My thread on #CoronaVaccine controversy 👇
1/N- While Covishield developed in India by @SerumInstIndia with a master seed from Oxford-AstraZeneca's, @BharatBiotech developed #COVAXIN derived from a strain of SARS-CoV-2 virus, isolated at NIV, Pune, India.
2/N While Covishield is based on the virus’s genetic instructions for building th spike protein using double-stranded DNA added to adenovirus,COVAXIN is an inactivated vaccine (uses dead virus)
Approval of vaccine,undergoing phase-3 clinical trials, has raised serious questions.
3/N -Phase III trial where the efficacy of the vaccine is tested on consented volunteers.There should be informed consent explaining the potential risks and benefits of the vaccine and post-vaccination follow-up. In case there is any serious adverse reaction
4/N- Since the beginning, Covaxin speed has raised so many unanswered questions.
ICMR transferred the strain NIV had isolated to Biotech Bharat on 9th May 2020. It takes at least three months to do animal trials to establish safety.
5/N - So there were only 50 days in between, during which time the company should have developed the inactivated vaccine, conducted preclinical animal trials (with mice and hamsters), and sent its reports to be evaluated and approved by DCGI.
6/N - ICMR’s Dr. Balram Bhargava has earlier created a similar uproar when he wrote a letter to Bharat Biotech in early August 2020 writing, “It is envisaged to launch the vaccine for public health use latest by 15th August 2020 after completion of all clinical trials.”
7/N- Covaxin Phase III efficacy trial was initiated in India on 25,800 volunteers on November 6, 2020. In a December 22 statement, Covaxin said it had recruited 13,000, or half of its target for these trials. On 1/01/2020 regulator says, 22,500 participants have been vaccinated
8/N -It can't happen so fast as the vaccine needs two shots 3-12 weeks apart,volunteers need to be tracked ,tested until enough of them have contracted Covid-19 to allow the vaccine’s efficacy to be analyzed. To be sure, there is no clarity on whether there is data from phase-3
9/N -In my view, DGCI should have given more time to BharatBiotech to complete its Phase III trial. it should not be seen as an unsurprising push in the wake of 26th January, Republic Day announcements at the cost of common citizens.
10/N -Bharat Biotech is a reputed drug manufacturer, method they have chosen is a very old and tested one & have high hopes coz of its proposed mechanism of action. Let us start with Covishield which has already started in the UK and let Bharat Biotech finish its Phase III trial.
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