1. 100% of test serum samples showed neutralization of the Delta variant and more than 90% of serum samples showed neutralization of the Omicron variant

2. . These data add to the body of evidence that the broad-spectrum mechanism of action of a whole virus inactivated COVID-19 vaccine, like COVAXIN® (BBV152), is a viable option in this continuously evolving pandemic.

Hyderabad: Bharat Biotech, a global leader in vaccine innovation and developer of vaccines for infectious diseases, has announced results from a study conducted at Emory University demonstrating that sera from subjects who received a booster dose of COVAXIN® (BBV152) six months after getting a primary two-dose series of COVAXIN® (BBV152), 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.

Sera samples from individuals who received a booster of COVAXIN® (BBV152) were observed to be effective in neutralizing Omicron and Delta variants on a live virus neutralization assay. The neutralization activity of COVAXIN®-boosted sera was comparable to what has been observed in mRNA vaccine-boosted sera against the Omicron variant. More than 90% of all individuals boosted with COVAXIN® (BBV152) showed neutralizing antibodies. All participants received an initial two-dose schedule of COVAXIN® (BBV152) at Day 0 and Day 28.

“As the dominant COVID-19 variant throughout the world, Omicron poses a serious public health concern,” said Mehul Suthar, Ph.D., Assistant Professor, Emory Vaccine Center and who led the laboratory analysis. “Data from this preliminary analysis show individuals receiving a booster dose of COVAXIN® have a significant immune response to both the Omicron and Delta variants. These findings suggest that a booster dose has the potential to reduce disease severity and hospitalizations.”

Dr. Krishna Ella, Chairman and Managing Director of Bharat Biotech said, “We are in a continuous state of innovation and product development for COVAXIN®. The positive neutralization responses against the Omicron and Delta variants, validates our hypothesis of a multi-epitope vaccine generating both humoral and cell mediated immune responses. Our goals of developing a global vaccine against COVID-19 have been achieved with the use of COVAXIN® as a universal vaccine for adults and children.”

“The global impact of Omicron shows us that the fight against COVID-19 continues, and we’re encouraged that these data demonstrate the value of COVAXIN® as a primary and booster vaccine,” said Dr. Shankar Musunuri, Chairman, CEO and Co-Founder, Ocugen, Inc. “These results show how a broad-spectrum vaccine has the potential ability to address ever-shifting public health challenges such as new variants and mutations.”

COVAXIN® is formulated uniquely such that the same dosage can be administered to adults and children alike. COVAXIN® is a ready-to-use, liquid vaccine, stored at 2 – 8°C, with 12 months shelf life and multi-dose vial policy. The same doses of vaccine can also be used for two-dose primary immunization in adults and children and for booster dose vaccinations, making it truly a universal vaccine.

 About the study:

In order to evaluate the effectiveness of COVAXIN® (BBV152) against the Omicron variant, Ocugen contracted with the Emory Vaccine Center (Atlanta, GA) to test human immune sera obtained from participants (n=13) in an ongoing Phase 2 clinical trial (ClinicalTrials.gov: NCT04471519). Sera was collected 28-days post booster – six months following the primary two-dose series. Each sera was tested in a neutralization assay. Following three doses, the FRNT50 geometric mean titers (GMTs) of neutralizing antibodies against the Omicron variant measured in the samples was 75, compared to 480 against the Delta variant and 706 against the vaccine strain, D614G. This study was sponsored by Ocugen, Inc. and Ocugen’s partner, Bharat Biotech, provided the sera of the subjects from the Phase 2 study.

About COVAXIN® (BBV152):

Covaxin was developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV). COVAXIN® (BBV152) is a highly purified and inactivated vaccine that is manufactured using a vero cell manufacturing platform. With more than 200 million doses having been administered to adults and children outside the U.S., COVAXIN® (BBV152) is currently authorized under emergency use in more than 20 countries, and emergency use authorization is in process in more than 60 other countries. The World Health Organization (WHO) recently added COVAXIN® (BBV152) to its list of vaccines authorized for emergency use. And, as many as 110 countries have agreed to mutual recognition of COVID-19 vaccination certificates with India that includes vaccination using COVAXIN® (BBV152).

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 6 months after receipt of the second COVAXIN^® dose:

• Durable neutralising, T and B cell responses detected, which suggests good immune memory responses and long-term protection from severe disease.
• 90% of recipients had a detectable neutralising antibody response against the wild – type strain (6 months after the second dose).

6 months after receipt of the second COVAXIN^® dose, participants received a third booster dose of COVAXIN^®:

• Neutralisation titers against wild – type and Delta variants were 5 times higher than after a two-dose schedule.
• Similar increases in neutralising antibodies against Alpha, Beta, Delta plus were observed.
• The booster dose led to a pronounced increase in CD4+ T- and CD8+ Tcell response.  This may allow COVAXIN^® to confer long term protective efficacy against severe SARS-CoV-2.
• The frequency of adverse events was lower than vaccines from other manufacturing platforms.

Hyderabad, India, 08 January 2022: Bharat Biotech, a global leader in vaccine innovation and developer of vaccines for infectious diseases, today announced the results from the highly anticipated trial studying the immunogenicity and safety of the COVAXIN^® (BBV152) a whole-virion inactivated COVID-19 vaccine as a booster dose.

This analysis re-emphasises Bharat Biotech’s continued efforts to stay ahead of COVID-19,  and this update provides a comprehensive vaccine booster strategy. COVAXIN^® is the first vaccine (in India) to report safety and immunogenicity results from a booster clinical trial. The analysis showed, six months after a two-dose BBV152 vaccination series cell-mediated immunity and neutralising 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. Booster BBV152 vaccination is safe and may be necessary to ensure persistent immunity to prevent breakthrough infections.

Dr. Krishna Ella, Chairman and Managing Director of Bharat Biotech, said, “These trial results provide a strong foundation towards our goal to provide COVAXIN^® as a booster dose. Our goals of developing a global vaccine against COVID-19 have been achieved. COVAXIN^® is now indicated for adults, children, 2 dose primary and booster doses. This enables the use of COVAXIN^® as an universal vaccine.”

We found the vaccine induces both memory B and T cells with a distinct  CD4  and CD8 phenotype. Further, reactogenicity after vaccine and placebo was minimal and comparable, and no serious adverse events were reported. While protection against the severe disease remains high across the full 6 months, a decline in efficacy against symptomatic disease over time and the continued emergence of variants are expected. Based on emerging data, Bharat Biotech believes that a third dose may be beneficial to maintain the highest levels of protection.

COVAXIN^® is formulated uniquely such that the same dosage can be administered to adults and children alike. COVAXIN^® is ready-to-use a  liquid vaccine, stored at 2- 8°C, with 12 months shelf life and multi-dose vial policy. The same vaccine can also be used for 2 dose primary immunization  and for booster dose vaccinations, making it truly an universal vaccine.

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Hyderabad, November 04,2021: Bharat Biotech, a global leader in vaccine development and innovation, today announced that COVAXIN®, India’s first indigenous Covid-19 vaccine, has been granted Emergency Use Listing by the World Health Organization (WHO). This vaccine is a whole virion-inactivated vaccine against SARS-CoV2, developed in partnership with ICMR and NIV, Pune.

The emergency use listing (EUL) procedure assesses the suitability of novel health products during public health emergencies, with the objective of providing rapid access to medicines, vaccines and diagnostics, while adhering to stringent criteria of safety, efficacy and quality.

With validation fromthe WHO, countries can now expedite their regulatory approval processes to import and administer COVAXIN®. Furthermore, UNICEF, Pan-American Health Organization (PAHO), GAVI COVAX facility, will be able to procure COVAXIN® for distribution to countries worldwide. This will enable them to secure the critical supply needed to meet the requirements of priority populations, thereby ensuring equitable access.

Dr. Krishna Ella, Chairman and Managing Director, Bharat Biotech, said,“Validation by WHO is a very significant step towards ensuring global access to India’s widely administered, safe, and efficacious COVAXIN®. As an organization, we have focused on maintaining stringent quality and safety standards that meet rigorous assessment, and scientific standards established by WHO, as a result, many of our vaccines have received WHO prequalification. The EUL authorisation for COVAXIN® will enable us to contribute to accelerating the equitable access of Covid-19 vaccine, and the access to our vaccine globally thereby addressing the current public health emergency.”

The phase 3 trial data for COVAXIN® was available during June 2021. The World Health Organisation (WHO) Emergency Use Listing (EUL) process commenced on July 6, 2021, with rolling data submission. The Strategic Advisory Group of Experts on Immunization (SAGE) of WHO had reviewed COVAXIN® data on October 5 in a meeting and granted EUL for COVAXIN® today (November 3, 2021). COVAXIN® has been specifically designed to meet the needs of global distribution chains, the requirements for which are more critical in low- and middle-income countries. It has been formulated to enable shipping and long-term storage at 2-8ºC. It is also formulated to adhere to a multi-dose vial policy, thereby reducing open vial wastage, saving money to procurement agencies and governments alike.

Mrs. Suchitra Ella, Joint Managing Director, Bharat Biotech, said, “The WHO nod for COVAXIN® is a validation of the tremendous effort made by everyone at Bharat Biotech and our partners. It is also an opportunity for us to create meaningful impact at a global level. Such an impact can only be orchestrated when multiple stakeholders come together to work towards a common goal. COVAXIN®is a great example of a successful public-private partnership in developing a world-class COVID-19 vaccine.  We look forward to playing a larger role to help the efforts by both the developed and developing nations to control the pandemic.”

COVAXIN® has been evaluated through neutralizing antibody responses against several variants of concern, namely B.1.617.2 (Delta), B.1.617.1 (Kappa), B.1.1.7 (Alpha), B.1.351 (Beta), P2- B.1.1.28 (Gamma). The data from these studies and others have been extensively published in more than 12peer-reviewed journals and available for review in the public domain.

Manufacturing capacity expansion was started during Q1 2021, as the first phase 3 efficacy readouts were available. Within a short period of ~9 months, the capacity was scaled up to 50-55 million doses per month, as of October 2021. Bharat Biotech has established COVAXIN® manufacturing to reach an annualized capacity of 1 billion doses by the end of 2021. Technology transfer activities are also in progress to companies in India, the United States, and other countries.

More about COVAXIN^® – https://www.bharatbiotech.com/covaxin.html

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Bengaluru, Dec 02 : Karnataka Chief Minister BS Yediyurappa virtually inaugurated phase-3 clinical trials of ‘Covaxin’ (COVID-19 vaccine), which is being developed by Bharat Biotech in collaboration with Indian Council of Medical Research (ICMR).

The trials are conducted at Vydehi Institute of Medical Sciences and Research Centre in Bengaluru. Clintrac International Pvt Ltd and Vydehi Hospital have partnered to initiate the third phase of the trial, and the vaccine will be given to the volunteers in two doses, the first on Wednesday. The second dose will be administered on December 30, officials said.

‘Covaxin’ is India’s indigenous COVID-19 vaccine and has been approved for phase-3 clinical trials on 26,000 participants in over 25 centres across India. The hospital has roped in Clintrac International Ltd for the trials, which will involve about 1,000 volunteers. 

Earlier, Vydehi Institute of Medical Sciences and Research Centre official K. Ravi Babu told “The ICMR (Indian Council of Medical Research) has permitted our hospital to conduct the third phase trial for Covaxin developed by the Hyderabad-based Bharat Biotech. Though the volunteers need not stay in the hospital,  they would be monitored daily through phone/video call for feedback and updates.

Karnataka is fully prepared for the distribution of Covid-19 vaccine

Karnataka Health Minister Sudhakar K said, “It’s a happy day for Karnataka as ICMR gave permission to Vydehi institution. I think they are doing clinical trial on about 1600-1800 people in Karnataka. Chief Minister has officially announced and given first dose today through Vydehi institution. I hope 3rd phase will be very successful and will be devoid of adverse effects on any individual and Karnataka is fully prepared for the distribution of Covid-19 vaccine”.

People should be wary of rumours and misinformation during this trial period, there may be side effects of vaccination and experts will be observing it carefully and there was no need for panic at this stage, Sudhakar said. Pointing out that the Narendra Modi government at the centre has reserved Rs 900 crore for vaccine research, he said the Yediyurappa government in Karnataka has released Rs 300 crore for providing COVID treatment free of cost.

The minister said 1.25 lakh tests are conducted per day in the state and 1.2 crore free Covid tests have been conducted so far. Karnataka was fully prepared for vaccine distribution and 29,451 vaccine distribution centres have been identified with 10,008 trained staff ready for the task on hand, he noted. He also pointed out that 2,855 cold storage centres were available for storage of vaccines.

Regional centres are being set up in Bengaluru, Shivamogga and Ballari, he said, adding that Healthcare workers will be given vaccination in the first phase followed by frontline warriors, people aged above 50 and those with comorbidities.

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