As India prepares for a massive inoculation drive to prevent the spread of coronavirus, a vaccine war has surfaced between Bharat Biotech and Serum Institute of India. A day after two vaccines got restricted emergency use authorization from the drug regulator, Bharat Biotech chief, Krishna Ella lashes out at competition, Serum Institute of India. This comes in the backdrop of wide criticism against the approval granted to Bharat Biotech, which is yet to complete its phase three trial and present efficacy data. 

 

 

Krishna Ella, chairman and managing director of Hyderabad-based Bharat Biotech, in a virtual press conference raised questions over the approval given to Pune-headquartered Serum Institute of India (SII) for the Oxford – AstraZeneca vaccine. 

Ella hit out at the trial done by AstraZeneca-Oxford, with which Serum Institute has a partnership for manufacturing the vaccine. Referring to the inadvertent dosing error in case of the Oxford-  AstraZeneca vaccine in the UK, where a group received a half-dose and full dose regimen instead of two full doses, he said if his firm had done a vaccine trial like AstraZeneca, the Indian regulator would have “shut down the company’’. 

He alleged that Serum Institute, which is making Covishield, had only immunogenicity data (whether a vaccine induces a desired immune response) from only 100 people and the company got emergency use license based on UK data. No  firm had safety data of over 1,000 people (Indians), while his firm had for over 25,000 Indians, he claimed.

He further alleged that it was likely that the  AstraZeneca vaccine would not be possible to give to a person a third time. According to Ella , if one needs a shot a year later, the vaccine is unlikely to work. When the two-shot vaccine is given, it induces an immune response against the vector and the spike protein. “If you give a third dose, it will neutralize the chimpanzee vector, and thus one cannot take it the third time or in the second year,” Ella said. AstraZeneca-Oxford vaccine has used a chimpanzee adenovirus or cold virus to deliver the genetic material of the pathogen into the cells.

Bharat Biotech has published details from its trials in five peer-reviewed journals, Ella pointed out, saying it’s at par with that of US-based Pfizer. "In contrast, none of the other Indian players have a single publication in peer reviewed journals," he said. 

Comparing the vaccine to its competitor, Ella said Bharat Biotech's Covaxin had around 15 per cent side effects, the lowest amongst its global peers. "The Oxford-AstraZeneca vaccine has 60 per cent side effects despite them giving 4 grams of paracetamol to their subjects to suppress these side effects. We have not given any paracetamol to our volunteers. We wanted the adverse effects (fever, pain etc) to be reported and even then our side effects are around 15 per cent only," he said.

Ella said that Covaxin has shown excellent animal challenge data. "It is the best among all global trials, 100 per cent data from animal challenge trials. It showed strong neutralizing antibody titer indicative of efficacy", he added.

Responding to queries on whether his vaccine works against the UK strain, he said, "give me one week's time, we will have that data. I am confident it would work." 

Ella said that the company has around 20 million doses ready and expects to have around 150 million doses by July-August. Around 700 million dose annual capacity is what he’s expecting from multiple facilities - three in Hyderabad and one in Bengaluru. Of the 20 million doses that are ready, 10 million could be made available right away and another 10 million by February. Batches of the product have been sent to Central Drugs Laboratory, Kasauli, for testing.

Talking about the price, Ella said, "Initially prices can be high and then once the scale increases and the market competition builds up, the prices come down".

As many as 12 nations including the US and many countries in the European Union have shown keen interest in Covaxin. "They do not want high-end technology, they want a safe vaccine for their citizens. We are in final stages before we start trials in Bangladesh," Ella said.