FDA authorizes coronavirus vaccine for younger youngsters with pictures doubtless subsequent week

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More than a year and a half after the oldest Americans gained access to coronavirus vaccines, the nation’s youngest citizens are poised to start getting shots next week, a move made possible when federal regulators Friday authorized vaccines for children as young as 6 months.

For many parents and pediatricians, the Food and Drug Administration clearing of two vaccines — one by Moderna and the other by Pfizer and its German partner, BioNTech — comes as a huge relief. Friday’s emergency use authorizations arrived two days after a panel of external advisers unanimously recommended that the agency greenlight vaccines for the last age group eligible for a shot of protection against the virus.

“Many parents, caregivers and clinicians have been waiting for a vaccine for younger children and this action will help protect those down to 6 months of age,” FDA Commissioner Robert M. Califf said in a statement. “As we have seen with older age groups, we expect that the vaccines for younger children will provide protection from the most severe outcomes of COVID-19, such as hospitalization and death.”

The vaccines for young children — a group that numbers at least 19 million — arrive at a critical moment in the nation’s quest to vanquish the virus, with vaccination levels overall flagging even as covid-19 hospitalizations reach their highest average level in more than three months. And they come a few months before cooler temperatures arrive, potentially ushering in another deadly surge of covid cases.

Many parents with babies and young children see the shots as critical to resuming their pre-pandemic lives, without frequent disruptions to day-care schedules or family celebrations. Some parents said they intend to get their children vaccinated as soon as possible.

Their first opportunity, if all goes as expected, will be early next week, following what are expected to be favorable recommendations from the Centers for Disease Control and Prevention on Saturday. Advisers to the CDC began meeting Friday to discuss the vaccines.

“This is a very important moment,” said Sallie Permar, an expert in pediatric vaccines at Weill Cornell Medicine in New York. “Children and their parents have been waiting since the pandemic began to have a tool to prevent disease.”

Yet indications are that initial uptake of the vaccines will be low. Federal officials, who have been taking early orders for the vaccine, say demand has been tepid. And in a recent Kaiser Family Foundation survey, only 18 percent said they plan to get their children vaccinated right away, while 27 percent said they will “definitely not” get their child vaccinated.

It’s not unusual for parents to be hesitant when childhood vaccinations first roll out, as was the case with the polio and pneumococcal vaccines, experts said. But it means pediatricians and family doctors, whom polls show parents trust the most, will have to work diligently in coming months to assuage parental anxieties about having their child vaccinated.

“There’s a lot of information and trust building that needs to happen,” said Tom Inglesby, director of the Johns Hopkins Center for Health Security at the Bloomberg School of Public Health. “It’s going to take time to reach other parents, and they’re going to need to really develop confidence in the vaccine and hear it from their most trusted local health-care providers. … Hopefully, with time, people will have increasing confidence that it’s both effective and safe.”

Other experts say it is important to be realistic about what the shots can do against a rapidly evolving pathogen. Neither vaccine was tested against the fast-spreading omicron subvariants, BA.4 and BA.5, that have an exceptional ability to evade immune protections.

The pediatric vaccines, like adult versions, “won’t hold up that well in protecting against infection by the new subvariants,” said Peter Hotez, a molecular virologist and dean of the National School of Tropical Medicine at Baylor College of Medicine in Houston. “But they will still be very effective in preventing children from going to the hospital or the intensive care unit.”

Some parents have been desperate to get access to the vaccines. Brennan Grignon, who lives in the District and has a 3-year-old daughter and 20-month-old son, said she has struggled with repeated disruptions to child-care schedules. She said the vaccines will offer much-needed stability to her life as a working parent.

“All of us are looking forward to exhaling and getting to this point where they may get sick, but not get as sick, and expect a little more predictability when it comes to child care,” Grignon said. “The ability for us to feel more confident in what a world with covid looks like and our experience with young kids in that world is something we’re looking forward to.”

The Moderna vaccine is for children 6 months through 5 years old. It consists of two doses of 25 micrograms each — one-quarter of the adult dose — given four weeks apart. In studies, it was shown to be 51 percent effective in preventing illness in children 6 months to 2 years old and 37 percent effective in children ages 2 to 5.

The Pfizer-BioNTech vaccine, which is for children 6 months through 4 years old, is three shots of 3 micrograms each, one-tenth the adult dose. The first two shots are given three weeks apart, and the third at least two months later. Preliminary data suggests the vaccine’s efficacy against symptomatic illness is about 80 percent, but FDA officials said that figure was based on so few cases that it “was determined to not be reliable.” The vaccine is already authorized for older children and teenagers.

As information about the two vaccines emerges, physicians and parents are sure to debate which is preferable. But many scientists say it will require additional data gathered during use of the two brands in the real world to determine which is more effective. In many cases, parents won’t have a choice because pediatricians might stock just one of the vaccines — though big, hospital-based practices might offer both.

Foreshadowing the Biden administration strategy of stressing that both shots are safe and effective, Califf said he has two young grandchildren and will suggest they get vaccinated as soon as possible, regardless of the brand.

Peter Marks, director of the FDA’s Center for Biologics Research and Evaluation, agreed: “Whatever vaccine your health-care provider or pediatrician has, that’s what I would give my child.” He said the differences between the shots are subtle.

Marks said Moderna’s two-shot vaccine might provide protection more quickly than the three-dose Pfizer-BioNTech shot. On the other hand, he said, the third dose of the Pfizer-BioNTech product may produce a stronger shield over the long run.

Moderna is testing a third dose of its vaccine and says it will have results during the summer. Some parents have expressed interest in Moderna because the immune-system protection will be in place before school starts in the fall. But some of the FDA advisers said this week they believe three shots will be needed to protect adequately against omicron and its subvariants.

Neither vaccine raised safety concerns. Studies showed that study participants who received Moderna were more likely to get fevers, but that high fevers were rare.

During the news conference, the officials were asked how children might be affected by possible changes in vaccine boosters to counter omicron and variants such as BA.4 and BA.5. The agency’s outside advisers are scheduled to meet June 28 to discuss whether and how boosters should be altered, with an eye toward deploying them for a fall inoculation campaign.

Marks said parents should get their children vaccinated now because the shots will provide a foundation of protection against serious illness from omicron. If the recipes of boosters are changed for the fall, he said, “We will make sure there is an option available” for children.

He said the FDA is watching BA.4 and BA.5 closely as it tries to determine which variants and subvariants should be targeted in a fall booster-shot effort.

“We will be looking at all the tools in our toolbox” to try to determine which reformulation will provide better and more durable protection, Marks said.

The FDA on Friday also authorized Moderna’s vaccine for children and adolescents from 6 through 17 years old, providing another option for youngsters in that age group, who already have access to a shot from Pfizer-BioNTech.

Assuming the CDC recommends the vaccines for young children, Richard E. Besser, president and CEO of the Robert Wood Johnson Foundation and former acting director of the CDC, said he will be a strong proponent.

“As a pediatrician, this is a tool I have been eagerly waiting for,” Besser said.

While most children don’t become seriously sick with covid, a small number develop severe illness even though they do not have underlying medical conditions. More than 400 children younger than 5 have died of covid, the FDA said this week. Others who are infected risk developing long covid, a constellation of symptoms that can extend for months or years with long-term effects, including on brain development, that are still being studied. In addition, Besser said, vaccines will ease the stress of parents who worry: “What if it is my child who has that bad outcome?”

It’s expected some parents will opt against immunizing their children, saying they have some natural immunity because they had covid. As many as 75 percent of children have been infected since the beginning of the pandemic, many during the recent surge in infections driven by omicron, according to a new study.

But Besser said it would be a mistake to skip vaccination because of prior infection.

“Having gotten infected does not change the equation,” Besser said. “We have seen people getting infected again, and those with the best protection are those who have had covid and have been vaccinated.”

Studies have shown that immunity from infection with omicron does not last long, and the rate at which omicron subvariants have been evolving means new strains are able to infect people who have recently had a covid infection. Health and Human Services Secretary Xavier Becerra announced this week he had contracted covid for the second time in less than a month.

Some parents have wondered whether babies younger than 6 months will be eligible for coronavirus vaccines at some point. Experts said some studies are underway but that the data is not yet available on whether a vaccine for that age group would be feasible or beneficial.

Some vaccines are not administered to infants because they have immature immune systems and therefore cannot generate a good immune response to a vaccine, said Inglesby of Hopkins. Babies also generally have their mother’s antibodies to protect them, Inglesby said.

Baylor’s Hotez said the immunization schedule for babies already is crowded and that studies are needed to show that any additional shot won’t diminish the effectiveness of a previous vaccine.

“You don’t undertake an added vaccine lightly for under 6 months,” Hotez said.

With the vaccines for children younger than 5 approaching the finish line so much later than shots for adults, some doctors and scientists ask whether the process could be accelerated.

“Why was it that children had to be left to last?” Weill Cornell’s Permar said. “What are the ways in which we can speed up availability?”

Part of the reason is that the pediatric coronavirus vaccines, unlike the adult versions, ran into delays and setbacks, with the Pfizer-BioNTech vaccine initially planned as a two-shot vaccine regimen but failing to mount an effective shield for children 2 through 4 years old. The vaccine makers added a third shot to their trial, delaying vaccine availability by months.

But Permar also raised questions about whether the traditional practice of first testing vaccines in healthy adults and then moving down the age scale should be adjusted.

“Once you have good results, without safety signals, you might want to think about doing things in a way that would include vulnerable groups, such as pregnant women and children, more quickly,” Permar said. Studies to determine the correct doses could be conducted on several age groups at once, she said.

Others said it was reasonable for the companies to do the “step-down” method to ensure they understand potential side effects before testing shots on children. “It’s the classic approach, for safety reasons,” Hotez said.

FDA officials acknowledged they can do better. They said they learned lessons during the pandemic that would help them speed studies next time for young children and also for pregnant and lactating women.

Rachel Roubein and Katie Shepherd contributed to this report.

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