Bharat Biotech tries to save face, but without clear defence

Bharat Biotech’s founder Dr Krishna Ella, in a press conference held on Monday, stated that the company doesn’t deserve the backlash it has received after the uncertainty and lack of transparency of the company’s vaccine against COVID-19 - Covaxin raised eyebrows. Yesterday, two vaccines - Oxford-Serum Institute’s Covishield and Bharat Biotech’s Covaxin received approval to be used for immunisation against COVID-19. While Covishield reported efficacy rate of 70.42 percent after phase 3 trials, Covaxin has failed to report any efficacy data with the phase 3 trial still being continued.

This has raised doubts as several experts and medical professionals have criticised the lack of clarity from Bharat Biotech. Serum Institute’s CEO Adar Poonawallah told NDTV: "... only three vaccines with proven efficacy - Pfizer, Moderna and Oxford-AstraZeneca. Everything else... safe, just like water."

Responding to these comments, Ella said that they don’t deserve this backlash. “Don't accuse us of inexperience. We are a global company... have manufactured 16 vaccines. It is not correct to say we are not transparent with data. We conduct clinical trials in many countries, including the UK. The point is we are not an Indian company... but a global one,” NDTV reported him saying.

Though every vaccine requires three phases of trials to determine the efficacy, Covaxin has only finished two phases of trials as of now, and the data from these phases only shows that the drug is safe. The third phase for the drug is still going on as 23,000 volunteers have been recruited just yesterday. Bharath Biotech will also be allowed to conduct trials on children under 12 years of age, in its third phase.

“We have published in a lot of journals. We were the first to identify the Zika virus and the first to file a global patent for the Zika vaccine and the Chikungunya vaccine. It is not correct to say that we are not transparent with data,” Ella said during a press conference earlier today. It should be noted that in 2016, Bharat Biotech had released and publicised the vaccine for Zika virus, ‘Zikavac’, without seeking any approval from the government. Following the Drug Controller General of India’s (DCGI) intervention, it was revealed in an investigation that Bharat Biotech hadn’t sought any permission to bring samples of the Zika virus to India for manufacturing the vaccine.

For the entire press conference, Ella has failed to comment on the efficacy of Covaxin, leaving the clouds of doubt surrounding the vaccine unattended. On the other hand, the Serum Institute has submitted data of all three phases of trials to the DCGI and has reported efficacy of 70.42 percent. The dates for when the vaccines will be rolled out hasn’t been released yet.

Once the vaccines are procured, priority will be given to 1 crore health workers and 2 crore frontline workers in the first phase of immunisation. Health Minister Dr Harsh Vardhan has stated that these vaccines will be administered for free. Those above the age of 50 and those below age 50 associated with comorbidities will also be included in this phase. While the government plans to complete the first phase of immunisation by August 2021, there is no information about the immunisation process for the rest of the population yet. Each person will require two doses of either vaccine for the immunisation to be successful. State governments of Delhi, Tamil Nadu and Kerala have promised free vaccines to its people, whereas, the BJP had promised free vaccines in Bihar as a part of their recent election manifesto.