Moderna plans to apply to the FDA for approval of a lower-dose COVID vaccination for children under the age of six.
A COVID-19 vaccination for babies and young children may finally be around the corner after Moderna revealed data on Wednesday demonstrating its vaccine is safe and effective in children aged 6 months to 6 years.
The vaccine developer aims to request emergency use authorization from the Food and Drug Administration in the next weeks and has already submitted an EUA for its vaccine in children aged 6 to 11, according to a news release.
"These newest results," said Stéphane Bancel, the company's chief medical officer, "are fantastic news for parents of children under the age of six." "We remain committed to assisting in the eradication of the COVID-19 pandemic through the development of a vaccine for children of all ages."
Parents of tiny children who are eager to vaccinate their children have been waiting for an announcement like this for months, following a series of setbacks and uncertainty over which vaccines would be effective and when.
The 18 million youngsters under the age of five in the country are the only ones who have not yet been vaccinated. According to the Centers for Disease Control and Prevention, over 400 children under the age of five have died with COVID-19 during the epidemic, with many of them dying in the last few months.
Dr. Katherine Matthias, a doctor and co-founder of Protect Their Future, a grassroots group lobbying for child COVID-19 immunizations, said, "We observed the devastating impact omicron had on children under the age of five who are still vulnerable without access to vaccines." "During that period, a considerable number of paediatric deaths occurred, and we must allow any more of these needless tragedies to occur. There should be no need for parents to bury their children, especially now that a safe and effective vaccine is available."
Pfizer, a competitor, presently offers school-age youngsters kid-size doses and full-strength shots for those aged 12 and up. Even smaller doses are being tested for youngsters under the age of five, although the company had to add a third injection to their trial when two injections were found to be insufficient. By early April, those results should be available.
In an interview before the firm revealed its findings, Dr. Bill Muller of Northwestern University, an investigator in Moderna's paediatric research, noted that vaccinating the youngest "has been somewhat of a changing target over the last couple of months." "I believe there's still a sense of urgency to get things done as soon as feasible."
In a trial of 6,700 children aged 6 months to 6 years, researchers discovered that after two doses of the 25 microgram vaccine, the young participants produced levels of virus-fighting antibodies comparable to adults aged 18 to 25 who received two doses of the full-strength 100 microgram vaccine.
In a Phase 3 study conducted during the omicron wave, researchers discovered that the vaccination was 43.7 percent effective in children aged 6 months to 2 years, and 37.5 percent effective in children aged 2 to 6 years. COVID-19 cases in the vaccinated group were mild, with no serious illness, hospitalisation, or death reported.
Many of the mild to severe adverse effects found in adults were seen in the younger children, with 17 percent of children aged 6 months to 2 years and 14.6 percent of children aged 2 to 6 years reporting a temperature of 100.4 degrees or higher.
There were no deaths, myocarditis or pericarditis, or multisystem inflammatory syndrome recorded in youngsters.
If authorities like what they see in Moderna's statistics, parents may finally start vaccinating their smallest children by the summer, according to Peter Pitts, a former FDA assistant commissioner.
"Immunisation for young children will be critical in accelerating COVID-19's transition from pandemic to endemic," he said.
While other nations have approved Moderna's vaccine for use in children as young as six years old, the United States has restricted its use to adults.
Since June 2021, Moderna's bid to expand its shots to 12- to 17-year-olds has been blocked. The original adult dose, according to Moderna, is safe and effective for this age range.
It uses 50 micrograms for elementary school children, which is half the adult dose.
Moderna's application for teen shots was never approved by the FDA because to concerns about a relatively unusual side effect. After getting either the Pfizer or Moderna vaccinations, heart inflammation can occur in teens and young adults, especially males. Moderna is being scrutinised more closely since their shots contain a far higher amount than Pfizer's.
The risk appears to be connected to puberty, and regulators in Canada, Europe, and other countries have lately expanded Moderna vaccines to include children as young as six years old.
However, parents and physicians are encouraging the FDA to complete this evaluation and go over Moderna's data of school-aged and younger children as soon as possible so that COVID-19 vaccines are available to all age groups.
"The FDA has a moral obligation to do everything possible to analyse Moderna's data as quickly as feasible and, if favourable, provide an emergency use permit, "Matthias remarked. "It's a matter of life and death for our children."