Pharma major Bharat Biotech on 4 January rejected criticism over the grant of emergency use authorisation by India's drug regulator to its COVID-19 vaccine, asserting it has a track record of producing safe and efficacious vaccines and has been transparent with all data.

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As industry experts and some opposition leaders expressed concern over the absence of Phase 3 trial data on Covaxin, the chairman of Bharat Biotech, said it has done "200 percent honest clinical trials" and yet it was receiving "backlash". He said sufficient data has already been revealed and is available online for people to access. He suggested that the vaccine was being targeted as it was a product of an Indian company.

The critics have cautioned that "sidestepping" processes and giving "premature" clearance could risk lives and fuel vaccine hesitancy in India. However, the chairman said Covaxin addresses an unmet medical need and has generated excellent safety data with a robust immune response to multiple viral proteins that persist. He said Covaxin Phase-3 efficacy data will be available by March. No interim analysis of efficacy in Phase 3 has been done so far. According to him, the firm is ready with 20 million dosages of Covaxin and would scale it up to 150 million by July-August.

Asked if the company is in talks with the government for vaccine supply, the chairman said, "Government is in talks with us." He alleged Indian companies are being targeted and called "inferior". "We do 200 percent honest clinical trials and yet we receive backlash. If I am wrong, tell me. Some companies have branded me like water," he said and stressed that Bharat Biotech's vaccine is not inferior to the one developed by Pfizer.

The chairman said it was wrong to say Bharat Biotech was not transparent with data and cited the number of publications by the company in comparison with industry peers. He said the emergency use authorisation was based on the 2019 rules of the Government of India and went on to state that even the US grants emergency authorisation to a company with good immunisation data. Bharat Biotech was the first to identify the Zika virus and the first to file global patents for the Zika and Chikungunya vaccines, he said.

Amid the controversy, All India Institute of Medical Sciences (AIIMS) director Randeep Guleria said Bharat Biotech's vaccine has been given approval only in emergency situations as a backup and also rejected claims of fast-tracking the whole exercise of coming out with a vaccine. "If there is a surge in cases, we may need larger doses of vaccine, then we may go with Bharat Biotech's vaccine. The Bharat Biotech vaccine is more of a backup," he said. "None of the clinical trials was fast-tracked in terms of safety and efficacy. Fast-tracking was done in taking regulatory approval which generally takes a long time while going from one phase to the other," he said.

The approval to Oxford University's COVID-19 vaccine Covishield, manufactured by the Serum Institute, and indigenously developed Covaxin on 3 January has been hailed by the Indian leadership as a major achievement for the scientists and the country. The Prime Minister said that the world's biggest inoculation drive against coronavirus is now set to begin in the country. "For this, the country is proud of the contributions of its scientists and technicians," he said at an event.

The UK already began rolling out on Monday the Oxford University vaccine developed by AstraZeneca, with an 82-year-old Oxford-born dialysis patient becoming the first to receive the new jab. The vaccine will cost USD 3-4 per shot (Rs 219-292) to the Indian government and will be priced at double that rate in the private market once such sales open up, said the CEO of its Indian manufacturer Serum Institute of India.

The world's largest vaccine manufacturer, SII, has a licence to produce the shot and has already manufactured close to 50 million doses. Its CEO said that the company will start selling the Covishield to the Indian government and GAVI countries in the first stage, followed by the private market. "We want the vaccine to be affordable and accessible to all. The government of India will receive it at a far more affordable price of USD 3-4 since they will be buying in a larger volume," he said. "The efficacy results of the vaccine are quite high if it is administered in 2-doses within a gap of 2 3 months," Poonawalla said.

The Centre has been coordinating with the states and union territories to prepare for the vaccination drive and a country-wide dry run was successfully held on January 2. The NITI Aayog member said India has enough stockpile of the COVID-19 vaccine for inoculation of priority groups, including healthcare workers and frontline workers, in the first phase.

The NITI Aayog member, who is also the Chairman of National Expert Group On Vaccine Administration for COVID-19 (NEGVAC) further said the government will soon announce its plans for the purchase and distribution of the COVID-19 vaccine. "Our first phase (of vaccination) comprises priority groups with a high risk of mortality and our healthcare and frontline workers. For them, we believe, we have enough (COVID-19 vaccine) stockpile," he said.

The NITI Aayog member noted that "three to four months from now, there will be other vaccines and the stockpile will be even bigger. The controversy over Covaxin has also led to sparring between the political parties after some opposition party leaders questioned the approval to the Bharat Biotech vaccine. "Those who have mand buddhi (are mentally challenged) and those who don't have faith in the scientists and power of India are making such baseless statements," the Union Minister said.

The political party alleged that some opposition parties, were helping "foreign forces" with their criticism of the approval process for the indigenous COVID-19 vaccine, alleging that they do not want India to be self-reliant, a centrepiece project of the Prime Minister. The political party spokesperson told a press conference that while India is happy with the approval of two coronavirus vaccines, Congress leaders have become "rumour mongers" and have tried their best to create "chaos".

Scientific and government bodies associated with the vaccines have given statements to dispel any doubt but the Opposition is trying to politicise the issue, he said, noting that the WHO has also praised the development. On 3 January, another political party chief spokesperson lauded scientists and researchers of Bharat Biotech for the indigenous vaccine but the party's senior leaders raised concern over the grant of approval to its vaccine without the phase 3 trials, saying it is "premature" and can prove dangerous.

The Health Minister had asserted that Covaxin is more likely to work against newer variants of the virus, including the UK variant, and asked politicians not to "discredit well laid out science-backed protocols". However, All India Drugs Action Network (AIDAN) has questioned the claim that Covaxin can work better against the UK strain of the virus which is more transmissible. "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," AIDAN, which is a network of NGOs working to improve the rational use of essential medicines, said.

India has so far reported 1,03,40,469 case, while the recoveries surged to 99.46 lakh, according to the Union Health Ministry data updated on 4 January. The death toll increased to 1,49,649 with 214 new fatalities, the data updated at 8 AM showed.