The Centers for Disease Control and Prevention recommended Saturday that children as young as 6 months old receive Covid-19 vaccines developed by Pfizer-BioNTech and Moderna.
The move follows an unanimous vote earlier in the day by an advisory panel of outside experts known as Advisory Committee on Immunization Practices, or ACIP.
“Together, with science leading the charge, we have taken another important step forward in our nation’s fight against COVID-19. We know millions of parents and caregivers are eager to get their young children vaccinated, and with today’s decision, they can,” said CDC Director Rochelle Walensky in a statement.
Shots could be offered at pharmacies and other providers as soon as Monday.
“I have the ability with my vote today to save more lives than my particular decisions with extremely sick children have saved throughout my career,” said Sarah Long, a professor of pediatrics at Drexel University College of Medicine and a committee member.
For a subset of parents and guardians with children under the age of 5, the vaccines have been eagerly anticipated for months — a tool, like the first inoculations for adults, for restoring their lives to a sense of normalcy. During a public comment period for the hearing Friday, parents shared stories of kids who haven’t been able to visit grandparents or spoke aspirationally about doing basic things they read about in books, like going to the aquarium.
Yet it remains unclear how many families will elect to vaccinate their kids. Although CDC officials spent two days presenting data on the risk Covid-19 poses to kids — in terms of severe disease, the rare inflammatory condition known as MIS-C, and potential long Covid — much of the public messaging over the past two years has emphasized that kids are unlikely to become gravely ill from the virus.
Pfizer’s Covid vaccine has been available for all adolescents since May 2021 and to children 5 to 11 since October, but only 59% of children ages 12 to 17 and 29% of children 5 to 11 have gotten two doses of vaccine.
Experts expect that trend to continue with even younger kids. In an April Kaiser Family Foundation poll, less than 1 in 5 parents of children under 5 said they were eager to get their kids inoculated once shots became available.
One state, Florida, declined to preorder vaccines for young children at all, although CDC officials assured the ACIP that pharmacies and clinics in the state are able to order them.
The advisory committee expressed little doubt about the need for vaccines in children. Rather, much of the discussion centered on how they can communicate to parents that need, and how to ensure the vaccines are made as widely available as possible, especially as the vaccine rollout will increasingly rely on primary care providers.
“There is a large risk of inequitable access,” said Beth Bell, a clinical professor at the department of global health at the University of Washington.
In a Friday presentation, CDC pediatrician Katherine Fleming-Dutra showed data that 202 children between 6 months and 4 years of age had died of Covid-19 during the pandemic, making it among the five leading causes of death for young children.
That’s more deaths per year than hepatitis, meningitis, rotavirus, and other common infectious diseases each caused before routine vaccinations were recommended. And the risk wasn’t limited to any particular group: More than half of young children hospitalized due to Covid-19 had no underlying conditions.
“I am struck by these numbers,” said Katherine Poehling, director of pediatric population health at Wake Forest University School of Medicine and a committee member. “I’m also concerned that there’s really an underappreciation of the potential severity.”
The Moderna vaccine appears to provide protection after two doses, inducing a similar level of antibody in kids as it did in adults and reducing the risk of developing symptomatic Covid-19 during the initial Omicron wave by around 37%.
Pfizer’s data, however, was more complicated, and advisers raised questions about the exact figure the company’s scientists put out.
The company initially tried to develop a two-dose shot before switching to a three-dose series after the initial strategy failed to induce a sufficient number of antibodies or protect kids against Omicron. The three-dose shot induced a high level of antibodies, but because Pfizer began the trial toward the end of the Omicron surge, it only saw 10 Covid cases in the three-dose study: three in the vaccine group and seven in the placebo group, for 80% efficacy.
Advisers raised questions about the small sample size for the 80% estimate, arguing the vaccine was safe and effective but that they needed to manage parental expectations about how much protection it really offers — and how important it is that children come back for a third dose.
“I would not bet against the vaccine here,” Bill Gruber, Pfizer’s vice president of vaccine clinical research and development, said during one exchange.
“To be clear, I’m not betting against the vaccine,” responded Matthew Daley, a senior investigator at the Institute for Health Research at Kaiser Permanente Colorado. “I’m just arguing for greater transparency about what we know and don’t know with parents and that includes what to expect after a second dose.”
Others argued clinicians shouldn’t focus on efficacy figures. Rather, the antibody levels from both trials suggest that young children develop the same levels of immunity that have protected adults against severe disease during Omicron. And the side effect data shows the vaccine is safe.
“We talk a lot about the data, and we may lose the notion that we’re saving children’s lives,” said Long.
In part because the two vaccines have different dose schedules, the rollout will raise new questions. In the public hearing, one parent asked for wide availability of both series, so families can make a choice, and one committee member, Veronica McNally, asked for the CDC to create handouts clearly comparing the two shots. But it’s unclear how many people will have both vaccines offered at local pharmacies or providers.
The vaccine is also being rolled out in children who are also going through their routine pediatric vaccination. Neither Moderna nor Pfizer studied how the vaccine performed when co-administered with another shot, but the CDC recommended that in most cases, clinicians should administer at the same time as other vaccines, especially as many kids have fallen behind their vaccination schedule during the pandemic.
Children who are moderately or severely immunocompromised would receive a different schedule: Three doses for Moderna and three doses of Pfizer-BioNTech but spread further apart.
And both shots come in 10-dose vials that expire 12 hours after they’ve been opened. Advisers asked about single-dose vials, fearing that a vial will be opened to vaccinate one child and the rest will be wasted.
CDC officials argued it was a legitimate concern but not the main one.
“It is important to get shots with the arms and take advantage of every opportunity,“ said José Romero, director of National Center for Immunization and Respiratory Diseases. “Don’t feel guilty.”