FDA advisers approve Moderna and Pfizer Covid-19 vaccines for babies and toddlers

The FDA should quickly clear for emergency use the Pfizer-BioNTech vaccine for children under 5 and the Moderna vaccines for children under 6. Both options could be used in children as young as 6 months old.

The CDC’s expert advisory panel will consider whether to recommend administering the injections at the Friday and Saturday meetings. Once CDC Director Rochelle Walensky approves a recommendation, children should begin receiving injections by Tuesday. Children under the age of 6 who receive the Moderna vaccine will receive two doses of 25 micrograms, 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 regimens of the products – especially since the Pfizer-BioNTech vaccine does not offer much protection after two doses, while Moderna’s primary series is complete with two doses.

“I’m very concerned that a lot of these kids won’t get the third dose,” Jeannette Yen Lee, professor of biostatistics at the University of Arkansas for Medical Sciences, said of the Pfizer vaccine. “It’s a struggle to get people in for two,” she added, noting that booster usage for older populations is also low.

Michael Nelson, head of UVA Health’s asthma, allergy and immunology division, urged manufacturers to quickly gather data on the prospect of vaccinating these children against Covid at the same time as they receive other routine vaccinations.

“If we don’t get a quick answer to the question of co-administration, it will be a barrier to completing the three-dose series for [the Pfizer] vaccine and probably for the Moderna vaccine,” he said. “Having to isolate him is going to be a big challenge for families and children here in the United States”

Peter Marks, the FDA’s lead vaccine regulator, began the day-long meeting by highlighting the burden of Covid hospitalizations for young children during the recent Omicron wave at rates that matched or surpassed those of other common childhood vaccine-preventable illnesses such as influenza. More than half of children under 5 who were hospitalized with Covid had no underlying health conditions, and 202 in the age group 6 months to 4 years died from the disease in 11 may.

“The intervention we’re talking about here is something we’ve accepted in the past to try to prevent flu deaths,” he said. “Here we have a different pathogen, but one that still wreaked havoc.”

The Biden administration is preparing for the hard work of convincing parents to vaccinate their young children quickly. Summer holidays — and young children receiving different levels of schooling before age 5 — along with misinformation about vaccines could lower early participation. Many young children also contracted Covid during the Omicron outbreak, which could convince parents not to vaccinate them until they are further away from their natural infections.

A recent Kaiser Family Foundation survey suggests that about 20% of parents are eager to get their children under 5 vaccinated as soon as they are allowed to, while nearly 40% plan to “wait and see.” » how the vaccine works and 40% are reluctant. immunize at all.

Only 29% of American children aged 5 to 11 are fully vaccinated against Covid, compared to nearly 56% of 12 to 15 year olds and 67% of 16 and 17 year olds, according to CDC data ending April 30. .

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

Actual efficacy against the Omicron variant in the 6 month to 5 year age group for Moderna’s vaccine ranged from 36% to 51%, and efficacy estimates were “generally consistent” with rates seen in observational studies of adults during the same waves of variants, the FDA said.

Preliminary analyzes of the Pfizer vaccine showed 80% effectiveness in children under 5 against the disease, although only 10 Covid cases were reported among study participants before the data deadline in April , which limits confidence in this figure.

Panel member Amanda Cohn, CDC, expressed concern that parents will compare the effectiveness percentages offered by companies and base the product they choose solely on those numbers.

“My level of confidence in that number…I have no idea what that number will end up being,” she said of the 80% figure for Pfizer’s vaccine, adding that she believes that is effective.

In the data from both companies, there were several unknowns that reflect the current state of adult vaccination in the United States, including how long it lasts and how well vaccination protects against outcomes like long Covid, the FDA said. Children will likely need booster doses in the future, given adults’ experience with waning antibody protection, the critics said.

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

The manufacturers reported no events in their trials that met the CDC’s definition for probable or confirmed myocarditis or pericarditis – two types of heart inflammation that have been detected as potential side effects of messenger RNA vaccines, in particularly for men aged 12 to 39.

The FDA reviews of data from Pfizer and Moderna come after months of angst from parents who felt shackled by claims that Covid-19 vaccines would be available to the country’s youngest children at first. of 2022, only to see the dates change. The FDA has scheduled an advisory committee meeting in February to review a two-dose primary series of Pfizer’s vaccine, only to withdraw once data suggested a third dose could boost its effectiveness.

Parents and advocates for children under 5’s access to vaccines have erupted over a POLITICO report in April that the Biden administration was leaning towards allowing products from Pfizer-BioNTech and Moderna at the same time. time to facilitate vaccine promotion, a move some believed regulators were sitting on Moderna’s request while Pfizer continued to collect data and complete its submission. FDA Commissioner Robert Califf then insisted that there would be no heists at Moderna’s request, but the advisory committee’s meeting schedule ultimately ensured that the two vaccines would be considered one-on-one.

Parents who spoke during the public comment period on Tuesday and Wednesday said they were still angry at the perceived delay, noting that most children who end up receiving Pfizer’s three-dose series will not be completely vaccinated at the start of the school year.

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

Arnold Monto, the committee’s acting chair and an infectious disease expert at the University of Michigan, said the 18-month gap in the availability of Covid vaccines to younger children in the United States was due to the need to take extra precautions to test vaccinations, as well as determine how best to vaccinate older Americans as the pandemic evolved.

“To say that there have been delays, unnecessary delays, does not represent the real situation, which involved working not with adults but with a vulnerable and younger population for which special care is needed”, a- he declared.

#FDA #advisers #approve #Moderna #Pfizer #Covid19 #vaccines #babies #toddlers

Add Comment