Moderna's Covid-19 vaccine was highly effective in 12-17 year-olds in a large study, paving the way for regulatory submissions around the world by early June, the company has said.
It said the vaccine was between 93 per cent and 100 per cent 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 12-17 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 authorised in the US and Europe for people 18 and up, on track to soon become the second shot authorised for younger teens. Earlier this month, the US Food and Drug Administration (FDA) expanded clearance of the Pfizer/BioNTech vaccine to include teenagers between the ages 12 and 15. That vaccine was originally authorised in the US for those 16 years-old and up.
Pfizer's application for use of the vaccine in younger teens is currently before the European Medicines Agency.
"We will submit these results to the US FDA and regulators globally in early June and request authorisation," Moderna chief executive Stephane Bancel said in a statement.
The company’s shares rose as much as 3.8 per cent in pre-market trading.
If Moderna’s vaccine gains clearance for teens, it could help broaden the US immunisation campaign.
In Moderna's study of 3,732 adolescents, its vaccine was 100 per cent 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 per cent 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 per cent 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. – Bloomberg
