The Food and Drug Administration has updated COVID-19 vaccine doses for children under 5, but changing authorized vaccination schedules is far from straightforward. It could further cripple efforts to vaccinate younger Americans, who are already off to a disastrous start.
After months of availability, only about 3% of infants and toddlers ages 6 months to 2 years have completed a primary series. According to data from the Centers for Disease Control and Prevention, only 6.5% have received at least one vaccine. For those aged 2 to 4, just under 5% completed a primary series, with 9% having received at least one dose.
It was June when the FDA cleared — and the CDC approved — small doses of Moderna and Pfizer’s COVID-19 vaccines for children as young as 6 months old.
- For Moderna’s vaccine, infants 6 months to 17 year olds could receive a primary series of of them doses, one month apart.
- For Pfizer’s vaccine, infants 6 months to children up to 4 years of age could receive a primary series of Three doses, the second being administered three weeks after the first and the third at least eight weeks after the second. (Pfizer’s vaccine was previously available for children 5 years and older.)
This fall, the FDA cleared an “updated” bivalent vaccine for use as a booster dose in people ages 5 and older. The bivalent shot targets both the original version of SARS-CoV-2 and the BA.4/5 subvariants of the omicron coronavirus, which dominated during the summer months. Now, the genetic offshoots of BA.5 dominate circulation. Recent real-world efficacy data suggest that bivalent booster provides up to 56% more protection against symptomatic COVID-19 infection than protection against original boosters.
But until now, kids under 5 only had the original primary series, not boosters or bivalent plans.
What’s new for young children
On Thursday, the FDA cleared bivalent injections for children 6 months to 4 years old and the CDC is expected to approve the clearance soon, opening up availability. But permissions are a bit complicated; this is not a general authorization for boosters in this age group.
Only children aged 6 months to 5 years who received the primary two-dose series of Moderna are eligible to receive a single bivalent vaccine as a booster dose. This booster dose should be given at least two months after the end of the primary series.
For Pfizer’s bivalent vaccine, there is still no booster available for children under 5 years old.
The FDA updated Pfizer’s three-dose primary series to include the bivalent vaccine as the third injection in the series. This means that any child aged 6 months to 4 years who has not been vaccinated and is starting a Pfizer series or who has already started a Pfizer three-dose series but has not yet completed it can receive the bivalent dose as third dose in Pfizer’s three-dose primary series. For example, if a 2-year-old has already received two doses of Pfizer and is within the two-month window before their third injection, that toddler will receive the bivalent injection as the third dose when the time comes. Similarly, any child now starting the three-dose series of Pfizer will end with a bivalent injection as the third dose.
But for any children under 5 who have already completed Pfizer’s original three-dose series, this week’s update does not offer them eligibility for a bivalent injection or a booster. The FDA said a bivalent booster could come early next year for this group, however.
“Children in this age group who have already completed their [three-dose Pfizer] primary series would still be expected to be protected against the most severe outcomes of the omicron variant currently in circulation,” the FDA said Thursday. Data to support an updated bivalent booster dose for these children is expected in January. The agency is committed to evaluating this data as soon as possible.”
The complicated nature of the update does not bode well for boosting the adoption of bivalent snaps for this young group, which has already seen low adoption. This is despite signs of rising COVID-19 cases and hospitalizations, as well as a continued crush of seasonal respiratory illnesses, such as RSV and influenza, which overwhelm US hospitals and hit young children especially hard.
This week’s update “won’t have much real-world impact,” Peter Hotez, a professor of pediatrics and molecular virology and microbiology at Baylor College of Medicine, told The Washington Post on Thursday. “It’s like arguing about how many angels can dance on the head of a pin.”
But the FDA is still asking for more protection for younger people.
“More children now have the option of updating their protection against COVID-19 with a bivalent COVID-19 vaccine, and we encourage parents and caregivers of eligible individuals to consider doing so, particularly at approaching the holidays and the winter months when more time will be spent indoors,” FDA Commissioner Robert Califf said Thursday. “As this virus has changed and immunity to previous COVID-19 vaccination wanes, the more people who keep up to date on COVID-19 vaccinations, the more benefits there will be for individuals, families and public health by helping to prevent serious illnesses, hospitalizations and deaths.”
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