3 ms·

The actual pledge is here [1]. There are 4 bullet points, 3 of them are quite generic; the one that made all the waves is: "[we pledge to] Only submit for app

The actual pledge is here [1]. There are 4 bullet points, 3 of them are quite generic; the one that made all the waves is: "[we pledge to] Only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA." I feel there's some weasel wording going on here. They don't pledge to ask for approval after the completion of Phase 3. Instead they use a very convoluted phrasing, that's designed to make people think it's after Phase 3 is completed, but if you read more closely says something quite different. When is the Phase 3 for Moderna expected to be completed anyway? This is readily available information at clinicaltrials.gov [2]. The estimated study completion date is October 27, 2022. Is the CEO of Moderna saying he will not seek approval prior to that date? Pfizer's estimated study completion date is November 14, 2022 [3]. Two years from now doesn't sound quite "warp speed" to me. Did they take billions of dollars of public money to deliver a vaccine in 2 years? [1] https://www.businesswire.com/news/home/20200908005282/en/Biopharma-Leaders-Unite-Stand-Science https://www.businesswire.com/news/home/20200908005282/en/Bio... [2] https://clinicaltrials.gov/ct2/show/NCT04470427 https://clinicaltrials.gov/ct2/show/NCT04470427 [3] https://clinicaltrials.gov/ct2/show/NCT04368728 https://clinicaltrials.gov/ct2/show/NCT04368728

darkerside 6y ago
I agree. They are only saying they will demonstrate safety and efficacy through the trials, not that the trials will be technically completed. And, I think that's fine. I'm not taking a politician's word for whether that has been achieved, but I agree with it in concept.
maxerickson 6y ago
'after demonstrating safety and efficacy' is not weasel wording though, it's just a different benchmark than 'completing the study'. The headline is inaccurate, but that's on Statnews. When studies go really well, doctors consider themselves ethically obligated to end them early, so that the placebo group can receive the treatment. That these studies have planned end dates well into the future doesn't mean that they must run that long (or that it will take that long to collect sufficient safety data).
- credit_guy 6y ago
  Yes, but then the pledge is devoid of content. The act of seeking approval is a submission of evidence that demonstrate safety and efficacy. The "pledge" is essentially just saying "we'll do everything as we always planned to do it". Why make this pledge then? What's the value added? There is value added indeed. In today's climate of general mistrust, simply stating that you will not cut corners (even if there was never any possibility of cutting corners) can allay some fears. But then, who is stoking these fears? Should they know better than doing that?

darkerside 6y ago

I agree. They are only saying they will demonstrate safety and efficacy through the trials, not that the trials will be technically completed. And, I think that's fine. I'm not taking a politician's word for whether that has been achieved, but I agree with it in concept.

maxerickson 6y ago

'after demonstrating safety and efficacy' is not weasel wording though, it's just a different benchmark than 'completing the study'. The headline is inaccurate, but that's on Statnews. When studies go really well, doctors consider themselves ethically obligated to end them early, so that the placebo group can receive the treatment. That these studies have planned end dates well into the future doesn't mean that they must run that long (or that it will take that long to collect sufficient safety data).

credit_guy 6y ago
Yes, but then the pledge is devoid of content. The act of seeking approval is a submission of evidence that demonstrate safety and efficacy. The "pledge" is essentially just saying "we'll do everything as we always planned to do it". Why make this pledge then? What's the value added? There is value added indeed. In today's climate of general mistrust, simply stating that you will not cut corners (even if there was never any possibility of cutting corners) can allay some fears. But then, who is stoking these fears? Should they know better than doing that?