Covaxin COVID-19 Vaccine Description
Bharat Biotech’s Covaxin (BBV152) is an inactivated COVID-19 vaccine that uses adjuvant Alhydroxiquim-II to boost immune response longer-lasting immunity. The Indian Council of Medical Research created the Covaxin (BBV152) vaccine. Inactivated vaccines do not replicate and are therefore unlikely to revert and cause pathological effects.
The vaccine is a whole virion inactivated SARS-CoV-2 vaccine, which develops from a well-known SARS-CoV-2 strain (NIV-2020-770) and a Vero cell platform (CCL-81) with adjuncts of either aluminum hydroxide gel (Algel) or a novel TLR7/8 agonist adsorbed gel. The SARS-CoV-2 virus strain was isolated from an asymptomatic COVID-19 patient at the National Institute of Virology, an Indian virology research institute. The TLR7/8 adjuvant formulation specifically induced significant Th1 biased antibody responses and increased SARS-CoV-2 lymphocyte responses.
The components of the vaccine include BBV152A, BBV152B, and BBV152C.
COVAXIN contains 6µg of whole-virion inactivated SARS-CoV-2 antigen (Strain: NIV-2020-770), and the other inactive ingredients such as aluminum hydroxide gel (250 µg), TLR 7/8 agonist (imidazoquinolinone) 15 µg, 2-phenoxyethanol 2.5 mg, and phosphate ® buffer saline up to 0.5 ml.
On March 8, 2021, The Lancet published a study 'Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBV152: interim results from a double-blind, randomized, multicentre, phase 2 trial, and 3-month follow-up of a double-blind, randomized phase 1 trial.' This study concluded by saying, 'In the phase 1 trial, BBV152 induced high neutralizing antibody responses that remained elevated in all participants at 3 months after the second vaccination. In the phase 2 trial, BBV152 showed better reactogenicity and safety outcomes and enhanced humoral and cell-mediated immune responses compared with the phase 1 trial. The 6 μg with Algel-IMDG formulation has been selected for the phase 3 efficacy trial.'
On April 21, 2021, Bharat Biotech announced phase 3 interim analysis results of COVAXIN. The second interim analysis results in a point estimate of vaccine efficacy of 78% (95%CI: 61-88) against mild, moderate, and severe COVID-19 disease. The efficacy against severe COVID-19 disease was 100% (95%CI: 60-100), with an impact on reduction in hospitalizations. The efficacy against asymptomatic COVID-19 infection was 70%, suggesting decreased transmission in COVAXIN® recipients.
On April 23, 2021, a non-peer-reviewed study reported, 'The drastic rise in the number of cases in Maharashtra, India has created a significant matter of concern for public health experts. Twelve isolates of VUI lineage B.1.617 were propagated in VeroCCL81 cells and characterized. Convalescent sera of the COVID-19 cases and recipients of BBV152 (Covaxin) were able to neutralize VUI B.1.617.
Covaxin (BBV152) Accession Number: DB15847; UNII: 76JZE5DSN6
Covaxin COVID-19 Vaccine Cell Lines
Covaxin COVID-19 Vaccine uses the following cell lines: Design and Development: Vero Monkey Cells; Production: Vero Monkey cells; Confirmatory Lab Tests: Antibody ELISA,
Plaque reduction, Vero monkey cells.
Covaxin COVID-19 Vaccine History
On September 28, 2020, ViroVax LLC licensed its adjuvant, Alhydroxiquim-II technology, to Bharat Biotech to produce Covaxin. 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 January 3, 2021, the Central Drugs Standard Control Organisation in India recommended emergency use permission.
Hyderabad-based Bharat Biotech creates innovative vaccines and bio-therapeutics trusted by physicians worldwide.
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. Analysis from the National Institute of Virology indicates that vaccine-induced antibodies can neutralize the UK variant strains and other heterologous strains, says the company. Indian Council of Medical Research announced on April 22, 2021, Covaxin offers protection against various SARS-CoV-2 mutations.
Individuals with HIV infection or other immunocompromising conditions or who take immunosuppressive medications or therapies might be at increased risk for severe COVID-19. However, data is NOT currently available to establish vaccine safety and efficacy in these groups. Individuals with immunosuppression may not generate a full immune response to COVID-19. There is no scientific information yet available on the appropriateness of the use of COVAXIN along with other vaccines.
Covaxin COVID-19 Vaccine While Pregnant or Breastfeeding
If you are pregnant or breastfeeding, you should not get the vaccine as the effect of the vaccine has not been studied in pregnant women and nursing mothers.
Covaxin COVID-19 Vaccine Side Effects and Risks
Side effects that have been reported with COVAXIN include, but are not limited to: Injection site pain / Swelling / Redness / Itching Headache Fever Malaise/body ache, Nausea, Vomiting Rashes. A severe allergic reaction may very rarely occur after getting a dose of COVAXIN. Serious and unexpected side effects may occur.
Covaxin - Ocugen Distribution Agreement
Ocugen, Inc., a Pennsylvania-based biopharmaceutical company and India-based Bharat Biotech, announced on February 2, 2021, has entered into a definitive agreement to co-develop, supply, and commercialize Bharat Biotech’s COVAXIN United States market. Under the terms of the agreement, Ocugen will have US rights to the vaccine candidate and will be responsible for clinical development, regulatory approval, and commercialization for the USA.
On March 14, 2021, Ocugen's CEO Shankar Musunuri told Reuters ' the company seeks to sell 100 million doses of Covaxin in the USA in 2021. "We are actively working with U.S. regulatory authorities to develop a plan around Emergency Use Authorization in the United States for COVAXIN™ and are preparing to file an Investigational New Drug application to initiate our first two clinical trials for OCU400 in the second half of this year. Proceeds from our recent registered direct offering provide the financial resources to drive our COVAXIN development efforts and ophthalmology pipeline forward,” said Dr. Shankar Musunuri in a press statement issued on March 18, 2021.
On April 28, 2021, Ocugen announced that it had closed the sale of its common stock offering were approximately $100 million.
"The Ocugen team submitted a comprehensive drug master file with the FDA and is currently diligently preparing the EUA application,” commented Dr. Shankar Musunuri, Chairman of the Board, CEO, and Co-founder of Ocugen, on May 3, 2021. Ocugen is additionally in discussions with the Biomedical Advanced Research and Development Authority regarding the U.S. government’s support of COVAXIN.
Covaxin COVID-19 Vaccine News
May 12, 2021 - Local media reported India's Subject Expert Committee on COVID-19 of the Central Drugs Standard Control Organization authorized Bharat Biotech to conduct phase II/III clinical trials to evaluate the safety, reactogenicity, and immunogenicity of Covaxin vaccination in people aged 2 to 18 years.
May 11, 2021 - The Government of Maharashtra announced the suspension of the COVID-19 vaccination drive for the 18-44 age group due to a shortage of jabs. State Health Minister Rajesh Tope told the media that the government had prioritized the second dose of the 45+ age group people with the remaining stock of vaccines. The minister said the move, however, is temporary.
May 7, 2021 - The Indian Council of Medical Research (ICMR) confirmed it is willing to share the know-how to produce the Covaxin vaccine with any company. Bharat Biotech has the sole license to manufacture Covaxin, which it developed in collaboration with scientists from ICMR’s Pune-based National Institute of Virology, reported local media.
May 3, 2021 - India's Ministry of Health and Family Welfare confirmed' 100% advance of Rs. 787.50 cr (after TDS Rs. 772.50 cr) was released on 28.04.2021 to Bharat Biotech India Ltd (BBIL) for 05 crore Covaxin doses during May, June, and July and was received by them on 28.04.2021. To date, against the last order of 02 crore doses for supplies of Covaxin vaccine, 0.8813 crore doses have been delivered till 03.05.2021. And, Under the Liberalised Pricing & Accelerated National COVID-19 Vaccination Strategy, the Govt of India would continue to procure its share of 50% of the monthly Central Drugs Laboratory cleared vaccines & would continue to make it available to the State Govts totally free of cost as was being done earlier.
May 3, 2021 - Scientists at Indian Council of Medical Research-National Institute of Virology have found that Covaxin is effective against the Brazil variant, B.1.128.2. This finding comes after their study that suggested that Covaxin was effective against the UK variant and the Indian (double mutant) variant B.1.617.
April 21, 2021 - Bharat Biotech’s Phase 3 clinical trial's second interim analysis is based on accruing more than 87 symptomatic cases of COVID-19. However, due to the recent surge in cases in India, 127 symptomatic cases were recorded, resulting in a point estimate of vaccine efficacy of 78% (95%CI: 61-88) against mild, moderate, and severe COVID-19 disease. The efficacy against asymptomatic COVID-19 infection was 70%, based on a subgroup of approximately 8,000 participants who visited the clinical trial site each month for an RT-PCR test.
April 20, 2021 - The BMJ published: What do we know about India’s Covaxin vaccine?
April 19, 2021 - Local media reported India has about 5.7 million Covaxin Covid-19 vaccine doses in possession of the states.
April 16, 2021 - Local media reported the New Delhi-based Indian government would double the production of indigenous Covaxin vaccine by May 2021 and increase it nearly seven-fold by August 2021.
April 13, 2021 - A non-peer-reviewed study assessed the humoral immune response after the first dose of two vaccines ChAdOx1-nCOV (Covishield) and the BBV-152 (Covaxin), in Indian healthcare workers. These researchers concluded 'While both vaccines elicited immune response, seropositivity rates to anti-spike antibody were significantly higher in Covishield recipient compared to Covaxin after the first dose. Ongoing COVAT study will further enlighten the immune response between two vaccines after the second dose.'
April 12, 2021 - Teena Thacker with ET Bureau reported Bharat Biotech might increase production of its Covaxin vaccine to 12 million doses a month at its Bengaluru facility by July 2021. The company's current production is about 5 million per month.
April 12, 2021 - The BBC reported, 'Bharat Biotech says it has a stockpile of 20 million doses of Covaxin and aims to make 700 million doses out of its four facilities in two cities by the end of 2021.'
April 9, 2021 - India has administered over 9.4 crore COVID-19 doses, according to the statement released by the ministry of health and family welfare.
April 6, 2021 - Mexico's health regulator Cofepris has authorized the emergency use of India's COVID-19 vaccine COVAXIN.
March 19, 2021 - Nepal's Department of Drug Administration issued emergency authorization for the Covaxin COVID-19 vaccine.
March 18, 2021 - Malvern, PA-based Ocugen, Inc. announced it had established a vaccine scientific advisory board composed of leading academic and industry experts with extensive experience in the vaccine field. Collectively, the team is working with U.S. regulatory authorities to develop the regulatory pathway to EUA in the U.S. market for the Covaxin vaccine.
March 8, 2021 - The Lancet reported: The BBV152 vaccine, adjuvanted with alum and a TLR 7/8 agonist, is designed to enhance humoral and Th1-skewed cellular immune responses after immunization by optimizing the inactivated vaccine formulation. Overall, Algel-IMDG-adjuvanted BBV152 was safe, immunogenic, and able to induce Th1-biased T-cell responses and could be a potentially superior vaccine over the alum-adjuvanted inactivated COVID-19 vaccines. However, this is the only study of an inactivated COVID-19 vaccine candidate to report a thorough evaluation of cell-mediated responses. The 6 μg with Algel-IMDG formulation has been selected for the phase 3 efficacy trial. BBV152 (developed using a well-established manufacturing platform) was safe, immunogenic (persisting for 3 months), and can be stored at 2–8°C, which is compatible with most of the immunization cold chain requirements countries. Follow-up studies to assess the efficacy and immune responses in older adults and people with comorbidities are underway.
March 3, 2021 - Bharat Biotech announced the first interim analysis of its BBV152 (COVAXIN®). The whole virion inactivated COVID-19 vaccine candidate demonstrated an interim vaccine efficacy of 81% in its Phase 3 clinical trial. The trials involved 25,800 subjects, the largest ever conducted in India, in partnership with the Indian Council of Medical Research. The first interim analysis is based on 43 cases, of which 36 cases of COVID-19 were observed in the placebo group versus 7 cases observed in the BBV152 (COVAXIN®) group, resulting in a point estimate of vaccine efficacy of 80.6%. An interim analysis is planned for 87 cases, and the final analysis is planned for 130 cases. All data from the second interim and final analyses will be shared via prepublication servers and submitted to a peer-reviewed journal for publication.
March 2, 2021 - The journal Nature published a study: Immunogenicity and protective efficacy of inactivated SARS-CoV-2 vaccine candidate, BBV152 in rhesus macaques. Altogether, this study demonstrates that a two-dose vaccination regimen using a 3-µg dose of the vaccine candidate with adjuvant B induces a significant immune response and provides effective protection in animals challenged with SARS-CoV-2.
February 26, 2021 - Brazil's health ministry announced it signed a contract to purchase 20 million doses of the Covaxin vaccine for delivery between March and May 2021.
February 19, 2021 - The Indian Council of Medical Research (ICMR) announced interim results of the ongoing Covaxin vaccine clinical trials indicated that the indigenous Covid-19 vaccine would be effective against SARS-CoV-2 coronavirus strains reported from the United Kingdom, South Africa, and Brazil. The third clinical trial of Covaxin had been completed as all the 25,800 volunteers involved had been administered both doses, reported The Hindustan Times.
February 18, 2021 - Reuters reported Bharat Biotech announced it is in the process of filing regulatory documents for approval of its COVID-19 vaccine, COVAXIN, in more than 40 countries.
February 2, 2021 - Ocugen, Inc. and Bharat Biotech announced they have entered into a definitive agreement to codevelop, supply, and commercialize Bharat Biotech’s COVAXIN™, an advanced stage whole-virion inactivated COVID-19 vaccine candidate, for the United States market.
January 31, 2021 - As part of the India-developed COVID-19 vaccine Covaxin, India's Bharat Biotech has applied for "Emergency Use Authorization" (EUA) in the Philippines. This is the first international regulatory filing for Bharat biotech's COVAXIN.
January 23, 2021 - The Lancet published an article: 'COVAXIN's approval in India came before the company had finished recruiting for the drug's phase 3 trial. Given that there is no efficacy data for COVAXIN yet, some health workers “may not have confidence in COVAXIN, and that is understandable,” said Vineeta Bal, immunologist and visiting faculty from the Indian Institute of Science Education and Research, Pune. “The government needs to put out all data, including for efficacy, for the sake of transparency and for building the confidence of the people,” she said. “The lack of data for COVAXIN leaves those who have been given it in an uncertain position regarding their status. The vaccine may work out to be safe and efficacious, but that would be owed more to good luck than to good government policy”, said Jammi Nagaraj Rao, a public health physician and epidemiologist.'
January 21, 2021 - India’s envoy to the Philippines, Shambhu Kumaran, said in a tweet: “A proud moment for Indian R&D! The first international regulatory filing for COVAXIN. Delighted that it is in the Philippines, a vital partner of the ‘Indo-Pacific. The process ahead will be difficult, but today we celebrate those who made this milestone possible!" Once Covaxin is approved by the local regulator, India is expected to donate certain vaccine doses and open the door to exports on a commercial basis.
January 21, 2021 - The Lancet published a 'report on the interim findings from the phase 1 clinical trial of BBV152; a whole-virion inactivated SARS-CoV-2 vaccine. The vaccine was well tolerated in all dose groups with no vaccine-related serious adverse events. Both humoral and cell-mediated responses were observed in the Algel-IMDG-based vaccine recipients. The most common adverse event was pain at the injection site, followed by headache, fatigue, and fever. The overall incidence of solicited local and systemic adverse events in this study was 14–21% in all vaccine-treated groups, which is noticeably lower than the rates for other SARS-CoV-2 vaccine platform candidates and similar to the rates for other inactivated SARS-CoV-2 vaccine candidates. BBV152 induced binding and neutralizing antibody responses, and with the inclusion of the Algel-IMDG adjuvant, this is the first inactivated SARS-CoV-2 vaccine that has been reported to induce a Th1-biased response. BBV152 is stored at 2–8°C, which is compatible with immunization cold-chain requirements. Both Algel-IMDG formulations were selected for the phase 2 immunogenicity trials. Further efficacy trials are warranted.'
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 vaccine's clinical efficacy was yet to be established, and it was still being studied in phase 3 clinical trials, the vaccine maker said.
January 12, 2021 - Bharat Biotech announced that it had signed an agreement with Precisa Medicamentos for the supplies of COVAXIN™ to Brazil. His Excellency Ambassador of Brazil to India, André Aranha Corrêa do Lago, joined on a virtual platform. He expressed his keen interest on behalf of the Govt. of Brazil towards the procurement of COVAXIN™. In principle, it is understood between both parties that supplies of COVAXIN™ to be prioritized for the public market through a direct procurement by the Govt. of Brazil. Supplies to the private market would be based upon receipt of market authorization from ANVISA, the Brazilian regulatory authority.
January 9, 2021 - Bharat BioTech achieved the recruitment target of 25,800 on January 7, 2021, for the ongoing Phase 3 Covaxin trial.
January 8, 2021 - Immunogenicity and protective efficacy of BBV152, whole virion inactivated SARS- CoV-2 vaccine candidates in the Syrian hamster model. BBV152A and BBV152B vaccine candidates remarkably generated a quick and robust immune response. Post-SARS-CoV-2 infection vaccinated hamsters did not show any histopathological changes in the lungs. The hamster's protection was evident by the rapid clearance of the virus from the lower respiratory tract, reduced virus load in the upper respiratory tract, absence of lung pathology, and robust humoral immune response.
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 3, 2021 - India's Drugs Controller General of India on Restricted Emergency approval announced the emergency use of a coronavirus vaccine produced by local firm Bharat Biotech.
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 India's trials.
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. Twelve 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, 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
Covaxin continues to be tested in clinical trials.