Pfizer and Valneva say Lyme disease vaccine candidate showed more than 70% efficacy but missed a key trial endpoint
The Facts
- Pfizer and Valneva said their Lyme disease vaccine candidate showed more than 70% efficacy in a late-stage trial.
- The trial did not meet its primary statistical endpoint because fewer Lyme disease cases occurred than expected.
- Pfizer said it plans to seek regulatory approval for the vaccine candidate despite the missed endpoint.
- The companies said the vaccine was well tolerated and no safety concerns were identified in the trial analysis.
- There is currently no approved human vaccine for Lyme disease.
- Valneva's shares fell sharply after the trial update.
Context
Why did the trial miss its main goal if the vaccine showed more than 70% efficacy?
The companies said the study did not accrue enough Lyme disease cases to make the primary analysis statistically conclusive, even though the vaccine showed more than 70% efficacy in the results they reported CNBC NBC News Reuters Investing.com France Investing.com India.
What did Pfizer say it will do next?
Pfizer said it plans to seek regulatory approval for the vaccine candidate, which it identified as PF-07307405, based on the trial results CNBC Reuters Boursorama Morningstar.
Why is this vaccine being watched closely?
It could become the first approved human vaccine for Lyme disease, and multiple outlets noted that no approved vaccine is currently available Reuters Hill Euronews English.
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