The race to develop a coronavirus vaccine is advancing rapidly, and some drug manufacturers have taken an unusual step to quickly implement their respective vaccines as the Food and Drug Administration gives the green light. Modern (NASDAQ: MRNA) It is the last drug maker to begin manufacturing millions of doses of its still-experimental vaccine, mRNA-1273, at risk.
During a recent conference call to discuss the encouraging results of the Phase 1 trial for mRNA-1273, CEO Stephane Bancel outlined a plan to produce enough doses to vaccinate everyone in the United States. In fact, the company believes it can produce between 500 million and one billion doses annually. Moderna and its manufacturing partners are currently producing doses of mRNA-1273 at three sites for the US market.
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During a phase 1 clinical trial, all 45 patients had antibodies in their bloodstream produced in response to mRNA-1273. But the immune system produces many different antibodies when it encounters something strange, so unfortunately it is difficult to draw meaningful conclusions from the results.
The volunteers vaccinated with mRNA-1273 produced high levels of some antibodies that were also observed in patients who recovered from COVID-19. But we still have no idea if the high concentrations of those antibodies will effectively prevent the spread of SARS-CoV-2.
By the end of July, Moderna plans to begin a phase 3 study of 30,000 mRNA-1273 patients that was previously scheduled to start on July 9. The fundamental study was delayed because the company was late to present the final protocol changes to the FDA. The delay puts mRNA-1273 behind AZD1222’s AstraZeneca (NYSE: AZN), another coronavirus vaccine candidate who began a phase 3 trial of 5,000 patients in Brazil in late June.
