Twitter
Advertisement

Carried out 200% honest trials, don't deserve this backlash: Bharat Biotech hits back at critics

Some opposition leaders and scientific researchers criticised Covaxin for being given emergency use authorisation without completion of phase 3 trials

Latest News
article-main
(Image: Twitter)
FacebookTwitterWhatsappLinkedin

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.

Krishna Ella said on Monday that the company does not deserve the backlash it is receiving in the light of India's drugs regulator granting its coronavirus vaccine Covaxin approval for emergency use.

"Don't accuse us of inexperience. We are a global company... have manufactured 16 vaccines," he said, highlighting that "200% honest" clinical trials were conducted.

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.

Ella said the company conducts clinical trials not only in India but also in many other countries.

Some opposition leaders and scientific researchers criticised Bharat Biotech's Covaxin for being given emergency use authorisation without completion of phase III trials.

However, Ella pointed at the number of journal articles Bharat Biotech published and claimed that it was the first to identify Zika virus and file a patent for Zika and Chikungunya viruses.

Bharat Biotech was the only company to have a Bio Safety Level 3 (BSL- 3) production facility, he noted.

"We do 200% honest clinical trials and yet we receive a backlash. If I am wrong, tell me. Some companies have branded me 'water'. I want to deny that. We are scientists," he said.

The World Health Organisation (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% of the criteria.

Questioning another Indian pharma giant without naming it, Ella said, "There is an Indian company which got license 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 percent 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 license 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.

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 agency inputs)

Find your daily dose of news & explainers in your WhatsApp. Stay updated, Stay informed-  Follow DNA on WhatsApp.
Advertisement

Live tv

Advertisement
Advertisement