Coming down heavily on critics expressing doubts about the Bharat Biotech's indigenously developed coronavirus vaccine COVAXIN, the Hyderabad-based biotech major's managing director Dr Krishna Ella on Monday slammed the critics for targeting Indian clinical trials and asked why they were not questioning the UK clinical trials of another vaccine.
On Sunday, soon after the Drugs Controller General of India (DCGI) announced "restricted emergency use" for two COVID-19 vaccine candidates-- Bharat Biotech's COVAXIN and Serum Institute of India's Covishield--people in the scientific and political community started to raise doubts on the safety and efficacy of the indigenously developed COVAXIN.
The World Health Orgsation (WHO) has three criteria for the approval of the vaccine. They include safety, immunogenicity, and efficacy.
However, under emergency circumstances like the COVID-19 pandemic in the large public health interest, the global health agency has fixed minimum criteria that the efficacy data should meet at least 50 per cent of the criteria.
Some opposition leaders and scientific researchers criticised Bharat Biotech's COVAXIN for being given emergency use authorisation without completion of phase III trials.
Questioning another Indian pharma giant without naming it, Ella said, "There is an Indian company which got licence based on international data in phase III clinical trial data. Did anybody question them? AstraZeneca was giving four grams of paracetamol to volunteers to suppress such adverse reactions. We have not given paracetamol to any volunteer. I can assure you our vaccine (COVAXIN) is 200 per cent safe," said Dr Ella to critics for not questioning UK clinical trials.
"Based on the 2019 notification of CDCSO, we have got the right to get an emergency licence for the vaccine. We would be ready with phase 3 data in some days because we are conducting a large phase III clinical trial in the country with about 25,800 volunteers. At least 24,000 have been vaccinated so far. Why no one is questioning the other Indian company which has done phase 3 trial in 1,000-odd people in India," he added.
He said that USA and Europe have refused to accept the data of AstraZeneca but the Indian drug regulator has given approval because Britain's Medical and Healthcare Products Regulatory Agency (MHRA) approved it in the public interest.
According to WHO, following "regulatory reliance" criteria, which means once the vaccine is approved by MHRA or US Food and Drug Administration (FDA), any country's drug regulator can permit it for their domestic use.
"Furthermore, COVAXIN is a simple two-dose vaccine. We are the only vaccine for above 12 years of age right now. We are planning to do even children trials soon, as per the protocol," he said.
The indigenous vaccine has been developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR)-National Institute of Virology (NIV).
Currently, Bharat Biotech has 20 million doses ready and the company is aiming to achieve 700 million doses capacity in four facilities--three in Hyderabad and one in Bengaluru--in the coming days for mass vaccination.
Bharat Biotech had said in a release earlier that COVAXIN is a highly purified and inactivated two-dose SARS-CoV2 vaccine, manufactured in a vero cell manufacturing platform with an excellent safety track record of more than 300 million doses.
( With inputs from ANI )
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