In light of advanced stages in its clinical trial, a Moderna vaccine is actively preparing for distribution. One of the Covid-19 vaccine leaders, Moderna’s mRNA-1273 vaccine is expecting trial results by November. An independent data monitoring committee will conduct an interim review in November. This involves sifting through data from 30,000 volunteers.
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Also, by the end of 2020, Moderna aims to produce 20 million doses, with another 500 million to 1 billion doses by next year.
Phase III Trial Infection Rates Meet Expectations
Moderna reported that trial infection rates were on track with expectations. Chief Medical Officer Tal Zaks said that they are “following the ZIP codes and the counties from which these participants come, we have pretty sophisticated models of what to expect.” He added that “I think we’re on track for those expectations.”
During Thursday’s results call, CEO Stephane Bancel said they hope for FDA approval soon. A U.S. regulatory green light for Moderna’s vaccine would endorse the biotech’s vaccine platform.
In a press release, Bancel wrote: “We are actively preparing for the launch of mRNA-1273 and we have signed a number of supply agreements with governments around the world. Moderna is committed to the highest data quality standards and rigorous scientific research as we continue to work with regulators to advance mRNA-1273.”
How does the Moderna vaccine work?
mRNA-1273 uses synthetic messenger RNA (mRNA) to mimic the surface of the coronavirus. It then “teaches” the immune system to recognize and attack it. This technology is the same used by Pfizer and BioNTech to create a rival COVID-19 vaccine. The method has yet to produce an FDA-approved vaccine.
The Phase III trials, which involve 30,000 participants, expects to end by early November. Moderna’s board will conduct its analysis only after there are 53 diagnosed cases of Covid-19.
The FDA will require a two-month safety data follow up after the final trial. So, Modena will have to file for emergency use authorization. This can happen as early as mid-November, upon completion of the trial review.
Moderna vaccine Getting Supply Deals Ready
This early, Moderna is readying its supply deals to its early customers. This includes governments of the US, Japan, Canada, and Israel. The US pre-ordered 100 million doses of the vaccine valued at $25/dose. They also have an option to buy an additional 400 million doses. All in, Moderna holds $1.1 billion in deposits from its customers. This includes grants and performance payments.
The most recent deal came via Takeda of Japan. Moderna announced earlier today that they will supply Takeda with 50 million doses. Pending local approval, this batch will arrive during the first half of 2021.
More inquiries are coming in. The company is in talks with the European Union for possible supplies to its members. It is also negotiating with the World Health Organization group COVAX. Discussions include vaccine distribution and scalable pricing.
Moderna Shares Up by 13%
Moderna stock prices rose as much as 13% in Thursday trades as investors warmed up to a potential vaccine. Shares traded higher by as much as 13%, as it reiterated that it is “actively preparing” for its vaccine launch.
During the earnings call, Moderna reported a 3rd quarter loss of $233.6 million, or 59 cents a share. This is greater than Refinitiv’s prediction of 43 cents per share. Moderna generated $157.9 million in revenue. This is more than double the expected $77.5 million.
Watch this as Yahoo! Finance reports that pharmaceutical firm Moderna is getting ready to distribute its vaccine across the globe:
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