Independent advisers to the Food and Drug Administration on Wednesday recommended use of the Moderna and Pfizer-BioNTech coronavirus vaccines for babies and young children, a milestone in the nation’s efforts to combat a wily pathogen that continues to infect tens of thousands of people a day and upend the lives of families across the country.
The outside experts said the benefits of the vaccines outweighed the risks — the standard for an emergency use authorization. The vote was 21 to 0 for the vaccines from Moderna and from Pfizer and its German partner, BioNTech.
Children younger than 5 — a cohort estimated to number at least 19 million — are the only group in the United States who still do not have access to coronavirus vaccination. Now, that is poised to change.
While the FDA does not always follow the recommendations of its advisers, it is expected to do so in this case, within a day or two. Assuming the Centers for Disease Control and Prevention and its advisers concur at a meeting scheduled for Friday and Saturday, the vaccines will be available by next week.
The broadened coverage comes as vaccinations have been stagnant for months and ahead of what the Biden administration has warned could be a difficult fall and winter, with up to 100 million coronavirus infections. And it follows some vexing twists and turns that slowed development of vaccines for the youngest.
Many parents and pediatricians see the pending arrival of vaccines as long overdue. Several parents, seething with frustration, have said their lives have turned into relentless risk assessments as most of the country has abandoned covid-19 restrictions.
“My own daughters have asked me what my recommendation is for my young grandchildren and, without hesitating, I recommended they get vaccinated the first day, if that’s humanly possible,” said Mark W. Kline, physician-in-chief and chief medical officer at Children’s Hospital New Orleans.
Kline expects a rush of parents seeking vaccinations who want to protect their children from a potentially serious illness — a rare but worrisome occurrence.
“We know there are some children who get severe disease who land in the ICU, who may even die from the disease,” Kline said. He and some other doctors called for a streamlining of the vaccine development and evaluation process.
Experts counter that there are solid reasons it has taken so long to get vaccines for the youngest. Typically, scientists want to ensure vaccines and drugs are safe in adults before they are administered to children. The vaccine makers moved sequentially through age cohorts to determine the doses that provided a robust immune response with limited side effects.
In contrast to some families’ sense of urgency, most parents say they are not in a hurry to get their children vaccinated. 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.
Throughout the day, the FDA advisers — the Vaccines and Related Biological Products Advisory Committee — debated the data and struggled to assess the benefits of a vaccine in an ever-changing pandemic now marked by highly transmissible omicron subvariants. While they all ultimately supported authorizing the vaccines, there were differences of opinion about how much the shots would help a population that already is at low risk of becoming seriously ill or dying of covid.
Opening the meeting, Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said 442 children younger than 5 had died of covid, a higher number than for many other pathogens, including influenza, for which there are vaccines. He added that it was important to avoid becoming numb to the deaths, adding that “each child who is lost essentially fractures a family.”
Cody Meissner, professor of pediatrics at Tufts University School of Medicine, said parents should be advised that it is rare for children to become seriously ill or die of covid.
“I think the vaccine should be available for, certainly, high-risk children and for families that are so concerned [about covid],” Meissner said. “But I … feel very strong that parents understand how small these numbers are, a very low risk from the vaccine, but it’s also a very low risk from the infection itself.”
But overall, even amid extensive debate about the number of doses needed in a vaccine regimen and whether the shots produced a robust enough immune response, there was strong support for both vaccines. Several committee members said parents who have been waiting for the shots should have the option to get their children vaccinated, and be given a choice of products.
“Some parents are so concerned about the risk of exposure that they’re still completely isolating their children,” said Mark Sawyer, a professor of clinical pediatrics at the University of California at San Diego’s School of Medicine. “The availability of these vaccines will liberate those children to some extent, whose parents will find relief and feel a little more comfortable to let their children start to socialize in the appropriate environment.”
Both pediatric vaccines met the FDA’s main test for effectiveness: Blood tests showed the shots generated enough virus-blocking antibodies to provide at least as much protection as the vaccines provide young adults.
Clinical trials also provided limited “supportive evidence” on effectiveness by comparing the number of covid cases among participants who received the vaccine with those who received saline shots, the agency said. And the FDA said it expects the vaccines to work better at preventing severe illness — a crucial measure — than at stopping any infection. The same is true in adults.
The Moderna regimen consists of two doses of 25 micrograms each — one-quarter of the adult dose — given four weeks apart. 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.
Moderna said it is testing a third dose, or booster shot, for the vaccine — a statement that was welcomed by experts who think three shots are needed against omicron and its subvariants.
“I think all of us agree that these children are going to need a third dose at some moment in time,” said Moderna senior vice president Jacqueline Miller. “But at this moment, our view is it’s just critically important to start vaccinating babies so that they can start benefiting from the same protection as other age cohorts.”
The Pfizer-BioNTech vaccine is three shots of 3 micrograms each, one-tenth the adult dose, with the third shot given at least two months after the second shot — though it was given later to many children in the trials. Preliminary data suggested the vaccine’s efficacy against symptomatic illness is 80 percent. But FDA officials said that estimate was based on so few cases that it will probably change and may decline.
Pfizer-BioNTech last year initially launched an effort to produce a two-dose regimen but found in clinical trials that it did not provide a strong enough immune response for children between 2 and 4 years old; the dose apparently was too small. In documents prepared for Wednesday’s meeting, Pfizer-BioNTech said effectiveness for two shots was just 28 percent for children 6 months through 4 years old and, according to the FDA, even lower for children 6 months through 23 months old. That dashed hopes that the vaccine could have been available as early as February.
Paul A. Offit, a vaccine expert at Children’s Hospital of Philadelphia, expressed concern that the effectiveness of the Pfizer-BioNTech vaccine after two doses was so low. He and some other members said they were worried that some parents would think their children were fully shielded after two shots, when in fact they needed that third shot.
In other differences between the shots, the Moderna vaccine results in more fevers, according to trial data. That isn’t surprising given that it is a higher dose, experts say. Pfizer-BioNTech officials say they used a lower dose to minimize side effects.
Hattie Egan-Young, who lives with her husband in New York, is eager to have her son Henry, who is just under a year old, vaccinated. She has been frustrated as mask mandates and other virus-related restrictions have fallen away even as the youngest remain vulnerable.
Once their son is vaccinated, she and her husband “could live our life again,” Egan-Young said. “To have that sort of freedom again would be such a gift, especially because so many people are getting to live that. I just want to join them.”
But many parents do not think it’s worth getting their young children vaccinated — at least not right now. Some cite the significantly lower risk of covid to their children, compared with adults, while others say young kids already receive myriad vaccinations as part of childhood immunization schedules.
Alec Brown, who lives in Georgia, said he does not plan to get his 4-month-old son vaccinated when he becomes eligible later this year.
“When I look at a very low risk of him getting covid and it actually harming him in any way versus the risk of side effects, I would rather just avoid possible side effects than get him the vaccine,” Brown said.
Jeanne Marrazzo, an infectious-disease specialist at the University of Alabama at Birmingham, said it was understandable that many parents want to avoid side effects. She said the vaccines probably provide just modest benefits to young children, at least in preventing infection.
“I would say there is no downside to getting it, but it’s not going to be a magic bullet,” Marrazzo said. Because the coronavirus keeps evolving, “we should not be fooled into thinking this will shut down the next surge.”
During the meeting of FDA advisers, panel members and agency officials expressed concern over the rampant misinformation circulating about the children’s vaccine, including potential adverse effects.
In his closing comments at the meeting, FDA’s Marks reiterated that the agency cares “tremendously” about the safety and efficacy of the vaccines, and that the FDA would continue to monitor the vaccines as they are distributed. He noted that anyone could report a problem to the Vaccine Adverse Event Reporting System (VAERS), which is co-sponsored by the FDA and the CDC. He said it was impossible to tell which adverse events are truly associated with the vaccine until regulators have a chance to sort through the claims.
“There seems to be a lot of misinformation, and I’m seeing it right now in real time because I’m watching Twitter storms in front of me about misunderstanding VAERS,” Marks said. “As we have findings … we will make sure the public knows about them.”