Schools across the country are resuming in-person classes as the highly contagious Omicron variant surges through their communities. Public health officials say COVID-19 vaccines, which are available for children as young as 5, can provide an important layer of protection for children on campus. But what is the timeline for admitting children under the age of 5?
dr William Hartman, the principal investigator of one of Moderna’s pediatric COVID-19 vaccine trials, says it’s reasonable to assume that emergency use authorization for children ages 6 months to 5 years could be granted in late March or early April. He said it’s “highly possible” that Moderna will get to that point ahead of Pfizer.
Based on the progress seen so far, Hartman, who directs the Hartman Laboratory at the University of Wisconsin, expects the first data around next month.
In December, Pfizer-BioNTech announced a setback in efforts to expand the use of its vaccine: data from its ongoing study in children aged 2 to 4 years indicates that the vaccine dose used – 3 micrograms, or one-tenth the adult dose – did not generate a strong immune response in this group after two shots. But the two-shot regimen produced a response in infants between 6 months and 2 years — comparable to that seen in 16- to 25-year-olds. Children aged 5 to 11 years are given a dose of 10 micrograms or one third of the formulation for those aged 12 years and older.
Moderna is conducting studies for the under-5s age group at a comparatively higher dose, which is about a quarter of the adult dose, Hartman said.
“As far as we can tell,” he said, the two-shot regimen is proving to be safe and effective in study participants. He added that they have observed no cases of myocarditis, mild cases of which have been rarely seen in adolescents who received the vaccines.
“I believe this is true nationally (in Moderna studies for this age group), that the fear of myocarditis that we all have doesn’t seem to be a problem in this age group,” he added.
Pfizer said it plans to test the subjects’ immune responses after administration of a third dose.
“The decision to take a third dose of 3 [micrograms] for children aged 6 months to less than 5 years reflects the companies’ commitment to carefully selecting the right dose to maximize the risk-benefit profile. If the three-dose study is successful, Pfizer and BioNTech expect to submit data to regulators in support of an emergency use authorization for children ages 6 months to less than 5 years in the first half of 2022,” wrote Jerica Pitts, a Pfizer representative, in an email.
What about Johnson & Johnson?
An emailed statement from Johnson & Johnson said phase 2 and 3 clinical trials are ongoing in adolescents aged 12 to 17. Meanwhile, the CDC has recommended that most eligible Americans opt for one of the mRNA vaccines over the Johnson & Johnson vaccine.
Winter outlook and safety
dr Leian Chen, the chief medical officer at UCLA Health Pediatrics in Marina del Rey, says she has immunization conversations on a daily basis.
“I have some families that every visit are very eager to ask ‘when their younger children might be able to get vaccinated,’ she said.
Elementary school-age children have been eligible for a vaccine since early November, when the Centers for Disease Control and Prevention granted emergency use authorization to Pfizer’s vaccine for children ages 5 to 11. The American Academy of Pediatrics reported that over 1 in 10 children in the US — nearly 7.9 million — have tested positive for COVID since the pandemic began.
But progress has been slow: Since vaccines for this age group became available, only 28% of eligible children in California have received at least one dose, according to the LA Times vaccine tracker — far behind the state’s 75.4% immunization rate.
Chen said in December that she expects to see more COVID-19 cases in children when the Omicron wave hit southern California. That prediction has come true: by the end of the first week of January, cases among students and staff at the Los Angeles Unified School District were nearly 10 times higher than before the winter break.
“We have seen that children definitely get COVID. And fortunately, most are doing well,” she said. “But some become seriously ill. And others have long had COVID symptoms.”
She said she regularly answers questions from parents about the long-term safety of these vaccines and reports of side effects such as myocarditis. She has reviewed the data for both her patients and herself personally. Her 7-year-old child, along with millions of other children, became a vaccine candidate this fall. She decided to have him vaccinated.
https://www.latimes.com/science/story/2021-12-17/whats-the-timeline-for-kids-under-5-to-get-a-covid-vaccine When can kids under 5 get vaccinated for COVID-19?