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Brazil clarified today that Sputnik V:
1) contains no more than 1 live particle per billion
2) was not actually tested by Brasil but by the manufacturer in regular QC
3) is an E1/E3-deletion vaccine.
Speculation that Sputnik is chock full of live virus is not data-based.
1) contains no more than 1 live particle per billion
2) was not actually tested by Brasil but by the manufacturer in regular QC
3) is an E1/E3-deletion vaccine.
Speculation that Sputnik is chock full of live virus is not data-based.
ANVISA made a legitimate decision not to approve because they want better quality: a more intrinsically safe manufacturing process, and 300×-lower cutoff for acceptable live-virus levels. They did not make a new discovery about how Sputnik V works.
In the absence of ANVISA's clarification, I wrote that the two possibilities were recombination and contamination but not failure to delete E1/E3 (as some incorrectly assumed). ANVISA cites mfg tests that would be more consistent with recombination than contamination.
I am surprised at the credulity of many of my colleagues who FAILED TO EXAMINE THE UNDERLYING TEXTS. Now, we didn't have the full ANVISA explanation until today, just an unclear report. But there was still a lot to go on that most of covid-twitter just ignored.
