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The five board members of Brazil's regulatory authority, Anvisa, have unanimously voted not to allow imports of Russia's Sputnik V vaccine. Several Brazilian states, municipalities, and the federal government have already bought millions of doses. (1/12) https://www.reuters.com/world/americas/brazil-health-regulator-anvisas-technical-staff-recommend-against-importing-2021-04-26/
The call on whether to let Brazil's pharma company União Química produce Sputnik V, as planned, is pending. The company's president is furious with Anvisa's requests for more data, calling it "hair in the egg" -- looking for the slightest justification not to do something. (2/12)
BBC details here the factors leading to Anvisa's decision to reject imports. First, incomplete data. Anvisa's spokesperson said there were "certainties but a sea of uncertainties" — noting that this decision could change if new data were presented. (3/12) https://www.bbc.com/portuguese/brasil-56897420#:~:text=A%20Anvisa%20n%C3%A3o%20teve%20acesso%20ao%20Instituto%20Gamaleya&text=%22Disseram%20que%2C%20por%20se%20tratar,foram%20apresentados%20dados%20e%20informa%C3%A7%C3%B5es
Anvisa was reportedly denied access to the Gamaleya Institute -- where Sputnik V was developed, and where quality control is carried out -- several times during its inspection visit to Moscow. The Anvisa spokesperson described the situation as "frustrating." (4/12)
Second -- and I'm burying the lede here -- in *all* the Sputnik V batches sent to Brazil for lab testing, the adenoviruses used in the vaccine, which are supposed to be modified so that they can't replicate after entering human cells, were able to replicate. (5/12)
We don't know how this might affect the health of someone who's received the vaccine. Anvisa says, "the correct strategy would be to develop a study on the potential impact of this." But there is no indication that Gamaleya has done so. (6/12)
Third, Anvisa was unable to validate the methodology Russian studies used to measure the immune system response generated by Sputnik V. There were also issues with the criteria and processes Gamaleya used to track and describe adverse events following vaccination. (7/12)
Fourth, there were questions about the quality of Sputnik V's efficacy data (reported at 91.6% in the Lancet), stemming from uncertainties about the study protocols that were in place: collection of samples, monitoring of symptoms, other issues. (8/12)
Finally, quality control. At a factory visit in Russia, Anvisa detected problems that could affect the sterility of the vaccine. There isn't adequate guarantee that the Sputnik V leaving manufacturing facilities is the same Sputnik V that was produced in Gamaleya's labs. (9/12)
Slovakia found these same inconsistency issues a few weeks ago, and you can bet this is high on the list of things WHO and EMA are checking in their ongoing review of Sputnik V. (10/12) https://www.nytimes.com/2021/04/08/world/europe/slovakia-coronavirus-russia-vaccine-sputnik.html
Not surprisingly, Sputnik V's developers are reacting strongly to this news, calling Anvisa's rejection a politically motivated decision. (11/12) https://www.themoscowtimes.com/2021/04/27/russia-accuses-brazil-of-political-sputnik-v-rejection-a73748
But Anvisa is a respected regulator with a reputation for thorough review. The smart Russian response would be to produce the data (!!!) so that Sputnik V can undergo the same level of rigorous int'l scrutiny as other covid vaccines. (12/12) https://www.outsourcing-pharma.com/Article/2015/06/10/Exporting-to-Brazil-ANVISA-is-tough-and-hands-on-says-Kemwell?utm_source=newsletter_daily&utm_medium=email&utm_campaign=11-Jun-2015&c=frllEubEPtJ7jX0j6z2sIw%3D%3D&p2#
