COVID-19 vaccines arrive for young children
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Around 18 months after the first adults began receiving COVID-19 vaccines in the United States, the FDA authorized and the CDC recommended vaccines for children as young as age 6 months.
Members of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRPBAC) unanimously recommended Moderna’s two-dose vaccine for children aged 6 months through 5 years at 25 g per dose and Pfizer-BioNTech’s 6 three-dose vaccine for children aged 6 months through 4 years at 3 g per dose.
In both cases, the committee voted 21-0 that the benefits of the vaccines outweighed the risks.
Two days later, the FDA announced that it has amended the emergency use authorizations for both vaccines in accordance with the VRBPAC’s recommendations. The CDC followed suit, with the Advisory Committee on Immunization Practices also voting unanimously to recommend the vaccines and CDC Director Rochelle P. Walensky, MD, endorsing the vote.
“Together, with science leading the charge, we have taken another important step forward in our nation’s fight against COVID-19,” Walensky said. “We know millions of parents and caregivers are eager to get their young children vaccinated, and with [this] decision, they can.”
Different dosing schedules
Moderna asked the FDA to authorize its vaccine for younger children in April, citing data from the phase 2/3 KidCOVE study, in which young children in two age groups — 6 months to less than 2 years and 2 years to less than 6 years — received the vaccine and had an immune response against the virus that was consistent with those seen in older children and adults.
According to the FDA’s briefing documents for the VRBPAC meeting, the Moderna vaccine’s efficacy among kids aged 2 to 5 years was 36.8% based on a CDC definition and 46.4% based on a Moderna study’s definition.
Other briefing documents compiled by the FDA reported that the efficacy of Pfizer-BioNTech’s three-dose series — calculated during the omicron wave — was 80.4% (95% CI, 14.1%-96.7%), based on three cases of COVD-19 that occurred in the study’s vaccine group and seven in its placebo arm. According to the documents, efficacy was far lower (28.3%) when calculated in between dose two and three.
This last point was noted at the VRBPAC meeting by some members of the committee, including Paul A. Offit, MD, director of the Vaccine Education Center at The Children’s Hospital of Philadelphia.
“It does worry me that there was no protection in dose two. That was surprising — and I think that was surprising for the company, and I fear that they may have underdosed,” Offit said during the meeting.
“With Moderna, you have low levels of protective efficacy after dose two, but you can assume that is predictive of better protection against serious disease. I’m not so sure you can predict that with Pfizer’s vaccine,” Offit said. “Now with the third dose, you get the kind of immune-bridging data that is reassuring, but that’s dose three.”
Offit said he supports the vaccine, “but I do worry that parents aren’t necessarily going to know that after two doses they won’t be protective at all and might engage in activity that could put their child at risk.”
The Pfizer-BioNTech vaccine is administered in intervals of 3 to 8 weeks between the first and second dose and at least 8 weeks between the second and third dose. There should be a gap of 4 to 8 weeks between the two doses of the Moderna vaccine.
‘More than enough’ supply
White House COVID-19 Response Coordinator Ashish Jha, MD, MPH, said during a press conference that “more than enough” COVID-19 vaccine doses were being distributed for the country’s 20 million infants and toddlers.
Jha called the availability of the vaccines an “important moment for parents” and “for families of kids under 5.”
“It’s a historic moment for our nation,” Jha said. “Because, essentially, every American from our oldest to our youngest is now eligible for the protection that vaccines provide.”
He said more than 4 million doses had already been delivered to approximately 13,000 vaccination sites across the country. However, he mentioned that the vaccination program for “our littlest Americans” would feel “a little different” from previous programs for adults and adolescents.
“That’s because we know parents will be turning to their pediatricians and their family physicians,” Jha said. “We have been guided in our approach by very clear data that say that most parents want to vaccinate their littlest ones in familiar settings. We also know that many parents have questions, and we want to encourage every parent to talk to their physician, to talk to the pediatrician, to talk to the family physician. We also know that confidence in vaccines builds over time.”
He noted that pharmacy chains such as Walgreens, CVS and Walmart were “already vaccinating children,” as were many private clinics and community organizations.
Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases and chief medical advisor to the president, discussed the clinical trials of the authorized vaccines, noting in particular that there were no cases of myocarditis or multisystem inflammatory syndrome in Moderna’s study of children.
“The known potential benefits clearly outweigh the known and potential risks in this pediatric population,” Fauci said.
Not time to wait
At a press conference held by the Infectious Diseases Society of America, C. Buddy Creech, MD, MPH, director of Vanderbilt University’s Vaccine Research Program, and Jason G. Newland MD, MEd, professor of pediatrics at Washington University School of Medicine in St. Louis, said it is better to vaccinate children now rather than later.
“I think that the best vaccine to get is the one that’s about to go into your shoulder,” Creech said. “I don’t think now in the middle of a pandemic is the time to wait.”
“Young families have been so impacted, from the logistics around being exposed at day care, to having an infection in your home,” Newland said. “It has impacted their lives so greatly over such a long period of time and they’ve all been waiting for [these vaccines].”
According to the American Academy of Pediatrics, more than 83,644 new pediatric COVID-19 cases were reported in the U.S. during the week ending June 16, representing 13.7% of weekly reported cases.
Although the CDC had not yet reported data regarding the number of infants and toddlers vaccinated, 10.2 million children aged 5 to 11 years had received at least one dose of COVID-19 vaccine, and 8.3 million completed a full vaccination series.
- Reference:
- CDC. At-a-glance COVID-19 vaccination schedules. https://www.cdc.gov/vaccines/covid-19/downloads/COVID-19-vacc-schedule-at-a-glance-508.pdf. Accessed June 28, 2022.
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