FDA authorizes COVID-19 vaccines for children under 5

On Friday, the Food and Drug Administration authorized COVID-19 vaccines for children as young as 6 months old, removing a major hurdle to expanding vaccine eligibility to 20 million babies, toddlers and children. preschool. The Centers for Disease Control and Prevention still needs to sign off before children under age 5 can start getting the vaccine, which could happen within days.

“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 announcing the move.

The FDA decision comes after unanimous votes of support following a day-long meeting Wednesday of the regulator’s external advisers, the Vaccines and Related Biologics Advisory Committee, which assessed submissions from Moderna as well as Pfizer and its partner BioNTech.

The FDA’s emergency use authorization is enough for shipments to begin nationwide to facilities and healthcare providers who have pre-ordered doses for the first wave of vaccines. These are expected to be delivered during the June 16 holiday weekend.

However, as with older age groups, federal supply agreements require that vaccinators await CDC approval before administering vaccines formulated for young children.

A group of CDC advisers, the Advisory Committee on Immunization Practices, is scheduled to vote on Saturday. After the CDC director officially gave the go-ahead for vaccinations after the meeting, federal officials said they expected many children to be able to start getting vaccinated as soon as Tuesday, June 21.

Federal officials said providers in 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.

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

In the first wave, vendors in some states pre-ordered just one of the brands, though the Biden administration hopes that will even out as supply climbs across the country in future rounds. of shipments.

The FDA also decided on Friday to authorize Moderna’s vaccine for children ages 6 to 17, after the company’s application to vaccinate those children was blocked for months over concerns it posed a higher risk. side effects of heart inflammation in adolescents.

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

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, Moderna packages offer two shots spaced a month apart. Their doses will be 25 micrograms, a fraction of the 100 microgram primary series rolled out last year for adults.

Pfizer and BioNTech the vaccine will be given as a total of three injections over an 11-week period, 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 vaccine official, Dr. Peter Marks, acknowledged the “nuanced benefits and risks relative to each other,” but urged parents to seek out the first. vaccines available to them.

Based on the study of antibodies to the virus in blood taken from children during clinical trials, both combos were potent enough to clear FDA clearance criteria.

These goalposts are based on comparing their immune response to that of older children and adults, after receiving their first two shots. Some of the children under 5 did not cross that threshold after receiving just two of their doses in Pfizer’s trials, the company revealed to investors last year, so a third dose Was asked.

“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 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.

Both doses of Moderna also resulted in fewer of most types of side effects compared to older age groups in their trial, the FDA review noted. Fever rates were higher in young children than in adolescents and adults for Moderna, although still around the levels seen in this age group after other routine vaccines.

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Pfizer’s estimate for the three-dose vaccine’s effectiveness in controlling symptomatic infection is also much higher than Moderna’s estimate for two doses during the Omicron wave.

But the FDA review cited a wide range of limitations on Pfizer’s estimate that weren’t expressed for Moderna, given the few overall cases that have been recorded in Pfizer’s trial so far. and very varied dosing intervals. Some trial participants received their third injection of Pfizer just eight months after their second, 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.

Marks also acknowledged that both vaccines may need to be updated over the next few months, but urged parents to start offering parents a “basic level of immunity” with current versions of the vaccines now. The agency has another meeting of its advisers scheduled to weigh in on the matter, 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.

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 warned the committee that the virus has still inflicted a unprecedented record on children. During the Omicron wavehospitalizations and deaths among young children have increased despite data suggesting that most children already had antibodies from a previous infection.

“We must be careful not to become insensitive to the number of pediatric deaths due to the overwhelming number of older deaths here. Every life is important. And the vaccine-preventable deaths are the ones we would like to try to do something about. “, said Marks on Wednesday, as the committee launched its deliberations.

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