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 NIV, Pune. The vector used in this new vaccine is a deactivated rabies vaccine that is known to produce a strong immune response, and that has been proven safe for all populations including children and pregnant women.
CoraVax has already been shown to induce high levels of neutralizing antibodies against SARS-CoV-2—the virus behind COVID-19—in hamster and mouse models, without triggering any serious adverse events. In viral challenge experiments, animals given CoraVax™ were fully protected against the viral disease, while all control animals showed infection at the expected levels.
Bharat Biotech has partnered with the Pennsylvania-based Thomas Jefferson University (TJU) to develop its experimental vaccine Coravax.
“Since we know the immune system reacts to the rabies vaccine with a strong response when we add the coronavirus component, we expect to see that level of protection, and immune memory, carry over to the SARS-CoV-2 viral protein as well," said TJU Infectious Diseases expert Professor Matthias Schnell, whose lab developed the vaccine in January 2020, and has recently completed preliminary tests in animal models.
Dr. Schnell stated on August 28, 2020: “CoraVax is built on a rabies platform, which is safe and effective in all groups, including pregnant women and children—an important consideration. This vaccine can be mass-produced quickly and cost-effectively, and it can be stored at simple refrigerator temperature, compared to other vaccines in the pipeline, which translates into cost-effective storage and distribution."
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. We own 160 global patents and our products help people in over 65 countries live to their fullest potential.
Covaxin SARS-CoV-2 Vaccine Indication
The Covaxin vaccine is indicated to prevent infection from the SARS-CoV-2 betacoronavirus that causes COVID-19 disease in humans.
Covaxin SARS-CoV-2 Vaccine News
August 28, 2020 - An award of $508,000 was granted to Thomas Jefferson University, which received the required matching funds from partner Bharat Biotech (Hyderabad, India) and The Philadelphia Foundation, was granted for the development of CoraVax™.
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 20, 2020 - Bharat Biotech and Thomas Jefferson University of Philadelphia have signed an exclusive deal to develop a new vaccine candidate for COVID-19 invented at Jefferson. The novel vaccine was developed using an existing deactivated rabies vaccine as a vehicle for coronavirus proteins.
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.
April 7, 2020 - Researchers at the Jefferson Vaccine Center at Thomas Jefferson University announced they have a COVID-19 vaccine candidate that could cover a global need. “Our vaccine candidate, CORAVAX™, is made from part of the current coronavirus and that is combined with another proven vaccine that serves as a carrier of sorts,” says Matthias Schnell, Ph.D., Director of the Jefferson Vaccine Center. “The benefit is that the ‘carrier’ vaccine has already been rigorously tested and shown to be safe and effective. There are manufacturing plants around the world already running and with the technological know-how to produce large quantities of that vaccine. We can leverage that efficiency and safety record.”
Covaxin SARS-CoV-2 Vaccine Clinical Trial
Human clinical trials are scheduled to start across India. To conduct the human trials, the Indian Council of Medical Research had selected 12 medical institutes across the nation including AIIMS Patna and Delhi. The medical institute in Patna will start the clinical trials on 18 volunteers who are between the age of 18 to 55. It should be noted that even though a lot of people contacted the medical institute to take part in the trials, only 18 were selected.
They will be given three doses of the vaccine candidate to complete the trial. To ensure the safety and efficacy of the vaccine, all the volunteers will remain under observation for two to three hours, after each dosage.