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Pfizer Wants FDA To Approve Its Vaccine For Lyme Disease
Pfizer said Monday the vaccine maker plans to submit its experimental Lyme vaccine to the FDA for approval, even though the drug failed to show conclusively that it was effective at preventing the disease. The move elicited skepticism from among even the most staunch supporters of the vaccine industry.
TL;DR
- Pfizer plans to submit its experimental Lyme disease vaccine to the FDA for approval, even though it did not conclusively prove effectiveness.
- Late-stage trial results showed over 70% efficacy but failed to meet the primary endpoint for statistical robustness.
- Critics argue that redefining success after the trial failure raises red flags, with some suggesting it reflects 'Big Pharma's' influence.
- Experts express skepticism about the FDA approving a vaccine that didn't meet its trial endpoints, citing the need for further studies.
- Concerns are raised due to parallels with GlaxoSmithKline's LYMErix vaccine, which was withdrawn due to side effects and declining demand.
- The new vaccine requires four doses over more than a year and targets six strains of the bacteria.
- Pfizer and Valneva have an agreement where Valneva could earn over $1 billion annually if the vaccine is approved.