The CDC and FDA are paving the way for COVID vaccines for children under 5 years of age

Approximately 20 million infants, toddlers and preschoolers are now eligible to be vaccinated for covid-19, after the director of the Centers for Disease Control and Prevention, Dr. Rochelle Walensky, signed unanimous votes from the agency’s external vaccine advisers to recommend shots from Moderna as well as Pfizer and BioNTech for children up to six months.

“Together with the science that leads the charge, we have taken another important step forward in our nation̵[ads1]7;s fight against COVID-19,” Walensky said in a statement.

About a third of the parents say they plan to have the child in the age group vaccinated, according to the findings from the CDC survey published on Saturday. Some of the long-awaited recordings can begin this holiday weekend. Federal officials expect the bulk of the vaccinations to begin after doctors’ offices reopen on Tuesday.

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

The CDC’s Advisory Committee on Immunization Practices voted after a two-day meeting to prepare data on the benefits and risks of shots in young children. A panel of Food and Drug Administration’s own external advisers also voted unanimously on Wednesday to support authorization.

“Those entrusted with the care of children can have confidence in the safety and efficacy of these COVID-19 vaccines and can rest assured that the Agency was thorough in its evaluation of the data,” said FDA Commissioner Dr. Robert Califf in a statement. .

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

Distribution of the first shot waves

Shipments have already started from the vaccines from Moderna as well as Pfizer and their partner BioNTech, after the Food and Drug Administration gave authorization on Friday. But as with older age groups, the government’s supply agreements require vaccinators to wait for the CDC’s sign-off before administering shots to young children.

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

Many of these will go to locations selected by the authorities, such as county health departments, which are able to store and redistribute smaller portions of the 100-dose shipments. States, including Florida, have now also begun allowing all registered vaccinators to directly request shots through them.

Some drug stores will also offer the shots, although the authorities have planned a rollout that will lean heavily on pediatricians and family doctors in the coming weeks. Pandemic liability extended to vaccinators as pharmacists cover only children as young as three years old.

The Biden Administration’s Vaccines.gov website will also soon include a feature to search for sites that specifically offer shots for younger children as more vaccinators begin to offer shots. About half of the doctors who vaccinate children plan to offer injections even to children who are not their regular patients, a CDC study found.

Suppliers in the first wave have ordered only one of the brands in some jurisdictions, although the Biden administration hopes that it will level off as supply rises around the country over future rounds of shipments.

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

In contrast to the largely similar regimens in the first round of COVID-19 shots 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, Modern the vaccine was tested as two shots at one month intervals. Their doses will be 25 micrograms, a fraction of the primary series of 100 micrograms launched last year for adults.

Pfizer and BioNTech’s vaccine will come in a total of three shots given over the course of 11 weeks, for children aged 6 months to 4 years. These doses are designed for 3 micrograms, only one tenth of the 30 microgram shots for those 12 and older.

At a briefing with journalists on Friday, the FDA’s top vaccine, Dr. Peter Marks, acknowledged the “nuanced benefits and risks compared to each other”, but urged parents to find the first shots available to them.

“The Moderna vaccine may give an immune response a little faster. On the other hand, the three-dose Pfizer regimen may also provide a greater immune response after the third dose. And there are some subtle differences in the safety profile.” in Marks.

Based on studying antibodies to the virus in the blood of test subjects, the FDA said that data from young children indicate that their immune response will be at least as good as that seen in adults after receiving the first two injections.

Some of the children under 5 did not meet this threshold after receiving only two of their doses in Pfizer’s trial, the company told investors last year, so a third dose was needed.

“If you want to put your child back in kindergarten or primary school in September, you have to take the Moderna vaccine. You can not do it on Pfizer’s schedule. And we know that two doses do not protect against Pfizer,” Modern’s CEO Stéphane Bancel said last week at the Jefferies Healthcare Conference.

The FDA’s review noted that Pfizer’s smaller dose probably resulted in the lower side effects seen in the group compared to older ages.

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

For Moderna, the fever rate was higher in younger children compared to adolescents and adults, but still around levels seen in this age group with other routine vaccines, the FDA’s review noted.

Pfizer’s estimate of the vaccine effect of three doses to prevent symptomatic infection is also much higher than Modera’s estimate of two doses during the Omicron wave, as well as better than those seen in some older age groups receiving Pfizer’s doses.

However, both the FDA’s and the CDC’s assessments raised questions about Pfizer’s estimate, suggesting that it was too early to say for sure exactly how effective the three doses would be and warned against direct comparisons. Some test takers also received their third Pfizer shots much later than the recommended eight weeks, the FDA noted.

In its release on Friday, where they announced 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 think the vaccine is effective. I have no idea what that number will actually end up with,” CDC’s Dr. Amanda Cohn told the FDA’s committee on 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 offering their children a “basic level of immunity” with current versions of the shots now.

The FDA has scheduled a new meeting with its advisors to weigh the topic for all ages, as both vaccine manufacturers have run to increase production of new formulations of their shots designed to target the Omicron variant.

“If it turns out that there is a very large change in strain that must occur in the fall, we will adjust for it and ensure that there is an alternative available for the youngest children and throughout the pediatric age group as needed.” in Marks.

A head of Moderna told CDC advisers on Friday that the company already plans to start studying boosters adapted to the Omicron variant in children under six from next week, given at least three months after their second dose.

“We hope in early autumn that we will be able to bring forward booster immunogenicity and safety data for this age group,” Modernas Dr. Rituparna Das told the CDC committee.

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

Younger children generally have a lower risk of severe COVID-19 compared to their older peers and adults, and many asymptomatic cases have probably not been reported. No serious cases of the disease were recorded in Moderna’s trial, even among children who had received placebo.

However, officials and experts warn that the virus has continued to impose a unique tariff on children.

“There’s a lot of information circulating that ‘I had the Omicron variant, or my child had the Omicron variant, and vaccination is not important,'” Mark 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 is new data to suggest that the Omicron variant does not produce the type of excellent immune response to a wide range of COVID-19 variants that vaccinations do,” he added.