Covaxin COVID-19 Vaccine Description
Bharat Biotech’s Covaxin is an inactivated COVID-19 vaccine candidate that will use adjuvant Alhydroxiquim-II to boost immune response and longer-lasting immunity. The SARS-CoV-2 virus strain was isolated from an asymptomatic COVID-19 patient at the National Institute of Virology (NIV) an Indian virology research institute.
In preclinical studies and animal challenge models (Syrian Hamster and Rhesus Macaques), the company showed that COVAXIN induced Th1 based response due to Algel-IMDG (chemosorbed imidazoquinoline onto the aluminum hydroxide gel) as an adjuvant.
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.
“COVAXIN™ utilizes a historically proven approach to vaccine design. The adjuvanted inactivated virus vaccine candidate elicited strong IgG responses against spike protein, receptor-binding domain, and the nucleocapsid protein of SARS-CoV-2 along with strong cellular responses in Phase 1 and 2 clinical trials. COVAXIN™ offers a vaccine candidate that is different from other options currently available in the US market with potentially broader coverage against multiple protein antigens of the virus,” said Harvey Rubin, M.D. Ph.D. of the University of Pennsylvania, a member of Ocugen’s Vaccine Scientific Advisory Board, on December 22, 2020.
Bharat Biotech is currently conducting Phase III human trials of COVAXIN in 26,000 participants in over 25 centers across India, after receiving India's Drug Controller General's approval.
The indigenous inactivated vaccine was developed and manufactured in Bharat Biotech’s Bio-Safety Level 3 High-Containment facility located in Genome Valley, Hyderabad, India.
On December 22, 2020, Ocugen, Inc. announced that it had signed a binding letter of intent to co-develop Bharat Biotech’s COVID-19 vaccine candidate, COVAXIN, an advanced stage whole-viron inactivated vaccine candidate, for the United States market.
Hyderabad-based Bharat Biotech creates innovative vaccines and bio-therapeutics trusted by physicians around the world.
Covaxin COVID-19 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 or pregnancy vaccine efficacy data has been released.
Covaxin COVID-19 Vaccine News
January 17, 2021 - Bharat Biotech to pay compensation if Covaxin causes side-effects. In phase 1 and phase 2 clinical trials, Covaxin has demonstrated the ability to produce antidotes against COVID- 19. However, the clinical efficacy of the vaccine was yet to be established and it was still being studied in phase 3 clinical trials, the vaccine maker said.
January 9, 2021 - Bharat BioTech achieved the recruitment target of 25,800 on January 7, 2021, for the ongoing Phase 3 Covaxin trial.
January 3, 2021 - Dr. Balram Bhargava, the Director General of the Indian Council of Medical Research, told NDTV, ''The indicators are that it has a very high efficacy,'' but declined to provide any specific detail. An efficacy report, he said, ''would be (available) within weeks.''
January 2, 2021 - The India Subject Expert Committee of Central Drugs Standard Control Organisation (CDSCO) has reportedly recommended Covaxin for emergency use authorization, reported news agency ANI. The CDSCO recommendation, along with rollout modalities, will now be taken up by the Drug Controller General of India for a final decision on the matter.
December 29, 2020 - Covaxin, a vaccine candidate being developed by Bharat Biotech for COVID-19, can offer protection against mutations of coronavirus, Chairman and Managing Director of the city-based vaccine maker Krishna Ella said. He also said the company had approached regulatory authorities seeking approval for an emergency license to use the vaccine, developed in collaboration with the Indian Council of Medical Research and the National Institute of Virology and now undergoing phase 3 trials.
December 22, 2020 - Pennsylvania based Ocugen, Inc. and Bharat Biotech announced that the companies had signed a binding letter of intent to co-develop Bharat Biotech’s COVID-19 vaccine candidate, COVAXIN™, an advanced stage whole-viron inactivated vaccine candidate, for the United States market. In preparation for the development of COVAXIN™ in the US, Ocugen has assembled a Vaccine Scientific Advisory Board featuring leading academic and industry experts to evaluate the clinical and regulatory path to approval in the US market.
November 16, 2020 - Bharat Biotech has announced the commencement of Phase III trials of COVAXIN™. The Phase III trials will involve 26,000 volunteers across India, conducted in partnership with ICMR, the largest clinical trial conducted for a COVID-19 vaccine in India.
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 to initiate 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 in 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, a 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 the Post-Graduate Institute of Medical Sciences, said no adverse events were reported in subjects vaccinated at the site. 12 medical institutes were selected to conduct Phase I/II trial, including AIIMS Delhi, Patna, Post-Graduate Institute of Medical Sciences in Rohtak, and Gillurkar Hospital and Research Institute Nagpur.
July 26, 2020 - The first part of a phase 1 study of the Covaxin human trial began on July 17, 2020. It 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 and a product supplier to over 65 countries globally.
Covaxin COVID-19 Vaccine Clinical Trial
Clinical Trial NCT04641481: An Efficacy and Safety Clinical Trial of an Investigational COVID-19 Vaccine (BBV152) in Adult Volunteers.
This is a phase 3 Event-Driven, randomized, double-blind, placebo-controlled, multicentre study to Evaluate the Efficacy, Safety, and Immunogenicity of BBV152, a Whole-Virion Inactivated SARS-CoV-2 Vaccine in Volunteers aged 18 years and above.
A total of 25,800 subjects will be enrolled and randomized in a 1:1 ratio to receive the BBV152 vaccine and control. All participants will be assessed for efficacy and safety endpoints and provide a Nasopharyngeal(NP) swab and blood sample before the first dose of IP. The NP swab and blood collected will be subject to RT-PCR and Anti-SARS-CoV-2 IgG antibodies. The results of this will not affect the enrollment of the participant. Participants who are found to be positive for either RT-PCR Or Anti-SARS-CoV-2 IgG antibodies will be excluded from the primary efficacy analysis. A safety follow-up will be done for all.
Clinical Trial NCT04471519: Whole-Virion Inactivated SARS-CoV-2 Vaccine (BBV152) for COVID-19 in Healthy Volunteers - last updated on October 1, 2020.
A double-blind, Multi-Centre study evaluates 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.
Estimated Study Completion Date: June 30, 2021.