Read on Twitter
Vaccines are held to higher Standards (side effects might endure ) and for Prevention .Also a lot of hesitancy due to rumours and misconceptions. No such clearance given for Vaccine globally except China/Russia.
Remember Indian Clinical trial Industry almost shut down due to controversies around HPV Vaccine. Do you want controversies for a promising , indigenous Vaccine with good phase 2 data when the CEO himself says they would meet end point in Feb/March
https://ijme.in/articles/hpv-vaccine-trials-and-sleeping-watchdogs/?galley=html
https://ijme.in/articles/hpv-vaccine-trials-and-sleeping-watchdogs/?galley=html
Q. Astra Zeneca ran only 1600 patient trial, Bharat Biotech is running 25000 . Is it love for "foren" https://twitter.com/Swamy39/status/1345365463371399173?s=20
GOv of India had policy to accept a Vaccine if
A) Large phase 3 data from outside + small bridging trial(only reactogenicity and immunogenicity data) in India given Vaccine responses might diverge with different ethnicity as
B) Large Vaccine Phase 3 trial in India.
A) Large phase 3 data from outside + small bridging trial(only reactogenicity and immunogenicity data) in India given Vaccine responses might diverge with different ethnicity as
B) Large Vaccine Phase 3 trial in India.
Oxford Trial is a bridging trial(Similar to what Sputnik is running in India and Novavax plants to run) ,Covaxin is an indigenous phase 3 trial. Hence trials aren't directly comparable. Oxford qualifies At the Moment and Covaxin doesn't.
Q. Even Pfizer/Moderna were approved on phase 2 data and only around half enrollment.
False. Pfizer/Moderna met their scheduled number of events (happened fast due to high Infection rate in US) and full trial and then only granted approval. https://www.wired.com/story/the-race-for-a-covid-vaccine-was-more-about-luck-than-tech/
False. Pfizer/Moderna met their scheduled number of events (happened fast due to high Infection rate in US) and full trial and then only granted approval. https://www.wired.com/story/the-race-for-a-covid-vaccine-was-more-about-luck-than-tech/
Q.Only Indian Companies are held to higher standards n mocked.
A. Partly True. However It must be remembered that Pfizer was criticized for applying for approval even at 34 events in phase 3 trial and asked for safety data for upto half of candidates for 2 months
A. Partly True. However It must be remembered that Pfizer was criticized for applying for approval even at 34 events in phase 3 trial and asked for safety data for upto half of candidates for 2 months
(95% of Vaccine side effects happen in this period). Pfizer declared efficacy (9th November) post larger events (94) and Eventually It was granted approval post full data.(11 December) For Covaxin even first Interim Analysis is pending. (43 events)
(Remember Sputnik was criticized for declaring efficacy at only 32 events.and Pfizer was forced to increase number of events at first analysis
Q. Astra Zeneca(AZ) Vaccine trial has many Issues(Dose, neurological side effects,interval ) https://www.wired.com/story/the-astrazeneca-covid-vaccine-data-isnt-up-to-snuff/
Yes AZ Infact US has asked AZ for large phase 3 trial before approval and Europe isn't too keen. And UK approved it probably pressured by Variant induced Surge. But Unfortunately this is better of 2 options available to us when all things are considered.
Q.This is an emergency and pre-pandemic rules don't apply.
A. It is a decision based on values rather than science. In India COVID-19 is tapering at the moment, a Vaccine is available and efficacy data of a promising Vaccine (Covaxin) can come In a month.
A. It is a decision based on values rather than science. In India COVID-19 is tapering at the moment, a Vaccine is available and efficacy data of a promising Vaccine (Covaxin) can come In a month.
So why discredit it like Russian and Chinese Vaccines by giving premature approval.
All this can/might change if Variant surge comes (as Guleria hinted).
All this can/might change if Variant surge comes (as Guleria hinted).
As of now even Bharat Biotech doesn't understand what clinical trial mode clearly means. And this definitely doesn't exude confidence. https://twitter.com/rdivia/status/1346074196938514433?s=20
