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Shares of Modern biotechnology fell 6.2% on Thursday afternoon after health news website Stat reported that the company was delaying the start of a Phase 3 trial of its experimental Covid-19 vaccine.
The report, based on quotes from unidentified sources described as “investigators,” says the delay is due to changes made to the trial protocol, a document that sets out the trial design.
In a statement, Moderna (ticker: MRNA) said it still hopes to start the trial, which will begin on July 9 of this month. “We hope to be the first to start a Phase 3 trial,” the company said. “We have worked closely with [National Institutes of Health/Operations Warp Speed] align with the final protocol to start the test on time. “
The report comes a day after Pfizer (PFE) released promising data on its own Covid-19 vaccine candidate. Both the Pfizer vaccine and the Modern vaccine are based on messenger RNA, and both companies have set increasingly aggressive development deadlines.
Moderna had said it plans to start a Phase 3 vaccine study of 30,000 patients in July, and that it could have efficacy data by Thanksgiving. Meanwhile, Pfizer hopes to start its own phase 2b / 3 study of 30,000 patients in July, and request approval from the Food and Drug Administration by October.
Pfizer shares rose 2.5% on Thursday.
In Stat’s story, the anonymous “researchers” said that changes in trial protocol are common. Meanwhile, Covid-19 cases are skyrocketing in the United States, with approximately 50,000 new cases reported across the country on Wednesday, a record.
Write to Josh Nathan-Kazis at [email protected]
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