Covaxin COVID-19 Vaccine (BBV152) 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.
The Covaxin vaccine is a whole virion inactivated SARS-CoV-2 vaccine, developed from the SARS-CoV-2 strain (NIV-2020-770) and a Vero Cell platform (CCL-81) with adjuncts of either aluminum hydroxide gel or a novel TLR7/8 agonist adsorbed gel. The virus strain is soaked in beta-propiolactone, an organic compound that deactivates them by binding to their genes, says the Company.
Inactivated vaccines do not replicate and are unlikely to revert and cause pathological effects, says the U.S. CDC.
The SARS-CoV-2 betacoronavirus strain was isolated from an asymptomatic COVID-19 patient at India's National Institute of Virology.
The vaccine's adjuvant was developed with funding from the U.S. National Institutes of Health has contributed to the success of the highly efficacious COVAXIN COVID-19 vaccine. The TLR7/8 adjuvant formulation specifically induced significant Th1 biased antibody responses and increased SARS-CoV-2 lymphocyte responses.
COVAXIN (BBV152) contains six µg 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. The components of the Covaxin vaccine include BBV152A, BBV152B, and BBV152C.
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 three 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), impacting reduction in hospitalizations. The efficacy against asymptomatic COVID-19 infection was 70%, suggesting decreased transmission in COVAXIN® recipients.
ANI reported on May 16, 2021, Covaxin (BBV152) was found effective against coronavirus strains found in India and the U.K. These findings are from a study conducted in collaboration with the India Council of Medical Research. "No difference in neutralization between B.1.1.7 (U.K.) and vaccine strain (D614G) was observed," Bharat Biotech added.
On June 4, 2021, a non-peer-reviewed study found 'Covaxin vaccinated healthcare workers could produce a high immune response in up to 95% of recipients and prevent serious disease in those infected after immunization.'
Dr. Balram Bhargava, Secretary Department of Health Research & Director General Indian Council of Medical Research, said in a press statement issued on July 3, 2021, "I am delighted to note that COVAXIN®, developed by ICMR and BBIL under an effective public-private partnership, has demonstrated an overall efficacy of 77.8% in India's largest COVID phase 3 clinical trial thus far. Our scientists at ICMR and BBIL have worked tirelessly to deliver a truly effective vaccine of the highest international standards. COVAXIN® will benefit the Indian citizens and immensely contribute to protecting the global community against the deadly SARS-CoV-2 virus. I am also pleased to see that COVAXIN® works well against all variant strains of SARS-CoV-2. The successful development of COVAXIN® has consolidated the position of Indian academia and industry in the global arena."
As of April 2021, Covaxin cost in India is about 295 rupees (US$ 3.97).
GAVI confirmed on July 6, 2021, Bharat Biotech insisted the vaccine was safe and provided a robust immune response. Supportive Phase 3 trial non-peer-reviewed data was published on July 2, 2021.
Covaxin (BBV152) Accession Number: DB15847; UNII: 76JZE5DSN6
Covaxin COVID-19 Vaccine (BBV152) History
On 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 vaccine's rights in all markets except the USA, Japan, and Europe.
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 in Genome Valley, Hyderabad, India.
On January 3, 2021, the Central Drugs Standard Control Organisation in India recommended emergency use permission.
On May 10, 2021, local media reported the Haffkine Institute located in Mumbai, India, can produce 22.8 crore Covaxin vaccine doses annually, and the roll-out will take around eight to 10 months.
GAVI confirmed that India's "Covaxin" vaccine is highly effective against COVID-19 infections in phase 3 clinical trial on July 6, 2021.
Hyderabad-based Bharat Biotech creates innovative vaccines and bio-therapeutics trusted by physicians worldwide. Chiron Behring Vaccines became a subsidiary in 2019.
Covaxin COVID-19 Vaccine (BBV152) Indication
Indian Council of Medical Research announced on April 22, 2021, Covaxin offers protection against various SARS-CoV-2 mutations. The Covaxin vaccine is indicated to prevent the SARS-CoV-2 beta coronavirus infection that causes COVID-19 disease in humans. The company says that the National Institute of Virology analysis indicates that vaccine-induced antibodies can neutralize the U.K. variant strains and other heterologous strains.
The National Institute of Virology analysis indicates that vaccine-induced antibodies can neutralize the U.K. variant strains and other heterologous strains.
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. In addition, individuals with immunosuppression may not generate a full immune response to COVID-19. There is no scientific information yet available on the appropriateness of COVAXIN along with other vaccines.
Covaxin COVID-19 Vaccine (BBV152) 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 says the company.
Covaxin COVID-19 Vaccine (BBV152) For Children
Media reported Bharat Biotech announced it would begin pediatric clinical trials with Covaxin beginning June 1, 2021. "It will be a trial on children aged 2-18 years," said Raches Ella, Bharat Bio's head-business development and international advocacy.
On July 23, 2021, local media in India reported that the All India Institute of Medical Sciences (AIIMS) is set to start its second dose clinical trial of Bharat Biotech's COVAXIN on 2-6-year-old children, said sources. The second dose of the COVID-19 vaccines has already been given to children aged 6 to 12 years at the Delhi AIIMS.
Local media in India reported on August 20, 2021, a senior official from the Indian Council of Medical Research's National Institute of Virology in Pune, which collaborated with Bharat Biotech for Covaxin, said she expected the results from the studies to be out soon and approval for children to follow shortly after.
On October 11, 2021, local media reported a doctor at the All India Institute of Medical Sciences stated 'The serosurvey done by ICMR found almost 60% of children were already infected with Covid-19. The death rate is 2 in a million in children, which is very low. There’s no such study to justify that vaccine will be very beneficial for children,” Dr. Sanjay K Rai, Professor at the Centre for Community Medicine in AIIMS Delhi, told news agency ANI.
The Times of India reported October 12, 2021, India's Subject Expert Committee (SEC) committee recommended grant of market authorization of the vaccine for the age group of 2 to 18 years for restricted use in emergency situations subject to certain conditions.
Covaxin COVID-19 Vaccine (BBV152) Side Effects and Risks
Side effects that have been reported with COVAXIN (BBV152) 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. However, serious and unexpected side effects may occur.
On July 2, 2021, a non-peer-reviewed study found the 'BBV152 vaccine was well tolerated with no clinically or statistically significant differences in the distributions of solicited, unsolicited, or serious adverse events between vaccine and placebo groups.' Adverse events reported were similar to placebo, with 12.4% of subjects experiencing commonly known side effects and less than 0.5% felt serious adverse events.
A case report was published on September 12, 2021: Recurrent herpes zoster after COVID-19 vaccination in three patients with chronic urticaria being treated with cyclosporine.
Covaxin - Ocugen 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 agreement terms, Ocugen will have U.S. rights to the vaccine candidate and be responsible for clinical development, regulatory approval, and commercialization for the USA. In addition, on June 3, 2021, the companies amendment to their Co-development to expand Ocugen's exclusive territory to commercialize COVAXIN to include Canada.
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. On April 28, 2021, Ocugen announced closing its common stock offering of approximately $100 million.
Ocugen, Inc. announced on June 10, 2021, that upon recommendation from the U.S. FDA, it would pursue submission of a biologics license application for the COVAXIN vaccine. Therefore, the Company will no longer pursue an Emergency Use Authorization for COVAXIN.
On June 15, 2021, Ocugen announced that it had selected Jubilant HollisterStier of Spokane, Washington as its manufacturing partner for Covaxin to prepare for potential commercial manufacturing for the U.S. and Canadian markets.
"With the Delta variant becoming a dominant strain of COVID-19 in the United States, we believe that the Phase 3 efficacy results reported by Bharat Biotech demonstrate that COVAXIN has the potential to become an important option to expand protection against this emerging variant. Combining these data with the only Delta-variant results from a controlled Phase 3 clinical trial, evidence continues to support a favorable benefit-risk profile for COVAXIN," said Dr. Bruce Forrest, Acting Chief Medical Officer and a member of the vaccine scientific advisory board of Ocugen, in a press statement issued on July 2, 2021.
On July 15, 2021, Ocugen confirmed it had initiated a rolling submission to Health Canada for Covaxin. Soon after, the Company announced the completion of its regulatory submission to Health Canada for COVAXIN™, which was accepted under the Minister of Health's Interim Order Respecting the Importation, Sale, and Advertising of Drugs for Use in Relation to COVID-19 and transitioned to a New Drug Submission for COVID-19. The submission was conducted through the Company's new affiliate, Vaccigen, Ltd., and the review process has begun in Canada.
Ocugen issued a press statement on August 6, 2021, which included the following disclosures: Discussions with the U.S. FDA are ongoing, and the Company is still proceeding with a strategy focused on the agency's requested Biologics License Application pathway and determining what data requirements and U.S.-based clinical trials will be required to support such submission.
Covaxin COVID-19 Vaccine (BBV152) News
October 12, 2021 - India's Subject Expert Committee expert panel granted emergency use approval to Covaxin – Bharat Biotech’s COVID-19 vaccine for children between the ages of two and 18.
October 11, 2021 - ANI News reported Covaxin vaccine clinical trials with children show similar results as on adults, stated Dr. Sanjay K Rai, Professor at the Centre for Community Medicine.
October 7, 2021 - Media reported the Union government of India had approved the export of 10 lakh Covaxin vaccine doses to Iran.
October 2, 2021 - Local media reported Bharat Biotech submitted clinical trial data to the DCGI on Covaxin vaccine use for children in the 2-18 years age group, seeking authorization.
September 28, 2021 - Local media reported Bharat Biotech had submitted all the necessary documents required for WHO approval on July 9, 2021.
September 22, 2021 - The World Health Organisation's Strategic Advisory Group of Experts on Immunization will be meeting on October 5, 2021, to consider granting the Covaxin vaccine authorization. The meeting agenda indicates the company will present evidence and draft recommendations on the use of the Bharat Biotech vaccine in priority populations.
September 22, 2021 - The Hindustan Times reported Bharat Biotech confirmed the Phase 2/3 trials of Covaxin for children under the age of 18 are over. The company also said that it expects to submit the dataIndia'sia's Drug Controller General of India by next week.
September 21, 2021 - BhaBiotech'sch's Krishna Ella informed media the company is planning to ramp up production of its Covaxin vaccine from 3.5 crore doses this month to 5.5 crore doses in October 2021.
August 29, 2021 - Local media in India report" ed "We want to ensure that Bharat Biotech can ably meet the demand for Covaxin such that individuals across the country, and the globe, have access to the vaccine," company's chairman and managing director Krishna Ella said in a recent statement.
August 26, 2021 - LocalCircles conducted a nationwide survey to understand better what (40,000) citizens in India experienced after 1st and 2nd dose of COVAXIN. On an aggregate basis, 78% of citizens surveyed experienced no or mild side effects—sore arm or fatigue after taking the 2nd dose of Covaxin.
August 24, 2021 - Manila media reported the Philippines Department of Science and Technology-VEP member Dr. Rontgene Solante said that Covaxin is at least 80% effective against the severe form of COVID-19 illness.
August 15, 2021 - Dr. Krishna Ella, chairman and managing director of Bharat Biotech, was reported to have said The Freedom Summit the company is working on a combination of Covaxin followed by a nasal vacc "ne "so that Covaxin primes the system of innate immunity and then the boost by the nasal which produces three immune responses, the IGG, the IGA and then mucosal immunity, all three of which are powerful and can protect a person from getting infec" ed."
August 7, 2021 - A non-peer-reviewed study in India suggests that immunization with a combination of an adenovirus vector platform-based vaccine followed by an inactivated whole virus vaccine (Covaxin) was not only safe but also elicited better immunogenicity. The immunogenicity profile against Alpha, Beta, and Delta variants in the heterologous group was superior; IgG antibody and neutralizing antibody response of the participants was also significantly higher than that in the homologous groups.
August 5, 2021 - Bharat Biotech announced via Twitter European regulatory in Hungary has certified Covaxin. This marks the 1st EUDRAGDMP compliance certificate issued for Covaxin.
August 2, 2021 - Covaxin was reported effective against SARS-CoV-2 coronavirus variants, according to a study conducted by the Indian Council of Medical Research. In conclusion, this non-peer-reviewed study sta'ed 'reduction in the NAb titer was observed in the sera of fully immunized Covid naïve, recovered cases with BBV152 vaccination, and breakthrough cases. However, with the observed high titers, the sera of individuals belonging to all the aforementioned groups would still neutralize the Delta, Delta AY.1, and B.1.617.3 variants effectiv'ly.'
July 31, 2021 - Local media reporIndia'sia's Subject Expert Committee approved BhaBiotech'sch's plan to experiment with a mixed-dosing of the intramuscularly administered Covaxin and a nasal inoculation based on a different vector.
July 23, 2021 - Media reported Bharat Biotech committed to supplying over 500 million doses of its Covaxin vaccine to the Centre under the countrywide immunization program. Speaking at a virtual conference, Suchitra Ella, joint Managing Director of Bharat Biotech, said company'sny's facilities in Hyderabad, Bengaluru, Pune, and Ankaleshwar are currently producing Covaxin.
July 23, 2021 - Bharat Biotech confirmed it terminated a Memorandum of Understanding with Precisa Medicamentos and Envixia Pharmaceuticals LL.C to produce its Covaxin for the Brazilian market. Media report" d, "Notwithstanding such termination, Bharat Biotech will continue to work diligently with ANVISA, the Brazilian drug regulatory body, to complete the regulatory approval process for Cova" in."
July 19, 2021 - BhaBiotech'sch's Covaxin for children aged 2-6 years is likely to be administered to those participating in the trials next week, according to local media. The second dose of Covaxin has already been given to children between ages 6-12 years, said sources, at the All India Institute of Medical Sciences.
July 7, 2021 - The HindustanTimes report" d, "The application of the booster (3rd) dose will depend on the knowledge of the efficacy of the vaccine. It is well known that natural antibodies after infection remain for 7-12 months. But the jury is still out to decide how long vaccine-generated antibodies remain effective, stated Dr. Balram Bhargava, director-general, the Indian Council of Medical Research.
July 6, 2021 - Gavi published an articIndia'si "'s "Cov" xin" vaccine shows high efficacy against COVID-19 infections in a phase 3 trial. Covaxin, also known as BBV152, was authorized for emergency useIndia'sia's Central Drugs and Standards Committee (CDSCO) on 3 January 2021, even though phase 2 clinical trials were unpublished and larger phase 3 trials still ongoing.
July 3, 2021 - Bharat Biotech announced safety and efficacy analysis data today from Phase III clinical trials of COVAXIN. Efficacy analysis demonstrates COVAXIN® to be 93.4% effective against severe symptomatic COVID-19. And Efficacy data demonstrates 65.2% protection against the SARS-CoV-2, B.1.617.2 Delta variant. Prof. Priya Abraham, Director National Institute of Virology ICMR, sa" d, "The overall efficacy of 77.8 % following the phase III clinical trial of COVAXIN® is wonderful n" ws."
July 2, 2021 - A non-peer-reviewed study funded by the vaccine owner found BBV152 was immunogenic and highly efficacious against symptomatic and asymptomatic COVID 19 variant associated disease, particularly against severe disease in adults. Vaccination was well tolerated, with an overall incidence of adverse events observed over a median of 146 days lower than other COVID-19 vaccines.
June 29, 2021 - An adjuvant developed with funding from the National Institutes of Health has contributed to the success of the highly efficacious COVAXIN COVID-19 vaccine, which roughly 25 million people have received to date in India and elsewhere. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, part of NIH, said in a press stateme "t, "I am pleased that a novel vaccine adjuvant developed in the United States with NIAID support is part of an efficacious COVID-19 vaccine available to people in In "ia."
June 25, 2021 - The Philippines Food and Drug Administration granted full emergency use authorization to the Covaxin COVID-19 vaccine developed by India-based Bharat Biotech.
June 9, 2021 - Local media repor'ed 'Bharat Biotech will conduct phase 4 clinical trials for Covaxin to check its real-world effectiveness. And, the company will apply for full licensure after a final analysis of Phase 3 studies.
June 7, 2021 - A non-peer-reviewed study fo'nd 'the whole-virion inactivated SARS-CoV-2 vaccine (BBV152) demonstrates protective response against VOC B.1351 and B.1.61'.2.'
June 5, 202Brazil'sil's National Health Surveillance Agency cleared BhaBiotech'sch's Covaxin vaccine for importation into Brazil.
June 3, 2021 - Local media repor'ed 'the majority of the breakthrough infections following vaccination with Covishield and Covaxin were caused by SARS CoV2 lineage, which found to be the predominant lineage with 23 samples (63.9%) out of which 12 were in fully vaccinated and 11 in partially vaccinated groups. In addition, four samples with 11.1% and 1 sample with 2.8% were assigned the lineages B.1.617.1 and B.1.1.7 respectiv "ly," according to the non-peer-reviewed study.
June 2, 2021 - Mumbai-based Haffkine Biopharma will produce 22.8 crore doses per year of the Covaxin vaccine with Bharat Biotech.
May 27, 2021 - The Tribune report'd, 'The Ministry of Health said trials for a booster dose of Covaxin were underway. Once the need and the duration of booster shots for available Covid vaccines worldwide are known, related protocols on booster doses will also be made availa'le.'
May 24, 2021 - Bharat Biotech launched trials for "he "t" ird" booster dose of Covaxin at the All India Institute of Medical Sciences in Delhi and Patna, reported All India Radio.
May 15, 2021 - ANI reported the Centre plans is to increase production from 1.5 crore vaccine doses to 10 crore doses monthly.
May 12, 2021 - Local media reporIndia'sia'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 fICMR'sMR's Pune-based National Institute of Virology, reported local media.
May 3, 202India'sia's Ministry of Health and Family Welfare confi'med' 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 the 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 the 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 U.K. variant and the Indian (double mutant) variant B.1.617.
April 21, 2021 - BhaBiotech'sch's Phase 3 clinitrial'sal'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 abIndia'sia's Covaxin vaccine?
April 16, 2021 - Local media reported the New Delhi-based Indian government would double the production of the 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 conclud'd, 'While both vaccines elicited immune response, seropositivity rates to anti-spike antibody were significantly higher in Covishield recipient than Covaxin after the first dose. Ongoing COVAT study will further enlighten the immune response between two vaccines after the second d'se.'
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, 202Mexico'sco's health regulator Cofepris has authorized the emergency useIndia'sia's COVID-19 vaccine COVAXIN.
March 19, 202Nepal'sal's Department of Drug Administration issued emergency authorization for the Covaxin COVID-19 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 stored at 2–8°C, compatible with most 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, partnering 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, 202Brazil'sil'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 Hindustan Times reported that the third clinical trial of Covaxin had been completed as all the 25,800 volunteers involved had been administered both doses.
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 BhaBiotech'sch's COVAXIN™, an advanced stage whole-virion inactivated COVID-19 vaccine candidate, for the United States market.
January 23, 2021 - The Lancet published an artic'COVAXIN'sIN's approval in India came before the company had finished recruiting for drug'sug's phase 3 trial. Given that there is no efficacy data for COVAXIN yet, some health work "rs "may not have confidence in COVAXIN, and that is understanda "le," said Vineeta Bal, immunologist and visiting faculty from the Indian Institute of Science Education and Research, Pu" e. "The government needs to put out all data, including for efficacy, for the sake of transparency, and for building the confidence of the peo "le," she sa "d. "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 po" icy", said Jammi Nagaraj Rao, a public health physician and epidemiolog'st.'
January 21, 2021 - The Lancet publishe' a 'report on the interim findings from the phase 1 clinical trial of BBV152; a whole-virion inactivated SARS-CoV-2 vaccine.
January 12, 2021 - Bharat Biotech announced that it had signed an agreement with Precisa Medicamentos for the supplies of COVAXIN™ to Brazil.
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. In addition, post-SARS-CoV-2 infection vaccinated hamsters did not show any histopathological changes in the lungs.
January 3, 202India'sia's Drugs Controller General of India issued a Restricted Emergency approval for the emergency use of a coronavirus vaccine produced by local firm Bharat Biotech.
December 22, 2020 - Pennsylvania-based Ocugen, Inc. and Bharat Biotech announced that the companies had signed a binding letter to co-develop BhaBiotech'sch's COVID-19 vaccine candidate, COVAXIN, the United States 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.
July 15, 2020 - Bharat Biotech announced the Phase-I clinical trialsIndia'sia's first indigenous COVID-19 vaccine, Covaxin, began across the country, enrolling 385 people in 12 hospitals.
June 29, 202India'sia's Covaxin has received permission to initiate Phase I & II Human clinical trials after the company submitted results 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 globally.
Covaxin COVID-19 Vaccine Clinical Trial
Covaxin continues to be tested in various clinical trials.
ClinicalTrials.gov Identifier: NCT04918797 - COVAXIN in a Pediatric Cohort (COVAXIN-Peds) study was last updated on July 2, 2021.
ClinicalTrials.gov Identifier: NCT04641481 - An Efficacy and Safety Clinical Trial of an Investigational COVID-19 Vaccine (BBV152) in Adult Volunteers.
ClinicalTrials.gov Identifier: NCT04471519 - 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.