Bharat Biotech claims its Covid-19 vaccine generated excellent safety data, gets permission for sale

DCGI came under flak from various quarters for approving Covaxin even before the completion of Phase 3 trials. Bharat Biotech has put all the concerns to rest and refuted criticism.

Covaxin is a highly purified and inactivated 2 dose SARS-CoV2 vaccine.

The Drug Controller General of India (DCGI) on Sunday approved two Covid-19 vaccine for emergency use in the country: Serum Institute of India's Covishield and Bharat Biotech's Covaxin. Soon after, DCGI came under flak from various quarters for approving Covaxin even before the completion of Phase 3 trials.

The All India Drug Action Network (AIDAN) had urged the DCGI to reconsider the recommendations of the SEC in granting approval to Covaxin, citing absence of efficacy data from its Phase 3 trials as well as evidence of effectiveness in the context of infection by mutant strains.

"It is not clear if there is any scientific basis to claim that Covaxin will be effective in the "context of infection by mutant strains" when its efficacy has not been established and is currently unknown against any strain of the virus", IANS quoted AIDAN as saying.

Putting all the concerns to rest and refuting criticism of its vaccine approval, Bharat Biotech on Sunday confirmed that Covaxin generated excellent safety data with robust immune responses to multiple viral proteins that persist.

Bharat Biotech submitted all data as per regulatory guidelines

In a statement, the Hyderabad-based company said that Covaxin is a highly purified and inactivated 2 dose SARS-CoV2 vaccine, manufactured in a Vero cell manufacturing platform with an excellent safety track record of more than 300 million doses.

According to the company, the evaluation of Covaxin has demonstrated several unique product characteristics including:

• Long-term persistence of immune responses to multiple viral proteins.
• Broad spectrum neutralising capability with heterologous SARS-CoV2 strains, thus potentially reducing or eliminating escape mutants.
• Ability to generate memory T cell responses, for its multiple epitopes, indicating longevity and a rapid antibody response to future infections.

The vaccine's most critical characteristic is "the demonstrated safety profile, which is significantly lower than several other vaccines with published data," Bharat Biotech added.

The company also claimed that it submitted all the data to the DCGI and CDSCO as per the regulatory guidelines.

So far, the product development and clinical trial data has generated 5 publications, which have been submitted to international peer reviewed journals. In fact, 4 of these publications have been accepted and will be published soon. Also, the publication of Phase 2 trial data is undergoing the peer review process, the company pointed out in its statement.

Bharat Biotech to manufacture Covaxin for sale

After DCGI approves Covaxin for emergency use, the Central Licensing Authority has granted permission to Bharat Biotech to manufacture the vaccine for sale and distribution, IANS reported quoting a top source.

Covaxin has to be administered in two doses and can be stored at 2-8 degree Celsius.

The inactivated virus vaccine is developed and manufactured in Bharat Biotech's BSL-3 (Bio-Safety Level 3) bio-containment facility in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV).

The Phase 3 human clinical trials of Covaxin began mid-November, targeting about 26,000 volunteers across India.

Till date, 22,500 participants have been vaccinated across the country and the vaccine has been found to be safe as per the data available till date, the The DCGI stated, adding that the clinical trial will continue.