Moderna banks $1.1bn in COVID-19 vaccine deposits, signs Japan supply deal

Moderna is still preparing for the launch of its COVID-19 vaccine mRNA-1273 – assuming phase 3 trials go to plan – but has already received $1.1 billion in deposits for the shot.

The figure was revealed by CEO Stéphane Bancel in Moderna’s third-quarter results call on which he also highlighted a new agreement to supply 50 million doses of mRNA-1273 to Japan in the first half of next year with the help of Takeda.

The Japanese deal adds to a 100 million-dose agreement with the US governments agreed in August, worth some $1.5 billion, as well as a 20 million order from Canada and others including a recent agreement with Qatar.

Bancel reiterated Moderna’s expectation of an initial data readout from the pivotal COVE trial of mRNA-1273 in early November, with the critical two-month safety follow-up on half the 30,000 enrolled subjects later towards the end of that month.

That is the basis for filing for emergency use authorisation (EUA) of the vaccine in the US, according to criteria set out by the FDA. In the meantime, rolling reviews are also underway in the UK and Canada and planned in the EU.

The $1.1 billion cash injection has been booked as deferred revenue by Moderna, and helped the company generate positive cash flow for the first time in its 10-year history.

The vaccine also sets up 2021 to be the “most important inflection year in Moderna’s history”, according to Bancel – not least because it has emerged as the test bed for the biotech’s entire drug development platform.

“We intend to reinvest the returns from the sales of the vaccine into our pipeline development and hope to bring more medicines to the market,” he said. “I believe that the long-term strategic implication are large.”

Moderna’s chief medical officer Tal Zaks said on the call that clinical results with mRNA-1273 to date indicate the shot is generally safe and well-tolerated – with flu-like symptoms and injection site reactions the most common side effect reported with the two-dose regimen.

He also stressed that neutralising antibodies rise quickly after a second dose, and are seen consistently in patients regardless of age – a positive result because the immune system tends to weaken with age and older people are those most at risk of dying from the coronavirus.

Last month, Moderna said it was slowing enrolment in COVE to make sure that older patients, younger people with chronic diseases, and subjects of African American, Hispanic/Latin and Asian descent were included in the trial population.

Hitting the data readout timeline depends on 53 cases of COVID-19 being diagnosed for the interim analysis, and with rates of infection climbing around the world that should be easier to achieve. Further analysis of the data will also be triggered COVID-19 cases reach 106 and then 151, the final threshold.

Moderna said it expects to produce around 20 million doses of mRNA-1273 ready to ship in the US this year, which is a reduction on earlier estimates. It says it could be able to make 500 million to a billion doses next year.

The biotech has retained full control of its vaccine rather than partnering with a larger company, and has agreed to supply it to the US at a cost of $25 per dose.