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Moderna on track to report late-stage COVID-19 vaccine data next month

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One of the leading COVID-19 vaccine developers Moderna Inc. said on Thursday that it was “preparing” for the release of its vaccine candidate, according to Reuters.Moderna recently finished enrolling participants for a 30,000-volunteer study and is on track to report early data from a late-stage trial of its experimental COVID-19 vaccine next month, offering the clearest timeline yet for when the world will know whether it is effective.The company, one of the front-runners in the global race to produce vaccines to protect against COVID-19, said an independent data monitoring committee is expected to conduct an interim review of its ongoing 30,000-person trial in November. Its shares rose 3%.The company said it is preparing to distribute the vaccine, known as mRNA-1273, and expects to be able to produce 20 million doses by the end of the year, and between 500 million and 1 billion in 2021.Moderna said infection rates in the trial were on track with expectations.“Since we are following the ZIP codes (US geographic areas) and the counties from which these participants come, we have pretty sophisticated models of what to expect, and I think we’re on track for those expectations,” Chief Medical Officer Tal Zaks said.A US regulatory greenlight for Moderna’s vaccine would be a major endorsement of the biotech’s vaccine platform, Chief Executive Stephane Bancel said during the company’s quarterly results conference call.

The Moderna vaccine uses synthetic messenger RNA (mRNA) to mimic the surface of the coronavirus and teach the immune system to recognize and neutralize it. The technology, which has yet to produce an approved vaccine, is also used in the COVID-19 vaccine being developed by Pfizer Inc PFE.N and German partner BioNTech SE 22AUy.F.Moderna said it expects two-month follow-up safety data, as required by the US Food and Drug Administration, in the second half of November, after which it will file for an emergency use authorization. Recent FDA guidelines called on COVID-19 vaccine developers to watch trial subjects for two months after they receive a final dose for any side effects that may crop up.The Cambridge, Massachusetts-based company has signed supply deals with the US government and several other countries, and is also in talks with the World Health Organization-led group, COVAX, about vaccine distribution and a tiered pricing proposal. Reuters contributed to this report.



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