Clarissa writes:
Hi Rich,
I listened to TWIV yesterday. Very good discussion and explanations. Thank you.
The discussions are still ongoing here because now Russia decides to go forward with a one-dose vaccine, Sputnik light.
However, it’s important to look at Anvisa not as an academic group of scientists like us reviewing a paper. The regulatory agencies are entitled to request any documents they feel it’s necessary to assure the safety and efficacy of products offered by any company. The FDA does the same. It took more than 15 years I think for FDA to approve ST-246, each time requesting another set of animal assays.
As I understood, ANVISA requested further documents on safety and about the replication-competent adenovirus, and Gamaleya instead of providing them at once, replied that ANVISA was being political. So Anvisa refused to approve the vaccine once the documents were not presented. Then Gamaleya released the document you discussed yesterday as a response to ANVISA.
The bottom line is that all the discussion turned out to be political, and Gamaleya probably should have just dropped the attitude and responded to a regulatory agency. The burden of proof lies with the developer. On the other hand, ANVISA should have not fed the press with accusations against Gamaleya.
Too bad all this. It just holds the vaccination program here.
Clarissa
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Clarissa Damaso, Ph.D.
Associate Professor
Universidade Federal do Rio de Janeiro
Roel writes:
Hi Twivers,
Love the podcast, I am an avid listener of all the twi series (especially enjoying the twiv non-covid episodes).
Following the discussion about the Sputnik vaccine/Anvisa, I decided to dig a little deeper as I found it hard to accept that an institute like Anvisa could misinterpret results regarding quantification limits.
Luckily I understand Portuguese and could read through some Brazilian media. As it turns out, the issue for Anvisa is that the Gamaleya institute specifies a limit for replicating virus of 5000 per dose. Anvisa wants this limit to be 0 (or under the limit of quantification). They are not arguing that the current batches aren’t fine (these are all under the LOQ), it’s that they don’t want future batches to possibly contain replicating virus up to 5000 per dose.
Below you can find a link for a part of the document in question (the table is in English).
https://super.abril.com.br/wp-content/uploads/2021/04/anvisa-documento-gamaleya.png
Kind regards,
Roel from Belgium
Ivan writes:
Hi Twivers, as you know Astronaut Michael Collins died April 28th at the age of 90. As I read his obituary in the NY Times, I got re-acquainted with his amazing life story, and how he dealt with being the one left to pilot the ship, while his two crewmates descended in the lunar module to land on and walk on the moon!
From the NYT’s obituary:
“Colonel Collins was greatly worried about the moment when the lunar module was to blast off from the moon to dock with Columbia for the trip back to Earth. He knew that if the lander’s ascent engine malfunctioned, Mr. Armstrong and Colonel Aldrin might be stranded on the lunar surface, or sent into a wild orbit.
“What happens if they veer this way, that way, the other way?” he remarked 50 years later, noting that he had carried a packet around his neck containing 18 contingency plans for rescuing his crewmates.
As he wrote of the moment in his memoir: “My secret terror for the last six months has been leaving them on the moon and returning to Earth alone; now I am within minutes of finding out the truth of the matter. If they fail to rise from the surface, or crash back into it, I am not going to commit suicide; I am coming home, forthwith, but I will be a marked man for life and I know it.” “
My pick is an interactive feature that I found alongside the obituary, called
“Apollo 11: As They Shot It.”
You may have seen it when it was first published. It takes the text of the dialogue between Armstrong, Aldrin, Collins and Mission Control during the lunar landing, the moonwalk and the return of the lunar module to Columbia and intersperses it with the actual photos they took with their Hasselblad camera.
It is surprisingly exciting and moving.
Thanks, and keep up the great work,
-Ivan
Michael Collins Obituary:
https://www.nytimes.com/2021/04/28/Obituary
“Apollo 11: As They Shot It.”