Moderna on Monday said it will immediately request U.S. and European emergency authorisation for its Covid-19 vaccine candidate – as well as asking the World Health Organization for an emergency use listing.
In a press release, the US drugmaker also announced that full results of a late-stage study showed that the vaccine candidate is 94.1 per cent effective with no serious safety concerns.
The announcements came in a week that will see movement towards the first approval of Covid-19 vaccines anywhere in the world outside of Russia and China. The United Kingdom’s independent regulatory agency was set to review the Pfizer candidate this week and possibly approve it as early as next Monday or Tuesday (7 or 8 December).
Approval from the US Food and Drug Administration (FDA) for the Pfizer vaccine could come as early as 10 December, the day after the Moderna review is scheduled, followed by a 17 December FDA review – and likely approval – of the Pfizer candidate.
The UK government also asked its Medicines and Healthcare Products Regulatory Agency, to evaluate AstraZeneca’s potential Covid-19 vaccine for an accelerated release of a temporary supply.
A letter from top officials at Britain’s National Health Service to NHS hospitals, already outlined plans for a staged rollout of vaccines to high-risk groups, saying that “latest advice indicates that the very earliest we will have the first vaccine approved is early December.”
The AstraZeneca adenovirus vaccine candidate, developed in partnership with researchers at Oxford University, is the least expensive and easiest to manage of the three front-running options.
Moderna’s latest vaccine results. Moderna said that its vaccine had a 94.1 per cent efficacy rate, in a primary analysis of results from 30,000 study participants in the USA. Significantly, efficacy against severe Covid-19 was 100 per cent, the company said, and efficacy was consistent across age, race, ethnicity and gender demographics.
The results, an update of an interim analysis reported earlier, found a total of 196 Covid-19 cases among Moderna’s 30,000 trial participants, of which 185 cases were in the placebo group, versus 11 in the group that received the vaccine. All 30 severe cases, including one Covid-19 related death, occurred in the placebo group, the company reported.
“This positive primary analysis confirms the ability of our vaccine to prevent COVID-19 disease with 94.1 per cent efficacy and importantly, the ability to prevent severe Covid-19 disease. 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, hospitalizations and death,” said Stéphane Bancel, Moderna’s chief executive.
As a result, the company said that it is requesting emergency use authorisation from the US FDA, as well as conditional marketing authorisation with the European Medicines Agency (EMA), and prequalification and/or emergency use listing with the World Health Organization (WHO). The company also said that it would be submitting its results to a peer-reviewed journal for publication.
WHO Emergency Use Listing Or Prequalification?
While Moderna so far has made no commitment to license its vaccine to other manufacturers, its move to apply for recognition of its vaccine with WHO could also position the company to open the doors to generic vaccine production, in collaboration with global health agencies – if it chose.
Currently, the Moderna vaccine carries an estimate $25 per dose, for the two-dose regime, as compared to the AstraZeneca vaccine, which will cost only about $3 per dose – for a two dose regime – placing it beyond the budgets of many countries in the world.
Access to affordable vaccines has loomed as the dominant global health issue of 2021 as the world’s rich nations, along with a few low- and middle-income countries such as India, Mexico and Brazil have already bought up – or placed options on – a dominant proportion of available supplies from the first vaccines becoming available – outside of Russian and Chinese vaccines which have not yet released full details of their data.