Moderna aims for Fall release for omicron, variant-specific COVID-19 vaccine boosters

Moderna has set a broad timeline to deliver a variant-specific COVID-19 vaccine booster just days after asking the Food and Drug Administration (FDA) for authorization to use its vaccine for children. 

“We announced a couple weeks ago a new, variant-specific booster that we’ve been testing, and we have an additional candidate, our lead candidate, in testing now that I believe is going to be even more superior,” Moderna Chief Medical Officer Paul Burton said during an appearance on “Face the Nation.”

“We are confident that by the fall of this year, we should have large amounts of that new booster vaccine that will protect against omicron and other variants, and really protect Americans and people around the world as we go into the fall of 2022.” 

The FDA set a deadline of June for drug manufacturers to submit a formula for variant-specific vaccines. Doses of modified vaccines could cost the U.S. government between $5 billion and $12 billion, The New York Times reported. 

Moderna’s timeline could allow them to meet that deadline, should testing run smoothly and not uncover any issues in the current formulation. 

Modern also recently filed with the FDA applications for the youngest children, aged 6 or younger. 

“The data in the study has been completed, and typically what we then do is package the data electronically for the FDA so they can conduct their own reviews, their own analyses,” Burton said. “That will go in by May 9, but they have the data they need now to begin.”

The vaccine is 37% effective in children aged 2 to 5 and 51% effective on children under 2 years old. The lower effectiveness, Burton argued, is due to the strong virulence of the omicron variant. 

“What it means for parents or caregivers is that if they give the Moderna vaccine to these little kids, they would basically cut in half the risk of that children getting symptomatic COVID,” “I know that 50% is often lower than what we’re used to seeing with our vaccine, but it’s because this study was conducted during omicron.” 

“When we look at the U.K. data that was released last week … exactly there we see vaccine effectiveness of 50%, but when we look at vaccine effectiveness against hospitalization that number 89-95%, so that’s why I think we can be very reassured and very confident in this result.”

Right now, only children ages 5 or older can be vaccinated in the U.S., using rival Pfizer’s vaccine.

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