Thanks for that additional context Mats. I did want to follow up on US vs ex-US P1 trials.
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At this point, Pfizer and Moderna have consistently gotten mRNA vaccines into US trials in ~2 months after receiving a new sequence. Are the timelines to starting a trial in Australia/South Africa/elsewhere considerably shorter?
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As a comment, big pharma does perform vaccine trials in the global South, although this is more about seasonality than speed. Pfizer performed a major P1/P2 trial for their RSV vaccine in Australia, because the timing of RSV season in Australia matched well with the development timelines for the drug.
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One of the main arguments I see in favor of US or EU P1 trials is that the FDA/EMA are the most sophisticated regulatory agencies, and will provide more useful feedback on your development plan than other agencies. This is particularly relevant if you intend to eventually market a drug in the US, since the FDA only accepts foreign trial data if the study was conducted according to FDA requirements. Since Alvea wasn’t really targeting the US market, this is less of a consideration. Still, what do you make of this argument?
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I’d also mention that once you get to the P3/BLA stage, filling in a country with a less sophisticated regulatory agency can be a burden. My own experience is that FDA/EMA/Japan are more willing to let sponsors deviate from official guidelines if there is a good scientific justification. Meanwhile, other agencies lack the expertise to assess drugs on the merits and will fall back to saying that you must follow the guidelines. For instance, I’ve been in the maddening position before of having agencies in small countries repeatedly cite FDA guidance to argue that we need to make some change to our plans, despite the fact that our drug was already approved by the FDA without said change!
I’d like to point out that many of the articles you provided linked vegetarian / vegan diets to poor health outcomes were performed in China or global contexts. Globally, meat is quite expensive and therefore you could expect that correlational studies will find that meat intake is correlated positively with health outcomes simply due to income effects. I don’t see that as particularly strong evidence that vegan / vegetarian diets are unhealthy when most existing research finds benefits for plant-based diets, especially for cardiovascular health.
Separately from the debate of veganism vs eating meat, we have strong evidence that high intake of fiber, low intake of saturated fats, and low intake of red and/or processed meats are all correlated with positive health benefits. Given that, my prior assumption is that a vegan/vegetarian diet (which is likely to be high in fiber, low in sat fats and have zero red and/or processed meat) is generally going to be healthier. It would take very strong evidence to the contrary for me to shift my mindset to believe that vegan diets are less healthy.
Finally, if you are going to consume animal products, aside from bivalves dairy probably causes the least suffering. Wild-caught fish might be more human than farmed, but substitution effects and a fixed population of wild-caught fish means that consumption of wild-caught fish is still going to result in higher demand for farmed fish. This analysis (If You’re Going To Eat Animals, Eat Beef and Dairy — EA Forum) found that dairy has the “least suffering per kg of product.” Dairy is also a great source of B12 and Calcium, which addresses two of the key nutrient deficiencies in vegan diets. Dairy is also healthier than beef, especially if you are consuming low fat dairy products.