FDA greenlights COVID vaccine update for children amid pathetic reception

To enlarge / Reisa Lancaster RN, left, administers the Covid-19 vaccine to 14-month-old Ada Hedge, center, who is comforted by mother Sarah Close and father Chinmay Hedge at the Children’s National Research and Innovation Campus in Washington, DC.

The Food and Drug Administration has green-lighted updated COVID-19 vaccine doses for children younger than 5, but the change to approved vaccine regimens is not straightforward. This could further boost efforts to vaccinate the youngest Americans.

After months of availability, only about 3 percent of infants and toddlers 6 months to 2 years of age completed the initial series. A total of 6.5 percent had been shot at least once, according to the Centers for Disease Control and Prevention. For those ages 2 to 4, just under 5 percent completed the primary series, and 9 percent received at least one dose.

It was back in June when the FDA authorized and the CDC approved small doses of both Moderna and Pfizer’s COVID-19 vaccines for children as young as 6 months old.

  • For the Moderna vaccine, the primary vaccination series can be given to adolescents from 6 months of age to 17 years of age. two doses, one month apart.
  • For the Pfizer vaccine, children from 6 months of age to 4 years of age can be given a primary vaccination series. three doses, the second three weeks after the first and the third at least eight weeks after the second. (The Pfizer vaccine was previously available for children age 5 and older.)

This fall, the FDA approved an “updated” bivalent vaccine for use as a booster dose in people 5 years of age and older. The bivalent shot targets both the original version of SARS-CoV-2 and the BA.4/5 coronovirus omicron subvariants that predominate during the summer months. Genetic branches of BA.5 are now in circulation. Recent real-world efficacy data show that the bivalent booster offers up to 56 percent greater protection against symptomatic COVID-19 infection compared to protection from the original boosters.

But until now, kids under 5 have been stuck with only the original core series, not boosters or bivalent shots.

Innovations for young children

On Thursday, the FDA approved the bivalent shot for children ages 6 months to 4 years, and the CDC is expected to approve the authorization soon. But permissions are a bit complicated; not a general permit for boosters in this age group.

Only children 6 months to 5 years of age who have received Moderna’s two-dose primary series are eligible to receive a single bivalent vaccine as a booster dose. This booster dose should be given at least two months after the completion of the main series.

Pfizer’s bivalent vaccine still doesn’t have a booster for children younger than 5.

The FDA has updated Pfizer’s three-dose pivotal series to include the bivalent vaccine as the third shot in the series. This means that any unvaccinated child aged 6 months to 4 years who has started the Pfizer series or has already started but not yet completed the Pfizer three-dose series can receive the bivalent dose as the third dose. Pfizer three-dose primary series. For example, if a 2-year-old child has already received two doses of Pfizer and is in the two-month window before the third injection, when the time comes, that child will receive the bivalent injection as the third dose. Similarly, every child who now begins the three-dose Pfizer series ends up with a bivalent injection as the third dose.

But for children younger than 5 who have already completed the original three-dose Pfizer series, this week’s update does not offer them eligibility for the bivalent injection or booster. The FDA said a bivalent booster for this group could arrive as early as next year.

“Children of this age group have already finished their education [three-dose Pfizer] The initial series is still expected to have protection against the most serious consequences of the omicron variant currently in circulation,” the FDA said Thursday. “Data to support the administration of the updated bivalent booster dose for these children are expected in January. The agency is committed to evaluating this information as soon as possible.”

Vaccination coverage

The complicated nature of the update doesn’t bode well for the uptake of bivalent shots for this young group, which is already seeing low uptake. That’s despite signs of an uptick in COVID-19 cases and hospitalizations, as well as the persistence of seasonal respiratory illnesses like RSV and influenza that have overwhelmed U.S. hospitals and hit young children particularly hard.

Peter Hotez, a professor of pediatrics and molecular virology and microbiology at Baylor College of Medicine, told the Washington Post on Thursday that this week’s update “won’t have much impact in the real world.” “It’s like arguing about how many angels can dance on the head of a pin.”

But the FDA is still calling for more protection for the youngest.

“More children now have the opportunity to renew their protection against COVID-19 with the bivalent COVID-19 vaccine, and we encourage parents and caregivers of those who are eligible to consider it, especially as we head into the holiday and winter months. they will,” FDA Commissioner Robert Califf said Thursday. “As this virus evolves and immunity declines compared to the previous COVID-19 vaccine, the more people who become aware of COVID-19 vaccines, the greater the benefits to individuals, families and public health by helping to prevent severe illness and hospitalizations. and deaths.”

Source link