Moderna nears COVID-19 vaccine finish line as it wraps up study enrolment

Moderna is close to completing its phase 3 trial of COVID-19 vaccine candidate mRNA-1273 after completing recruitment of the 30,000 subjects in the trial.

It’s also revealed that more than 25,000 of them have already received the second dose of the shot in the COVE study, putting it in contention to be the first coronavirus vaccine company to be ready to file for emergency use authorisation in the US.

As with all COVID-19 vaccines, Moderna will need two months of safety data following the final vaccine dose before it will be able to file for an EUA, but the milestone puts it just behind Pfizer and BioNTech in the race to that objective with a possible filing date in early December.

Shares in the company climbed nearly 5% after the announcement continuing an upwards trend that means the stock is now trading at almost four times its value at the start of the year.

The latest milestone follows a rolling reviews of mRNA-1273 in Canada, which allow the country’s regulator to start reviewing data as it becomes available, and Moderna is now gearing up to file via  similar mechanism in Europe.

Moderna shared demographic data from the study at an FDA committee meeting today which showed that it included some of the groups most at risk from COVID-19.

That includes 7,000 people aged over 65 and more than 5,000 younger people with chronic diseases that make them more likely to get severe symptoms like diabetes and obesity, while around a third of subjects of African American, Hispanic/Latin and Asian descent.

Last month, Moderna said it was slowing enrolment in COVE to “ensure the representation of…communities of colour, ” and on that measure it seems to have an advantage over Pfizer/BioNTech’s BNT162b2 vaccine, which completed phase 3 recruitment in mid-September but has only 25% ethnic minorities.

Studies have suggested that that black and minority ethic people are at higher risk of dying from COVID-19 than the rest of the population.

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The study – funded with the help of $955 million of US government money – is comparing two 100 µg doses of mRNA-1273 given by intramuscular injection 28 days apart to a matched placebo, and the primary endpoint is the prevention of symptomatic COVID-19 disease 14 days after the second administration.

Like Pfizer/BioNTech and other coronavirus vaccine developers, Moderna has committed to ensuring that it has full safety and efficacy data available before filing for an EUA.

If COVE is positive and mRNA-1273 gets approved, Moderna has said it is on track to deliver up to 500 million doses per year, and possibly up to a billion doses per year beginning in 2021, thanks to a manufacturing collaboration with Lonza.

Initially supplies will be much more limited of course, and the US has already placed orders for 100 million doses of mRNA-123 in a $1.5 billion deal agreed in August.