Moderna is asking the FDA to authorize its COVID-19 vaccine for children from ages 6 months to under 6 years old.
If emergency authorization is granted, the Cambridge-based biotech company will be the first to have a vaccine for that age group available for distribution in the U.S., with other countries likely to follow. It will be ahead of Pfizer, which is currently the only company to have a U.S.-approved vaccine for ages 5-17.
"Given the need for a vaccine against COVID-19 in infants and young children we are working with the U.S. FDA and regulators globally to submit these data as soon as possible," Stéphane Bancel, CEO of Moderna, said in a press release.
Pfizer is still wrapping up clinical trials and will likely release data next month on a three-dose vaccine for children between 6 months and 4 years old. Moderna said it also plans to evaluate the potential of a booster dose for children and adolescents.
Being the first to market a vaccine for young children may help Moderna secure more contracts in the short-term. But Myles Minter, a senior biotech analyst for the financial firm William Blair, said the extent of that advantage is not entirely clear.
"It does seem to me at least that it might be a race to get something approved to fill a gap," Minter said. "[It] didn't really matter if you were first to market if someone just comes along with maybe a better product with better validation."
Moderna's said its two-dose vaccine showed an efficacy rate of 43.7% during the omicron wave in children under two and 37.5% for children 2 to under 6 years old. No cases of severe illness, hospitalization or death were recorded.
Minter said it's unlikely parents are going to rush to get kids vaccinated two years into the pandemic, even with concerns about the fast-spreading BA.2 subvariant of omicron. The current vaccination rate among adults in the U.S. is 65%, but as people's fears of COVID subside, Minter believes the rate will likely be much lower for younger children.
In a recent earnings call, Moderna's CEO said the company is expecting $19 billion in sales from its COVID vaccine in 2022. That does not include any additional sales from children's vaccines.
This article was originally published on March 23, 2022.