FDA approves COVID-19 vaccines for children under 5 years old

The Food and Drug Administration on Friday approved COVID-19 vaccines for children as young as 6 months, removing a key hurdle in expanding eligibility for the vaccines to 20 million babies, toddlers and preschoolers. The Centers for Disease Control and Prevention has yet to sign off before children under 5 can start vaccination, which could happen within days.

“Those entrusted with the care of children can have confidence in the safety and effectiveness of these COVID-19 vaccines and that the agency has thoroughly evaluated the data,” said FDA Commissioner Dr. Robert Califf in a statement announcing the move.

The FDA’s decision comes after that unanimous consent from a day-long meeting Wednesday of the regulator’s external advisors, the Vaccines and Related Biological Products Advisory Committee, which considered filings from Moderna and Pfizer and its partner BioNTech.

FDA emergency approval is sufficient for shipments to begin across the country to facilities and healthcare providers who have pre-ordered doses for the first wave of vaccines. These are expected to be delivered by the bank holiday weekend of June 16th.

However, as with older age groups, federal supply agreements require vaccinators to wait for CDC approval before administering vaccines formulated for younger children.

A panel of CDC advisors, the Advisory Committee on Immunization Practices, is scheduled to vote on Saturday. Once the CDC director officially gives the green light for immunizations after the meeting, federal officials have said they expect many children to be able to start vaccinating as early as Tuesday, June 21.

Federal officials said providers in most jurisdictions – except Florida – had pre-ordered cans from the total of 10 million recordings were made available; 2.5 million orders were received for Pfizer shots and 1.3 million for Moderna.

In Florida, the state health department says they are accept orders of the programs for the coming weeks.

In the first wave, carriers in some states had only pre-ordered one of the brands, although the Biden administration hopes this will even out as supply increases in future rounds of shipments across the country.

The FDA also approved Moderna’s vaccine for children ages 6 to 17 on Friday, after the company’s application to vaccinate those children stalled for months over concerns it posed a greater risk of side effects from heart inflammation in adolescents could.

If recommended by the CDC, Moderna’s vaccine would offer the first alternative to the Pfizer shots that have been available to these older children for several months. CDC advisors are expected to vote on these updated guidance next week.

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

In contrast to the broadly similar regimens of the first round of COVID-19 vaccines available in adults, manufacturers of the two mRNA vaccines have taken different approaches to immunizing young children.

In children aged 6 months to 5 years, Modern Plans to offer two shots a month apart. Their doses will be 25 micrograms, a fraction of the 100-microgram primary series launched for adults last year.

Pfizer and BioNTechs The vaccine is given for children aged 6 months to 4 years in a total of three shots given over the course of 11 weeks. These doses are 3 micrograms in size, just a tenth of the 30 microgram intakes for people 12 and older.

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

Based on testing of antibodies to the virus in blood drawn from children during clinical trials, both combinations were potent enough to meet FDA’s benchmarks for approval.

These goalposts are based on comparing their immune responses to older children and adults after receiving their first two shots. Some of the children under the age of 5 have not crossed that threshold, having received only two of their doses in Pfizer’s studies, the company told investors last year, so a third dose was needed.

“If you want to send your child back to kindergarten or elementary school in September, you have to take the Moderna vaccine. They can’t do this on Pfizer’s schedule. And we know two doses isn’t protective, from Pfizer,” Stéphane, CEO of Moderna, told Bancel at the Jefferies Healthcare Conference last week.

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

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

The two doses of Moderna also resulted in fewer of most types of side effects compared to older age groups in their study, the FDA review found. Fever rates were higher in younger children compared to adolescents and adults for Moderna, although they are still around the levels seen in this age group after other routine vaccinations.

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Pfizer’s estimate of the vaccine’s effectiveness of three doses to ward off symptomatic infections is also much higher than Moderna’s estimate of two doses during the Omicron wave.

However, the FDA’s review cited a number of limitations of Pfizer’s estimate that weren’t noted for Moderna, given the small overall cases captured in Pfizer’s study to date and the wide dosing intervals. Some study participants didn’t receive their third Pfizer shot until eight months after their second, the FDA noted.

In its Friday press release announcing the approvals, the FDA said Pfizer’s analysis “was deemed unreliable due to the small number of COVID-19 cases encountered in study participants.”

“I believe the vaccine is effective. I have no idea what that number will actually be,” said Dr. Amanda Cohn from the CDC to the FDA’s committee.

Marks also acknowledged that both vaccines may need updating in the coming months, but urged parents to offer parents a “basic level of immunity” now with the current versions of the shots. The agency has scheduled another meeting of its advisers to weigh the issue as both vaccine makers have scramble to ramp up production of new formulations of their shots targeting the Omicron variant.

“If it turns out that there is going to be a very large change in loads in the fall, we will adapt and ensure that an option is available for the youngest children and for the entire pediatric age group,” said Marks.

Younger children are generally at lower risk of severe COVID-19 than their older peers and adults, and many asymptomatic cases likely went unreported. No severe cases of the disease were found in Moderna’s study, even in children who received a placebo.

However, officials and experts warned the committee that the virus had still inflicted one unprecedented toll on children. While the omicron waveHospital admissions and deaths among young children rose despite data suggesting most children already had some antibodies from a previous infection.

“We have to be careful not to turn deaf to the number of pediatric deaths because of the overwhelming number of elderly deaths here. Every life matters. And against vaccine-preventable deaths, we want to try and do something,” Marks said Wednesday as the committee began deliberations.

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