Massachusetts Based Biotech Company Moderna Receives FDA Approval To Continue Coronavirus Vaccine Trials
(Photo : Getty Images/Maddie Meyer)
CAMBRIDGE, MASSACHUSETTS - MAY 08: A view of Moderna headquarters on May 08, 2020 in Cambridge, Massachusetts. Moderna was given FDA approval to continue to phase 2 of Coronavirus (COVID-19) vaccine trials with 600 participants.

Moderna is gearing up for the global launch of its novel coronavirus vaccine candidate. The biotech firm has raked in $1.1 billion in deposits from governments awaiting the potentially life-saving drug.

According to the Cambridge-based company in Massachusetts, it was in an underway negotiation with the World Health Organization-backed COVAX goal on a tiered pricing proposal for its probable vaccine. The vaccine candidate is tentatively named mRNA-1273.

Preparing for Global Launch of COVID-19 Vaccine

In the race to create a vaccine for the coronavirus, Moderna Inc. is one of the frontrunners in the race to develop a vaccine for the new coronavirus

The company has signed negotiations with the United States government and many other countries. It is in talks with a World Health Organization-led group for the supply of the vaccine candidate. The vaccine is currently in its late-stage human trials, reported The Economic Times.

According to Moderna CEO Stéphane Bancel on Thursday, along with the firm's quarterly results presentation, it is "actively preparing" for the launch. He stated, "We have signed a number of supply agreements with governments around the world," reported FirstWord Pharma.

The CEO noted the customer deposits for the vaccine candidate during the third quarter is to be recorded as deferred revenue.

Also Read: WHO Cautions of 'Pandemic Fatigue,' Italy Guidelines Ignite Protests

Bancel said that in addition to the study's Phase 3 of the vaccine mRNA-1273, which is fully enrolled, Moderna now has four programs undergoing Phase 2 studies.

"Moderna is committed to the highest data quality standards and rigorous scientific research as we continue to work with regulators to advance mRNA-1273," added the Moderna CEO, reported The Star.

Moderna also said it is on the stage of reporting early data from a late-stage trial of its experimental COVID-19 vaccine in November. It provided the clearest timeline yet for the time that the world would know whether it is effective.

An independent data overseeing committee is expected to establish an interim review of its ongoing 30,000-person trial in November with its shares increasing by 3%.

On Oct. 22, the 3rd phase of the study of mRNA-1273 completed the enrollment of the said participants with approximately 37 percent of participants from diverse communities.

The 1st phase interim analysis of the vaccine candidate was published in "The New England Journal of Medicine" on July 14. The study displayed that mRNA-1273 was generally tolerable across all age groups and produced quick and strong immune responses against COVID-19.

The biotech firm has already secured supply agreements with the Middle East and North America among other regions.

The vaccine in the works consists of messenger RNA which may help the body initiate an immune reaction upon detection of the virus.

At least 5,000 of the participants in the study have received their second of two jolts.

If the results are positive alongside the required two months of safety data, Moderna made an announcement that it will be immediately filed for Emergency Use Authorization (EUA) with the US Food and Drug Administration (FDA).

Related Article: UK Pharmacy Boots To Offer New COVID-19 Test With Results in Only 12 Minutes