The Food and Drug Administration has authorized vaccines against COVID-19 for 6-month-olds on Friday, removing a key obstacle to extending vaccination to 20 million babies, young children and preschoolers. Centers for Disease Control and Prevention still have to sign before children under the age of 5 get vaccinated, which can happen within days.
“Those who are entrusted with the care of children can have confidence in the safety and effectiveness of these vaccines against COVID-19 and can be sure that the agency has been thorough in its assessment of the data,” said the FDA commissioner. Robert Calif. in a statement announcing the movement.
The FDA’s decision comes after a unanimous vote in support of Wednesday’s one-day meeting of the regulator’s external advisers, the Advisory Committee on Vaccines and Related Organic Products, which weighed on statements by Moderna, Pfizer and its partner BioNTech.
The FDA’s emergency use permit is enough to start nationwide deliveries to facilities and health care providers that have pre-ordered doses for the initial wave of vaccines. They are expected to be delivered over the holiday weekend on June 16.
However, as with older groups, federal supply agreements require vaccinators to wait for CDC approval before administering vaccines formulated for younger children.
A group of CDC’s own advisers, the Advisory Committee on Immunization Practices, is due to vote on Saturday. After the director of the CDC officially gave the green light for vaccinations after the meeting, federal officials said they expect many children to start receiving vaccines as early as Tuesday, June 21.
Federal officials said suppliers in most jurisdictions – with the exception of Florida – had pre-ordered doses of a total of 10 million injections that had been provided; 2.5 million orders were received for Pfizer’s photos and 1.3 million for Moderna’s.
In Florida, the state health department says it is accepting orders for shipments for the coming weeks.
In the initial wave, suppliers in some states pre-ordered only one of the brands, although the Biden administration hopes that this will be offset by an increase in supply across the country in future supply rounds.
The FDA also moved on Friday to allow Moderna vaccine for children ages 6 to 17 after the company’s request to vaccinate those children was suspended for months over fears it could pose a greater risk of side effects of heart inflammation in adolescents. .
If recommended by the CDC, the Moderna vaccine will offer the first alternative to the Pfizer vaccines that have been available in these older children for several months. CDC advisers are expected to vote on this updated guide next week.
Lower doses for children – and the differences between Moderna and Pfizer
Unlike the largely similar schemes of the first round of COVID-19 vaccines that were available in adults, the creators of the two mRNA vaccines have adopted different approaches to immunizing young children.
For children aged 6 months to 5 years, Moderna plans to offer two photos at a distance of one month. Their doses will be 25 micrograms, part of the primary series of 100 micrograms introduced last year for adults.
The Pfizer and BioNTech vaccine will be available in a total of three injections over 11 weeks for children aged 6 months to 4 years. These doses are 3 micrograms, only one tenth of the 30 microgram injections for those aged 12 and over.
At a briefing with reporters on Friday, FDA senior vaccine officer Dr. Peter Marx acknowledged “the nuanced benefits and risks compared to each other,” but urged parents to look for the first vaccines available to them.
Based on a study of antibodies to the virus in blood taken from children during clinical trials, both combinations were strong enough to clear the FDA’s criteria for authorization.
These goals are based on comparing their immune response to older children and adults after receiving their first two shots. Some children under the age of 5 did not pass 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 needed.
“If you want to bring your child back to kindergarten or elementary school in September, you need to get the Moderna vaccine. You can’t do it on a Pfizer schedule. And we know that two doses don’t protect against Pfizer,” he said. of Moderna Stefan. Bansel said at a health conference in Jeffries last week.
The FDA review noted that lower doses of Pfizer may have resulted in lower side effects in the group than in older adults.
“We already know that 30% of older people get the vaccine. There may be many reasons for this, but one of them is reactogenicity,” said William Gruber, head of clinical research and development at Pfizer vaccines. of the FDA, citing short-term side effects such as pain, fever and injection site pain.
The two doses of Moderna also resulted in fewer side effects than most of the older age groups in their study, according to an FDA review. The rate of fever was higher in younger children than in adolescents and adults for Moderna, although still around the levels observed in this age group after other routine vaccines.
Medical expert Dr. David Agus answers questions about childhood vaccines continuing COVID symptoms 04:38
Pfizer’s assessment of the efficacy of the three-dose vaccine in preventing symptomatic infection was also much higher than Moderna’s assessment of two doses during the Omicron wave.
But the FDA review cites a wide range of limitations on Pfizer’s assessment that were not expressed for Moderna, given the few common cases that have been recorded in Pfizer’s experience so far and the wide dosing intervals. Some participants in the trials received their third Pfizer vaccine just eight months after their second, the FDA said.
In a statement Friday, announcing the permits, the FDA said Pfizer’s analysis “found it unreliable due to the small number of COVID-19 cases in study participants.”
“I believe the vaccine is effective. I have no idea what that number will be, “said Dr. Amanda Cohn of the CDC to the FDA committee.
Marx also acknowledged that both vaccines may need to be updated in the coming months, but called on 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 assess the issue, as both vaccine manufacturers have been vying to increase production of new formulations of their vaccines designed to target the Omicron variant.
“If it turns out that there is a very big change in strains that should happen in the fall, we will adapt to this and make sure that there is an option for the youngest children and in the entire pediatric age range, as appropriate. “Marx said.
Younger children are generally at lower risk of severe COVID-19 than their older peers and adults, and many asymptomatic cases are unlikely to be reported. The Moderna study did not report severe cases, even among children who received placebo.
However, officials and experts warned the commission that the virus was still causing unprecedented damage to children. During the Omicron wave, hospitalizations and deaths in young children increased, despite data suggesting that most children already had some antibodies from a previous infection.
“We must be careful not to remain insensitive to the number of pediatric deaths due to the huge number of older deaths here. Every life is important. And vaccine-preventable deaths are those we would like to try to do something about, “Marx said Wednesday as the committee began its deliberations.
More Alexander Tin
CBS News reporter covering public health and the pandemic.
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