Read on Twitter
Dr Krishna Ella's (CEO, Bharat Biotech) press brief today.
He angrily described how big of blunder "dosing error" in a single-blind AZD1222 (AstraZeneca/Oxford COVID19 vaccine) trial in UK was.
Points out trial data being so unclear that @US_FDA didn't consider it.
\\1 https://twitter.com/das_seed/status/1336548968965279744
He angrily described how big of blunder "dosing error" in a single-blind AZD1222 (AstraZeneca/Oxford COVID19 vaccine) trial in UK was.Points out trial data being so unclear that @US_FDA didn't consider it.\\1 https://twitter.com/das_seed/status/1336548968965279744
In response to a local vaccine competitor's comment on how safe vaccine candidate without efficacy evidence is as good as water. \\2
https://twitter.com/das_seed/status/1345617289597644801
@BharatBiotech talks about no. of publications (Phase III ongoing). @ZydusCadila (Phase III to begin) & @SerumInstIndia (bridging trial data/results not in public domain) have no publications from Indian trials. None disclosed detailed protocols
\\3
https://twitter.com/das_seed/status/1326253041683673088
Dr Ella confused on age limit in trail phases. Minimum age limit for Phase III is 18 yrs.Phase I: 375 (all of 18-55 yrs)
Phase II: 380 (14 of 12-18 yrs
, 349 of 18-55 yrs, 17 of 55-65 yrs 
)Phase III: 25800 (all ≥18 years
)\\4
https://twitter.com/das_seed/status/1345779399363334145
Dr Ella confirms that no data from Phase III was submitted as unbliding wasn't possible at given stage. Many participants enrolled in Phase III yet to receive second dose, while enrollment isn't complete either.
\\5
https://twitter.com/das_seed/status/1326253041683673088
On safety profile of COVAXIN and COVISHIELD. Raises question on how adverse events were mitigated by giving paracetamol to trial participants for AZD1222 in UK (Indian version is called COVISHIELD).https://vaccine.icmr.org.in/images/pdf/2020.12.21.20248643v1.full.pdf
https://vaccine.icmr.org.in/images/pdf/2020.12.11.20210419v1.full.pdf
\\6
https://twitter.com/das_seed/status/1343664922689994752
Stockpiled 20 million doses. Aiming to reach capacity of 700 million doses over 4 facilities (3 in Hyderabad, 1 in Banaglore).[Is it being ensured that essential vaccines manufacturing & supplies not only don't see any downslide but are scaled-up as per need?]
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Cost of price would initially be high as volume production would be low. With increase in volume, price would get lower. Price will later be demand by competition in the market once more options are available. \\8
https://twitter.com/ndtv/status/1345761646564704263
Government is talking to @BharatBiotech for procurement of COVAXIN. Only hypothesis that COVAXIN is effective against SARS-CoV-2 B.1.1.7 strain. No such study data was submitted to CDSCO; need more time for suggestive evidences.\\9
https://twitter.com/ndtv/status/1346120643054501888
"Clinical trial mode" confusion. Ella thinks it is like post-marketing surveillance (Phase IV). [Already uncertainty about restricted emergency use, which in application has become full approval, now we've clinical trial mode w/in emergency use].
\\10
https://twitter.com/das_seed/status/1327319807516172296
Dr Ella says he hasn't got monetary grants from @gatesfoundation, govt or other agencies. He claimed they took complete risk. [COVAXIN is developed by ICMR-NIV along w/ some pre-clinical studies. ICMR is co-sponsor for Phase III trials.]
\\12
https://twitter.com/das_seed/status/1333124539765710848
Clinical Trials Rules 2019 @CDSCO_INDIA_INF & @MoHFW_INDIA has provision for emergency approval w/o efficacy trial. @BharatBiotech made use of it. [Regulatory mishaps for COVID19 treatment related drugs ]
\\13
https://twitter.com/das_seed/status/1327319807516172296
On safety profile of COVAXIN and COVISHIELD. Raises question on how adverse events were mitigated by giving paracetamol to trial participants for AZD1222 in UK (Indian version is called COVISHIELD).https://vaccine.icmr.org.in/images/pdf/2020.12.21.20248643v1.full.pdf
https://vaccine.icmr.org.in/images/pdf/2020.12.11.20210419v1.full.pdf
\\17 https://twitter.com/das_seed/status/1343664922689994752
No clue as to what "clinical trial mode" means.[Can participants in Phase III demand unblinding & get COVAXIN, since DCGI & ICMR thinks it's probably efficacious enough? How ethical is it to have Phase III along w/ emergency use?
]\\18
https://twitter.com/malini_aisola/status/1337850482010718208
Data that led to grant of emergency approval in lack of human efficacy data:
Excellent animal challenging data
Strong neutralizing antibodies titers data
Long term immuno-response data
(No human data could be submitted on age 65+ years)
\\
https://twitter.com/das_seed/status/1337797742777733120
Excellent animal challenging dataStrong neutralizing antibodies titers dataLong term immuno-response data(No human data could be submitted on age 65+ years)
\\
https://twitter.com/das_seed/status/1337797742777733120
[
tl;dr] COVAXIN vs COVISHIELD regulatory approval is like analogous to:
One kid didn't do homework, while other kid did partial homework but mostly wrong. Both kids get to pass since school wanted to have early graduates.
[And public health fails.]
https://twitter.com/das_seed/status/1344981093389393922
tl;dr] COVAXIN vs COVISHIELD regulatory approval is like analogous to:One kid didn't do homework, while other kid did partial homework but mostly wrong. Both kids get to pass since school wanted to have early graduates.
[And public health fails.]
https://twitter.com/das_seed/status/1344981093389393922
