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Since the extraordinary initial announcement last August, everything about Sputnik V has seemed worthy of detailed scrutiny...
My piece in @bmj_latest on Open Data, the weaknesses of peer review and #Sputnikvaccine
https://www.bmj.com/content/373/bmj.n1108
My piece in @bmj_latest on Open Data, the weaknesses of peer review and #Sputnikvaccine
https://www.bmj.com/content/373/bmj.n1108
Sputnik was developed at an institution in a country with no substantial track record of vaccine development and was intensively marketed without being submitted for authorisation to a major regulator.
These things alone might have raised the need for exceptional caution in publishing the results of a phase III vaccine trial. Yet The Lancet chose to accompany publication with favourable editorials that made no mention of the need for regulatory scrutiny https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00191-4/fulltext
After publication, credible concerns around the data were raised, but the Lancet has been unable or unwilling to enforce the data sharing agreements. Here are some of the concerns https://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(20)31960-7.pdf
& here https://www.nature.com/articles/d41586-020-02619-4
& here https://cattiviscienziati.com/2020/09/07/note-of-concern/
& here https://www.nature.com/articles/d41586-020-02619-4
& here https://cattiviscienziati.com/2020/09/07/note-of-concern/
The Lancet does phenomenal work highlighting causes and work I care deeply about - global health, infant nutrition and open data. But their stated enthusiasm for open data isn't supported by their actions or responses to questions here.
If Sputnik is not authorised we will need to ask
1. how much avoidable harm was caused by overconfidence in The Lancet's peer review process
2. how far reaching will the damage be to the publicâs already fragile confidence in vaccines that are truly safe and effective.
1. how much avoidable harm was caused by overconfidence in The Lancet's peer review process
2. how far reaching will the damage be to the publicâs already fragile confidence in vaccines that are truly safe and effective.
