A panel of the Centers for Disease Control and Prevention’s outside vaccine advisers voted unanimously Tuesday to recommend Pfizer’s COVID-19 vaccine for children as young as 5.
CDC Director Dr. Rochelle Walensky is expected to issue guidance formally adopting the panel’s recommendations soon, clearing the way for doses to be administered as early as Wednesday.
The White House says millions of vials of Pfizer’s lower-dose vaccine formulated for younger children have already begun shipping to health care providers following the Food and Drug Administration’s authorization last week. The children’s vaccine will come in new packaging to differentiate the smaller 10 microgram doses from the 30 micrograms offered to people ages 12 and up.
The vote follows a day-long meeting of the CDC’s Advisory Committee on Immunization Practices or ACIP.
“Today’s a monumental day in the course of this pandemic and one that many of us have been very eager to see. Ever since your vote on December 12th last year recommending COVID-19 vaccination for those 16 and older, we have been asking when we will be able to expand this protection to our younger children,” Walensky told the committee at the opening of their meeting.
Much of the panel’s discussion focused on weighing the benefits of the vaccine against the potential risk of rare cases of myocarditis, a heart inflammation side effect. While the exact rate of myocarditis after the vaccine in 5- to 11-year-old children remains unknown, it is rare enough that zero cases turned up in the clinical trial. The CDC’s advisers concluded the risk was “likely lower” in younger children than adolescents.
Overall, Pfizer’s clinical trial data suggests younger children will experience fewer side effects than adolescents or young adults. Side effects that did occur, such as fever and body aches, were generally mild.
The smaller doses were highly effective at triggering antibodies to the virus in Pfizer’s study, and were more than 90% effective at blocking symptomatic disease.
At the request of regulators, Pfizer looked for safety issues and side effects in around 3,100 younger children who received the vaccine. That trial is “at the upper end or even beyond” the size typically used to license other vaccines for children, the FDA’s Dr. Doran Fink told the committee.
“You can add that to the extensive experience that we’ve had to date with the vaccine in older age groups as well,” added Fink.
The Delta variant led to record surges in COVID-19 hospitalizations among younger children this year, the agency’s data suggests, despite around 38% of kids potentially having antibodies from surviving a prior infection. Thousands of children aged 5 to 11 years old have been hospitalized for COVID-19 and 172 have died, though they are at a far lower risk of severe COVID-19 than adults.
CDC officials told the committee that modeling suggests that if 5- to 11-year-olds are vaccinated at a similar rate as adolescents, it could prevent some 600,000 cases of the disease through March nationwide.
“Projections showed that vaccination among 5- through 11-year-olds is expected to accelerate the decline in cases we’re currently experiencing, reducing the cumulative incidence expected by 8%,” the CDC’s Dr. Sara Oliver told the committee.
“We all have a responsibility to make this vaccine available to children and to their parents. We have excellent evidence of efficacy and safety. We have a favorable benefit-risk analysis. And we have many parents out there who really are clamoring and want to have their children vaccinated,” Dr. Beth Bell, one of the panel’s members, said ahead of the vote.
For parents on the fence about the shots, health officials are planning an extensive outreach campaign to help educate parents and boost confidence in the vaccine.
A CDC survey found concerns over side effects ranked among the top reasons for parents who said they would not “definitely get” their child vaccinated.
“Our communications experts have done a fantastic job of laying out a plan to make sure we’re communicating to key populations, including parents, obviously, but also our providers so that they can then amplify the appropriate messages, and then our partners as well, including health departments, and academics,” the CDC’s Dr. Kevin Chatham-Stephens told the committee.
Providers and health officials have also been preparing for weeks to meet a potential surge in demand from parents already eager to have their children vaccinated, with up to 15 million doses being shipped out over the next week.
Over half (57%) of parents surveyed by the CDC said they would “definitely” or “probably” get their child vaccinated, officials told the committee. Most parents said they were hoping to get their 5- to 11-year-old child vaccinated at their regular doctor’s office or clinic.
Once the rollout begins, parents will be able to find a vaccination site near them on the website vaccines.gov. The vaccinations for children will be free.
Vaccinators have undergone new training for handling and preparing Pfizer’s new kid-sized doses. Jurisdictions and providers have been updating their IT systems to prepare for scheduling and tracking the new shots.
“Logistically where the vaccine is going has already been mapped out for the first week, and those providers who are receiving the vaccine are approved and enrolled providers. They should have already completed the training and are familiar with the vaccine packaging and know how to handle it,” says Claire Hannan, executive director of the Association of Immunization Managers.
CDC officials told the panel that many jurisdictions anticipate pediatricians will likely handle most vaccinations for younger children, more than temporary mass vaccination sites or clinics set up at schools.
“Doing all of this behind-the-scenes work has been going on for months,” Hannan says.
