Thread by @IndiaSpend

Today, Deepak Maravi, 45, of Bhopal was reported to have died during a @BharatBiotech & @ICMRDELHI #COVIDvaccine trial. It is unclear if Maravi received a vaccine or a placebo, & what exactly caused his death, but a media storm has ensued. Follow @AnooBhu’s thread from Bhopal:

On Jan 3, 2021, India’s drug controller approved 2 #COVID19 vaccines, #COVISHIELD by @AstraZeneca & @UniofOxford, & #COVAXIN by @BharatBiotech & the Indian Council of Medical Research (@ICMRDELHI). The approvals were controversial as relevant data was not made public

All #vaccine trials are required to record, investigate and report on ‘adverse events’, or serious medical reactions. When these occur, a committee evaluates if the reaction was related to the vaccine. There is no information yet from @bharatbiotech on Maravi’s death

@Indiaspend has reached out to @bharatbiotech and the People’s College of Medical Sciences and Research Centre in Bhopal, where the injection was administered, for comment. We will post an update once we receive a response

For anyone part of a trial who suffers from an illness after the vaccine/drug is administered, it is difficult to understand that the events are related in time but not in cause, @Gkangind of the @WHO's working group on #COVID19 vaccines, told us in Dec 2020

Maravi’s family in Bhopal say they believe he died because of the vaccine. They have not received any information from the govt or @bharatbiotech on what happened to Maravi, they say

The post mortem report for Maravi, from Dec 22 says he died because of “cardio respiratory failure as a result of suspected poisoning”. The organs are yet to be analysed, the report says

Given the many unknowns about this death and the lack of public data on the #vaccine, Maravi’s family are in the midst of a media clamour and political storm, with Congress leader Digvijay Singh visiting the family this afternoon
(Photo credit: Anoo Bhuyan/IndiaSpend)

When India’s drug controller approved #COVAXIN, he did not make public data on the efficacy of the #vaccine. In India, #COVISHIELD & #COVAXIN are yet to complete phase 3 of their clinical trials

https://twitter.com/IndiaSpend/status/1346064459375099904?s=19

Phase 3 for #COVAXIN began on Nov 16, 2020. The vaccine is given in 2 doses, 28 days apart, per the clinical trial registry. As such, it is unlikely that there could be adequate efficacy data for the vaccine in less than 2 months from the start of trial
ctri.nic.in/Clinicaltrials…

Bharat Biotech should not be a contender for a license because it is yet to publish Phase III results for #COVAXIN, experts had told us in Dec 2020: indiaspend.com/covid-19/why-v…