Pressure mounts on COVID vaccines for children; the docs warn against improper use

After Pfizer’s COVID-19 vaccine received full regulatory approval on Monday, pressure mounts to make the vaccine available to children under 12, and so do fears that it may be for them. administered prematurely.

The Food and Drug Administration’s approval covers the use of the vaccine in people aged 16 and older, while the agency’s emergency use authorization still allows its use in adolescents aged 12. at 15. Some experts expect the FDA to grant full approval. for relatively quick use in 12 to 15 year olds.

But many parents and pediatricians are very anxious to get the green light to offer the vaccine to children under 12. Immunization of young children has become a particularly urgent problem with the savage spread of the hypertransmissible delta variant, back to school, conflicts over masks and a major vacation just around the corner. In a letter sent to the FDA earlier this month, the American Academy of Pediatrics urged the agency to clear the vaccine for children under 12 “as soon as possible.”

For now, the FDA is awaiting data on which to base a decision. Clinical trials in children aged 5 to 11, 2 to 5, and 6 months to 2 years are still ongoing. The trials will provide essential data on the safety of vaccines and on the doses that provide optimal immune responses in each age group. The trials included several dosage options for each age group.

U.S. officials have offered slightly different estimates as to when vaccines will get the green light from the FDA. In a Tuesday morning interview with the Today, Anthony Fauci, a leading infectious disease specialist, said vaccines for children under 12 will be available, “hopefully by mid-late fall and early winter. “

Meanwhile, Francis Collins, director of the National Institutes of Health, proposed a slightly longer time frame in an interview with NPR’s Morning Edition, also on Tuesday. “I don’t see the approval for children aged 5 to 11 coming long before the end of 2021,” he said.

Emergency

However, the FDA’s decision could have come sooner. Last month, the FDA urged Pfizer and its partner BioNTech, as well as Moderna, to increase the size and design of their trials to better detect potential rare side effects, particularly myocarditis or inflammation of the heart muscle. Data from older groups suggests that myocarditis is a rare, although generally mild, side effect of mRNA-based COVID-19 vaccines, which includes the Pfizer / BioNTech and Moderna vaccines. The risk is low, with an estimate of around 13 cases after one million doses of vaccine administered. But the risk seems greatest, so far, in young men aged 12 to 17.

In the AAP’s letter to the FDA earlier this month, the group of doctors wrote that they appreciated the FDA’s rigorous commitment to review safety, but said the expansion of trials should only not delay authorization.

“In our opinion, the rise of the delta variant is changing the risk-benefit analysis to allow vaccines in children,” wrote the AAP. “The FDA should seriously consider authorizing these vaccines for children aged 5 to 11 years based on data from the initial enlisted cohort, which is already available, while continuing to monitor the safety data of the extended cohort in the future. the post-marketing framework. not slow down the authorization period for these essential vaccines in the 5 to 11 age group. “

Pushing for the FDA to act faster, the AAP noted that children historically accounted for about 14% of COVID-19 cases in the pandemic, but the share of pediatric cases has recently increased, reaching 19% for the week. ending in July. 29. “The higher proportion of cases in this population means this age group could be contributing to the continued spread of COVID-19,” wrote the AAP. Although children have relatively low risks of serious illness and death from COVID-19, the group noted that “[s]Sadly, more than 350 children have died from COVID since the start of the pandemic, and millions of children have been negatively affected by lack of education, social isolation and, in too many cases, the deaths of parents. and other caregivers. “

For now, the FDA says it is still awaiting data on safety, dosage, and efficacy. At a press briefing on Monday, acting FDA commissioner Janet Woodcock said the agency simply does not have the data to make decisions and vaccines should not be used in children. until that data is available and reviewed. “We need to get information and data on uses in young children,” she said. “They’re not just little adults, and we’ve learned that time and time again.”

Off-label warnings

On this point, the AAP agreed and cautioned against jumping to use in children. With the approval of the Pfizer / BioNTech vaccine on Monday, the AAP along with many parents and physicians have raised questions and concerns about off-label use, i.e. physicians offering the vaccines to under 12 years old despite age limits for approval and authorization.

Normally, doctors have the flexibility to use approved drugs in unapproved ways. But because COVID-19 vaccines are distributed by the federal government, anyone administering the vaccines must adhere to a supplier agreement with the Centers for Disease Control and Prevention, which prohibits off-label use. If pediatricians go rogue and decide to offer vaccines to children under 12 anyway, they may be covered by administrative costs, they may lose liability coverage, and they may lose the ability to provide vaccines. completely.

But more importantly, doctors shouldn’t go off the label because it’s not in the best interests of younger patients, the AAP argued on Monday.

“Clinical trials of the COVID-19 vaccine in children aged 11 and under are ongoing, and we need to see the data from these studies before we give this vaccine to young children,” said AAP President, Lee Savio Beers, in a statement. On Monday.

Dr Yvonne Maldonado, chair of the AAP Committee on Infectious Diseases, also intervened, saying: “We don’t want individual doctors to calculate doses and dosing schedules one by one for young children based on experience with the vaccine in older patients. We should do this on the basis of all the evidence for each age group, and for that we need the trials to be completed. I know parents care about protecting their children, but we want to make sure children benefit fully from ongoing clinical trials. “

In his interview with NPR on Tuesday, Dr Collins echoed this point while urging patience for the results of the trial. “It’s a difficult situation,” he said, “because children under 12 are not just little miniature human beings. They have differences in their metabolism, their immune system.”