Fri. Mar 31st, 2023
All You Need To Know

Prime Minister Narendra Modi 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 COVID-19 vaccines with foreign partners. PM Modi’s review of these vaccines came days after he visited vaccine manufacturing facilities in Ahmedabad, Pune, and Hyderabad.

Biological E Vaccine

This company 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.
It has entered into an agreement with Janssen Pharmaceutical for the latter’s vaccine candidate.

Biological E obtained 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 the vaccine.
The trials would enroll 360 health adults across Delhi, Andhra Pradesh, Telangana, and Bihar, according to the Clinical Trials Registry – India (CTRI).

The clinical trial will be randomized and administered intramuscularly in two-dose schedules 28 days apart, as per CTRI. The results of this clinical trial expected to be available by February 2021.

Dr. Reddy’s Sputnik Vaccine

The company has partnered with the Russian Direct Investment Fund (RDIF) to conduct Phase – II and Phase – III trials of the Sputnik V vaccine and 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, developed by the Gamaleya Research Institute, Moscow.

According to the CTRI, the trial conducts at nine centers across Uttar Pradesh, Maharashtra, Rajasthan, Karnataka, Tamil Nadu, and Puducherry. The randomized, double-blind, placebo-controlled trial will assess the 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 trial will enroll 100 volunteers and 1,500 in Phase- III.

Gennova Biopharmaceuticals

The company has developed an mRNA vaccine in collaboration with HDT Biotech Corporation, Seattle, USA. Gennova claimed that their vaccine candidate has demonstrated safety, immunogenicity, neutralization antibody activity in rodents, and non-human primate models.

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, the mRNA vaccine directs the body cells to express or create a virus protein to spur an immune response.

The vaccine carries molecular guidance from a synthetic RNA of the virus to generate the protein in the body, the company said.

The host body does this to produce the immune system recognized viral protein, making the body able to defend against the disease.

By gnews