A New Vaccine Strategy for Kids: Just One Dose for Now

Even as parents in the United States wrestle with tough questions over vaccinating their children against the coronavirus, families in other countries have been given a new option: giving children just one dose of vaccine. To dose

Officials in Britain, Hong Kong, Norway and other countries have recommended a single dose of the Pfizer-BioEntech vaccine for children 12 years of age and older – which provides partial protection from the virus, but sometimes without the potential harm. Seen after two doses. On Wednesday, Sweden and Denmark joined ranks, declaring that teens should only get one jab of the Moderna vaccine.

Health officials in those countries are particularly concerned about rising data suggesting that myocarditis, an inflammation of the heart, may be more common in adolescents and young adults after vaccination than was thought.

The risk remains very small and significant only after a second dose of mRNA vaccine. But the numbers have changed the risk-benefit calculation in countries where new infections are mostly lower than in the United States.

Advisors from the Centers for Disease Control and Prevention reviewed data on myocarditis in June, and voted unanimously to recommend the vaccine for children 12 years of age and older, saying the benefits far outweigh the risks.

The agency’s research has estimated that for every million vaccinated boys ages 12 to 17 in the United States, the shots can cause a maximum of 70 myocarditis cases, but they can lead to 5,700 infections, 215 hospitalizations, and more. Will prevent two deaths. Studies have also shown that the risk of heart problems is much higher after COVID-19 than after vaccination.

Myocarditis was one of the concerns that led the Food and Drug Administration this summer to ask vaccine manufacturers to increase the number of children in clinical trials. The issue is likely to be discussed in depth at a meeting of agency advisors next week to review the evidence for immunization of children aged 5 to 11 years.

The latest analysis, which was published Wednesday in The New England Journal of Medicine, found that the incidence of myocarditis after vaccination in Israel was highest among men aged 16 to 29. About 11 out of every 100,000 men in that age group developed the condition a few days after vaccination, which is higher than earlier estimates. (The risk was negligible in women of any age.)

Of the 54 cases identified in the study, one was so critical that it required ventilation. Another patient with a history of heart disease died of unknown cause soon after discharge from the hospital.

Of the 14 patients in the new study who showed heart abnormalities when admitted to the hospital, 10 still had symptoms of some problems when they were discharged. But when the patients were examined again a few weeks later, all five of them for whom the results were available made a full recovery.

A second study, also published in the journal, found that the incidence of myocarditis after the second dose was highest in boys aged 16 to 19 — unvaccinated boys of the same age during the same time period. nine times more than .

Health officials in other countries plan to revisit a dosing strategy as more safety information becomes available, and they may choose to proceed with another shot. But the prospect of postponing the second jab hasn’t received enough attention in the United States, said Dr. Walid Gelaid said.

“In America, people don’t want to talk about it for unclear reasons,” Dr. Gelad said. “Parents who are hesitant can appreciate the fact that the risk of side effects is actually much lower for one dose than for two doses.”

He added that since serious side effects have been seen mainly in boys, dosage calculations for boys and girls should be different.

Dr Jeremy Brown, a specialist in respiratory diseases at University College London and member of the UK’s Vaccine Advisory Group, said it was too early to know whether post-vaccination myocarditis could permanently weaken the hearts of some people.

“This makes it very difficult for us to make a full statement that this vaccine is completely safe to give,” Dr. Brown said. “We need to get some feel for what the long-term consequences of myocarditis may be.”

Experts said the urgency of fully vaccinating children with two doses needs to be weighed for each country’s particular situation. In the UK, high vaccination rates among older and high-risk adults have helped to keep hospitals free of seriously ill patients from COVID-19.

“The chances of a healthy 12 to 15-year-old child with severe covid are almost negligible,” Dr Brown said. “Against that, you have to make sure the vaccine you’re giving is completely safe.”

Some experts have argued that vaccinating children would help break the chain of transmission and contain the virus. But vaccinating children to protect others — when there may be a risk to the recipient, however small — was inexcusable, Dr. Brown said.

“You don’t vaccinate a 15-year-old to prevent infecting other adults — it’s not the morally, morally right thing to do,” he said.

In Hong Kong, the rationale for a double dose of adolescents is even weaker than in Britain, said Benjamin Cowling, an epidemiologist at the University of Hong Kong.

Hong Kong has recorded only 213 deaths and just over 12,000 cases of COVID-19 since the start of the pandemic, with fewer than 10 cases per day since April. So the risk of myocarditis, although rare, outweighs the benefits of fully vaccinated teens, Dr. Cowling said.

He said clinical trials of the vaccine in children are not enough to detect rare side effects such as myocarditis. “You’ll only see it when it goes to the population level, and then it’s too late.” Whether offering a second dose to children “needs to be considered with caution.”

But the United States is not in the same position as other countries, said Dr. Jeffrey Duchin noted.

About 2,000 Americans are dying every day, and hospitals are still full in many parts of the country. “We have had a significant impact on our pediatric population,” said Dr. Duchin.

Nearly 900,000 children have been hospitalized with COVID-19 since the pandemic began, and about 520 have died. Some children have developed so-called prolonged COVID-19, in which symptoms can persist for months, and more than 4,000 children have been diagnosed with a dangerous condition called multisystem inflammatory syndrome.

Dr. Duchin said, “All the data we have so far suggests that the disease is much worse than the side effects of the vaccine.” Given all this, a small risk of myocarditis is worth taking, he said, and two doses are reasonable.

Dr. Duchin said he also has some concerns that a single dose of the vaccine may not protect children from infection or disease — at least, not for long. “I just haven’t seen data to suggest that a single dose will have a sustainable and high level of protection,” he said.

Some experts said that all of these concerns, as well as myocarditis data, should inform the national conversation about the wisdom of giving teens one dose versus two shots.

“There hasn’t been enough discussion about the potential harms of vaccination, because everyone is very sensitive about hesitation and doesn’t want to give any fuel to anti-vaccination campaigns,” said Dr. Cowling said.

In the United States, in particular, many public health experts have been reluctant to raise their voices about vaccines, Dr. Gelad said: “No one wants to project the doubt that children should be vaccinated.”

“But I think there are ways to talk about it that will appeal to people who are hesitant.”

Christina Rogers, a 51-year-old mother of two in Oklahoma, said she would welcome the option of giving her 12-year-old daughter only one dose of the vaccine.

Ms Rogers, who is fully immunized, worried that not enough was known about the long-term effects of vaccines in children and said she wanted more open discussion.

Ms. Rogers has diabetes and developed chronic kidney disease last year after a serious battle with COVID. He had lost his brother-in-law to Kovid a year ago.

But two doses of the vaccine left her feeling flabby and tired, and she worried the shot might prove to be too much for her children. Her children go to school wearing masks and wash their hands regularly, but she and her husband are not yet ready to vaccinate them.

“The last thing you want to do is mess with their ticker, man — that’s what makes them go,” she said. “I’d be more for a dose, if that was an option.”

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