Bharat Biotech MD Dr Krishna Ella says they gave ‘excellent safety data tested on around 25,000 participants’ & their efficacy data will be available by February-March.
New Delhi: Hyderabad-based vaccine maker Bharat Biotech Monday said the company is aiming to manufacture 70 crore doses this year of its approved Covid-19 vaccine — Covaxin.
The second vaccine approved by the Drug Controller General of India Sunday is Oxford-AstraZeneca’s Covishield, manufactured by Pune-based firm Serum Institute of India.
At a virtual press briefing, the company’s chairman and managing director Dr Krishna Ella lashed out at the Oxford-AstraZeneca’s vaccine trial in the UK, saying that it gave “paracetamol doses” to its volunteers to suppress the side-effects.
On the issue of efficacy data, Ella said his company “gave excellent safety data tested on around 25,000 participants”, adding that they are “confident of having efficacy above the set benchmark of 50 per cent”. The efficacy data will be available by February-March, he added.
The remarks came in the wake of a controversy that the home-grown vaccine was given the approval without any efficacy data.
‘Ready to roll out vaccines anytime’
Ella said the company plans to produce the doses in four of its facilities based in Hyderabad and Bengaluru.
“We have 20 million (2 crore) doses right now. We can manufacture 700 million (70 crore) doses in 2021 (annual capacity),” Ella said.
The company has manufactured a stock pile of one crore doses already even before the vaccine was cleared by the drug regulator. These doses will be available for rollout by next month.
“10 million (1 crore) doses (to be) available by February 2021,” said the presentation given by the company during the presser.
Ella said, “We are ready to roll out anytime if the Government of India allows. I would love to roll out tomorrow.”
Ella further added that “the company has sent 50 lakh doses for testing at the country’s apex laboratory, Central Drug Laboratory, Kasauli”. The testing at CDL, Kasauli, is the mandatory testing of vaccines done before the final rollout.
He said that “initially, the cost of the vaccine may be a little higher but as production will increase, price will come down and get determined by the market forces”.
‘We are far better than others’
Ella, in the briefing, said the drug regulator and the Subject Expert Committee were given the “excellent animal challenging data on monkeys and hamsters, which was given in comparison with published data in Indian medical journals”.
He added sarcastically, “But we won’t trust, we want the UK people to publish our data…
“We also gave excellent safety data tested on around 25,000 participants,” Ella said, adding that the “immunogenicity data was also given”.
“The data is correlated to the efficacy. But I am not claiming efficacy, here. In this data, we are far better than others.”
Targeting the Oxford vaccine trial, Ella said, “60, 70 or 90. Nobody knows the efficacy. High dose, low dose… DCGI would have shut down the company on quality issues (if it was an Indian company doing the trials).”
The company said that it is confident about the high efficacy rate of its vaccine.
“We are confident of having efficacy above the set benchmark of 50 per cent… We will get the efficacy data by February-March.”
The vaccine was cleared by the DCGI over chances of working better against the mutated virus, to which Ella explained that the vaccine can work by changing the strains, which is generally done in flu vaccines every year.
“The strain in the vaccine changes but the manufacturing process remains the same. We can plug and play the same vaccine, after due permissions from the regulatory authorities.”
Oxford Covid vaccine trial ‘lousy’
Ella targeted the Oxford trial several times during the briefing. Claiming that Covaxin has shown the lowest side-effects, Ella said the company has noticed less than 10 per cent adverse reactions during trials.
Hitting out at the Oxford’s pattern of conducting clinical trials, Ella said, “You (media) never question the UK’s trial. Four gram of paracetamol dose was given to participants for suppressing the adverse reactions. We haven’t given any such thing… We wanted people to report all kinds of adverse reactions. We have noted the adverse reaction on a real time basis.
“Will that type of trail happen in India… this dose, that dose,” he said.
“Despite doing one of the largest ever trials conducted in India and probably, also in the developing world, we are facing backlash,” he said, adding that the Indian drug regulator won’t allow any company to do a clinical trial in a “lousy” manner.
