By Jacqueline Howard, CNN
Now that the United States has started rolling out child doses of the Pfizer/BioNTech coronavirus vaccine for children ages 5 to 11, many parents are wondering when shots could be available for even younger kids.
US health officials estimate that could be next year.
“We’re probably a few more months off for the younger children,” Dr. Peter Marks, director of the US Food and Drug Administration’s Center for Biologics Evaluation and Research, said during a video call with reporters last week.
That means early 2022 at the soonest.
Of the three companies with authorized Covid-19 vaccines in the US, Pfizer is furthest along in testing shots for children under the age of 5.
Moderna is studying its coronavirus vaccine in children younger than 12. Johnson & Johnson has planned trials in those younger ages but hasn’t started yet.
The FDA will want much more safety data for the younger children, Marks said.
“It has to do with when they were enrolled in the trials, and the fact that as we get down to younger children, the benefit-risk gets to be even more of a careful consideration, because the youngest children are affected the least directly in terms of severe Covid-19,” Marks said. “We want to have robust safety data sets.”
Where each vaccine maker is on shots for younger ages
The Pfizer/BioNTech studies are in two young age groups: children ages 2 to 5 and those 6 months to 2 years old. Both age groups are in Phase 2/3 trials, a Pfizer company spokesperson confirmed Wednesday.
Pfizer and BioNTech hope to have initial data for ages 2 to 5 by the end of the year.
The companies would need to submit their clinical trial data to the FDA to apply for emergency use authorization of their vaccine for children younger than 5. Once the FDA authorizes the vaccine for these younger ages, the US Centers for Disease Control and Prevention would need to recommend it before shots can go into arms.
“The Food and Drug Administration and CDC won’t approve the vaccine until there’s some data showing safety and efficacy,” Dr. Philip Landrigan, a pediatrician and immunologist at Boston College, told CNN on Wednesday.
“There’s every reason to think that it will be safe, and it will be efficacious,” Landrigan said. “But the agencies need to be cautious, justifiably so, and so they’re not going to give the approval until they have the data.”
Pfizer and BioNTech announced last week that the United States has purchased 50 million more doses of the companies’ coronavirus vaccine and “will receive these additional doses to continue to support preparedness for pediatric vaccinations, including securing vaccines for children under 5 years of age, should they receive regulatory authorization.”
Pfizer and BioNTech noted that they expect to deliver those doses by April 30 next year.
Vaccine maker Moderna is gathering and analyzing data on how well its coronavirus vaccine works in children younger than 5, Dr. Anthony Fauci said last month.
“Those studies are ongoing right now — not only with Pfizer but also Moderna, which has a study called KidCOVE, which is for younger children,” Fauci, director of the National Institute of Allergy and Infectious Diseases, told a White House coronavirus briefing. Investigators from NIAID and Moderna co-developed the vaccine.
“We don’t have enough data now to present it for a regulatory approach, but right now, the data are being collected and analyzed,” Fauci said. “So we will be able to answer the question, I believe, within a reasonable period of time regarding the safety and the immunogenicity among those lower than 5 years old.”
Meanwhile, Johnson & Johnson is currently studying its coronavirus vaccine in adolescents.
“We have recently initiated our first phase 3 study in adolescents ages 12 to 17 years and anticipate results for dose and regimen selection in the coming months,” company spokesperson Jake Sargent wrote in an email to CNN on Wednesday. “We also have three other studies planned in pediatric populations and are in active discussions with regulatory authorities regarding our development plan and trial designs. These studies have not yet been initiated.”
‘We’ve got to do our best to protect them’
Once vaccine doses are authorized for children younger than 5, the nation might face a slow uptake of the vaccine.
Parents continue to be more cautious about getting their younger children vaccinated, according to polling results from the Kaiser Family Foundation.
A survey of more than 1,500 adults, conducted in September, found that about 23% said they will get their child under the age of 5 vaccinated right away once a vaccine is available for that age group and about a third or 35% said they would definitely not get their child under 5 vaccinated against Covid-19.
Until younger children are eligible to get vaccinated, “we’ve got to do our best to protect them,” Dr. Stephen Parodi, national infectious disease leader for Kaiser Permanente, told CNN on Wednesday.
“For the youngest children that we have, we still got to take those protective measures when it comes to distancing, and ideally, if people are coming into the household, that they have gotten vaccinated so that you’re minimizing the risk,” Parodi said, adding that mask-wearing is key too.
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