What’s Going on With Vaccines for Kids Under 5?

I was surprised to see the news this week that the F.D.A. may be getting closer to authorizing a Covid vaccine for children under 5. Why surprised? Because Pfizer and its partner, BioNTech, put out a less-than-crystal-clear news release in December, helpfully encapsulated by The Times’s Apoorva Mandavilli and Rebecca Robbins, suggesting that in trials, two three-microgram doses of their Covid vaccine did not produce the desired immune response in children ages 2 to 5. At the time, the companies said they were evaluating a third dose administered two months after the first two to see if it increased the efficacy of the series.

After I read this, I mentally filed the information away as: “Oh, well, I guess it’s back to the drawing board for little kid vaccines.” And a lot of other parents did, as well, judging from questions that I got on Twitter. But when I talked to Dr. Sean O’Leary, a pediatric infectious disease specialist who has spent years researching vaccines, he explained that the question of whether a vaccine works isn’t answered with a binary yes or no.

“Just because they didn’t meet the immunological endpoint doesn’t mean there’s not some benefit” for kids 2 to 5, O’Leary said. As with adults, he added, “we know there’s some benefit in a single dose, and there’s more benefit from a second and third dose.” Which could explain why the F.D.A. appears closer to moving forward now.

On Tuesday, The Times’s Sharon LaFraniere and Noah Weiland reported, based on an anonymous source familiar with the Pfizer-BioNTech data, that “children 2 to 4 years old who were given two shots were infected at a rate 57 percent lower than the children in the placebo group. Children 6 months to 2 years old who got shots were infected at a rate 50 percent lower than the placebo group.”

We know that the vaccine is safe for this age group, O’Leary told me. The vaccine approval process “is very deliberate and very careful in terms of safety, and that process has been followed to a ‘T’ throughout.”

I asked him about the risk of myocarditis, an inflammation of the heart muscle, for this age group — something parents have expressed concerns about. Myocarditis is a rare Covid vaccine side effect. A study from Israel based on health records of about two million people, published in September, found that Covid-19 is more likely to cause myocarditis than the Pfizer vaccine and, as The Times reported, that “the median age of people who developed the condition after vaccination was 25, and 19 of the 21 cases were in males.” O’Leary said that based on the epidemiology of classic myocarditis, unrelated to Covid or Covid vaccines, which also appears to be most common in young men, he doesn’t think there should be an increased risk for little kids who get vaccinated.

Some experts, like Dr. Jeremy Faust, are concerned that pushing for emergency use authorization too soon, rather than waiting for, perhaps, a few extra weeks, might turn some parents off from getting their under-5 children vaccinated. “Allowing parents to vaccinate their children under age 5 now will certainly increase the number of vaccinated kids between now and March,” he wrote in the newsletter Inside Medicine. “That will feel like progress. But will it really be? This strategy could come at a cost if other parents lose faith in the scientific process. I’m worried that if we rush now, there will be fewer young children vaccinated by next fall than if we wait a few more weeks.”

I had this concern as well when I first saw the news about the F.D.A.’s move. And I agree with Dr. Faust that the messaging around the vaccine for young children has been a mess. But it’s likely that we’re already talking about a relatively small percentage of parents who are going to run out to get the shot for their under-5s in the first place. Though vaccines have been available for them since November, “just 31 percent of kids 5-11 have gotten a shot, compared with 75 percent of the total population,” Jonathan Levin pointed out in Bloomberg News, and the seven-day average for vaccinations among this age group fell to its lowest level the week of Jan. 28.

Most parents in America aren’t paying attention to every Pfizer news release. My guess is that once the vaccine is available for children under 5, it will be individual pediatricians and other local organizations, such as schools, that will be most effective in persuading parents to get Covid shots for their kids. As I’ve mentioned before, the Kaiser Family Foundation found that when schools encouraged it, parents were more likely to report that they got their children vaccinated. Kaiser also found that “pediatricians remain parents’ most trusted source of information on the Covid-19 vaccine for children.”

Dr. Hina Talib, an adolescent medicine specialist at Children’s Hospital at Montefiore in the Bronx, said that “from working in a place that is a lower vaccination area for children in this borough, in this community, I don’t hear the desperation-slash-joy — the joysperation — of having the ability to protect your under 5-year-olds.” She said that one-on-one conversations with parents who know and trust her are among the most valuable ways she shares information.

A concern of both Talib and O’Leary is that a lot of children in the United States are still missing well visits and the normal set of non-Covid vaccinations they receive during those visits. During the past two years, “a lot of people missed health care visits, especially adolescents and adults,” said Talib. “A lot of it switched to tele-health, which is newer for adolescents” and “those can be missed opportunities.”

The biggest takeaways right now should be: First, Covid vaccine efficacy is not a binary “works” or “doesn’t work” — it’s looking more like an ascending scale of protection. Second, nothing has happened yet. Authorization hasn’t occurred but when it does, ideally, the data that it’s based on will be public by the time shots are actually getting shipped for the littlest children, so we can see for ourselves. And third, kids of all ages having regular contact with a trusted pediatrician is among the best things parents provide for their own health and their families’ health.

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