Moderna seeks COVID vaccine okay as data backs 94% efficacy

Moderna has said it will file for US, European and UK emergency approval of its coronavirus vaccine straight away, after reporting updated phase 3 results for the shot.

The primary analysis from the 30,000-subject COVE trial of mRNA-1273 – based on 196 confirmed cases of COVID-19 – has come in at 94% efficacy, with 185 cases in the placebo arm and just 11 among those given the vaccine after two months of follow-up.

The efficacy rate is almost identical to an earlier readout after 95 confirmed cases of COVID-19 in COVE, which is being run by the US National Institute of Allergy and Infectious Diseases (NIAID), and the safety profile also looks clean, according to Moderna.

It also appears to prevent volunteers from getting very sick from the virus, as all 30 cases of severe COVID-19, and single coronavirus-related death, were in the placebo arm.

The FDA and EMA will now look at the results and see if the mRNA-based vaccine can be given a green light for widespread use, and according to Moderna the data will be discussed at a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on 17 December.

Pfizer and BioNTech’s mRNA-based shot BNT162b was the first coronavirus vaccine to be submitted for emergency approval in the US on 20 November, but at the time of writing hadn’t yet been given a green light.

AstraZeneca and the University of Oxford’s adenoviral shot AZD1222 meanwhile has also been submitted for approval in Europe under the rolling review procedure, as well as in the UK. The company expects to file for approval in the US after the readout of a US trial in 40,000 patients that hasn’t yet generated results.

While AZD1222’s efficacy hasn’t matched the mRNA vaccines in trials so far, it will be cheaper and easier to distribute as it can be kept at standard refrigeration temperatures.

As it stands, the Pfizer/BioNTech shot has to be kept at -70 degrees Celsius – although the partners are testing stability at warmer temperatures – and Moderna has data suggesting its vaccine is stable for a month in standard refrigeration once taken out of a freezer.

AZD122 is expected to cost around $4 per dose, compared to approximately $20 for BNT162b and $32-plus for mRNA-1273.

Russia’s adenoviral shot Sputnik V meanwhile has a claimed efficacy of 92%, will cost less than $10 a dose, and can also be stored at standard fridge temperatures.

Moderna said that it will also seek prequalification and emergency use listing from the World Health Organization (WHO), which provide a route to market for vaccines, drugs and other healthcare products that meet pressing public health needs, particularly in low- and middle-income countries.

As with the other vaccine data readouts, there are still a lot of unanswered questions, including whether the shots can cut viral transmission rates – including asymptomatic transmission – how long protection may last, the impact on hospitalisation rates, and long-term safety.

“We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalisations and death,” commented Moderna’s chief executive Stéphane Bancel.

The US biotech has reiterated its expectation of having 20 million doses of mRNA-1273 available by the end of the year, which is earmarked to supply the US, which has ordered 100 million doses. 50 million doses are also due to head to Japan, and 20 million to Canada, while the UK has just raised its order to 7 million.

Shares of Moderna were up more than 16% on the Nasdaq as the markets opened in the US.

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