Moderna likely to report late-stage Covid-19 vaccine data in November
Moderna says it is preparing to distribute the vaccine, and expects to be able to produce 20-million doses by the end of 2020
Moderna said on Thursday it was on track to report early data from a late-stage trial of its experimental Covid-19 vaccine in November, 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 was expected to conduct an interim review of its ongoing 30,000-person trial in November. Its shares rose 3%.
The company said it was preparing to distribute the vaccine, known as mRNA-1273, and expected to be able to produce 20-million doses by the end of 2020, and between 500-million and one-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, CEO 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 recognise and neutralise it. The technology, which has yet to produce an approved vaccine, is also used in the Covid-19 vaccine being developed by Pfizer and German partner BioNTech.
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 authorisation. 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 Massachusetts-based company has signed supply deals with the US government and several other countries, and is also in talks with the World Health Organisation-led group, Covax, about vaccine distribution and a tiered pricing proposal.
Moderna said its deal with the US government for 100-million doses values the vaccine at $25 per dose, based on the grants it received and performance payments. The US government has an option to buy an additional 400-million doses.
The company, whose supply agreements include deals with Japan, Canada and Israel, said it was in talks with the EU and others.
Other vaccines in the final stages of human testing include those from Pfizer, AstraZeneca and Johnson & Johnson.
Pfizer said this week that there had not yet been enough infections in its 44,000-volunteer trial to trigger the first analysis of whether its vaccine worked.
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