As news broke recently that the Covid vaccine for children under five would be delayed in the US amid ongoing clinical trials, a call to make the vaccines off-label for use among those children gained force – but officials caution against vaccinating young children without any safety or efficacy data for this age group.
When providers sign an agreement to provide Covid-19 vaccine shots, they also agree not to give the vaccine off-label, or use it for purposes other than what it was approved to do.
In this case, the Moderna vaccine is approved for adults aged 18 and up, and the Pfizer-BioNTech vaccine is approved for those aged 16 and up. But the vaccines are still under emergency use authorizations for younger patients.
Providers who give off-label vaccinations in the US may not be protected by legislation that keeps them from being held liable in the case of a rare adverse event.
The US Centers for Disease Control and Prevention (CDC) warned last summer against providing the vaccine off-label for kids under 12, though that guidance does not seem to be available now on the CDC’s page answering common questions about vaccinations. (The CDC did not respond to requests for comment.)
The US Food and Drug Administration (FDA) and the American Academy of Pediatrics (AAP) also spoke out against off-label use of the emergency vaccines.
Offering the vaccine to children under five is illegal, “and that dose has not been studied in kids under five”, Sean O’Leary, a pediatric infectious diseases specialist and vice-chair of the AAP’s committee on infectious diseases, said in an email.
“If providers were to give it to these children, they could lose their status as a vaccine provider,” he said.
The 10-microgram dose authorized for kids five to 11 has not been tested among younger kids, who received a 3-microgram dose in the Pfizer/BioNTech pediatric trial.
It’s possible that the dose intended for older children is more likely to cause side-effects in younger children, O’Leary said. And if a serious side-effect were to occur in a younger child, medical expenses might not be covered under the current vaccination compensation program.
Also, “as a parent, I’d feel terrible. The risk of that is almost certainly quite low, but something to consider,” he said.
“As much as I want a vaccine for these younger kids, I think it’s very important to follow the process as it’s designed, as that process has given us many safe, effective vaccines over the decades.”
However, some families and physicians are pushing to change these rules, arguing that the clinical trials demonstrate the safety of the 3-microgram dose in young children, and millions of children over five have been safely vaccinated.
“I don’t see a difference in a child four years and five years, except for the age – the immune system works the same,” said Dr Wolfgang von Meissner, a family doctor in Germany. “I don’t see why I shouldn’t protect little kids.”
Some vaccines – for instance, in kids who might be too young to get them before traveling abroad – and treatments, like certain antibiotics, are given to kids off-label based on a physician’s judgment and with parental consent.
“In pediatrics in particular, off-label use of various kinds of medicines is pretty common,” Govind Persad, assistant professor at the University of Denver Sturm College of Law, said. “Often you have medications … that seem like they might be beneficial, but there haven’t been pediatric trials.”
In November 2021, several states began recommending boosters for all adults before the CDC and FDA changed guidelines, and in San Francisco, third shots are now available for those who received the Johnson & Johnson vaccines. This, too, is off-label use.
But off-label use of unapproved vaccines is never allowed, Yvonne Maldonado, professor of pediatric infectious diseases at Stanford University and chair of the AAP’s committee on infectious diseases, pointed out in an email, and the Covid vaccines for children still fall under this category.
She said that she was strongly against the use of off-label vaccines.
In Germany, where the Covid vaccines are not recommended for children under five but no restrictions against off-label use exist, Von Meissner has been giving children Covid vaccinations since April 2021, beginning with children under 12 who were not yet eligible for the vaccines.
He has given 2,500 vaccines to kids between the ages of six months and five years old.
He emphasized the importance of informed consent for parents in off-label uses, especially given potential liability issues. “They need to understand, and then they need to make the decision.”
He sees the vaccines as particularly important since mask mandates and other precautions are ending in many places.
He believes expanding off-label use in the US would provide an additional level of safety to desperate families – including those so eager to get the vaccines, they lie about their children’s ages. This was a move that all experts strongly cautioned against.
“I think lying about this is the worst idea,” von Meissner said. “It’s stupid to do it that way, I’m sorry.”
Vaccines and medication should only be given under the supervision of a trained health worker who understands the child’s health history.
Lying “encourages subterfuge”, Persad said, which might create perverse incentives for parents not to report side-effects or seek follow-up care.
Even traveling out of the country, for those lucky enough to do so, isn’t ideal, because it makes it more difficult to track safety signals and data on how effective the vaccines are and who has received them, Persad said. “You could do some of that same stuff for off-label.”
Another option for eager families could be expanding the Pfizer trial to include more under-five kids, offering additional data on efficacy, which is particularly important if the trials are shifting from measuring immune responses to tracking real-life cases, Persad said.
And new arms of the trials could test different doses among different ages of children. The 3-microgram doses were effective in children six months to two years, but not in kids aged two to five.
“It is baffling to me that they did not try these small trials at a more intermediate dose,” Persad said.
Companies could also make the vaccines available, especially for higher-risk kids, through the FDA’s expanded access program, Persad said.
“Honestly, I would love to see that, as opposed to off-label, where you don’t have the ability to collect as much of this data.”
• This article was amended on 17 February 2022. Due to an editing error, the amount of 3 micrograms was incorrectly rendered as “3mg”, which is the abbreviation for milligrams. The article was amended on 18 February 2022 to remove a portion of Govind Persad’s quotation that may have been incorrectly transcribed.
