Moderna’s investigational vaccine candidate has proven to be 94.5 per cent effective in preventing Covid-19 infection based on the interim data from a large-scale late stage trial, the company said on Monday.
This makes Moderna the second US firm to report late-stage efficacy data from vaccine trials together with Pfizer. Last week, Pfizer and BioNTech vaccine candidates were found to be over 90 per cent effective in interim analysis. Moderna’s interim analysis was based on 95 infections among trial participants who received either a placebo or the vaccine. Only five infections occurred in those who received the vaccine, which is administered in two shots 28 days apart.
Based on these interim safety and efficacy data, Moderna intends to submit for an Emergency Use Authorisation (EUA) with the US Food and Drug Administration in the coming weeks and anticipates having the EUA informed of the final safety and efficacy data (with a median duration of at least 2 months). Moderna also plans to submit applications for authorisations to global regulatory agencies.
Pfizer-BioNTech and Moderna vaccines are based on messenger RNA technology, a new technology that has not been used so far to develop an approved vaccine.
The US could have two vaccines authorised for emergency use in December with as many as 60 million doses of the vaccine available this year. In 2021, the US could have access to more than a billion doses from these two vaccine makers. US has 330 million residents. Therefore, there would be more supply than what could be absorbed by the country alone.
Pfizer has already indicated it is engaging with the Indian government to advance dialogue and explore opportunities to make this vaccine available for use.
A Pfizer spokesperson had recently indicated to Business Standard that it had created two dedicated supply lines with established vaccine capabilities — one each in US and Europe — to exclusively manufacture this vaccine for use across the world. It has said its priority was to ensure rapid manufacturing and deployment of the vaccine.
Moderna is likely to have an edge over Pfizer when it comes to distribution in developing countries due to temperature requirements. Moderna's vaccine can be stored at normal fridge temperatures of 2 to 8 degrees Celsius for 30 days and it can be stored up to six months at minus 20 degrees Celsius. In contrast, Pfizer’s vaccine must be shipped and stored at minus 70 degrees Celsius. It can be stored for up to five days in a standard refrigerator or up to 15 days in a thermal shipping box.
Moderna does not yet have an Indian partner to make or distribute its vaccine for Covid-19. India is likely to begin its mass inoculation drive from January-February next year and is banking primarily on the AstraZeneca and Bharat Biotech candidates for the same.