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Covaxin COVID-19 Vaccine

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May 23, 2022
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Covaxin COVID-19 Vaccine (BBV152) Description - 2022

Bharat Biotech's Covaxin (BBV152) is an inactivated COVID-19 vaccine that uses adjuvant Alhydroxiquim-II to boost immune response and longer-lasting immunity. The Indian Council of Medical Research created the COVAXIN vaccine in 2020 that 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.

In addition, the virus strain is soaked in beta-propiolactone, an organic compound that deactivates them by binding to their genes, says the Company. The SARS-CoV-2 betacoronavirus strain was isolated from an asymptomatic COVID-19 patient at India's National Institute of Virology. According to the U.S. CDC, inactivated vaccines do not replicate and are unlikely to revert and cause pathological effects. The vaccine's adjuvant was developed with funding from the U.S. National Institutes of Health (NIH) and has contributed to the success of the highly efficacious COVAXIN COVID-19 vaccine. The TLR7/8 adjuvant formulation induced significant Th1 biased antibody responses and increased SARS-CoV-2 lymphocyte responses.

On November 11, 2021, the peer-reviewed journal The Lancet published the results from a phase 3 study that reported 'BBV152 was highly efficacious against laboratory-confirmed symptomatic COVID-19 disease in adults. Vaccination was well tolerated with no safety concerns raised in this interim analysis.' And on November 23, 2021, The Lancet published another study that concluded the adjusted effectiveness of two doses administered at least 14 days before testing was 47% (95% CI 29–61). And non-peer-reviewed studies published on December 15, 2021, and January 8, 2022, found the inactivated virus vaccine BBV152 induces robust immune memory to SARS-CoV-2 and variants of concern, which persist for at least six months after vaccination. 

The WHO granted emergency use listing to COVAXIN on November 3, 2021. On January 21, 2022, an India central drug authority expert panel cleared Covaxin for 'full use'. As of April 13, 2022, about 350 million Covaxin doses had been distributed worldwide.

The WHO Strategic Advisory Group of Experts on Immunization (SAGE) issued updated interim policy recommendations for using the Bharat Biotech BBV152 COVAXIN vaccine on March 16, 2022. Vaccination is recommended for people living with conditions that have been identified as increasing the risk of severe COVID-19, including cardiovascular disease, respiratory disease, diabetes, liver disease, and obesity. The SAGE recommends using the BBV152 vaccine in two doses (0.5 ml) given intramuscularly, administered at an interval of 4 weeks. And SAGE recommends that severe and moderately immunocompromised persons be offered an additional dose of vaccine.

And the WHO reported that the vaccine efficacy against COVID-19 of any severity, 14 or more days post-dose 2, and against severe disease is 93%. In adults aged less than 60 years, efficacy was 79%; and in those aged 60 years and over, it was 68%. The WHO confirmed the suspension of the supply of Covaxin produced by Bharat on April 2, 2022. This suspension is in response to the outcomes of the WHO post EUL inspection (14 – 22 March 2022). Bharat Biotech has committed to addressing the GMP deficiencies and is developing a corrective and preventive action plan for submission to the Drugs Controller General of India (DCGI) and WHO. In the interim and as a precautionary measure, the Company has indicated that it will suspend production of Covaxin for export. The risk assessment does not indicate a change in the risk-benefit ratio, and data indicates that Covaxin is effective and no safety concern exists.

The U.S. Food and Drug Administration (FDA) lifted its clinical hold on the Company's Investigational New Drug application (IND) to evaluate COVAXIN on February 18, 2022. On April 12, 2020, the FDA issued a second clinical hold. Soumya Swaminathan, Chief Scientist at the WHO, assured that the freeze on the Covaxin vaccine supply does not involve the safety or efficacy of the vaccine as of April 21, 2022. On May 23, 2022, the FDA removed its clinical hold.

As of May 2022, Covaxin (BBV152) had been licensed for use in 25 countries globally, including Mexico. And 187.95 cr vaccine doses have been administered in India under Nationwide Vaccination Drive. Covaxin (BBV152) Accession Number: DB15847; UNII: 76JZE5DSN6 Covaxin clinical trials are listed

Hyderabad-based Bharat Biotech creates innovative vaccines and bio-therapeutics trusted by physicians worldwide. Chiron Behring Vaccines became a subsidiary in 2019. The indigenous, inactivated COVID-19 vaccine is manufactured in Bharat Biotech's Bio-Safety Level 3 high containment facility.

Covaxin COVID-19 Vaccine Effectiveness Against SARS-CoV-2 Variants (Omicron, BA.2 Sublineages)

A non-peer-reviewed study, co-fund by Ocugen, published on January 28, 2022, found that 100% of boosted subjects showed neutralizing activity against the Delta variant while over 90% showed neutralizing activity against the Omicron variant. The Omicron variant has more than 30 mutations within the spike protein that could impact vaccine-mediated immunity. 

Ocugen, Inc. and Bharat Biotech announced on January 12, 2022, results from a phase 1/2 clinical study conducted at Emory University in Georga demonstrating that sera from subjects who received a booster dose of candidate vaccine COVAXIN six months after getting a primary two-dose series of COVAXIN neutralized the SARS-CoV-2 Omicron and Delta variants. Earlier studies demonstrated the neutralizing potential of COVAXIN™ (BBV152) against SARS-CoV-2 Variants of Concern Alpha, Beta, Delta, Zeta, and Kappa.

A recent study published on January 8, 2022, found that Covaxin strongly protected New Delhi healthcare workers against reinfection with the virus in the first half of 2021, including a period during the height of the Delta variant surge. Among those fully vaccinated, the vaccine's estimated effectiveness against reinfection was 86% (95% CI: 77% – 92%). The analysis showed that six months after a two-dose BBV152 vaccination series, cell-mediated immunity and neutralizing antibodies to both homologous (D614G) and heterologous strains (Alpha, Beta, Delta, and Delta plus) persisted above baseline, although the magnitude of the responses had declined. Furthermore, Neutralising antibodies against homologous and heterologous SARS-CoV-2 variants increased 19 to 265-fold after a third vaccination.

Previously, Covaxin was proven to neutralize the variants - B.1.1.7 (Alpha), P.1- B.1.1.28 (Gamma) & P.2 - B.1.1.28 (Zeta), B.1.617 (Kappa) first, B.1.351 & B.1.617.2 (Beta & Delta). And efficacy data demonstrates 65.2% protection against the SARS-CoV-2, B.1.617.2 Delta variant.

As of May 12, 2022, the U.S. NIH's OpenData Portal reported in vitro Therapeutic Activity against the Omicron variant. But, given the breaking nature of these releases, Omicron data should be interpreted with caution. The U.S. CDC publishes updated virus variant information in this Tracker App. And the WHO publishes Tracking SARS-CoV-2 Variants on this webpage.

The Coalition for Epidemic Preparedness Innovations (CEPI) announced on May 10, 2022, it would provide funding of up to US$19.3 million to support the development of a ‘variant-proof’ SARS-CoV-2 vaccine candidate to an international multidisciplinary consortium comprising Bharat Biotech International Ltd., the University of Sydney, and ExcellGene SA, Switzerland.

Covaxin COVID-19 Vaccine Availability in 2022

Covaxin was granted Emergency Use Listing by the WHO on November 3, 2021. Over 25 countries have authorized Covaxin, such as MalaysiaMauritiusMexico, and others listed on this webpage. And as many as 110 countries have agreed to mutual recognition of Covaxin vaccination certificates. On April 10, 2022, the Company confirmed Japan would also recognize travelers with 2-doses of the Covaxin vaccine. 

On April 2, 2022, the WHO confirmed the suspension of the supply of Covaxin produced by Bharat through UN procurement agencies and recommended that countries that received the vaccine take action as appropriate. This suspension is in response to the outcomes of the WHO post EUL inspection (14 – 22 March 2022) and the need to conduct process and facility upgrades to address recently identified GMP deficiencies.

Covaxin COVID-19 Vaccine Booster Dose

The companies announced results from a study conducted at Emory University on January 12, 2022, demonstrating that sera from people who received a booster dose of candidate vaccine COVAXIN six months after getting a primary two-dose series neutralized SARS-CoV-2 coronavirus variants. A previous, non-peer-reviewed study published on January 8, 2022, found participants receiving a booster dose six months after the second dose of COVAXIN™ saw a significant increase (>10-fold across Alpha, Beta, Delta, and Delta Plus variants) in neutralizing titers compared to baseline at six months.

A non-peer-reviewed research paper announced on March 9, 2022, that despite a weakening in antibody response after six months, those in the heterologous study group who were given one dose of Covishield and a second dose of Covaxin six weeks apart showed a better immune response than people who were given either Covishield or Covaxin as both doses.

The WHO confirmed its support for 3rd-dose booster vaccinations for certain people on March 16, 2022.

Covaxin COVID-19 Vaccine (BBV154) Nasal Vaccine

The experimental BBV154 intranasal vaccine stimulates a broad immune response – neutralizing IgG, mucosal IgA, and T cell responses. Immune responses at the site of infection (in the nasal mucosa) – are essential for blocking both infection and transmission of COVID-19. BBV154 was developed by Bharat Biotech, Precision Virologics, and the Washington University School of Medicine. Bharat Biotech's BBV154 vaccine completed the phase 1 study, phase 2, and launched a phase 3 clinical trial at nine sites in India. India's Department of Biotechnology and its PSU, Biotechnology Industry Research Assistance Council, supported BBV154's development. On December 20, 2021, the Company requested authorization to use the nasal vaccine as a booster dose.

Covaxin COVID-19 Vaccine 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. 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-Biotech'svel 3 High-Containment facility in Genome Valley, Hyderabad, India.

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.' In addition,' GAVI confirmed Covaxin's effectiveness against COVID-19 infections in phase 3 clinical trial on July 6, 2021. On January 3, 2021, the Central Drugs Standard Control Organisation in India recommended emergency use permission.

On March 4, 2022, Ocugen, Inc. announced that the FDA, at this time, has declined to issue a EUA for COVAXIN for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 2 to 18 years of age. Ocugen and BharatBiotech announced on Twitter that they intend to continue working with the FDA and Canada to evaluate the regulatory pathway for the pediatric use of COVAXIN.

Covaxin COVID-19 Vaccine Indication

Covaxin is indicated for certain people for protection against SARS-CoV-2 coronavirus infection risk and severe COVID-19 prevention. A peer-reviewed study published on February 11, 2022, found 'precaution needs to be taken while vaccinating individuals having allergies, comorbidities, acute infection in the last three months and individuals on chronic medications.'

The WHO reported on March 16, 2022, that the SAGE has thoroughly assessed the data on the safety and efficacy of the vaccine and has recommended its use for people aged 18 and above.

Covaxin COVID-19 Vaccine While Pregnant or Breastfeeding

As of March 16, 2022, the WHO recommends using BBV152 in pregnant women when the benefits of vaccination outweigh the potential risks. The WHO does not recommend pregnancy testing before vaccination. And data are not available on the potential benefits or possible risks of the BBV152 vaccine to breastfed children. However, as the BBV152 vaccine is not a live virus vaccine, it is biologically unlikely to pose a risk to the breastfeeding child.

Covaxin COVID-19 Vaccine For Children and Adolescents 

As of April 12, 2022, in Madurai, India, around 87% of children aged 17 had taken one dose, with no side effects reported. On March 16, 2022, the WHO stated that the safety and immunogenicity data for under-18s are currently being generated, but until such data are available, vaccination of individuals in this age group is not recommended.

On December 25, 2021, Covaxin was approved for 12 and 18-year-olds by the Drugs Controller General of India. At the request of the U.S. FDA, Ocugen shared real-world safety data from 36 million teenagers who had been vaccinated with COVAXIN. Additionally, data (in-vitro) suggesting robust neutralization against Delta and Omicron variants were submitted to bolster the Company's pediatric EUA submission.

A Phase 2/3, open-label, multicenter study was conducted in India from May 2021 to July 2021 to evaluate COVAXIN - BBV152 in healthy volunteers 2-18 years of age. All participants received two doses of the whole virion inactivated SARS-CoV-2 virus vaccine 28 days apart. In Bharat Biotech's efficacy and safety trial, the neutralizing antibody responses against wild-type strain in the pediatric age group of 2-18 years were equivalent to those seen in adults ages 18+ years of age. More than 90% of the seroconversion rates were observed for antibody titers against S1, RBD, N proteins, and wild-type neutralizing antibodies.

Covaxin COVID-19 Vaccine For People With HIV

There are not enough data at present (Mar. 16, 2022) to allow an assessment of the efficacy or safety of this vaccine for people living with HIV. In the interim, however, given that the vaccine is nonreplicating, people living with HIV that is stable may be vaccinated with the standard primary series of 2 doses.

Covaxin COVID-19 Vaccine Side Effects and Risks

A phase 2, double-blind, randomized controlled COVAXIN trial demonstrated long-term safety with no serious adverse events as of January 8, 2022. 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% feeling 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 treated with cyclosporine.

Covaxin - Ocugen Agreement 2021 - 2022

Ocugen, Inc., a Pennsylvania-based biopharmaceutical company, and India-based Bharat Biotech announced on February 2, 2021, that they entered into a definitive agreement to co-develop, supply, and commercialize COVAXIN in the U.S. On June 3, 2021, the companies amended their Co-development agreement to expand Ocugen's territory to commercialize COVAXIN in Canada. The Company announced the completion of its regulatory submission to Health Canada for COVAXIN, which was conducted through Vaccigen, Ltd. On April 18, 2022, the companies amended their agreement empowering Ocugen with full commercial rights to North America, including Mexico.

The Company confirmed on May 6, 2022, that it is actively engaged in discussions with the U.S. FDA to address its questions and resume the Company’s Phase 2/3 immuno-bridging and broadening clinical trial for COVAXIN™, OCU-002. In addition, the Company intends to continue working with the FDA to finalize the additional studies required for a Biologics License Application. On October 27, 2021, Ocugen submitted an Investigational New Drug application with the FDA. And on November 5, 2021, Ocugen applied for pediatric use in the U.S. On November 26, 2021, Ocugen announced that the FDA issued a clinical hold on the Company's IND. This Hold was removed on February 18, 2022. However, on April 12, 2022, the Company announced that it was informed by the FDA that the agency placed its Phase 2/3 immuno-bridging and broadening study OCU-002 on clinical hold. This is a result of the Company’s decision to voluntarily implement a temporary pause in dosing participants of OCU-002 while it evaluates statements made by the WHO on April 4, 2022.

Ocugen Inc. Financial News 2022

On May 6, 2022, Ocugen’s cash, cash equivalents, and restricted cash totaled $129.9 million as of March 31, 2022, compared to $95.1 million as of December 31, 2021. Ocugen, Inc. (Nasdaq: OCGN) announced on Feb. 23, 2022, the pricing of its underwritten public offering of approximately 15,973,420 million shares of its common stock for gross proceeds of approximately $53.5 million before deducting the underwriting discounts and commissions and other estimated offering expenses payable by Ocugen.

Covaxin COVID-19 Vaccine Price

The Mint reported on January 26, 2022, that the price of the Covaxin vaccine is likely to be capped at ₹275 per dose plus an additional service charge of ₹150. On April 9, 2022, @BharatBiotech announced Covaxin would be available for Rs 225 per dose.

Covaxin COVID-19 Vaccine (BBV152) News For 2021 - 2022

May 23, 2022 - Ocugen, Inc. announced that the U.S. FDA lifted the clinical hold on the Company’s Phase 2/3 clinical trial, OCU-002, for COVAXIN™ (BBV152).

April 26, 2022 - India health minister Mansukh Mandaviya tweeted - Bharat Biotech's Covaxin has been granted emergency use permission for the six-12 age group,

April 18, 2022 - Ocugen gained commercialization rights for COVAXIN in all of North America.

April 12, 2022 - Ocugen, Inc., a U.S.-based biotechnology company, announced it was informed the U.S. FDA had placed a Clinical Hold on its Phase 2/3 clinical study in the U.S.  

April 10, 2022 - The media confirmed Bharat Biotech’s Covaxin would be available for Rs 225 per dose in India.

April 8, 2022Hester Biosciences confirmed a grant of Rs 60 crores from India's Biotechnology Industry Research Assistance Council to manufacture the Covaxin Covid vaccine under Mission Covid Suraksha.

April 4, 2022 - Local media reported Bharat Biotech said it is working on improvements and upgrades to ensure that the production of Covaxin continues to meet ever-increasing global regulatory requirements.

April 2, 2022 - The WHO announced vaccine supply disruption following a manufacturing facility inspection. This suspension is in response to the outcomes of the WHO post EUL inspection (14 – 22 March 2022) and the need to conduct process and facility upgrades to address recently identified GMP deficiencies.

March 7, 2022 - Bharat Biotech Tweeted 'it is committed to bringing Covaxin to Canada and the U.S.'

March 4, 2022 - The U.S. FDA declined to issue a EUA for COVAXIN for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 2 to 18 years of age.

February 18, 2022 - Ocugen, Inc. announced that the U.S. FDA had lifted its clinical hold on the Investigational New Drug application on BBV152.

February 15, 2022 - A survey conducted online by The Harris Poll on February 3-7, 2022, shows that 73% of Americans would like to see additional vaccine options developed from more traditional methods.

February 10, 2022 - Local media reported Malaysia's Health director-general Dr. Noor Hisham Abdullah confirmed the Drug Control Authority authorized the Covaxin vaccine for use.

January 31, 2022 - Local media reported: "The list of vaccines recognized for entry use in Denmark was expanded to include Covaxin.

January 27, 2022 - Media in New Delphi reported Covaxin was cleared by the Drugs Controller General of India (Dr. V. G. Somani) for sale in the market.

January 13, 2022 - Local media reported Bharat Biotech announced that Coavaxin is now a universal vaccine for adults and children.

January 12, 2022 - Ocugen, Inc. and Bharat Biotech issued a press release stating a booster (3rd) dose of COVAXIN generated robust neutralizing antibody responses against both Omicron (B.1.529) and Delta (B.1.617.2) using a live virus neutralization assay; and 100% of test serum samples in the phase 1/2 study showed neutralization of the Delta variant and more than 90% of serum samples showed neutralization of the Omicron variant.

January 3, 2022 - The Times of India reported that a study led by AIG Hospitals determined mixing Covishield and Covaxin vaccines showed that mixing vaccines is safe, and the spike protected neutralizing antibodies in the mixed vaccine groups were found to be significantly higher than the same-vaccine groups.

December 30, 2021 - Ocugen, Inc. announced Bharat Biotech posted results on (Dec. 29) from a Phase 2/3 trial conducted in India of COVAXIN in children aged 2 – 18 years, demonstrating a robust neutralizing antibody response and favorable safety profile.

December 25, 2021 - Local media reported the Covaxin was approved for emergency use on adolescents 12 and 18 by the Drugs Controller General of India.

December 20, 2021 - The Company announced India's India'snCentraIndia'sd Control Organisation had approved the extension of Covaxin'Covaxin'sashelCovaxin'sonths from the date of manufacture.

December 17, 2021 - Bharat Biotech and its local partner Dunc Minh have donated 200,000 doses of Covaxin to the Republic of Vietnam.

December 15, 2021 - Ocugen, Inc. announced that data analyzing immune response following two doses of COVAXIN™ (BBV152), compared the immune memory response of 71 vaccinated and 73 naturally infected subjects with SARS-CoV-2, including variants of concern, for up to six months. The study found that COVAXIN generated a robust immune memory against spike and nucleoprotein comparable to that following natural COVID-19 infection for the levels of antibodies, memory B cells, and memory CD4+ T cells. In the analysis, COVAXIN generated T-cells against spike and nucleocapsid proteins in nearly 85% of subjects that persisted for at least six months.

December 14, 2021 - Local media reported the Rajya Sabha was informed about 50-60 million doses of the Covaxin vaccine are being produced.

December 9, 2021 - Media sources reported the WHO's StWHO'siStrategiWHO'sisoryf Experts on Immunisation said people who are immune-compromised (such as those on dialysis or immuno-suppressants) or have received an inactivated Covid-19 vaccine, such as Covaxin, should receive boosters to protect them against waning antibodies.

December 3, 2021 - India's India'snCentraIndia'sd Organisation approved the shelf life of COVID-19 vaccines Covaxin to 12 months.

November 23, 2021 - This study published by The Lancet is, to our knowledge, the first real-world observational study assessing vaccine effectiveness of BBV152. We found vaccine effectiveness of 50% (95% CI 33–62) for complete vaccination at least 14 days before testing, against symptomatic laboratory-confirmed COVID-19. 

November 22, 2021 - The U.K. added the Covaxin vaccine to its travel approval list, requiring at least 14 days of immunization before arriving in England.

November 19, 2021 - The Government of Canada announced adjustments to recognize the Covaxin vaccine within acceptable border measures. Travelers should check if they are eligible to enter Canada and meet all entry requirements before heading to the border. 

November 18, 2021 - According to a Twitter post by ANI, 110 countries agreed to mutual acceptance of vaccination certificates with Covaxin.

November 16, 2021 - New Zealand health leader Tweeted the Covaxin vaccine would be acceptable for border entry requirements.

November 11, 2021 - The Lancet published a study: Efficacy, safety, and lot-to-lot immunogenicity of an inactivated SARS-CoV-2 vaccine (BBV152): interim results of a randomized, double-blind, controlled, phase 3 trial. Findings: 24 (0·3%) cases occurred among 8471 vaccine recipients and 106 (1·2%) among 8502 placebo recipients, giving an overall estimated vaccine efficacy of 77·8% (95% CI 65·2–86·4).

November 5, 2021 - Ocugen, Inc. announced that it has submitted a request to the U.S. FDA for EUA of Ocugen'sOcugen'suCOVIDOcugen'sinete BBV152, known as COVAXIN outside of the U.S., for pediatric use.

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 vaccine 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 infected.

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.

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.

June 2, 2021 - Mumbai-based Haffkine Biopharma will produce 22.8 crore doses per year of the Covaxin vaccine with Bharat Biotech.

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.

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 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 2, 2021 - Ocugen, Inc. and Bharat Biotech announced they have entered into a definitive agreement to codevelop, supply, and commercialize BhaBioteBhaBiotech'schBhaBiotech'sch'sadvancedhole-virion inactivated COVID-19 vaccine candidate, for the United States market.

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.

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 trialsIntrialsIndia'sitrialsIndia'sia'sous9 vaccine, Covaxin, began across the country, enrolling 385 people in 12 hospitals.

June 29, 2020 - India's India'snCovaxiIndia'seceivedion 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.

Clinical Trials: NCT05049187 - Observational study to determine the characterization and durability of COVID-19 Vaccine-induced immunity responses in Healthcare/Frontline Workers

Clinical Trial: NCT04918797 - Phase 2/3 COVAXIN in a Pediatric Cohort (COVAXIN-Peds) study was last updated on July 2, 2021.

Clinical Trial: NCT04641481 - An Efficacy and Safety Clinical Trial of an Investigational COVID-19 Vaccine (BBV152) in Adult Volunteers.

Clinical Trial: NCT04471519 - Whole-Virion Inactivated SARS-CoV-2 Vaccine (BBV152) for COVID-19 in Healthy Volunteers (BBV152). A total sample size of 755 healthy volunteers, with 375 and 380 volunteers in phase 1 and 2 studies, respectively.