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Hilda Bastian, PhD Profile picture
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29 Apr, 10 tweets, 4 min read
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 ..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

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More from @hildabast

Hilda Bastian, PhD Profile picture
26 Apr
Anvisa (Brazil's drug regulator) has just announced it has denied the request to import Sputnik V vaccine because of absence of data & issues with the development of the vaccine, including vax quality. g1.globo.com/bemestar/vacin… Meeting still streaming ..1/n
...Unanswered questions about the vaccine include basic biological data about its actions in the body, data on adverse events (including questions about thromboembolic events) ...2/n
...I think with all the focus on Lancet paper for phase 3, people forget how little study there had been of this vax: eg only 38 people in phase 1/2 trial version with lots of problems. (absolutelymaybe.plos.org/2020/09/11/pha…) Assessing a vaccine isn't only about the phase 3 trial results...3/n
Read 13 tweets
Hilda Bastian, PhD Profile picture
17 Apr
Woke up to see this BBC graphic & claim doing the rounds. It's a great example of how data can come with a variety of biases & why perspectives on Covid vaccines is dramatically skewed in entire countries because of national/media bias. Here's why...1/n
..First the claim about AZ being the cheapest: it's on the cheaper end, but it's not the cheapest.

There are 2 aspects to this: the costs of a dose & the costs of vaccinating. Eg vaccinating with a single dose is far cheaper; needing super-freezers is far more expensive...2/n
...Out of vaxes on the BBC list, cheapest per person are Covaxin & CanSino (single dose).

J&J not far off AZ in real costs: manufactured in richer countries so doses more expensive, but it's one of several non-profit vaccines & it's a single dose ...3/n

absolutelymaybe.plos.org/2021/03/16/com…
Read 15 tweets
Hilda Bastian, PhD Profile picture
16 Apr
Sinovac's CoronaVac in Chile: for Feb-Mar, during major outbreak. Data from National Health Fund, comparisons adjusted for age, gender, region, income, nationality. Fully vaccinated after 14 days was effective; 1 dose wasn't ...1/n
minsal.cl/wp-content/upl… (TY for all the alerts!)
...Data doesn't report dosing interval. Covers about 10.5 million aged 16+. 34% of the group was fully vaccinated, but only the CoronaVac data reported here. Comparisons are for people with positive PCR tests: no info on how good that coverage is...2/n
...5.1m had 2 doses, 7.6m, 1; 90% are CoronaVac, reported here. Partially vaxed = 14 days after 1 dose; fully = 14 days after 2.

Symptomatic Covid-19:
- Partial: 16.1% (CI 14-18)
- Full: 66.96% (CI 65-69)

Hospitalized:
- Partial: 36.7% (CI 32-39)
- Full: 84.8% (CI 83-87)

3/n
Read 5 tweets
Hilda Bastian, PhD Profile picture
15 Apr
Sinovac's CoronaVac, in healthcare workers in Uni of São Paulo hospital vs the city: considerable uncertainty, but suggests ca 50% effective despite high level of variants of concern 2 wks after dose 2, rising to around 70% some weeks later...1/n medrxiv.org/content/10.110… Preprint
.For the healthcare workers, "cases" = Covid-19, symptomatic & confirmed. Around 22,000 healthcare workers were vaccinated. If they had symptoms, they left work & got tested... 2/n
...The data are compared with the officially published rates of Covid-19 in the city (presumably not necessarily all symptomatic). Early testing was inadequate as the rate of confirmed cases didn't track with deaths. Later on though the estimates for the city more reliable...3/n
Read 6 tweets
Hilda Bastian, PhD Profile picture
13 Apr
Some things to keep in mind when you see people dumping on "low efficacy" of "Chinese Covid vaccines", particularly based on that single medium-sized trial in Brazil of doses only 2 weeks apart...1/n
...There's the obvious ones: the results of this trial aren't the whole picture - not of the trials that are underway, nor of the way the vaccine is being used (doses more than 2 wks apart)...2/n
...The efficacy against fearsome outcomes was good in this trial - a vaccine that could prevent over 80% of the worst outcomes & reduce the severity in a major way is incredibly needed in a world bereft of enough options...3/n
Read 9 tweets
Hilda Bastian, PhD Profile picture
11 Apr
Preprint on Brazilian trial by @butantanoficial of Sinovac's CoronaVac, 2 weeks apart. Data for 9,823 people who had 2 doses, 12,396 after 1 dose.The P1 ("Brazilian") variant of concern was not circulating in the areas the trial ran...1/n papers.ssrn.com/sol3/papers.cf… HT @josegallucci
...14-day interval seems too close, & immunity may increase over time: they recommend 28 days. Their primary efficacy, unlike other vax trials, includes people who had previous SARS-CoV-2 infection. But this table provides the comparable number: 50.5% (CI 34-63)..2/n
...Their primary efficacy analysis was based on 85 vs 168 people with symptomatic Covid-19. Unfortunately, they don't provide detailed data on symptoms so can't try to see whether this was milder disease than other trials... 3/n
Read 10 tweets

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