Advisors to the Food and Drug Administration voted unanimously Tuesday to recommend expanding Moderna's Covid vaccine to children as young as 6 — and Moderna stock jumped after hours.
The Vaccines and Related Biological Products Advisory Committee voted 22-0, saying the benefits of Moderna's two-dose regimens outweigh the risks. The FDA isn't bound by the panel's suggestion, but it often follows the recommendation.
Dr. Paul Offit, a panelist, argued a two-dose vaccine should not be considered "fully vaccinated." Omicron changed the Covid landscape in the U.S. He expects Moderna to have data from its booster studies in July.
"This is a three-dose series if it's to be effective against omicron and its sub-variants," Offit said as he explained his positive vote. "You do need the affinity maturation (protection) that comes with the third dose to be protected against omicron."
Another panelist argued Covid carries less risk for children. Dr. James Hildreth noted some estimates suggest 70% of children — roughly 35 million — have contracted Covid. There have been 637 deaths in children under age 11.
"Clearly some kids get infected and do just fine," he said.
Following the vote, Moderna stock crept 1% higher near 122.80. During the regular session, shares stepped up 3.8% near 121.60.
Moderna Stock: Trailing Pfizer, BioNTech
Specifically, the panel endorsed the original vaccine for teens age 12-17. It also backed a half-sized two-dose regimen in children age 6-11. Moderna is following Pfizer and partner BioNTech which already offer Covid jabs for children as young as 5 in the U.S.
Regulators held off on Moderna's request to inoculate children as they studied the potential for heart inflammation — particularly in young males — following vaccination. It's important to note, children in other countries have been able to receive the shot.
Both vaccines carry a heightened risk for the condition. But, panelists noted, so does Covid.
Dr. Tom Shimabukuro, of the Centers for Disease Control and Prevention, said the myocarditis risk is higher in a Covid infection than it is following vaccination. However, he couldn't offer any specific numbers.
"That is an area of research that deserves some attention," he said during the meeting.
Carla Vinals, Moderna's head of regulatory affairs, said the company is not testing a longer span of time between doses in teens to help avoid the potential for myocarditis. But it is considering a longer dosing interval in infants.
Many Children Are Unvaccinated
Uptake could be a struggle for Moderna, however. Panelist Dr. Cory Meissner noted less than a third of children aged 6-11 have received a Covid shot. He acknowledged the benefit of offering another shot, especially when it comes to dodging supply chain and manufacturing problems.
Next, the matter heads to the full FDA. From there, the CDC will have the chance to tweak guidance for vaccine administration.
On Wednesday, the same panel will meet to discuss Pfizer's and Moderna's vaccines in children as young as 6 months of age. In this age group, Moderna tested a two-shot regimen at one-quarter the dosage given to adults. Pfizer tested three jabs at one-tenth the level of its adult vaccine.
This will be an important vote as there are currently no vaccines available for children under the age of 5. Moderna's vaccine proved 37% and 51% effective in children age 2-5 years old and 6-23 months old during the omicron surge, respectively.
But that's somewhat bearish for Moderna stock. Pfizer says its vaccine was about 76% protective in the younger group and 82% effective in the older group.
Expanding Vaccines To All Ages
FDA staffers acknowledged the need to expand vaccines to every age group.
"Given the uncertainty of the Covid-19 pandemic and likelihood of continued (viral) transmission during the ensuing months, deployment of the vaccine for use among children 6 months through 4 years of age will likely have a beneficial effect on Covid-19 associated morbidity and mortality in this age group," the FDA said in the Pfizer-BioNTech briefing document.
Follow Allison Gatlin on Twitter at @IBD_AGatlin.
