FDA clears Pfizer, current Covid-19 vaccines for infants, toddlers

“Many parents, caregivers and clinicians have been waiting for a vaccine for young children, and this action will help protect children under 6 months of age,” FDA Commissioner Robert Kaliff said in a statement. said in a statement. “As we have seen with older age groups, we expect vaccines for young children to provide protection against the most severe consequences of COVID-19, such as hospitalization and death.”

In addition to approving the mRNA vaccine for the youngest children, the FDA has approved the Moderna Covid-19 vaccine for children aged 6 to 17. The FDA has determined that, for all ages, a third dose of the Moderna vaccine should be given to children with certain types of compromised diseases. immune systems for at least one month after they receive their second vaccination. The Pfizer-BioNTech vaccine has already been approved for use in children as young as 5 years of age.

A panel of expert advisors from the CDC will consider whether to recommend vaccinations during Friday and Saturday meetings. Children are expected to begin receiving vaccinations by Tuesday after CDC Director Rochelle Walensky signs the recommendation.

Children under 6 years of age receiving the Moderna vaccine will receive two doses of 25 mcg four weeks apart. The Pfizer vaccine consists of two 3 microgram doses three weeks apart, followed by a third dose at least eight weeks later.

Some members of the FDA advisory panel have raised concerns that parents may be confused by different product dosing regimens, especially because the Pfizer-BioNTech vaccine does not provide sufficient protection after two doses, while Moderna’s core series includes two doses.

“I’m very concerned that many of these kids won’t get their third dose,” Jeannette Yen Lee, professor of biostatistics at the University of Arkansas Health Sciences, said of Pfizer’s vaccine. “It’s a fight to get people for two,” she added, noting that the use of senior boosters is also low.

Actual efficacy for the Moderna vaccine against the Omicron variant in the 6 months to 5 year age range ranged from 36 percent to 51 percent, with efficacy estimates “generally consistent” with those observed in adult observational studies. during the same waves of options, the FDA said.

Preliminary analyzes of the Pfizer vaccine showed 80 percent effectiveness against the disease in children under 5 years of age, although there were only 10 cases of Covid among study participants before the data collection cutoff date in April, limiting confidence in that figure.

Some FDA consultants have expressed concern that parents will compare percentages of efficacy claimed by companies and base product selection solely on those numbers. When asked at a press conference, Commissioner Kaliff said that speed should be the deciding factor for parents. “I am a grandparent and I have two children of the age category that we are discussing,” Kaliff said at a press conference with reporters. “They all get the first one available.”

To date, states, territories, pharmacies and other federal partners have ordered approximately 2.5 million doses of the Pfizer vaccine — half of what has been offered so far — and 1.3 million doses of Moderna, or about a quarter of what was available for advance purchases. HHS Assistant Secretary for Preparedness and Response Dawn O’Connell said Thursday.

Michael Nelson, Head of Asthma, Allergy and Immunology at UVA Health, urged manufacturers to quickly collect data on the prospects for vaccinating these children against Covid at the same time as other routine childhood immunizations.

“If we do not get a prompt response to the co-administration question, this will prevent us from completing the three-dose series for [the Pfizer] vaccines and probably for the Moderna vaccine,” he said. “Having to get it in isolation will be a big test for families and kids here in the US.”

“Today is a day of tremendous relief for parents and families across America,” President Joe Biden said in a statement. “As early as next week, pending recommendations from the Centers for Disease Control and Prevention, parents will finally be able to ensure their youngest children are protected by a safe and effective Covid-19 vaccine.”

The Biden administration is gearing up to urge parents to vaccinate their young children quickly. Summer holidays — and young children receiving varying levels of schooling up to age 5 — along with misinformation about vaccines could reduce early turnout. Many young children also contracted Covid during the Omicron surge, which may persuade parents to hold off on immunizing them until they are clear of their natural infections.

Administration faced criticism for the time it took to authorize these vaccines. Modern requested permission from the FDA in April, long before Pfizer-BioNTech asked the FDA to approve their vaccine earlier this month. Modern frames could be ready for use in the arms and thighs by mid-May.

“I wouldn’t call it a delay,” said Peter Marks, director of the Center for Biological Evaluation and Research. “There was a full application from 6 months to 17 years. It was very important to get [the data review] right, and we did it.”

“It so happened that towards the end we agreed on an updated application from Pfizer,” he added. “We think actually presenting them to the American public … actually gives people a choice.”

A recent survey by the Kaiser Family Foundation suggests that about 20 percent of parents are willing to vaccinate their children under 5 as soon as they are allowed to, while nearly 40 percent plan to “wait and see” how the vaccine works, and another 40 percent do not want to be vaccinated at all .

As of April 30, only 29 percent of U.S. children ages 5 to 11 are fully vaccinated against Covid, compared with nearly 56 percent of children aged 12 to 15 and 67 percent of children aged 16 and 17, according to CDC data as of April 30. .