Moderna Inc is on track to report early data from a late-stage trial of its Covid-19 vaccine candidate next month, the company said on Thursday, offering the clearest timeline yet on when the world will know whether the vaccine is effective.
The company, one of the front-runners in the global race to produce a vaccine, said its independent data monitoring committee is expected to conduct an interim review of its ongoing 30,000-volunteer late-stage trial in November.
Moderna said it expects two-month 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.
The Cambridge, Massachusetts-based company has signed deals with the US government and several other countries, and is in talks with a WHO-led group for supply of the vaccine.
Moderna, which has no approved products on the market yet, is among a handful of companies in final trials for the vaccine, along with large drugmakers like Johnson & Johnson and Pfizer Inc.
"I believe that if we launch our Covid-19 vaccine, 2021 could be the most important inflection year in Moderna's history," said Chief Executive Officer Stéphane Bancel.
The company said it was in talks with the World Health Organization-backed COVAX facility on a tiered pricing proposal for its vaccine.