COVAXIN IS SAFE AND WILL PROTECT AGAINST MUTANTS, SAYS BHARAT BIOTECH

The Drug Controller General of India (DCGI) had on Sunday granted restricted use approval “in clinical trial mode” to Covaxin “in the public interest”. However, the regulator did not say whether the approval had been granted on the basis of efficacy data. 

NEW DELHI: Bharat Biotech, which has jointly developed India’s indigenous vaccine against COVID-19 ‘Covaxin’ with the ICMR, has sought to dispel rumours and claimed that the anti-coronavirus jab is completely safe. Addressing a press conference on Monday, the head of Bharat Biotech said that Covaxin will be effective on mutant strains of the novel coronavirus.

Bharat Biotech chairman Dr Krishna Ella stressed that this a major factor why the candidate has been granted approval for restricted use by the authorities. Dr Ella further expressed confidence that the company will be able to establish the “hypothesis” of the candidate’s ability to protect against mutations in a week and submit the relevant data in this regard soon.

Ella said this while responding to a question on whether there were data to show Covaxin is effective against the mutant strain of the SARS-CoV-2 virus. It may be noted that the mutant strain of the SARS-CoV-2 virus was first detected in the United Kingdom and has since been found in more than 30 other countries.

Evidence from vaccines for other viruses like rabies supports the hypothesis, Dr Ella said — because of the platform it uses, Covaxin would be highly effective against such mutations. Dr Ella added that the vaccine uses an inactivated platform – it was developed by using killed strains of the SARS-CoV-2 virus.

Bharat Biotech has sent around 5 million doses of its candidate for quality checks and clearances at the Central Drugs Laboratory in Kasauli. The company hopes to be able to roll out the vaccine for use among the public as soon as possible.

It has stockpiled around 10 million doses, and will be ready with another 10 million by February, Dr Ella said. It may be noted that Bharat Biotech has come under the scanner for seeking approval for Covaxin without providing data on the vaccine’s efficacy.

The Drug Controller General of India (DCGI) had on Sunday granted restricted use approval “in clinical trial mode” to Covaxin “in the public interest”. However, the regulator did not say whether the approval had been granted on the basis of efficacy data. 

Meanwhile, the Indian Council of Medical Research (ICMR) has said that the Indian vaccine against COVID-19 – Covaxin – has drawn global attention. In a tweet, the ICMR said, “India’s indigenous vaccine against COVID19 Covaxin-a product of ICMR-Bharat Biotech collaboration, achieves remarkable feat. Data generated from within India underlines impressive safety and immunogenicity profile of Covaxin and sparks Lancet’s interest in publishing them.”

News Credit Zee News