Anvisa (Brazil's drug regulator) just held a press conference on Sputnik V, including responding to the developers' allegations about their assessment & decision. You can see it here Live-tweeted (in Portuguese) by @jasonptodd
https://twitter.com/jasonptodd/status/1387859091352064005..1/n
...They confirmed the presence of replication-competent adenovirus in Ad5 (2nd shot) batches wasn't a finding of their own batch testing - it was reported to them by Gameleya (developers of Sputnik V), who had apparently set a high level of acceptable replication-competence...2/n
...for the Ad5 shot (but not for the 1st, Ad26, dose). They pointed to the US FDA standard for this, here: fda.gov/media/113760/d… That's what they expected Gamaleya to certify. However, apparently Gamaleya set the level at 300, not 3 ...3/n 
...Here's are screenshots of excerpts from Gamaleya's dossier they showed: in English. If I'm understanding this correctly, it's results for 3 batches, all saying the levels were below 1 x 10^2, which is higher than the FDA maximum.../4n
...So Anvisa then had a videoconference with the Russian laboratory on March 23. They re-played this bit, where this section of the dossier explaining why the Ad26 shot wasn't tested (arguing that it's not possible for it to occur - I'm not qualified to comment on this) ...5/n
...The next relevant bit of the tape is Anvisa asking (in English) why they didn't go back & use a method (presumably for the Ad5 shot) that made recombination impossible: audio played back is Portuguese translation of what was presumably a Russian answer ...6/n
...The next snippet shown was the Gamaleya spokesperson confiming (in English) that they appreciated the data Anvisa was requesting - tests showing an absence of these particles (⬇️) & asking that a list of all outstanding questions after the meeting would be helpful...7/n
...So Anvisa sent the list of data/test results they needed to see: on March 26 they got a reply that included none of it. ...8/n
...Then Mendes (head of the relevant Anvisa department) explained what a drug dossier provided by a drug developer to a drug regulator is, how much detail it contains - showed the size...9/n
... tl;dr? Anvisa had the receipts.
Moral to this story? Do not mess with a well-resourced & transparent drug regulator. Just in case anyone had any doubts.
(And yes, they've sent this to EMA & WHO.) 10/10
Moral to this story? Do not mess with a well-resourced & transparent drug regulator. Just in case anyone had any doubts.
(And yes, they've sent this to EMA & WHO.) 10/10
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