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

(Reuters) - Moderna Inc MRNA.O on Thursday said it 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.

FILE PHOTO: A sign marks the headquarters of Moderna Therapeutics, which is developing a vaccine against the coronavirus disease (COVID-19), in Cambridge, Massachusetts, U.S., May 18, 2020. REUTERS/Brian Snyder/File Photo

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 (U.S. 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 U.S. 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 U.S. 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 U.S. 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.

Moderna said its deal with the U.S. government for 100 million doses values the vaccine at $25 per dose, based on the grants it received and performance payments. The U.S. 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 is in talks with the European Union and others.

Other vaccine in final stages of human testing include those from Pfizer, AstraZeneca Plc AZN.L and Johnson & Johnson JNJ.N.

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 works.

Reporting by Manas Mishra and Manojna Maddipatla in Bengaluru and Carl O’Donnell in New York; Editing by Saumyadeb Chakrabarty and Bill Berkrot