Moderna to Ask FDA to Authorize Vaccine for Children as Young as 6 Months

Effectiveness lower than threshold deemed acceptable by FDA, WHO

A health worker administers a dose of a Moderna COVID-19 vaccine during a vaccination clinic at the Norristown Public Health Center in Norristown, Pa., on Dec. 7, 2021. Matt Rourke/AP Photo

Moderna on March 23 said its clinical trial for its COVID-19 vaccine in children aged 6 months to 5 years old successfully met its primary endpoint, and plans to ask the Food and Drug Administration (FDA) to grant emergency use authorization for the age group, even as the estimated effectiveness is lower than the bar set by the FDA and the World Health Organization.

Moderna, a Massachusetts-based biotechnology firm, said the phase 2/3 trial showed the safety profile in young children was similar to that seen in adults and older kids, with no cases of post-vaccination heart inflammation recorded.

The company also said the vaccine provided a similar neutralizing antibody response to that seen in adults 18 to 25 years of age, who have been cleared since December 2020 to get a two-dose regimen.

“We believe these latest results from the KidCOVE study are good news for parents of children under 6 years of age,” Moderna CEO Stephane Bancel said in a statement, adding that the company plans to submit a package of data to the FDA for consideration soon.

The interim data outlined by Moderna, which hasn’t been released for outside review, was from about 6,700 participants younger than 6.

Children under 5 years old currently cannot get a COVID-19 vaccine in the United States, spurring calls from some parents for regulators to clear one or more options.

But the effectiveness of the vaccine in Moderna’s trial in terms of preventing infection from SARS-CoV-2 came in at just 43.7 percent for children aged 6 months to 2 years and even lower, 37.5 percent, in those 2 to 5 years old.

The FDA has said that vaccines should be at least 50 percent effective in preventing infection or decreasing its severity to receive emergency authorization. The World Health Organization says vaccines are required to be 50 percent effective or better to receive clearance.

The FDA and Moderna didn’t respond to requests for comment by press time.

Moderna said that lower effectiveness was expected because of the dominance of the Omicron virus variant. Omicron bypasses vaccine protection more than earlier variants of SARS-CoV-2, also known as the CCP (Chinese Communist Party) virus.

“Overall, this is great that the vaccine was shown to be safe in this population of children, generated a good antibody response, and was shown to be clinically effective at decreasing risk of infection by approximately 40 percent,” Dr. David Boulware, an infectious disease physician and scientist at the University of Minnesota, told The Epoch Times via email.

But some questioned the effort to get authorization.

“To convince parents of children as young as six months old to allow their children to be injected with Moderna’s mRNA COVID-19 vaccine, the company is going to have to do a lot more than claim a woefully inadequate 37 to 43 percent efficacy when COVID disease is either asymptomatic or very mild for the majority of young children,” Barbara Loe Fisher, president and co-founder of the National Vaccine Information Center, told The Epoch Times via email, adding that long-term risks of the vaccine remain unknown.

Both the Moderna and Pfizer COVID-19 vaccines are built on messenger RNA technology.

Moderna, meanwhile, was unable to peg the efficacy of its shot against severe disease in young children because no severe COVID-19 cases were observed in the vaccine or placebo groups.

“The absence of any severe disease, hospitalization, or death in the study precludes the assessment of vaccine efficacy against these endpoints,” it said.

But it also claimed that the immune response seen in kids predicted protection from severe COVID-19.

The young children received 25-microgram doses, a quarter of the amount adults receive.

Moderna also plans to ask regulators to authorize 50-microgram doses for children 6 to 11 and update its submission package for children 12 to 17. The FDA opted in the fall of 2021 not to decide on Moderna’s vaccine for the latter group because of concerns of post-vaccination heart inflammation.

Children are less likely to experience any symptoms from COVID-19, much less severe cases of the disease, when compared to adults, a fact that prompted the FDA in February to delay a decision on Pfizer’s vaccine for young children.

Regulators and Pfizer also said the two-shot primary regimen didn’t perform well enough to win emergency authorization. The company and its partner BioNTech are currently testing a three-dose regimen, with results expected in April.