Moderna shot effective in teens, opening path for clearances

By Robert Langreth

Bloomberg News

Moderna Inc.’s COVID-19 vaccine was highly effective in 12- to 17-year-old adolescents in a large study, paving the way for regulatory submissions around the world by early June.

In a news release, the company said its vaccine was between 93% and 100% effective in preventing symptomatic COVID in a study of teenagers, depending on whether very mild cases are included in the count. The study met its primary goal of showing that immune responses to the vaccine in 12- to 17-year-olds were as good as those produced in adults, and no significant safety concerns were observed, according to the company.

The results put Moderna’s vaccine, currently authorized in the U.S. for people 18 and up, on track to soon become the second shot authorized in the U.S. for younger teens. Earlier this month, the U.S. Food and Drug Administration expanded clearance of the Pfizer Inc.-BioNTech SE vaccine to include teenagers ages 12 to 15. That vaccine was originally authorized for those 16 and up.

“We will submit these results to the U.S. FDA and regulators globally in early June and request authorization,” Moderna Chief Executive Officer Stephane Bancel said in a statement.

The company’s shares rose as much as 3.8% in pre-market trading.

If Moderna’s vaccine gains clearance for teens, it could help broaden the U.S. immunization campaign. However, there have been signs that overall demand for shots across the country has peaked. As of Monday, about 1.8 million doses a day were being administered in the U.S., down from more than 3 million a day on average in mid-April, according to the Bloomberg Vaccine Tracker.

In Moderna’s study of 3,732 adolescents, its vaccine was 100% effective starting 14 days after receiving the second dose, based on the same strict definition of COVID-19 that was used to assess the vaccine in a final-stage adult trial. There were no cases of COVID-19 in kids who got the vaccine compared with four cases in the smaller group of teens who received a placebo.

Using a broader case definition that includes milder cases with just one symptom and a positive test result, the vaccine was 93% effective starting 14 days after the first dose, Moderna said. The new findings are consistent with data from the same study released by Moderna earlier this month. That data found the vaccine was 96% effective starting 14 days after the first dose.

In the study, Moderna said common side effects included injection- site pain, headache, fever, muscle pains, and chills. The company said it planned to submit the data for publication in a scientific journal.