A day after Bharat Biotech founder and chairman Dr Krishna Ella lashed out at detractors who criticised the speed at which emergency use authorisation (EUA) was given to Covaxin, the company’s Covid-19 vaccine, Serum Institute of India & Bharat Biotech issued a joint statement in which they pledged towards a smooth roll out of Covid-19 vaccines to India and the world.
Adar Poonawala and Dr. Krishna Ella, jointly on behalf of the two companies, said the more important task in front of them is saving the lives and livelihoods of populations in India and the world. Vaccines are a global public health good and they have the power to save lives and accelerate the return to economic normalcy at the earliest.
Now that two COVID-19 vaccines have been issued EUA (emergency use authorization) in India, the focus is on manufacturing, supply and distribution, such that populations that need it the most receive high quality, safe and efficacious vaccines. “Both our companies are fully engaged in this activity and consider it our duty to the nation and the world at large to ensure a smooth rollout of vaccines. Each of our companies continue their Covid-19 vaccines development activities as planned,” they said.
On Monday, Dr Krishna Ella had said: “We don’t deserve this backlash,” he said and urged people to stop politicising the issue. Without naming Serum Institute of India CEO Adar Poonawala, Ella said, “We do 200% honest clinical trials and yet we receive backlash. If I am wrong, tell me. Some companies have branded me (our vaccine) like ‘water’. I want to deny that. We are scientists.”
Poonawala had said in a TV interview on Sunday that there were only three vaccines with proven efficacy – Pfizer, Moderna and Oxford-AstraZeneca and the rest were just “safe like water”.
Ella said the US and Europe had refused to accept the AstraZeneca-Oxford vaccine trial data from the UK because it was not “clean”, but no one was questioning Oxford data.
Meanwhile, Congress leaders raised concern over the grant of permission for the restricted use of Covaxin without its phase 3 trials. Congress leaders asked the government to explain why mandatory protocols and verification of data has been dispensed with and warned the approval was “premature”.
Congress leader Anand Sharma, who heads the Parliamentary panel on Home Affairs which dealt with the issue at length, said the issue of granting authorisation to Bharat Biotech’s vaccine needs to be taken carefully as no country has dispensed with the mandatory phase 3 trials and verification of data.
Congress MP Shashi Tharoor also expressed apprehensions over approval to Covaxin, saying it has not yet had phase 3 trials. “The Covaxin has not yet had Phase 3 trials. Approval was premature and could be dangerous.@drharshvardhan should please clarify. Its use should be avoided till full trials are over. India can start with the AstraZeneca vaccine in the meantime,” Shashi Tharoor said.
Jairam Ramesh raised the same concern and said, “Bharat Biotech is a first-rate enterprise, but it is puzzling that internationally-accepted protocols relating to phase 3 trials are being modified for Covaxin. Health Minister @drharshvardhan should clarify.”