No Indian partner yet for production or distribution; results not final
United States-based Moderna Inc November 30, 2020 said the vaccine it was developing for the novel coronavirus disease (COVID-19) has registered 94.1 per cent efficacy in trials on 196 cases.
An earlier interim result announced November 16, based on analysis of trials on 95 patients, had shown an efficacy of 94.5 per cent.
Moderna said it would apply for an emergency use authorisation in the US as well as in Europe based on ‘primary efficacy’ results.
No Indian company has partnered Moderna for production or distribution of the vaccine candidate so far.
The way to 94%
Trial participants were divided into two groups: Only those in one group received the vaccine while others were administered a placebo. Of 196 cases, as many as 185 of those who were infected by the virus were in the placebo group after the inoculation of the vaccine.
The secondary endpoint of the trial was to see how many among the 196 developed a severe form of COVID-19. Eventually, 30 patients did, all from the placebo group. This indicated a cent per cent efficacy against severe form of the disease.
There has been one COVID-19-related death in the study to date; it was in the placebo group.
Moderna claimed November 16 that no serious adverse event was observed, indicating the vaccine was safe.
According to the company’s latest statement:
A continuous review of safety data is ongoing and no new serious safety concerns have been identified by the Company. Based on prior analysis, the most common solicited adverse reactions included injection site pain, fatigue, myalgia, arthralgia, headache, and erythema/redness at the injection site.
Like other candidates, knowledge on Moderna’s vaccine too remain confined to statements; full data are yet to be examined by experts.
Moderna said it has submitted its data to a peer-reviewed publication.
According to Moderna:
The Company has already initiated the rolling review process with the European Medicines Agency (EMA), Health Canada, SwissMedic, the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA), Ministry of Health in Israel, and Health Sciences Authority in Singapore and intends to seek Pre-qualification and/or Emergency Use Listing with the World Health Organization.
This should not be construed as the final Phase 3 result of the ongoing 30,000-participants trial. The final estimate will account for the totality of the data.
The company claimed the data was consistent across ages, races, ethnicities and gender demographics.
Like Oxford-AstraZeneca’s candidate, Moderna’s vaccine also uses mRNA platform. Long-term (six months) storage of Moderna’s vaccine required a temperature of -20 degree Celsius. It can be stored at normal refrigerated conditions for 30 days.
Moderna expects to produce 20 million doses of the vaccine by the end of 2020. For global production, the company intends to make 550 million-1 billion doses in 2021.
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