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CDC and FDA pave the way for COVID vaccines for children under 5

Some 20 million babies, toddlers and preschoolers are now eligible to be vaccinated against COVID-19, after Centers for Disease Control and Prevention director Dr. Rochelle Walensky signed the unanimous votes from his agency’s outside vaccine advisers to recommend vaccines from Moderna as well as Pfizer and BioNTech for children as young as six months old.

“Together, with science in the lead, we have taken another important step forward in our country’s fight against COVID-19,” Walensky said in a statement.

About a third of parents say they plan to have their child vaccinated in the age group, according to CDC survey results released Saturday. Some of the long-awaited filming could begin as early as this holiday weekend. Federal officials expect the bulk of vaccinations to begin after doctors’ offices reopen Tuesday.

“We know millions of parents and caregivers are eager to get their young children vaccinated, and with today’s decision, they can. I encourage parents and caregivers who have questions to speak to their doctor, nurse or pharmacist to learn more about the benefits of vaccinations and the importance of protecting their children by having them vaccinated,” added Walensky.

The CDC’s Advisory Committee on Immunization Practices voted after a two-day meeting to gather data on the benefits and risks of injections in young children. A group of outside advisers to the Food and Drug Administration had also voted unanimously on Wednesday to support the authorization.

“Child caretakers can be confident in the safety and effectiveness of these COVID-19 vaccines and can be assured that the agency has been thorough in its evaluation of the data,” the FDA commissioner said. , Dr. Robert Califf, in a statement.

The FDA also decided on Friday to add Moderna’s vaccine as an alternative to Pfizer’s vaccines for children ages 6 to 17, though the CDC said its advisers won’t vote on updated recommendations for those vaccines until then. next week.

Distribute the first waves of shots

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

Federal officials say most jurisdictions… except Florida – had pre-ordered doses out of the total 10 million doses that have been made available; 2.5 million orders were received for Pfizer shots and 1.3 million for Moderna shots.

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

Some pharmacies will also offer the shots, though officials have planned a rollout that will rely heavily on pediatricians and family doctors over the next few weeks. Pandemic liability protections extended to vaccinators like pharmacists only cover children as young as three years old.

The Biden administration’s Vaccines.gov website will also soon include a feature to search for sites specifically offering vaccines for young children, as more vaccinators begin offering vaccines. According to a CDC survey, about half of doctors who vaccinate children plan to offer vaccines even to children who are not their usual patients.

Initial wave vendors ordered only one of the brands in some jurisdictions, though the Biden administration hopes that will balance out as supply climbs across the country in future rounds of shipments.

Smaller doses for children – and the differences between Moderna and Pfizer

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

In children 6 months to 5 years old, by Moderna The vaccine was tested in two injections spaced one month apart. Their doses will be 25 micrograms, a fraction of the primary 100 microgram series rolled out last year for adults.

The vaccine from Pfizer and BioNTech will come in a total of three shots administered over the course of 11 weeks, for children aged 6 months to 4 years. These doses are sized at 3 micrograms, which is only a tenth of the 30 microgram injections for ages 12 and older.

In a briefing with reporters on Friday, the FDA’s top vaccines official, Dr. Peter Marks, acknowledged the “nuanced benefits and risks relative to each other” but urged parents to seek vaccines early at their disposal.

“It may be that the Moderna vaccine provides a slightly faster immune response. On the other hand, Pfizer’s three-dose regimen may also provide a stronger immune response after the third dose. And there are some subtle differences in the safety profile,” says Marc.

Based on the study of antibodies to the virus in blood taken from trial participants, the FDA said the data in young children suggests that their immune response will be at least as good as that seen in children. adults after receiving their first two vaccines.

Some of the children under 5 did not cross that threshold after receiving only two of their doses in Pfizer’s trials, the company revealed 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 take the Moderna vaccine. You can’t do it on Pfizer’s schedule. And we know that two doses don’t protect, from Pfizer “, said Stephane, CEO of Moderna. Bancel said last week at the Jefferies Healthcare Conference.

The FDA review noted that Pfizer’s lower dose likely resulted in the fewer side effects seen in the group compared to older people.

“We already know that, in older people, 30% of children get the vaccine. There could be many reasons for that, but one of them is reactogenicity,” said William Gruber, head of clinical vaccine research and development at Pfizer. told FDA advisers, referring to short-term side effects like body aches, fever and pain at the injection site.

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

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Pfizer’s estimate for the three-dose vaccine’s effectiveness in fending off 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 groups of people. older ages who received the doses of Pfizer.

But the FDA and CDC reviews raised questions about Pfizer’s estimate, suggesting it was too early to say for sure how effective the three doses will be 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 its Friday posting announcing the clearances, the FDA said Pfizer’s analysis “has been determined to be unreliable due to the low number of COVID-19 cases that occurred among study participants.”

“I believe the vaccine is effective. I have no idea what that number will end up being,” CDC’s Dr. Amanda Cohn told the FDA committee on Wednesday.

When will young children receive a reminder?

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

The FDA has another meeting of its advisers scheduled to weigh in on the topic for all ages, as the two vaccine makers race to ramp up 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 strains that needs to happen in the fall, we will adjust accordingly and ensure that there is an option available for younger children and across the pediatric age range, where appropriate,” says Marc.

A Moderna executive told CDC advisers on Friday that the company already plans to begin studying boosters tailored to the Omicron variant in children under six years old starting next week, given at least three months after their second dose.

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

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

Young children are generally less at risk of severe COVID-19 than their older peers and adults, and many asymptomatic cases have likely gone unreported. No severe cases of the disease were recorded in Moderna’s trial, even among children who had received a placebo.

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

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

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

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

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