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

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

Some of the long-awaited features could begin as early as this weekend, once the CDC’s director, Dr. Rochelle Walensky, approves the panel’s updated recommendations. Federal officials expect most vaccines to begin at doctor’s appointments after the holiday weekend.

About a third of parents say they plan to vaccinate their child in the age group, according to findings from the CDC poll released Saturday.

The votes of the CDC Immunization Practices Advisory Committee follow a two-day meeting to analyze data on the benefits and risks of vaccination in young children. A group of external advisers to the Food and Drug Administration had also voted unanimously on Wednesday in favor of the permit.

“Those who have confidence in the care of children can be confident in the safety and effectiveness of these vaccines against COVID-19 and can be sure that the agency was thorough in its evaluation of the data,” he said. 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, although the CDC said its advisers will not vote on updated recommendations for these injections until next week.

Distribution of the initial waves of fire

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

Federal officials say most jurisdictions except Florida had pre-order doses of the 10 million total shots available; 2.5 million orders were received for Pfizer shots and 1.3 million for Moderna shots.

Many of them will go to places selected by the authorities, such as county health departments, which can store and redistribute smaller portions of the 100-dose shipments. States, including Florida, have also begun to allow all registered vaccinators to apply for vaccinations directly through them.

Some pharmacies will also offer vaccinations, although authorities have been planning a release that will be heavily supported by pediatricians and GPs in the coming weeks. Pandemic liability protections that extend to vaccinators such as pharmacists only cover children up to the age of three.

The Biden administration’s website will also soon include a feature to look for sites that offer vaccinations specifically for younger children as more vaccinators start offering vaccinations. About half of doctors who vaccinate children plan to offer vaccinations even to children who are not their usual patients, a CDC survey found.

Initial wave suppliers have only commissioned one of the brands in some jurisdictions, although the Biden administration expects it to expand as supply increases nationwide during the next rounds of shipments.

Smaller doses for children and the differences between Moderna and Pfizer

Unlike the largely similar regimens of the first round of COVID-19 vaccinations that were available in adults, the manufacturers of the two mRNA vaccines have taken different approaches to immunizing young children.

In children aged 6 months to 5 years, the Moderna vaccine was tested with two separate injections a month. Their doses will be 25 micrograms, a fraction of the 100 microgram primary series released last year for adults.

The Pfizer and BioNTech vaccine will arrive in a total of three injections administered over 11 weeks, for children aged 6 months to 4 years. These doses are 3 micrograms in size, only one-tenth of the 30 microgram doses for those over 12 years of age.

At a briefing with reporters Friday, FDA’s top vaccine officer, Dr. Peter Marks, acknowledged the “nuanced benefits and risks compared to each other,” but urged parents to seek the first available vaccinations.

“Modern vaccine may provide a slightly faster immune response. On the other hand, the three-dose Pfizer regimen may also lead to a greater immune response after the third dose. And there are some subtle differences in the security profile “, he added. said Marks.

Based on the study of antibodies against the virus in the blood extracted from test 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 later. of having received the first two injections.

Some of the children under the age of 5 did not exceed this threshold after receiving only two of their doses in the Pfizer trials, the company revealed to investors last year, so a third dose was required.

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

The FDA review noted that the lower dose of Pfizer probably caused the lowest side effects seen in the group compared to the older ages.

“We already know that in the elderly, 30% of children are getting the vaccine. There could be many reasons for that, but one of them is reactogenicity,” said William Gruber, head of vaccine research and development. by Pfizer. he told FDA advisers, referring to short-term side effects such as aches, fevers and pain at the injection site.

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

The medical expert Dr. David Agus answers questions about childhood vaccines, persistent symptoms of COVID 04:38

Pfizer’s estimate for the efficacy of the three-dose vaccine to prevent symptomatic infection is also much higher than Moderna’s estimate for two doses during the Omicron wave, as well as better than those observed in some groups. older people who received doses of Pfizer.

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

In a statement on Friday announcing the clearances, the FDA said Pfizer’s analysis “was found to be unreliable due to the low number of COVID-19 cases that occurred in participants in the ‘study’.

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

When will younger children receive reinforcement?

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

The FDA has scheduled another meeting of its advisors to evaluate the issue for all ages, as both vaccine manufacturers have struggled to increase production of new formulations of their vaccines designed to target the Omicron variant.

“If it turns out that there is a very significant change in the strains that will occur in the fall, we will adjust to that and make sure that there is an option available for younger children and for the whole age group. pediatric care as appropriate “. said Marks.

A Moderna executive told CDC advisers on Friday that the company already plans to begin studying enhancements for the Omicron variant in children under the age of six starting next week, administered at least three months after the second. dose.

“We hope to be able to advance immunogenicity and safety data for this age group in early fall,” Dr. Rituparna Das of Moderna told the CDC committee.

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

Younger children tend to have a lower risk of severe COVID-19 compared to their older peers and adults, and many asymptomatic cases are unlikely to have been reported. No serious cases of the disease were reported in Moderna’s trial, even among children who had received a placebo.

However, officials and experts warn that the virus has still caused an unprecedented toll on children.

“There’s a lot of information circulating that, well,‘ I had the Omicron variant, or my son had the Omicron variant, and vaccination isn’t 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 suggesting that the Omicron variant does not produce the type of excellent immune response against a wide range of COVID-19 variants that do vaccinations,” he added.

More Alexander Tin

CBS News reporter covering public health and pandemic.

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