Monday, 27 June, 2022
HomeHealthOxford trial 'lousy', we'll be ready with 70 cr Covaxin doses this...

Oxford trial ‘lousy’, we’ll be ready with 70 cr Covaxin doses this year, says Bharat Biotech

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.

Text Size:

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”.


Also read: Why Bharat Biotech’s Covaxin is the object of national pride & scientific scepticism


‘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.


Also read: Congress questions why Bharat Biotech’s Covaxin was cleared without completing phase-3 trials


 

Subscribe to our channels on YouTube & Telegram

Why news media is in crisis & How you can fix it

India needs free, fair, non-hyphenated and questioning journalism even more as it faces multiple crises.

But the news media is in a crisis of its own. There have been brutal layoffs and pay-cuts. The best of journalism is shrinking, yielding to crude prime-time spectacle.

ThePrint has the finest young reporters, columnists and editors working for it. Sustaining journalism of this quality needs smart and thinking people like you to pay for it. Whether you live in India or overseas, you can do it here.

Support Our Journalism

18 COMMENTS

  1. There is no data yet that Covaxin will work with the mutant virus. How does DCGI and ICMR do science – by sales pitch or hard evidence?

    How can DCGI assume that Covaxin would work against the mutants? They have not even shared safety and efficacy data for the existing strains itself.

  2. Mother Nature herself has been conducting a vaccination programme already and that’s why the daily infection rate n mortality rate are coming down at a consistent rate. In other words, it can be said that the virus which came to human in an unusual way is soon loosing it’s virulence and going to exist in a stable state in nature next, even when there is no social distancing maintained in the country, mask usage is next to nill, unlock process is almost complete, temperature is going record deep and no preventive medicine around.

  3. THE CONTRIVERSY OVER COVACCINE IS ILL FOUNDED. GOVT HAS MADE IT CLEAR THAT IT CAN BE USED ONLY IN EMERHENCY. IF SUCH ANEEDARISES
    IT WILLGET THE NORMAL APPROVAL ONLY AFTER THIRD F.PHASE TRIAL IS COMPLETED AND IT TURNS OUT TO BE WITHIN ACCEPTABLE LIMITS. GOVT HAS NOT REPEAT NOT AUTHOROSED RELEASE OF COVACINYET. IT IS TRUE ELLA HAS 10 MILLION DOSES READY
    BUTIT WILL RWMAIN IN THHE STORE. IT WILL BERELEASED.ONLY AFTER THIRD PHASE. SO.FOR THE TIME BEING IT IS NOT GOING TO BEUSED.INTHEMEANWHILE. ELLA HIMSELF HAS RAISED A.CONTOVERSY AGAINST HIS COMPETETOR WHICH IS INVERYPOOR TASTE. SUCH MUDSLINGING HAS TO STOPPEOPLR EHO AREGOING TOFET THEVACCINESSHOULDNOT START GETTING DPUBTS ABOUTTHEEFFICACY AND SAFETY OF THESR VACCIBRS.I NOTOCED SOMR PEOPLE SAYONG THAT THEY WILL NOT TAKETHEVACCINE NOW.THEYWILL WAIT ANDWATCH
    ALREADY WEHAVECREATEDA LOBBY IF DOUBTONG THOMASES.

  4. What an arrogant and reckless individual! He claims in the same sentence to be more effective than western vaccines and hopes to meet 50% efficacy. Atleast they published data in peer reviewed journals. If your data is public and published in any peer reviewed journal of standard (Indian or western) one can claim the efficacy. Barking and mud-slinging will not convince me to take your trial vaccines.

    • True. He should have been mature in front of media.

      All Indians would want an indigenous company like Bharat Biotech to succeed. But let one’s quality of work do the talking.

    • this is the most arrogant scientific person i have ever heard of. Push his personal agenda after a half baked trial against a well settled regulatory and scientific trial results.

      As if there is not enough arrogance amongst our political class, this is a new class of fools

  5. Poonawalla is doing only outsourcing job. Does he has any standing to criticize companies doing origional research, let it be water or anything. Poonawallas are real cheap. It is possible that Bharat biotech may emerge as the most efficient candidate against the mutating corona. Brown sepoys want white people research, approval and seal. Tharoor is just person who does this- find a difficult word and engage in all bullshit. Guy cant name his book as era of darkness for uk edition. Such loser. He is like jnu ir scholar talking about biotech. Stick to your field which is english dictionary.

    • be careful when you criticise people like Dr Shashi Tharoor. Poonawala is the biggest vaccine manufacturer in the world and he has not criticised anybody. He has put millions of his own money and taken a chance for the country; by manufacturing hundreds of millions of doses of the covid vaccine with his own money. The other guy is obviously a political joker

    • Talk with data and evidence, buddy.

      Science cannot progress by manipulating people’s opinions. Manipulating is only in realms like religion and politics. Science is based on hard data and evidence and it has to be accepted internationally. It is important to set high standards.

  6. Wow really happy to know this. I have always doub on Oxford vaccine as many candidates have got severe allergies from it. Even though I was waiting for bharatbiotech vaccine as I trust these more than others.

  7. Any vaccine I think safety matters more than efficacy. Unfortunately this is an emergency situation and there is not much time to assess safety over long term.

    It is a choice for each person to take vaccine or not. But an average man just does not have the scientific knowledge to make a decision.

    Let us not put the pressure on vaccine companies and their scientists, they are just doing their job and trying to do their best – instead we need to train our guns on the government.

    The executives of the govt agencies and committees in India approving use of the vaccine must demonstrate to the public that they themselves have taken the vaccines and it is safe. So also people holding the top constitutional posts in the country. This will boost confidence of the public.

  8. All chaps who want some limelight even if it means spitting into one own plate ,who do not know anything about Science are yapping!!

  9. Indian science seems proving the western disbelief of Indian data a right. The hurry to approve without data solidly supports the attitude of western scientists trashing Indian science that was slowly disappearing. We have measured our length in dust. Bravo Expert committees and DCGI.

    • It is the same in history for the Indo-Aryan invasion theory and other Hindu mythology.

      In general, we jump to conclusions too soon.
      Generally we don’t do a thorough job in our research and publications. It’s one thing to be acknowledged best in India, it’s totally another to compete with better people in other countries esp. West and Japan.

  10. Oh my god, the way the politicians, commentators and now even Mr.Ella entering the fray to comment on various vaccines. I hope we are not about to see “Vaccine Wars” in India in 2021….

Comments are closed.

Most Popular

×