Health and Human Services Secretary Robert F. Kennedy Jr. is cancelling 22 mRNA vaccine contracts funded by BARDA. Without evidence, Kennedy claimed these vaccines fail to protect effectively against upper respiratory tract infections.
The company announced a contract with BARDA to develop intravenous ganaxolone for a seizure disorder that can result from exposure to nerve agents, in addition to announcing successful results from its Phase III trial of the oral version of the drug in a CDKL5 deficiency disorder, or CDD.
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The drugmaker licensed the vaccine last month from the University of Oxford, which is developing it in a Phase I/II clinical trial in southern England. The company also plans a Phase III study.
Rick Bright's attorneys said in an emailed statement Friday that the Office of the Special Counsel would request a 45-day stay on Bright's removal as director of BARDA. Bright was removed over his objections to broad use of two malaria drugs in Covid-19.
Bright alleges that his removal from BARDA was the culmination of tensions that had arisen starting three years ago over contracts worth millions of dollars he says were awarded on the basis of political connections and "cronyism" rather than scientific merit.
The funding will support the development of the vaccine, mRNA-1273, through to its potential licensing by the Food and Drug Administration. The company said a Phase II study is expected to start in the second quarter.
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With New Enterprise Associates at the helm of the round, the company is setting out to develop antibiotics for drug-resistant bacterial infections.