After mudslinging, Pune-based Serum Institute of India (SII) and Hyderabad-based Bharat Biotech declared a truce on Tuesday, issuing a joint statement pledging a smooth roll out of their COVID-19 vaccines Covishield and Covaxin respectively to India and the world.
The statement issued by Adar Poonawalla, Chief Executive Officer of Serum Institute of India and Krishna Ella Chairman & Managing Director of Bharat Biotech on Tuesday states, “Mr. Adar Poonawala and Dr. Krishna Ella, jointly on behalf of the two Companies, today communicated their combined intent to develop manufacture and supply the COVID-19 vaccines for India and globally. They 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.”
It also went on to say, “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 concluded, “We are fully aware of the importance of vaccines for people and countries alike, we hereby communicate our joint pledge to provide global access for our COVID-19 vaccines.”
The joint statement comes after the two firms engaged in a heated war of words in the last few days. The trigger appeared to be a statement by Poonawala in a TV interview on Sunday that there were only three vaccines (Pfizer, Moderna and AstraZeneca-Oxford) with proven efficacy. The rest he said, were just “safe like water”.
Many scientists and activists have questioned the haste with which approvals were granted for both SII’s Covishield and Bharat Biotech’s Covaxin, but in particular the latter that is yet to complete phase 3 clinical trials. Taking strong exception to the comments and criticism, Bharat Biotech Chairman and Managing Director Krishna Ella on Monday took on both critics and competitors in the vaccine race, stating that his firm was in “no way inferior”. Without naming SII, he launched into a scathing attack on the Pune-based manufacturer which makes the Covishield vaccine that has been developed by AstraZeneca-Oxford. “Some local company has released a press release yesterday in the news. They said safety is like a water in other companies. Only three companies have done efficacy, other vaccines are like a water, safety is like a water. And I want to deny that. It hurts us as a scientist. We work 24 hours, we deserve that kind of bashing from the people?”
Without naming SII, he pointed out that the company had received approval from the Indian drug regulator based on phase 3 data from the UK and Brazil trials. SII had submitted interim data to Indian drug regulators from its phase 2 and 3 bridging study. However, complete analysis of this study is yet to be done. On the other hand, Bharat Biotech did not submit efficacy data as its phase 3 trials are still underway.
Questioning the UK clinical trial carried out by AstraZeneca-Oxford, which has been criticised for its efficacy data, Krishna Ella said, “No, I will ask a simple question on UK clinical trial -whether it’s 60%, 70% or 90%. Which is clinical trial efficacy of that country? No one knows. One says 60%, one says 70% another one says 90%. One says high dose-high dose or low dose-low dose.” He went to hit, “If I had done that type of clinical trial in India, the drug controller of India would have shut down the company.”
Krishna Ella had also questioned safety data with regard to AstraZeneca-Oxford, claiming that Bharat Biotech’s safety data showed less than 15% adverse reaction. “You look at safety data, some people think safety data is not important...You look at Oxford, Pfizer, Sputnik, Bharat Biotech in safety data. We are less than 15%. In fact as we go to phase 3, we found less than 10% side-effects reaction in any of the phase 3 trial right now, where have done 24,000 people vaccinated we have less than 10% side-effects.” However, it is important to note that Bharat Biotech’s phase 3 trial that has enrolled 24,000 people is still underway and is yet to be completed.
He went on to allege that the AstraZeneca-Oxford trial had given four grams of paracetamol to participants who were vaccinated to suppress an adverse reaction. “You look at Oxford-AstraZeneca, they have given four grams of paracetamol for every subject that was vaccinated. That means they are suppressing adverse reactions by giving paracetamol, whereas we haven’t given paracetamol to the volunteers. So whatever the adverse reaction whether it is good or bad that was captured in the clinical trials is exactly 100%. But here four grams of paracetamol is given to suppress adverse reactions.” However, his claims of the Covaxin having minimal adverse effects have been contested by scientists.