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Setback for Moderna as Key Vaccine Candidate Misses Study Goal
Moderna's CMV vaccine showed only 6% to 23% efficacy in nearly 7,500 women, prompting cessation of Phase 3 testing due to failure to meet primary efficacy goals.
- Moderna said late Wednesday that mRNA-1647 missed its primary efficacy endpoint in the Phase 3 CMVictory trial and halted development for congenital cytomegalovirus .
- The Phase 3 data revealed the vaccine was only 6% to 23% effective in nearly 7,500 women aged 16 to 40, well below around 50%.
- We are clearly disappointed by the failure to prevent primary infection because it means there is still no vaccine for congenital CMV, said Stephen Hoge, and Moderna will continue testing mRNA-1647 in high-risk transplant patients in an ongoing Phase 2 study.
- Moderna's stock plummeted amid declining COVID-19 vaccine sales, but the company said it does not expect the CMV programme's end to affect current financial guidance or breakeven in 2028.
- CMV's prevalence and lack of an approved vaccine underline public-health stakes as analysts projected $3 billion peak sales, while Moderna faces 10% layoffs and a $800 million net loss with sales down 41% to $142 million.
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Vaccine for Birth Defects Didn’t Work Well, Won’t Be Continued: Moderna
Moderna on Oct. 22 said its vaccine for cytomegalovirus (CMV) did not perform well in a clinical trial. The investigational shot did not meet the primary efficacy endpoint in preventing CMV infection in healthy females of childbearing age, or aged 16 to 40, Moderna said. The phase 3 randomized, placebo-controlled trial involved about 7,500 women across approximately 300 sites in 13 countries, including Finland, Israel, and the United States. The…
·New York, United States
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Coverage Details
Total News Sources12
Leaning Left2Leaning Right3Center4Last UpdatedBias Distribution45% Center
Bias Distribution
- 45% of the sources are Center
45% Center
L 22%
C 45%
R 33%
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