Health · June 22, 2022

FDA Advisors Advocate Giving Moderna, Pfizer Covid-19 Vaccines to Babies and Young Children

The FDA is expected to quickly grant emergency use clearance for the Pfizer-BioNTech vaccine for children under age 5 and the Moderna vaccines for children under age 6. Both options could be used in children as young as 6 months.

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 panel members expressed concern that parents might be confused by the different dosing schedules of the products — particularly since Pfizer-BioNTech’s vaccine doesn’t offer much protection after two doses, while Moderna’s primary series is completed at 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.

Michael Nelson, UVA Health’s head of asthma, allergies and immunology, urged manufacturers to quickly collect data on the prospect of vaccinating these children against Covid at the same time as other routine 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.”

Peter Marks, the FDA’s top immunization regulator, began the day-long meeting by noting the burden of Covid hospitalizations for young children during the recent Omicron surge at rates that matched or exceeded other more common vaccine-preventable childhood diseases like the flu. More than half of the children under 5 hospitalized for Covid had no underlying health problems and 202 in the 6 months to 4 years age group have died from the disease as of May 11.

“The intervention we’re talking about here is something that we’ve accepted in the past to try to prevent deaths from influenza,” he said. “Here we have another pathogen, but it still caused a lot of chaos.”

The Biden administration is gearing up for a slog to convince parents to vaccinate their young children quickly. Summer vacations – and young children receiving 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.

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 more 40 percent hesitate to immunize at all.

According to CDC data released on Dec.

The FDA analyzed the vaccines’ ability to induce neutralizing antibody responses in children comparable to young adults, a concept known as immune bridging. Both met the agency’s criteria for success.

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 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.

Panel member Amanda Cohn of the CDC expressed concern that parents would compare the efficacy percentages proposed by companies and base the product they choose solely on those numbers.

“My confidence in that number…I have no idea what that number is going to be like at the end,” she said of Pfizer’s vaccine 80 percent figure, adding that she thinks it’s effective.

There were several unknowns in both companies’ data that reflect the current state of vaccination among adults in the United States, including how long it has lasted and how well the vaccine protects against outcomes like Long Covid, the FDA said. Given adults’ experience of declining antibody protection, children will likely need booster doses in the future, the reviewers said.

Side effects such as headaches and fatigue were more common in teenagers than in younger children, likely because they received larger doses of the vaccine, the FDA said. Fever was reported more frequently in the youngest vaccinees.

Manufacturers did not report any events in their studies that met the CDC definition of probable or confirmed myocarditis or pericarditis — two types of heart inflammation identified as potential side effects of messenger RNA vaccines, particularly in men ages 12 to 12 39 years.

The FDA’s review of Pfizer and Moderna’s data comes after months of anxiety from parents, who were feeling strained by statements that Covid-19 vaccines would be available for the country’s youngest children by early 2022, just to see that the data is shifting. The FDA called an advisory committee meeting in February to consider a two-dose primary series of Pfizer’s vaccine, only to withdraw once data suggested a third dose could bolster its effectiveness.

Parents and advocates for giving children under 5 access to vaccines broke out in April over a POLITICO report that said the Biden administration is leaning towards concurrent approval of Pfizer-BioNTech and Moderna’s products to stop advertising the vaccines , a move some believed resulted in regulators sitting at Moderna’s request while Pfizer continued to collect data and complete its filing. FDA Commissioner Robert Califf later insisted there would be no raid at Moderna’s request, but the Advisory Committee meeting schedule ultimately ensured that both vaccines would be considered head-to-head.

Parents who spoke during Tuesday and Wednesday’s public comment period said they were still upset by the perceived delay, noting that most children receiving Pfizer’s three-dose series will have until the start of the school year will not be fully vaccinated.

“We’ve waited too long and too many families have already suffered,” said Fatima Khan, co-founder of Protect Their Future, a grassroots group campaigning for access to vaccines for the youngest children.

Arnold Monto, acting chair of the committee and an infectious disease expert at the University of Michigan, said the 18-month gap in the delivery of Covid vaccines to the US’s youngest children is a result of the need to be extra careful when testing the vaccines Taking care to determine how best to vaccinate older Americans as the pandemic progresses.

“To say there have been delays, unnecessary delays, does not represent the real situation, which was not working with adults but with a vulnerable, younger population that needs special care,” he said.