New discoveries about vaccines in young children

For American parents, especially those with young children, the past two months have been hectic and very frustrating.

In early February, US federal regulators announced they would test Pfizer-BioNTech’s coronavirus vaccine for younger children, but scrapped that plan ten days later, saying they had doubts about the vaccine’s effectiveness. in that age group.

Shortly thereafter, scientists reported that the vaccine offered only weak protection against omicron variant infection among children aged 5 to 11 years and appeared to offer little protection against moderate disease caused by COVID-19 among adolescents aged 12. to 17 years.

On Monday, March 7, citing this data, Florida’s chief public health officer declared that healthy children do not need to be vaccinated, advice that Jen Psaki, the White House press secretary, called “extremely concerning.”

Regardless, experts have continued to defend vaccines, pointing out that while the omicron variant can penetrate immune defenses and infect people, vaccines still prevent serious complications and deaths, and can do so for years.

The US Centers for Disease Control and Prevention (CDC) found that a record number of children under 5 years of age had been hospitalized during the wave of omicron, and stressed the need to vaccinate them, but the agency has since said that 90 percent of Americans can stop wearing masks in public indoor spaces, including in schools with young children.

Who could blame the parents for being flummoxed?

“The confusing thing is that there is no clear, right answer anymore,” said Anne Gonzalez, a 41-year-old mother of two who oversees volunteers for a large religious nonprofit in St. Louis. “I’ve gotten to the point where the only thing I can do is what feels right for my family.”

Luckily, the next few weeks could bring some clarity. Both Pfizer and Moderna plan to report the results of trials of their vaccines in young children. If positive, they should undergo a new round of regulatory review — perhaps in April — that could allow tens of millions of children to be vaccinated.

However, those results will be ready when the omicron variant reduces its presence in the United States, which will complicate the decision of parents about the advisability of vaccinating children.

Fewer than 1 in 4 children between the ages of 5 and 11 already have a complete vaccination schedule. More than half of adolescents aged 12 to 17 years have completed their vaccination schedules, but only 12 percent have received a booster dose. These percentages are even lower in rural America.

Children are less likely to get sick, so the balance of risks and benefits was never the same as for adults. Now, up to 95 percent of the country has some degree of protection against the virus due to vaccinations or previous infection, according to recent data from the CDC.

Experts worry that the latest results have made it even harder to convince some parents to vaccinate their children.

“The data should disappoint us, we wish it was better,” said Luciana Borio, a former acting chief scientist for the US Food and Drug Administration (FDA). “But in the short term, it’s important for parents to get their kids vaccinated.”

The country may see a spike in infections in the fall or winter, and the best protection for children will be having received at least two doses before then, Borio said.

Vaccines continue to prevent serious illness and death, even with the omicron variant. That trend is particularly clear in hospitals, said James Campbell, a physician at the University of Maryland School of Medicine and a member of the American Academy of Pediatrics committee on infectious diseases.

Among his pediatric patients who were sick enough to need a mechanical ventilator or die, “every single one of them was unvaccinated,” Campbell said.

Recent studies suggest that the problem is not so much the vaccine as the dose.

In trials conducted in adults in 2020, vaccine manufacturers made their best guesses about the correct dose and opted for short intervals between injections to protect people as quickly as possible during the initial surge in infections.

The Pfizer-BioNTech and Moderna vaccines were shown to be safe and offer strong protection in clinical trials and were quickly licensed for use, but trials in children were complicated by the advent of delta and omicron variants, and the vaccine appeared to offer less protection in children aged 2 to 4 years.

For now, the Pfizer-BioNTech vaccine is the only one licensed for children. (Vaccines manufactured by Moderna and Johnson & Johnson are only licensed for adults.)

In the Pfizer trials, adolescents ages 12 to 17 received 30 micrograms, the same dose given to adults. But children ages 5 to 11 received 10 micrograms, and those ages 6 months to 5 years only received three micrograms.

These doses may have been too low to elicit an adequate and long-lasting response. But federal officials who have seen the data told The New York Times that the higher doses produced too many fevers in children.

What is done when a high enough dose cannot be given to protect children against the omicron variant due to side effects? That’s the problem scientists and federal officials are now grappling with.

Pfizer and BioNTech are currently testing a third dose in children under 12 years of age to see if it can offer the level of protection that the two doses did not. The FDA is still evaluating the Moderna vaccine for use in children 6 to 11 years of age. Last week, the agency rejected an application for authorization of the Covaxin vaccine for children, which is made in India.

There are other covid vaccines, such as those made by Novavax and Sanofi, that may work well in children. Federal health officials should consider all of these options and test whether a different dose or a longer interval between injections would improve the immune response, the experts said.

“It seems to me that vaccines for children are taking longer than they should, given the importance of protecting that population,” Borio said. “The sooner we revive our search for safe and effective vaccines for children, the better off we will be.”

The disappointing results, coupled with the subsidence of the omicron surge, have complicated the political decisions of local health officials.

Contrary to Florida’s recommendations, the states of Louisiana and California will require students to be vaccinated by the fall, and the District of Columbia had set a March 1 deadline for students 12 and older to have a schedule. full vaccination.

Other states could adopt similar policies, but are likely to do so only if the FDA fully approves the use of the vaccine in school-age children, said Hemi Tewarson, executive director of the National Academy for State Health Policy, a nonpartisan organization. partisan.

“For many, that will be the key factor in requesting vaccination as a mandatory requirement,” he said.

Making vaccinations mandatory at school would ease the fears of many families with children who have medical vulnerabilities.

Nearly everyone in Heather Keever’s family, including her 14-year-old son Wesley, suffers from heart disease, high blood pressure and kidney disease, but because they’re not technically immunocompromised, they’re not entitled to preferential treatment at work or school. said Keever, 42, a consultant in suburban Chicago.

“They forget that some of us can’t literally take our masks off,” at least until the rates go much lower, he said. “I felt that I didn’t matter, that I wasn’t important and that I was most likely disposable. And I still feel it.”

Some scientists have said they will continue to wear masks until infection numbers drop because of the risk of infection.

Since younger children have yet to be vaccinated, “I would refuse to ask a child under 5 to remove their mask indoors,” said Akiko Iwasaki, an immunologist at Yale University who studies persistent Covid, and the set of symptoms that continue long after the acute infection has resolved.

Given the confusing results about the effectiveness of vaccines and mixed messages about the benefits of masks, families are weighing the risks on their own and reaching very different conclusions.

Jennifer Steinberg, a management consultant in Wilmington, Delaware, has two daughters who share time with her and their immunocompromised father.

“Yes, it’s great, it protects against serious diseases,” Steinberg said of the vaccine. “But if your children are still going to get infected, it’s a huge disruption to family life. I think I will continue to wear a mask in the future.”

Katie Sunderland, of Arlington, Virginia, has long been willing to give up the mask. If her children, ages 7 and 5, get infected, “it will seem like fair compensation to me in exchange for being able to take off the mask and see each other’s faces,” she said.

“Either way, I’m not convinced that wearing a mask significantly reduces the risk of contracting COVID-19, especially the type of masks I see most children wearing,” said Sunderland, 37. “In my opinion, it is not logical to prevent the development of my children because of such a low, low risk.”

However, many other parents still don’t know what to do. Gonzalez has a niece and nephew who have congenital heart defects and lung capacity issues, and he will continue to wear masks to protect them, he noted.

But if your child’s school drops the mask requirement, “we don’t know what we’re going to do yet.”

Apoorva Mandavilli is a reporter for the Times, focusing on science and global health. In 2019 she won the Victor Cohn Award for Excellence in Medical Science Reporting. @apoorva_nyc

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