Covaxin SARS-CoV-2 Vaccine Description
Bharat Biotech’s Covaxin is an inactivated SARS-CoV-2 vaccine candidate. The SARS-CoV-2 virus strain was isolated from an asymptomatic COVID-19 patient at the National Institute of Virology (NIV).
COVAXIN is an inactivated vaccine derived from a strain of SARS-CoV-2 virus, isolated at the NIV, Pune, an Indian virology research institute. The inactivated virus is formulated with ViroVax’s adjuvant to produce the vaccine candidate.
In preclinical studies and animal challenge models (Syrian Hamster and Rhesus Macaques) the company showed that COVAXIN induced Th1 based response due to the use of Algel-IMDG (chemosorbed imidazoquinoline onto the aluminum hydroxide gel) as an adjuvant.
Bharat Biotech is currently conducting Phase II human trials of COVAXIN after receiving approval from the Drug Controller General of India.
On September 28, 2020, ViroVax LLC licensed its adjuvant, Alhydroxiquim-II technology to Bharat Biotech to produce Covaxin.
News agency PTI reported on November 1, 2020: "If we get all the approvals after establishing strong experimental evidence and data, and efficacy and safety data in our last stage of trials, we aim to launch the vaccine in Q2 of 2021," Sai Prasad, executive director, Bharat Biotech International Ltd, told the news agency
The indigenous inactivated vaccine was developed and manufactured in Bharat Biotech’s BSL-3 (Bio-Safety Level 3) High Containment facility located in Genome Valley, Hyderabad, India.
Bharat Biotech creates innovative vaccines and bio-therapeutics trusted by physicians around the world.
Covaxin SARS-CoV-2 Vaccine Indication
The Covaxin vaccine is indicated to prevent infection from the SARS-CoV-2 beta coronavirus that causes COVID-19 disease in humans.
No pediatric vaccine efficacy data has been released.
Covaxin SARS-CoV-2 Vaccine News
November 1, 2020 - Various media sources reported that Bharat Biotech is planning to launch its vaccine for COVID-19 in the second quarter of 2021 if it gets the requisite approvals from the Indian regulatory.
October 22, 2020 - Bharat Biotech has received the drug regulatory authority's approval for the initiation of the final phase of clinical trials. Phase 3 trials are likely to start in November. As many as 28,500 people are expected to enroll for the trials in India.
September 28, 2020 - ViroVax LLC has licensed its adjuvant, Alhydroxiquim-II, to Bharat Biotech International Limited. Bharat Biotech is partnering with the Indian Council of Medical Research to produce India’s first COVID-19 vaccine approved for human trials, COVAXIN, which uses ViroVax’s adjuvant technology.
September 23, 2020 - Bharat Biotech announced a licensing agreement with Washington University School of Medicine in St. Louis for a novel chimp adenovirus, single-dose intranasal vaccine for COVID-19. Bharat Biotech owns the rights to distribute the vaccine in all markets except the USA, Japan, and Europe. While the Phase I trials will take place in Saint Louis University’s Vaccine & Treatment Evaluation Unit, Bharat Biotech, upon obtaining the required regulatory approval, will pursue further stages of clinical trials in India and undertake large scale manufacture of the vaccine at its facility located in Genome Valley, Hyderabad.
August 14, 2020 - According to local media reports in India, preliminary Phase I trial results showed that the vaccine is safe, and the participants are receiving the 2nd dose. The trial’s principal investigator Dr. Savita Verma at Post-Graduate Institute of Medical Sciences said that no adverse events were reported in subjects vaccinated at the site. 12 medical institutes were select to conduct Phase I/II trial, including AIIMS Delhi, Patna, Post-Graduate Institute of Medical Sciences in Rohtak and Gillurkar Hospital and Research Institute in Nagpur.
July 26, 2020 - The first part of a phase 1 study of Covaxin human trial which began on July 17, 2020, was completed on July 25th, at Post-Graduate Institute of Medical Sciences, Rohtak, said Dr. Savita Verma, principal investigator of the vaccine trial team.
July 15, 2020 - Bharat Biotech announced that the Phase-I clinical trials of India’s first indigenous COVID-19 vaccine Covaxin began across the country, enrolling 385 people in 12 hospitals across the country.
July 13, 2020 - All India Institute of Medical Sciences in Patna, India, is set to begin human trials of India’s first coronavirus vaccine, Covaxin
June 29, 2020 - India's Covaxin has received permission to initiate Phase I & II Human clinical trials after the company submitted results generated from preclinical studies, demonstrating safety and immune response.
May 8, 2020 - The Council of Scientific and Industrial Research (CSIR) under its flagship program NMITLI has sanctioned a project to develop human monoclonal antibodies as therapy for COVID-19 infections. The project is being led by Bharat Biotech, a leading manufacturer of vaccines and biotherapeutics as well as a supplier of products to over 65 countries in the world.
Covaxin SARS-CoV-2 Vaccine Clinical Trial
Clinical Trial NCT04471519: Whole-Virion Inactivated SARS-CoV-2 Vaccine (BBV152) for COVID-19 in Healthy Volunteers - last updated on October 1, 2020.
- Double-blind, Multi-Centre study to evaluate the safety, reactogenicity, tolerability, and immunogenicity of three investigational vaccine groups and one placebo group in healthy volunteers who receive two intramuscular doses of BBV152 vaccine formulations and placebo. A total sample size of 755 healthy volunteers, with 375 and 380 volunteers in phase 1 and 2 studies, respectively.