For American parents, especially those with young children, the past few months have been dizzying and beyond frustrating.
In early February, federal regulators announced they would be evaluating Pfizer-BioNTech’s coronavirus vaccine for the youngest children — only to scrap that plan 10 days later, citing doubts about the vaccine’s effectiveness in that age group.
Shortly afterwards, scientists reported that the vaccine offered only weak protection against infection with the Omicron variant in children aged 5 to 11 and that it appeared to offer little protection against moderate Covid disease in adolescents aged 12 to 17.
On Monday, citing this data, the Florida surgeon general stated that healthy children should not be vaccinated, advice that White House press secretary Jen Psaki called “deeply troubling.”
Through it all, experts have continued to support vaccines, noting that while the Omicron variant may be able to penetrate immune defenses and infect humans, the vaccines still prevent serious illness and death — and could do so for years to come.
The Centers for Disease Control and Prevention found that record numbers of children under 5 were hospitalized during the Omicron peak, underscoring the need for vaccines for those children. But the agency has since said that 90 percent of Americans can safely stop wearing masks in indoor public areas, even in schools with young children.
Who can blame parents for feeling baffled?
“The part that’s confusing is like there’s no clear, right answer anymore,” said Anne Gonzalez, a 41-year-old mother of two who directs volunteers for a large religious nonprofit in St. Louis. “I’ve come to the point where I can only do what I think is right for my family.”
Fortunately, the coming weeks should bring some clarity. Both Pfizer and Moderna plan to report results of trials of their vaccines in young children. The results, if positive, should lead to another round of regulatory revisions, perhaps as early as April, which will allow for vaccinations for tens of millions of young people.
But those findings will come as the Omicron variant fades in the United States, complicating parental decisions about whether or not to vaccinate children.
Less than one in four children ages 5 to 11 are now fully vaccinated. More than half of adolescents ages 12 to 17 have been fully vaccinated, but only about 12 percent have received a booster dose. Those percentages are even lower in rural areas of the United States.
Children are less likely to get sick, so the balance of risk and benefit was never the same as it was in adults. And now, as many as 95 percent of the country has some degree of protection against the virus because of vaccines or previous infection, according to recent data from the CDC.
Experts worry that the most recent findings have made it even more difficult to convince some parents to vaccinate their children.
“We should be disappointed with the data — we wish it could be better,” said Luciana Borio, former acting chief scientist at the Food and Drug Administration. “But in the short term it is important that parents vaccinate children anyway.”
The country can still see a wave in the fall or winter, and the best protection for children is to have had at least two shots before then, she said.
The vaccines continue to prevent serious illness and death, even with the Omicron variant. That trend is especially evident in hospitals, said Dr. 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 so sick that they needed a mechanical ventilator or died, “each of them had not been vaccinated,” said Dr. Campbell.
A dosage riddle
The recent studies suggest that the problem is not so much the vaccine, but the dose.
In the 2020 adult trials, vaccine manufacturers made the best estimates of the correct dose and chose short intervals between shots to protect people as quickly as possible during the first wave.
The Pfizer-BioNTech and Moderna vaccines were shown to be safe and potent protective in clinical trials and were quickly approved for use. But the studies in children were complicated by the advent of the Delta and Omicron variants, and the vaccine appeared to be less protective in children ages 2 to 4.
At the moment, the Pfizer-BioNTech vaccine is the only one approved for children. (The vaccines made by Moderna and Johnson & Johnson are only approved for adults.)
In the Pfizer studies, adolescents aged 12 to 17 years received 30 micrograms, the same dose as adults. But kids ages 5 to 11 got 10 micrograms, and those ages 6 months to 5 years got just three micrograms.
These doses may have been too low to elicit an adequate and lasting response. But federal officials who saw the data told DailyExpertNews that higher doses caused too much fever in children.
What to do if due to side effects you are unable to give a high enough dose to protect children from the Omicron variant? That’s the problem scientists and federal officials are grappling with right now.
Pfizer and BioNTech are now testing a third dose in children under the age of 12 to determine if it can provide the level of protection two doses could not. The FDA is still evaluating the Moderna vaccine for use in children ages 6 to 11. Last week, the agency rejected an application for authorization of the Indian-made vaccine Covaxin for children.
There are other Covid vaccines, such as those from 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 longer interval between doses would improve immune response, experts said.
“It seems to me that childhood vaccines are taking longer than they should be, given the importance of protecting that population,” said Dr. borio. “The sooner we revive our quest for safe and effective vaccines for children, the better off we’ll be.”
Masks in schools
The disappointing findings, along with the waning Omicron spike, have greatly complicated policy decisions for local health officials.
Despite Florida’s recommendations, Louisiana and California will require schoolchildren to be vaccinated by the fall of 2022, and the District of Columbia has set a March 1 deadline for students 12 and older to be fully vaccinated.
Other states may adopt similar policies, but are likely to do so only if the FDA grants the vaccine full approval for use in schoolchildren, said Hemi Tewarson, executive director of the National Academy for State Health Policy, a nonpartisan organization.
“For many of them, that will be the key to demanding vaccines as a mandate,” she said.
A school vaccine mandate would allay the fears of many families with children with medical vulnerabilities.
Nearly every member of Heather Keever’s family, including her son Wesley, 14, has heart disease, high blood pressure, and kidney disease. But because they are not technically immunocompromised, they are not eligible for housing at work or school, said Ms. Keever, 42, a consultant in suburban Chicago.
“They forget that some of us literally can’t take the mask off,” at least until rates drop much further, she said. “I felt like I didn’t matter and that I wasn’t important and that I was arguably a disposable item. And I still do.”
Some scientists have also said they would continue to wear masks until the number drops due to the risk of infection.
Because the youngest children have not yet been vaccinated, “I would be very reluctant to ask a child under 5 to remove masks indoors,” Akiko Iwasaki, an immunologist at Yale University who has studied Covid for a long time, told the newspaper. cluster of symptoms that may persist. long after the acute infection has resolved.
Given the muddled results on vaccine effectiveness and the mixed reports of the benefits of masks, families are weighing the risks themselves — and coming to very different conclusions.
Jennifer Steinberg, a management consultant in Wilmington, Del., has two daughters who divide their time with her and their immunocompromised father.
“Yeah, great, it protects against serious disease,” Ms. Steinberg said of the vaccine. “But if your children do get infected, this is a huge disruption to family life. I will probably remain masked for the foreseeable future.”
Katie Sunderland of Arlington, Virginia, has long been ready to give up masks. If her children, 7 and 5, get infected, “that’s a trade-off that I think is good if they can unmask and see faces,” she said.
“I am not convinced that wearing a mask would significantly reduce the risk of getting Covid anyway – especially not the kind of masks I see most children wearing,” said Ms Sunderland, 37. sense of hindering my children’s development for that very, very, very low risk.”
But many other parents don’t know what to do yet. Ms. Gonzalez has a niece and nephew with congenital heart defects and lung capacity problems, and she will continue to wear masks to protect them, she said.
But when her son’s school drops the mask requirement, “we don’t know what we’re going to do yet.”