Bharat Biotech claims that Covaxin produced excellent safety data

“The evaluation of covacin resulted in several unique product properties, including long-lasting immune responses to multiple viral proteins, not just spike proteins, and showed extensive neutralizing capacity in heterologous SARS-CoV2 strains, thus escaping. Eliminate mutants. ”

“In the criticism of the Indian Drug Controller General (DCGI) for granting approval for the emergency use of the Covid-19 vaccine Covaxin, its manufacturer Bharat Biotech has given a strong immune response to multiple viral proteins that the vaccine sustains. He claimed to have generated excellent safety data in preparation.

“It has also been shown to generate memory T cell responses to multiple epitopes, demonstrating longevity and rapid antibody response to future infections, the most important characteristic of which is the proven safety profile. Yes, it is significantly lower than some other vaccines with published data. “It added.

DCGI participated in anti-air warfare from various quarters to approve covaxin, even before the Phase 3 trials were completed. Critics wondered how regulators could approve the vaccine in the absence of Phase 3 data.

DCGI approval for Covaxin took place the day after the recommendation by the Subject Expert Committee of the Central Drugs Standard Control Organization (CDSCO).

Bharat Biotech said it submitted all data to DCGI and CDSCO in accordance with regulatory guidelines.

Based on data from product development and clinical trials to date, five publications have been produced and submitted to international peer-reviewed journals. Four of them have been approved and will be published shortly. The company said the release of Phase 2 study data is undergoing a peer review process.

DCGI said Bharat Biotech generated safety and immunogenicity data for a variety of animal species. “All of this data is shared by CDSCO and the company. Phase 1 and Phase 2 clinical trials were conducted in approximately 800 subjects, and the results show that the vaccine provides a safe and strong immune response. Phase 3 efficacy trials have begun. In India, 25,800 volunteers have participated and 22,500 participants have been vaccinated nationwide so far. According to the data available at, the vaccine is known to be safe, “said the regulator.

“The Subject Expert Committee (SEC) reviews data on vaccine safety and immunogenicity and limits it in emergencies for the public good as a wealth of precautions to increase vaccination options in clinical trial mode. We recommended that you give permission to use the vaccine, especially in the case of infection with a mutant strain. The company will continue its ongoing clinical trials in Japan. ”

The Indian-specific Covid vaccine by Bharat Biotech was developed in collaboration with the Indian Medical Research Council (ICMR) -National Institute of Virology (NIV).

This is an inactivated intramuscular vaccine that works by injecting an inactivated version of Sars-Cov-2, the virus that causes Covid-19, into the body to provoke an immune response.

According to the vaccine manufacturer, covaxin has been evaluated in approximately 1000 subjects in Phase 1 and Phase 2 clinical trials and is expected to have safety and immunogenicity results in an international peer-reviewed scientific journal. It has been accepted.

The Phase 3 human clinical trial of Kovacin will begin in mid-November and is targeted to be conducted by 26,000 volunteers across India. This is India’s first and only Phase 3 efficacy study for the Covid-19 vaccine and the largest Phase 3 efficacy study ever conducted for any vaccine in India.

This unique inactivated vaccine is being developed and manufactured at Barrat Biotech’s BSL-3 (Biosafety Level 3) biocontainment facility, which is unique in the world, according to Barrat Biotech’s Chairman and Managing Director. Dr. Krishnaela said.

It was June when Bharat Biotech announced the successful development of covacin in collaboration with ICMR and NIV.

The SARS-CoV-2 strain was isolated on NIV in Pune and transferred to Bharat Biotech.

Phase 1 trials began in July and Phase 2 trials began in September.

Sai Prasad, executive director of Bharat Biotech, told IANS in November that covacin was found to be safe in the first two stages of the trial without serious adverse events.

“We follow well-designed vaccine development protocols and ensure that each stage of vaccine development is facilitated with the sole goal of achieving a strong immune response rate in clinical trials. When designing trials Takes into account attacks. When asked about the rate, type of disease, ability to detect disease, and recruitment timeline, and how it compares to vaccines being developed by several companies around the world. , Officials said.

The company has already built a capacity to produce 200 million doses of vaccine and plans to increase it to 500 million doses.

We have invested approximately Rs. 35-40 billion in vaccine development and new manufacturing facilities, including investment in conducting Phase 3 trials.

Source: IANS

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