Around 20 million babies, toddlers and preschoolers are now eligible to be vaccinated against COVID-19 after Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention, unanimously decided by her agency’s external vaccine advisors to recommend vaccinations from Moderna as, as well as Pfizer and BioNTech for children six months and older.
“Together, and with science at the forefront, we have taken another important step forward in our nation’s fight against COVID-19,” Walensky said in a statement.
About a third of parents plan to have their child vaccinated in the age group, according to CDC survey results released Saturday. Some of the long-awaited recordings could start as early as this bank holiday weekend. Federal officials anticipate the bulk of immunizations will begin after doctors’ offices reopen on Tuesday.
“We know millions of parents and carers are anxious to get their young children vaccinated, and with today’s decision, they can. I encourage parents and carers to reach out to their doctor, nurse or local pharmacist with any questions to learn more about the benefits of vaccination and the importance of protecting their children through vaccination,” added Walensky.
After a two-day meeting, the CDC’s Advisory Committee on Immunization Practices voted to consider data on the benefits and risks of immunization in young children. A panel of the Food and Drug Administration’s own outside advisers had also voted unanimously on Wednesday to support the approval.
“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.
The FDA also on Friday added Moderna’s vaccine as an alternative to Pfizer’s shots in children ages 6 to 17, though the CDC said its advisors won’t vote on updated recommendations for those shots until next week.
Distribution of the first waves of fire
The vaccines from Moderna and Pfizer and its partner BioNTech have already begun shipping after the Food and Drug Administration granted approval on Friday. However, as with older age groups, government supply agreements require vacciners to wait for CDC approval before giving immunizations to young children.
Federal officials say most jurisdictions — with the exception of Florida — had pre-ordered cans from the 10 million total recordings available; 2.5 million orders were received for Pfizer shots and 1.3 million for Moderna.
Many of them will go to places chosen by the authorities, such as B. County Health Departments who are able to stockpile and redistribute smaller portions of the 100-dose shipments. States, including Florida, have also now begun allowing all enrolled vaccinators to request vaccinations directly through them.
Some drugstores will also offer the shots, although authorities have planned a rollout that will rely heavily on paediatricians and GPs in the coming weeks. The pandemic liability protection, which is extended to include vaccinators and pharmacists, only applies to children over the age of three.
The Biden administration’s Vaccines.gov website will also soon include a feature to find sites that offer vaccines specifically for younger children, as more vaccinators begin offering vaccines. About half of the doctors who vaccinate children plan to offer immunizations to children who are not their regular patients, according to a CDC survey.
Vendors in the first wave have only ordered one of the brands in some jurisdictions, although the Biden administration hopes this will even out as supply increases in future rounds of deliveries across the country.
Smaller doses for kids – and the differences between Moderna and Pfizer
In contrast to the broadly similar schedules of the first round of COVID-19 vaccinations 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, Moderna’s vaccine was tested as two injections one month apart. Their doses will be 25 micrograms, a fraction of the 100-microgram primary series launched for adults last year.
Pfizer and BioNTech’s vaccine is given to children ages 6 months to 4 years in a total of three shots given over an 11-week period. 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, Dr. Peter Marks, the FDA’s lead vaccine commissioner, said the “nuanced benefits and risks compare to each other,” but urged parents to look for the first vaccines available.
“It may be that the Moderna vaccine elicits a slightly faster immune response. On the other hand, the three-dose Pfizer regimen may also induce a stronger immune response after the third dose. And there are some subtle differences in the safety profile,” said Marks.
Based on examining antibodies to the virus in the blood of study participants, the FDA said data in young children suggests their immune response will be at least as good as that in adults after they receive their first two shots.
Some of the children under the age of 5 didn’t cross that threshold, having only received two of their doses in Pfizer’s studies, the company told investors last year, so a third dose was required.
“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.
For Moderna, fever rates were higher in younger children than in adolescents and adults, although they were still about the same as in that age group with other routine vaccines, the FDA review found.
The medical expert Dr. David Agus answers questions about children’s vaccinations and ongoing COVID symptoms 04:38
Pfizer’s estimate of vaccine effectiveness for three doses in warding off symptomatic infections is also much higher than Moderna’s estimate for two doses during the Omicron wave, and also better than estimates from some of the older age groups who received Pfizer’s doses.
But both the FDA and CDC reviews raise questions about Pfizer’s estimate, suggesting it’s too early to say with certainty exactly how effective the three doses will be, and cautioning against direct comparisons. Some study participants also received their third Pfizer shots well later than the recommended eight weeks, 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. CDC’s Amanda Cohn before the FDA’s committee on Wednesday.
When do younger children get a refresher?
Marks acknowledged that both vaccines may need updating in the coming months but urged parents to offer their children a “basic level of immunity” now with updated versions of the shots.
The FDA has scheduled another meeting of its advisors to weigh the issue for all ages 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.
A Moderna executive told CDC advisors Friday that the company already plans to begin studying boosters suitable for the Omicron variant in children under the age of six, starting next week and at least three months after their second dose would be administered.
“We hope to be able to present the booster immunogenicity and safety data for this age group by early fall,” said Dr. Rituparna Das from Moderna to the CDC committee.
Children as young as six months are already eligible by the FDA to receive a third dose of Moderna’s vaccine if they are significantly immunocompromised.
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.
But officials and experts warn the virus has still taken an unprecedented toll on children.
“There’s a lot of information circulating that says, ‘I had the Omicron variant or my child had the Omicron variant and vaccination is not important,'” Marks said Friday.
Hospitalizations and deaths in young children increased during the Omicron wave, although data suggested many children already had some antibodies from a previous infection.
“There is new data to suggest that the Omicron variant does not elicit the kind of excellent immune response against a variety of COVID-19 variants that vaccines produce,” he added.
More Alexander Tin