. “I also want to take a moment to remember all the children who have died of Covid-19 in this pandemic, because that should not be forgotten here,” Marks told the meeting in closing remarks.
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“I just want to reiterate something here – this is an illness that takes the lives of children. We know that over 300 children have died in the pandemic so far,” said Marks, who is director of FDA’s Center for Biologics Evaluation and Research.
The CDC says it has reports of 314 deaths in children 17 and younger in the United States from Covid-19.
“And that if one looked at the death rate of the 11-17-year-olds who had Covid-19, it was about 1 in 3,600 of those individuals. And since we had over a million cases in that age range, you can see that there are deaths due to this,” Marks added.
“All of us have the goal to eliminate any vaccine-preventable deaths that we can with a reasonable benefit-risk.”