Coronavirus vaccine maker Moderna Inc MRNA 4.79% is closing in on the final stages of its vaccine program and could have the efficacy data by Thanksgiving, paving the way for a potential Emergency Use Authorization approval by the FDA, Bloomberg reported, citing an interview with the company’s CEO Stephane Bancel.
What Happened: Moderna’s coronavirus vaccine, codenamed mRNA-1273, is in Phase 2 testing and could yield efficacy data as early as Thanksgiving if everything goes right, Bancel told Bloomberg.
The CEO also discussed about the possibility of the FDA according EUA at high risk.
“They might decide to give us emergency use approval for people at very high risk, while the agency more carefully reviews the data before granting approval for a broader population, ” Bancel said.
Moderna is measuring whether the vaccine prevents COVID-19 or potentially prevents infection, she said.
Working On Pricing: Moderna’s CEO also suggested in the interview the company is working on how best to price a coronavirus vaccine to make it both affordable and viable for the company.
“What we need to make sure is that the vaccine is affordable. But vaccines won’t be free,” Bancel said.
Moderna is scheduled to start a Phase 3 trial evaluating about 30,000 volunteers, in Jul while the NIAID-sponsored Phase 1 trial and the company-managed Phase 2 trial are ongoing.
Preliminary results from the Phase 1 study released in mid-May demonstrated positive immunogenicity and safety.
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