04 Jan 2021: COVAXIN is 200% safe: Bharat Biotech MD on efficacy concerns
The statement comes amid backlash over emergency approval for the restricted use of the vaccine, which was granted on Sunday.
Some experts and the Opposition have questioned the regulatory approval in the absence of efficacy data from Phase III trials.
Vaccine: COVAXIN Phase III trials still underway
COVAXIN is an inactivated vaccine, i.e., it uses an inactivated or killed pathogen (SARS-CoV-2) to trigger an immune response.
It has been developed jointly by Bharat Biotech and the Indian Council of Medical Research's National Institute of Virology (ICMR-NIV).
Phase III trials of the vaccine are yet to be completed, however, at least 22,500 out of 25,800 intended subjects have been vaccinated.
Quote: 'Merck's Ebola vaccine received emergency approval without trial'
Addressing a presser, Ella said, "Merck's Ebola vaccine never completed a human clinical trial at all but WHO gave emergency authorization for Liberia and Guinea."
He said, "Now that the vaccine is being politicized, I want to state very clearly that none of my family members is associated with any political party. Many people are just gossiping. It's just a backlash against Indian companies."
Experience: 'Not a company without experience; we don't deserve this'
Ella said the company does not deserve the backlash as they have submitted sufficient data that is available on the internet.
"We are not a company without experience in vaccines," he said, "We are touching 123 countries. We are the only company that has got such extensive experience and extensive publication in review journals."
COVAXIN trials were conducted in over 12 countries, he added.
Fact: 'People should have patience to read our articles'
Ella further said, "Many people say that I am not transparent in my data. I think people should have the patience to read on the internet and how many articles we have published. More than 70 articles have been published in various international journals."
Safety: COVAXIN showed less than 10% adverse reactions, says Ella
Ella said, "COVAXIN has shown less than 10% adverse reactions, while others have 60-70% adverse reactions. AstraZeneca was giving 4g paracetamol to volunteers to suppress such reactions. We haven't given paracetamol to any volunteer."
"I can assure you our vaccine is 200% safe," he said.
Ella also requested a week's time for confirmed data on the vaccine's efficacy against the new strain of coronavirus.
New strain: COVAXIN will work better against new strain, says government
A new strain of SARS-CoV-2 has caused a stir as authorities say it can be as much as "70% more infectious."
India has reported at least 52 such cases so far.
Health Minister Dr. Harsh Vardhan and ICMR Director-General Dr. Balram Bhargava have said that COVAXIN has a better chance against the new strain as it uses a killed version of the whole virus.
Also see: All you need to know about vaccines approved in India
SII's Covishield, Bharat Biotech's COVAXIN granted emergency approval, says DCGI
Coronavirus vaccine: Bharat Biotech's COVAXIN gets expert panel nod
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