Ø The National drug regulator, Drugs Controller General of India (DCGI) has granted emergency use authorisation to US biotechnology firm Moderna for its vaccine against the novel coronavirus, paving the way for its Indian partner Cipla to import the first mRNA Covid-19 vaccine into the country for commercial use. This is also the first internationally developed vaccine to be granted a waiver from conducting bridging trials in India.
Ø It is the fourth vaccine in the country to be given the emergency use authorisation (EUA). Currently, India has made available three COVID vaccines — Covaxin, Covishield and Sputnik. Health Ministry’s press statement added that, India is also in talks with Pfizer and JJ to add to the basket of vaccines available in the country.
Ø The Ministry also said that the discussions on whether Moderna and Cipla would receive indemnity —protection from legal liability in the case of adverse effects — are still underway. Covid-19 mRNA vaccines have demonstrated high efficacy in clinical trials — Moderna’s vaccine was found to have an impressive 94 per cent efficacy in phase 3 trials in the US — but require ultra-cold storage systems. Moderna vaccine would be brought in as a readytouse injectable vaccine, which can be stored for seven months at prescribed temperature, and can be stored for 30 days at normal storage after a vial is opened.
Other three Covid-19 vaccines currently approved for use in India:
Covishield: The Oxford-AstraZeneca vaccine produced by the Serum Institute of India was one of the first Covid vaccines to be approved for use in India. Experts note that even one dose of Covishield is over 70 per cent effective in protecting from severe disease and hospitalisation against the Delta variant of the SARS-CoV2 coronavirus.
Covaxin: The Bharat Biotech’s vaccine, India’s first indigenously produced Covid jab, was approved for emergency use while it was still undergoing trials. The vaccine has shown the ability to bring down symptomatic Covid-19 cases by 77.80 per cent, according to data from its phase 3 trials, which was reviewed by the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO).The pharma company has recently submitted its proposal for Emergency Use Listing approval by the World Health Organisation.
Sputnik V: The Russian vaccine, developed by Gamaleya National Research Institute of Epidemiology and Microbiology in Moscow, was approved for use in India in May, 2021. Dr.Reddy’s Laboratories, based in Hyderabad, has partnered with the Russian sovereign fund
RDIF, to distribute the doses in India. According to results published in The Lancet, the vaccine has an efficacy of 91.6 per cent.