India covid vaccine results and its testing sometime sluggish then at nick taken in hurly burly.
ShashiTharoor through tweet, claims that Bharat Biotech’s Covaxin has not gone through phase 3 trials and that it can prove to be dangerous.If India gets vaccines to its own vulnerable people & makes arrangements to meet the needs of the global population, it could yet regain credibility on the global stage.”
The Covaxin has not yet had Phase 3 trials. Approval was premature and could be dangerous.
@drharshvardhan, please clarify. Its use should be avoided till full trials are over. India can start with the AstraZeneca vaccine in the meantime.
But there are welcome tweets, The decisive turning point to strengthen a spirited fight! DCGI granting approval to vaccines of Serum Institue of India & Bharat Biotech accelerates the road to healthier & COVID-free nation.
CitizenPolitix_Replying to @drharshvardhan There is big lobby promoting this at cost of risking public health. Covaxin is not even updated in vaccine tracker yet. No conclusive reports updated in any medical journal. @WHO not even listed this. This is unethical and compromised. Lot of underreporting happening on this.
We’ll never approve anything if there’s slightest of safety concern. Vaccines are 110 % safe. Some side effects like mild fever, pain & allergy are common for every vaccine. It (that people may get impotent) is absolute rubbish: VG Somani,Drug Controller General of India
This is official PIB tweet, Serum Institute of India, Pune submitted safety, immunogenicity, and efficacy data generated on 23,745 participants aged more than or equal to 18 years or older from overseas clinical studies. The overall vaccine efficacy was found to be 70.42%: DCGI
Now turn up another Congress leader question Covaxin clearance. Senior Congress leader Anand Sharma on Sunday raised concerns over India’s drugs regulator granting permission for restricted use of Bharat Biotech’s COVID-19 vaccine and asked the government to explain why mandatory protocols and verification of data has been dispensed with.
India’s drugs regulator DCGI on Sunday approved Oxford’s COVID-19 vaccine Covishield and Bharat Biotech’s Covaxin for restricted emergency use.
Sharma, who heads the Parliamentary panel on Home Affairs which dealt with the issue at length, said the issue of granting authorisation to the vaccine use needs to be taken carefully as no country has dispensed with the mandatory phase 3 trials and verification of data.
As per submissions made before the expert panel, phase 3 trials have not been completed and therefore, the data on safety and efficacy has not been reviewed, which is a mandatory requirement, he said.
“The Health ministry needs to give cogent reasons for dispensing with the mandatory protocols and requirements in this case, since it involves the health and safety of those frontline workers who will be vaccinated under the restricted category,” he told PTI.
Another senior Congress leader Jairam Ramesh also raised concerns and asked Health Minister Harsh Vardhan to clarify why internationally-accepted protocols on phase 3 trials are being modified.
‘Bharat Biotech is a first-rate enterprise, but it is puzzling that internationally-accepted protocols relating to phase 3 trials are being modified for Covaxin. Health Minister Harsh Vardhan should clarify,’ he said on Twitter.