Moderna is pushing for emergency authorization from the U.S. Food and Drug Administration (FDA) for its jab for kids as young as 6 months of age, based on the results of the trial.
The decision to authorize would mean some 20 million of the youngest children in America could get a COVID-19 vaccine for the first time since the pandemic started.
Some parents and experts want that to happen sooner rather than later and are willing to accept less than ideal results. But others aren't convinced that most of the age group needs a vaccine, especially a shot that doesn't perform well against emerging variants.
The very low risk of severe COVID-19 for children presents a much different risk-benefit calculus, experts say.
Particularly for children, "you've really got to show the benefits markedly outweigh any risks," Dr. Peter Collignon, an infectious diseases physician at Canberra Hospital, told The Epoch Times over Zoom.
Does the Trial Meet Regulatory Standards?The trial from which Moderna announced interim results is called KidCOVE. It involves two groups: children 6 months of age to under 2 years, and children 2 years of age to 5 years.
The results were so positive that "we are working with the U.S. FDA and regulators globally to submit these data as soon as possible," Stephane Bancel, Moderna's CEO, said in a statement.
But the actual clinical impact was substandard.
During the wave driven by the Omicron virus variant, the vaccine was just 43.7 percent effective in the youngest group, and 37.5 percent effective in the other children.
Both measures are lower than the 50 percent bars established by the FDA and the World Health Organization for emergency authorization.
"That's not acceptable by the FDA's own standards," Dr. Steven Hatfill, a virologist who advised the Trump administration, told The Epoch Times.
"Our approach has always been to conduct a regulatory review that’s responsive to the urgent public health needs created by the pandemic, while adhering to our rigorous standards for safety and effectiveness. While we cannot comment on any submissions pending before the agency, we remain committed to conducting a timely and thorough evaluation of the available data and information on the use of COVID-19 vaccines in the youngest children," Alison Hunt, an FDA spokeswoman, told The Epoch Times in an email.
Rival Fails to Generate Adequate ResultsPfizer, another large vaccine maker, planned to ask the FDA for emergency clearance for young children in October 2021, but interim results from a clinical trial showed the two-dose regimen did not produce an adequate immune response in some of the children.
The U.S.-based firm and its partner, Germany's BioNTech, turned to a three-dose regimen, hoping that would prove more successful.
"The data that we saw made us realize that we needed to see data from a third dose, as in the ongoing trial, in order to make it the determination that we could proceed with doing an authorization," Dr. Peter Marks, the official in charge of the FDA's Center for Biologics Evaluation and Research, told reporters on a call at the time.
It remains unclear whether Pfizer's jab returned results similar to Moderna's.
A Freedom of Information Act request for documents and presentations from Pfizer and other outside parties sent to the FDA for the abruptly-canceled meeting was rejected. Officials said they had not received any such documents.
Vaccine Effectiveness WaningIn recent months, a growing amount of data show that the Moderna and Pfizer vaccines provide little protection against infection from Omicron in all recipients 5 years and older, undermining earlier risk-benefit calculations, though the shielding against severe disease has held up better.
"Our trial actually was powered on immunobridging," Jacqueline Miller, a senior vice president at Moderna, told investors in a recent call. "The idea was to infer effectiveness."
"At the end of the day, that's the objective we've been asked to meet by regulators, and we committed ourselves to meet, which is, can we demonstrate a dose of the vaccine that provides the same benefit to children, in this case under the age of 6, that is provided to older adults," added Stephen Hoge, Moderna's president.
Moderna executives say the less than ideal efficacy against infection was expected since the vaccine does poorly in shielding against the virus in adults.
That theme was picked up by some other experts, including Dr. Anthony Fauci, the longtime head of the National Institute of Allergy and Infectious Diseases.
The average efficacy "may seem like a low number, but in the era of Omicron this is actually quite comparable to the efficacy against infection in what we’re seeing now with other vaccines,” he said during a recent briefing.
The interim trial results did not include an estimate of effectiveness against severe disease or hospitalization, because no severe COVID-19 was observed in the vaccinated or unvaccinated cohorts.
Executives claimed that efficacy against severe disease could be assumed.
Low Uptake Among Kids Prompts CautionOn a recent call with reporters, Marks, the FDA official, said that he is pestered by family members regularly about vaccines for the youngest children.
"We at FDA really understand the urgency that people feel about wanting to get the youngest children vaccinated. We also understand that this is the age range when people are most concerned about potential side effects and potential safety of vaccines. And we know that in this population, we have to do our job extremely well to make sure that we ensure that there is very good evaluation of the safety and effectiveness, so that when we make our recommendation, people will trust that recommendation ... [and] parents will pick up and go vaccinate their children," he said.
Lagging vaccination rates among the 5- to 11-year-olds emphasize the need to make sure a vaccine is properly evaluated before being cleared for the younger kids, Marks said.
Just 35 percent of children in that age group have gotten at least one dose of a COVID-19 vaccine since it was cleared in the fall of 2021.
Surveys indicate parental concerns include potential long-term side effects.
Dr. William Schaffner, an infectious diseases professor at Vanderbilt University Medical Center, said he thought the Moderna results would be received "with favor" by the panel.
"There will be the notion that, as with older populations, the effectiveness of the vaccine will be better against severe disease than relatively minor infections," Schaffner, a liaison for the Centers for Disease Control and Prevention's advisory panel, told The Epoch Times.
Still, Schaffner was among the experts hesitant to make a judgment about whether the vaccine was effective enough to warrant clearance. They said they wanted to see more data first.
Other experts were adamant that regulators should not assume adequate efficacy against severe disease.
Safety Concerns and Natural ImmunityModerna said its trial did not show any "new safety concerns." That wording alarmed some experts.
Moderna vaccine recipients are at higher risk of post-vaccination heart inflammation, according to the CDC's safety surveillance.
Other side effects from the Moderna and Pfizer vaccines, both built on messenger RNA, have also been detected.
Vaccine supporters say the benefits, primarily the prevention of severe disease, outweigh the risks, but that cannot be said about the shots for young children at this time.
Long-term issues could crop up, as with various vaccines over the years. The H1N1 flu vaccine, for instance, was shown to cause an increased risk of narcolepsy among children.
"We don't know the long-term effects of any of these vaccines. We know that it does disturb natural immunity," said Hatfill, the virologist, referring to studies that indicate people with natural immunity are more prone to side effects and re-infection after getting a vaccine.