about unproven and unlicensed vaccines of China
Except that...
Taking safety, immunogenicity, and production capacity into account, the 3 μg dose of CoronaVac is the suggested dose for efficacy assessment in future phase 3 trials.
www.thelancet.com
Sinovac is validated with published phase 1 and phase 2 data and ongoing phase 3 data collection. That is the standard required for vaccine validation everywhere as per WHO guidance.
How's the Bharat vaccine going? Last I heard, Somani sahib assured Indians that it was validated "in clinical trial mode". Is it still in clinical trial mode (I.e. India has no published data to support its authorisation of this vaccine, so it is continuing its "trial" phase 1/2 data collection after the official rollout)?
Here's what Bharat vaccine has published in the Lancet. Note that it is barely out of phase 1, and actual data in the publication is limited. This is in sharp contrast to what Sinopharm published in the same journal, and in contrast to what other vaccine studies have published in USA, UK etc.
“BBV152 (Covaxin) led to tolerable safety outcomes and enhanced immune responses. Both Algel-IMDG formulations were selected for phase 2 immunogenicity trials. Further efficacy trials are warranted," the results said.
As I predicted, all hell has indeed broken loose over India's shoddy workmanship and corner-cutting...this is the BMJ, not some two bit tabloid:
"News
India: Doctors call for investigation into allegations of ethical abuse in covid-19 vaccine trial
BMJ 2021; 372 doi:
https://doi.org/10.1136/bmj.n131 (Published 14 January 2021)Cite this as: BMJ 2021;372:n131
Read our latest coverage of the coronavirus outbreak
- India Correspondent BMJ
- Author affiliations
Multiple health groups in India have called for an investigation into allegations of ethical violations during a clinical trial of a covid-19 vaccine developed jointly by India’s Bharat Biotech and the Indian Council of Medical Research.
In a statement released on 14 January, groups of doctors and health rights advocates asked the Indian government to halt the trial at the People’s Hospital in Bhopal, exclude any data from the site during trial analysis, and take action against those responsible for violations.
The Bharat Biotech vaccine is among two covid-19 vaccines granted accelerated approval on 3 January by India’s drug regulatory authority for restricted emergency use, relying on safety and immunogenicity data without efficacy data.
1
India has also approved the Oxford AstraZeneca vaccine, after reviewing safety, immunogenicity, and efficacy data from outside India and safety and immunogenicity data in India. A trial to evaluate the efficacy of the Bharat Biotech vaccine has enrolled 25 800 participants at 25 sites in 12 cities.
Seven participants enrolled in the trial by the People’s Hospital have claimed that they were not informed that they would receive either a vaccine or a placebo. In testimonies at a press conference on 10 January, the participants said that they were told that they would receive a vaccine that would protect them from the novel coronavirus and had been paid Rs750 (£7.5; €8.6; $10.3) to have the injections"
Multiple health groups in India have called for an investigation into allegations of ethical violations during a clinical trial of a covid-19 vaccine developed jointly by India’s Bharat Biotech and the Indian Council of Medical Research. In a statement released on 14 January, groups of doctors...
www.bmj.com
