CDC advisers unanimously vote to recommend COVID vaccines for children under 5

CDC advisers unanimously vote to recommend COVID vaccines for children under 5

CDC advisers unanimously vote to recommend COVID vaccines for children under 5

A panel of outside vaccine advisors from the Centers for Disease Control and Prevention voted unanimously Saturday to recommend COVID-19 vaccines for children up to 6 months of age, removing one of the last hurdles to expanding eligibility to 20 million babies, toddlers and preschoolers.

Some of the long-awaited takes may begin as early as this weekend, as CDC Director Dr. Rochelle Walensky, approve the panel’s updated recommendations. Federal officials expect most vaccinations to begin in doctors’ offices after the holiday weekend.

About a third of parents say they plan to vaccinate their children in that age group, according to CDC survey results released Saturday.

The CDC Advisory Committee on Immunization Practices votes follow a two-day meeting to weigh data on the benefits and risks of vaccines in young children. A panel of outside advisers to the Food and Drug Administration also voted unanimously on Wednesday to support the authorization.

“Those who care for children can have confidence in the safety and efficacy of these COVID-19 vaccines and can be confident that the agency has been thorough in its assessment of the data,” said FDA Commissioner Dr. Robert Califf, in a statement.

The FDA also moved on Friday to add the Moderna vaccine as an alternative to Pfizer injections in children ages 6 to 17, though the CDC said its advisers will not vote on updated recommendations for those injections until next week.

Distributing the initial waves of shots

Shipments have already started of vaccines from Moderna, as well as from Pfizer and its partner BioNTech, after the Food and Drug Administration issued authorization on Friday. However, as with older age groups, government supply agreements require vaccinators to wait for CDC approval before administering injections to young children.

Federal officials say most jurisdictions— except Florida — had pre-ordered doses of the 10 million total injections that were made available; 2.5 million orders were received for Pfizer’s injections and 1.3 million for Moderna’s.

Many of them will go to places chosen by the authorities, such as county health departments, which are able to stock and redistribute smaller portions of the 100-dose shipments. States, including Florida, have also begun allowing all registered vaccinators to order vaccines directly through them.

Some pharmacies will also offer the injections, though officials are planning a rollout that will rely heavily on pediatricians and family doctors in the coming weeks. Pandemic liability protections extended to vaccinators such as pharmacists only cover children three years of age and older.

The Biden administration’s website will also soon include a feature to search for websites that offer vaccines specifically for younger children, as more vaccinators begin offering vaccines. About half of doctors who vaccinate children plan to offer vaccines even to children who are not their regular patients, according to a CDC survey.

Suppliers in the initial wave ordered just one of the brands in some jurisdictions, though the Biden administration expects this to even out as supply increases across the country in future shipping rounds.

Smaller Doses for Children – and the Differences Between Moderna and Pfizer

Unlike the broadly similar regimens of the first round of COVID-19 injections available in adults, the makers of the two mRNA vaccines took different approaches to immunizing young children.

In children 6 months to 5 years of age, from Modern The vaccine was tested with two injections spaced one month apart. Its doses will be 25 micrograms, a fraction of the 100 microgram primary series released last year for adults.

Pfizer and BioNTech vaccine will come in a total of three injections given over 11 weeks, for children aged 6 months to 4 years. These doses are sized at 3 micrograms, just a tenth of the 30 microgram doses for ages 12+.

In a briefing with reporters on Friday, FDA’s top vaccine official, Dr. Peter Marks, acknowledged the “differentiated benefits and risks compared to each other” but urged parents to look for the first vaccines available to them.

“It could be that the Moderna vaccine brings about a slightly faster immune response. On the other hand, Pfizer’s three-dose regimen may also bring about a greater immune response after the third dose. And there are some subtle differences in the safety profile.” said Mark.

Based on the study of antibodies to the virus in blood collected from study participants, the FDA said that data from young children suggest that their immune response will be at least as good as that seen in adults after they receive the first two injections.

Some of the kids under 5 didn’t make it past that threshold after receiving just two of their doses in Pfizer’s trials, the company disclosed to investors last year, so a third dose was needed.

“If you want to get your child back to daycare or elementary school in September, you have to get the Moderna vaccine. You can’t do that on Pfizer’s schedule. And we know two doses don’t protect, from Pfizer,” said Pfizer. Moderna’s CEO, Stéphane. Bancel said last week at the Jefferies Healthcare Conference.

The FDA review noted that the lower dose of Pfizer likely resulted in the lowest side effects seen in the older age group.

“We already know that in older individuals, 30% of children are receiving the vaccine. There could be many reasons for this, but one of them is reactogenicity,” William Gruber, Pfizer’s head of clinical research and vaccine development, told FDA advisors, referring to short-term side effects such as aches, fever, and pain at the injection site.

For Moderna, fever rates were higher in younger children compared to teens and adults, although still around the levels seen in this age group with other routine vaccines, the FDA review noted.

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Pfizer’s estimate for the effectiveness of the three-dose vaccine in fighting symptomatic infection is also much higher than Moderna’s estimate for two doses during the Omicron wave, as well as better than those seen in some older age groups that received Pfizer doses.

But the FDA and CDC reviews raised questions about Pfizer’s estimate, suggesting it was too early to say with certainty the effectiveness of the three doses and warning against direct comparisons. Some study participants also received their third dose of Pfizer much later than the recommended eight weeks, the FDA noted.

In its Friday statement announcing the authorizations, the FDA said that Pfizer’s analysis “was determined to be unreliable due to the low number of COVID-19 cases that occurred in study participants.”

“I believe the vaccine is effective. I have no idea what that number will be,” said Dr. Amanda Cohn of the CDC told the FDA committee Wednesday.

When will younger children get a booster

Marks acknowledged that both vaccines may need to be updated in the coming months, but urged parents to start giving their children a “fundamental level of immunity” with current versions of the vaccines now.

The FDA has another meeting of its advisors scheduled to look into the matter for all ages, as the two vaccine makers raced to ramp up production of new formulations of their injections designed to target the Omicron variant.

“If there’s a very big change in strains that needs to take place in the fall, we’ll adjust that and make sure there’s an option available for younger children and across the pediatric age group as appropriate,” he said. said Mark.

A Moderna executive told CDC consultants on Friday that the company already plans to begin studying Omicron-adapted boosters in children under six starting next week, given at least three months after the second dose.

“We hope that by early fall we will be able to present the immunogenicity and safety data of the booster for this age group,” said Dr. Rituparna Das of Moderna to the CDC committee.

Children six months and older are already authorized by the FDA to receive a third dose of Moderna’s vaccine if they are significantly immunocompromised.

Younger children are generally at lower risk of severe COVID-19 compared to their peers and older adults, and many asymptomatic cases have likely gone unreported. No serious cases of the disease were recorded in the Moderna study, even among children who received placebo.

However, authorities and experts warn that the virus has still had an unprecedented impact on children.

“There’s a lot of information floating around that, well, ‘I had the Omicron variant, or my son had the Omicron variant, and vaccination is not important,'” Marks said Friday.

During the Omicron wave, hospitalizations and deaths in young children increased, despite data suggesting that many children already had some antibodies from a previous infection.

“There are emerging data that suggest that the Omicron variant does not produce the kind of excellent immune response against a wide range of COVID-19 variants that vaccines do,” he added.

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