New Delhi: Prime Minister Narendra Modi on Monday held a virtual meeting with three companies working on developing and manufacturing vaccines for Covid-19. These companies – Gennova Biopharmaceuticals Ltd. Pune, Biological E Ltd. Hyderabad and Dr Reddys Laboratories, Hyderabad – are working on vaccines with foreign partners. Modi’s review of these vaccines came days after he visited vaccine manufacturing facilities in Ahmedabad, Pune and Hyderabad.
News18 explains the progress made on these three vaccine candidates.
Biological E vaccine
Hyderabad-based Biological E. Ltd has partnered with US-based Dynavax Technologies Corporation and Baylor College of Medicine, a health sciences university in Houston, Texas, on a vaccine candidate that consists of the Receptor Binding Domain of the Spike Protein of SARS-CoV-2. . Biological E has also entered into an agreement with Janssen Pharmaceutical for the latter’s vaccine candidate, according to the website of Biological E.
The company obtained an approval from the Drugs Controller General of India to conduct Phase-1 trials followed by Phase-II trials to assess the safety, reactogenicity and immunogenicity of their vaccine. The trials would enrol 360 health adults across Delhi, Bihar, Andhra Pradesh and Telangana, according to the Clinical Trials Registry – India (CTRI).
The trial will be randomised and it would be administered intramuscularly in two dose schedules 28 days apart, as per CTRI. The results of this clinical trial are expected to be available by February 2021.
Dr Reddy’s Sputnik Vaccine
Dr Reddy’s Laboratories, also based in Hyderabad, has partnered with the Russian Direct Investment Fund (RDIF) to conduct Phase – II and Phase – III trials of the Sputnik V vaccine and for the vaccine’s distribution in India. For manufacturing, RDIF has entered into a separate contract with Hetero Biopharma. Hetero is going to produce 100 million doses of the Sputnik V vaccine, which was developed by the Gamaleya Research Institute, Moscow.
According to the Clinical Trials Registry – India, the trial would be conducted at nine centres across Uttar Pradesh, Rajasthan, Maharashtra, Karnataka, Puducherry and Tamil Nadu. The randomized, double-blind, placebo-controlled trial will assess safety and immunogenicity of the Gam-Covid-Vac Combined Vector Vaccine. It will essentially be a bridging study to support efficacy trials underway elsewhere in the world. In Phase I the trial will enrol 100 volunteers and 1,500 in Phase- III.
Pune-based Gennova Biopharmaceuticals has developed an mRNA vaccine in collaboration with HDT Biotech Corporation, Seattle, USA. Gennova has claimed that their vaccine candidate has demonstrated safety, immunogenicity, neutralization antibody activity in rodents and non-human primate models. Gennova’s vaccine has received funding from the Indian government’s Department of Biotechnology.
The company is aiming to begin clinical trials in December. Gennova’s vaccine candidate is the only one in India to use the mRNA platform. According to the National Institutes of Health (NIH), the national medical research agency of the United States, mRNA vaccine directs the body’s cells to express or create a virus protein to spur an immune response. The vaccine carries a molecular instructions to make the protein in the body through a synthetic RNA of the virus, the company said. The host body uses this to produce the viral protein that is recognized by the immune system, thereby making the body ready to fight against the disease.