India has formally approved the emergency use of two vaccines against the coronavirus disease (Covid-19) as it prepares for one of the world’s biggest drives and plans to inoculate some 300 million people on a priority list this year. Drugs Controller General of India VG Somani gave the green light for the emergency-use of two coronavirus vaccines, one developed by Astra Zeneca and Oxford University and the other by local company Bharat Biotech. Prime Minister Narendra Modi called it “a decisive turning point”.
Serum Institute of India (SII) is producing the vaccine Covi shield developed by Oxford University and pharmaceutical company AstraZeneca. It has got permission for restricted use in an emergency situation subject to certain regulatory conditions. The ongoing clinical trial within the country by the firm will continue.
Bharat Biotech has developed a whole virion inactivated Covaxin in collaboration with the Indian Council of Medical Research (ICMR) and National Institute of Virology (Pune). “The Subject Expert Committee has reviewed the data on safety and immunogenicity of the vaccine and recommended for grant of permission for restricted use in an emergency situation in the public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains. The clinical trial ongoing within the country by the firm will continue,” Somani said on Sunday.
1. ZyCoV-D: Zydus Cadila’s vaccine is being made on the DNA platform and is named ZyCoV-D. Cadila has collaborated with the Department of Biotechnology for this. DCGI has given its approval to the Ahmedabad-based drug firm to initiate Phase III clinical trials of its Covid-19 vaccine ZyCoV-D.
2. Sputnik V: This is a vaccine developed by Russia’s Gamaleya Institute. Dr Reddy’s Laboratories is conducting phases 2 and 3 clinical trials of Russian vaccine Sputnik V, while Biological E is conducting phase 1 trial of its indigenously developed vaccine candidate. Russia said on November 24 last year that its Sputnik V vaccine was 91.4% effective based on interim late-stage trial results. It started vaccinations in August and has inoculated more than 100,000 people so far. India plans to make 300 million doses of Sputnik V this year.
3. NVX-Cov 2373: NVX-COV-2373 is being developed by Serum Institute of India in collaboration with American company NovaVax. Phase 3 trial under consideration.
4. Biological E Limited vaccine: Biological E Ltd plans to start large late-stage trials of its potential Covid-19 vaccine candidate in April this year. The Hyderabad-based privately held company had said in November it had started early-stage and mid-stage human trials of its vaccine candidate, being developed in collaboration with Baylor College of Medicine in Houston and US-based Dynavax Technologies Corp, and expects results by February.
5. HGCO19: The novel mRNA vaccine candidate, HGCO19, has been developed by Pune-based Gennova Biopharmaceuticals, and supported with a seed grant under the Ind-CEPI mission of the department of biotechnology of the Union ministry of science and technology. Gennova has worked in collaboration with US’ HDT Biotech Corporation to develop the mRNA vaccine candidate. Gennova will start the phase 1 clinical trial of its indigenous vaccine candidate with the enrolment of 120 participants starting from early January, Mint reported in December last year.
6. Bharat Biotech’s second vaccine: Another vaccine is being developed by Bharat Biotech International Ltd in collaboration with Thomas Jefferson University, US, which is at the pre-clinical stages.
7. Aurobindo Pharma vaccine: Aurobindo Pharma Ltd has announced its own Covid-19 vaccine development programme through its US subsidiary Auro Vaccines. That vaccine, which uses recombinant vesicular stomatitis virus (RVSV) vector platform, is being developed by Profectus BioSciences. This vaccine is still in the pre-clinical phase. Aurobindo Pharma has said it would also make and sell US-based COVAXX’s Covid-19 vaccine candidate for supply in India and to the United Nations Children’s Fund (UNICEF) under a licensing deal.