“Many parents, caregivers and doctors have been waiting for a vaccine for younger children, and this action will help protect children under 6 months,” FDA Commissioner Robert Califf said in a statement. “As we have seen with older age groups, we expect that younger children’s vaccines will provide protection against the most serious consequences of COVID-19, such as hospitalization and death.”
In addition to approving the mRNA vaccines for the youngest children, the FDA approved Moderna’s Covid-19 vaccine for children ages 6 to 17. For all age groups, the FDA determined that children with certain types of impairments should receive a third dose of Moderna’s immune system vaccine at least one month after they receive their second vaccine. The vaccine from Pfizer-BioNTech was already approved for children from the age of 5.
The CDC’s panel of experts will consider whether to recommend administering the vaccines at Friday and Saturday meetings. Once CDC Director Rochelle Walensky approves a recommendation, the children are expected to start receiving shots starting Tuesday.
Children under the age of 6 receiving the Moderna vaccine will receive two 25 microgram doses 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 expressed concerns that parents might be confused by the products’ different dosing schedules — especially since the Pfizer-BioNTech vaccine doesn’t offer much protection after two doses, while Moderna’s primary series has completed two doses.
“I am very concerned that many of these children will not get the third dose,” Jeannette Yen Lee, a professor of biostatistics at the University of Arkansas for Medical Sciences, said of the Pfizer vaccine. “It’s a struggle to get people for two,” she added, noting that uptake of booster vaccines is also low among older populations.
Actual efficacy against the Omicron variant in the 6-month to 5-year age group for Moderna’s vaccine ranged from 36 percent to 51 percent, and efficacy estimates were “generally consistent with rates observed in observational studies in adults during.” of the same variant waves, the FDA said.
Preliminary analyzes of Pfizer’s vaccine showed 80 percent efficacy in children under the age of 5 against the disease, although just 10 Covid cases were reported among study participants prior to the April data cut-off, limiting confidence in that number.
Some FDA advisors expressed concern that parents would compare the efficacy percentages proposed by the companies and base the product they choose solely on those numbers. When asked at a press conference, Commissioner Califf said speed should be the deciding factor for parents. “I’m a grandparent and I have two who are in the age category that we’re talking about,” Califf said in a news conference with reporters. “You all get the first available.”
To date, states, territories, pharmacies and other federal partners have ordered about 2.5 million doses of Pfizer’s vaccine — half what was previously offered — and 1.3 million doses of Moderna, or about a quarter of what is available for preventive measures was made available. Order, HHS Assistant Secretary for Preparedness and Response Dawn O’Connell said Thursday.
Michael Nelson, UVA Health’s head of asthma, allergies and immunology, urged manufacturers to quickly gather data on the prospect of vaccinating these children against Covid while they receive other routine childhood vaccinations.
“If we don’t get a quick answer to the question of co-administration, that will serve as an obstacle to the completion of the three-dose series for.” [the Pfizer] Vaccine and probably for the Moderna vaccine,” he said. “It’s going to be a big challenge for families and kids here in the US to get it isolated.”
“Today is a day of great 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 provide their youngest children with the protection of a safe and effective Covid-19 vaccine.”
The Biden administration is gearing up for a slog to convince parents to vaccinate their young children quickly. Summer vacations – and young children getting different grades of school before age 5 – combined with misinformation about vaccines could hurt early voter turnout. Many young children also contracted Covid during the Omicron surge, which could convince parents not to vaccinate them until they are further from their natural infections.
The government has been criticized for the time it has taken to approve these vaccines. Moderna applied for FDA approval in April, well before Pfizer-BioNTech asked the FDA to approve their vaccine earlier this month. Moderna shots could potentially be ready to go into arms and thighs by mid-May.
“I wouldn’t call that a delay,” said Peter Marks, the director of the Center for Biologics Evaluation and Research. “There was one full submission ranging in age from 6 months to 17 years. It was very important to get [the data review] right, and we did it.”
“Coincidentally, we partnered with Pfizer’s updated filing towards the end,” he added. “We believe that bringing it together with the American public actually gives people a choice.”
Recent surveys by the Kaiser Family Foundation suggest that about 20 percent of parents are keen to vaccinate their children under the age of 5 as soon as they are allowed, while nearly 40 percent plan to “wait and see” how the vaccine works, and another 40 percent hesitate to immunize at all.
According to CDC data released on Dec.