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

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(Reuters) – Moderna Inc MRNA.O Thursday, said he was on track to report first data from an advanced stage trial of his investigational COVID-19 vaccine next month, offering the clearest timeline yet for when the world will know if it is effective.

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

The company, one of the pioneers in the global race to produce vaccines to protect against COVID-19, said an independent data monitoring committee should conduct an interim review of its ongoing trial of 30,000 people in November. Its shares rose 3%.

The company said it was 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 as expected.

“Since we track the zip codes (US geographies) and the counties these participants come from, we have pretty sophisticated models of what to expect, and I think we’re on the right track to meeting those expectations. Chief Medical Officer Tal Zaks told me.

A U.S. regulatory go-ahead for Moderna’s vaccine would be a major approval for the biotechnology vaccine platform, chief executive Stephane Bancel said on the company’s quarterly earnings conference call.

The Moderna vaccine uses synthetic messenger RNA (mRNA) to mimic the surface of the coronavirus and train the immune system to recognize and neutralize it. The technology, which has yet to produce an approved vaccine, is also being used in the COVID-19 vaccine under development by Pfizer Inc PFE.N and German partner BioNTech SE 22AUy.F.

Moderna has said it expects two-month tracking safety data, as required by the United States Food and Drug Administration, in the second half of November, after which it will file an authorization for use. emergency. Recent guidelines from the FDA have called on COVID-19 vaccine developers to monitor test subjects for two months after receiving a final dose for any side effects that may arise.

The Cambridge, Massachusetts-based company has signed supply agreements with the US government and several other countries, and is also in talks with the World Health Organization-led group COVAX over the distribution of vaccines and a tiered price proposition.

Moderna said his deal with the US government for 100 million doses valued the vaccine at $ 25 per dose, based on the grants it received and performance payments. The US government has the option to purchase an additional 400 million doses.

The company, whose supply agreements include deals with Japan, Canada and Israel, said it was in talks with the European Union and others.

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

Pfizer said this week that there had not yet been enough infections in its trial of 44,000 volunteers to trigger the first analysis of its vaccine’s effectiveness.

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

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