This news came on the same day the FDA announced that it has given full authorization to Pfizer’s coronavirus vaccine, a move that will make it easier for governments and private companies to enforce mandates among employees.
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The thing with drug approvals is that they occur at the interface between science and public policy. One can be a strong supporter of the international scientific community and still be skeptical regarding the influence of certain more authoritarian regimes… including a certain former US president.
As for the quality and effectiveness standing up… I hope you are right, but I fear that we are running the experiment as we speak.
ETA: to clarify, by “quality and effectiveness” I am referring to Sputnik, SinoVac, etc. as opposed to the vaccines currently authorized by the FDA and/or EMA on a permanent or emergency basis.
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Institutions built up over a century are not so easy to completely undermine as you might think. One thing that did come out of this whole debacle of the former president, was that many of our institutions DID hold up under an authoritarian assault, including the FDA. But, I am less concerned with those sorts of organizations and more concerned with the continued attacks on our political institutions.
Plus, the MRNA type vaccinces were not developed overnight, but have been in development since at least the 1980s… Pfizer, Moderna, etc, were simply building on years of research and applying it to this specific virus.
Plus, at this point HUNDREDS OF MILLIONS OF PEOPLE have gotten the vaccine with what seem like the expected amount of problems.
At this point, if you’re not vaccincated for a good reason (lack of access, medical advice, etc), then you are pretty much part of the problem here.
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Agreed 100%.
The only reason I brought up the unmentionable one is because one of his appointees at the FDA did overstep the scientists to approve Biogen’s mAb indicated for Alzheimer’s, which smells like snake oil to me but is also probably OT.
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And yet, we now have full approval of one of the vaccines. This is not to say that the FDA is perfect or can’t be impacted by political considerations. Any institution can. But most of us can rely on the drugs that are approved by the FDA to do what it was meant to do. On the whole, I’d argue that the FDA is one of our more robust institutions. There are clearly other institutions that are more fragile and prone to political interference, such as our voting systems and our political systems. If you want to ensure that institutions like the FDA continue to function and can be made even more robust and insulated from politics, we need to focus on ensuring our electoral system.
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What you said, and you might as well have been wearing jodphers, was that the “only” regulatory institutions you take seriously in the whole wide world are the US FDA and the EU EMA.
Hot damn
Maybe you are unaware that the laws of many countrues require that their own regulatory bodies run their own clinical trials for safety and effectiveness after their scientists have approved QA.
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Can we maybe assume good faith and not make Nazi pants insults? Or was that a reference to British imperialists? So many of history’s assholes wore silly pants, apparently. This is completely atypical for you based on your comment history, so I apologize if I have wronged you, but WTF?
Sure, every country has their own regulatory agency, but the largest markets by far are the US and the EU and they are also the biggest players in pharma R&D. For these reasons, most drugs are first developed in the US/EU. These are the areas where the expertise in launching new products is concentrated, so this is the norm. If I see a drug that is approved in country X, but not in the US or EU, it raises certain questions:
- Is it inferior to existing drugs in the US/EU?
- Does it have issues that preclude approval in the US/EU?
- Was it developed somewhere else and is now pending in the US and/or EU? If so, why?
So yeah, when I see new launches in atypical markets, it makes me wonder what the catch is and recalibrate my expectations accordingly. I was originally going for a pithy statement for why I thought the local AZ vaccine was a better option than the local Sputnik, while admitting that I (like anyone) am not perfectly objective. Perhaps I should have more explicitly said that I think that the FDA and EMA are the best arbiters of safety and efficacy and that I am less confident in the vaccines developed in more totalitarian countries until they have been reviewed by the EMA/FDA. As far as I know, the EMA is still reviewing the Sputnik application, but the data is messy.
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Their point was that there is more to the world than the US, Europe, Russia and China and there is absolutely no reason to dismiss the professionalism or good faith of, say, the Argentine or Thai medical authorities. These are also people who love their families and don’t want to poison their compatriots.
The jodphurs were clearly an allusion to imperialism, I don’t think anyone associates them with Nazis as their first thought.
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The situation in Thailand is an omnishambles caused by incompetent politicians who have prioritised sucking up to King Vajiralongkorn and positioning him as the nation’s saviour. The government persuaded AstraZeneca to grant a licence to Siam Bioscience, a small company owned by the king, which has never made vaccines before and cannot deliver enough.
In July 2021, the National Vaccine Institute apologized for slow vaccine deployment.[12] Meanwhile, the government’s prior commitment to secure 61 million doses of AstraZeneca vaccine became doubted after a leaked document showed that the company would deliver no more than 60 percent of the number planned per month.[13] A virology advisor also endorsed an untested plan to mix AstraZeneca and Sinovac vaccines.[14] There was already a report of death from the practice, but health professionals said they have to rule out other causes first.[15]
COVID-19 vaccination in Thailand - Wikipedia
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My take has nothing to do with local professionalism or good faith. Pharma is a global industry that is focused on the larger markets. As such, the regulatory authorities in the larger markets are the key gatekeepers. They are the agencies that see applications for new medications, therefore they are the agencies with the most expertise on evaluating new medications. Therefore, it is pretty weird when a new medication is not launched in the largest markets.
The covid vaccines in TH and AR, to use your examples, are licensed versions of vaccines developed and launched in other countries. Regardless of their personal and professional qualities, the TH and AR medical authorities are regulating products that already underwent the review process in larger markets. Some of the vaccines in question have been reviewed by the EMA or FDA, who have the most expertise, the most resources, and the best track record. Therefore, my recommendation with regards to efficacy is to choose the EMA or FDA authorized products first, licensed versions thereof second, and other options third. I would be mindful of any and all safety warnings, though.
I think people see a lot more depictions of WWII villains than Victorian Brits in the media, so the only thing that was clear to me was an accusation of extreme cultural chauvinism. My take is based on experience, resources, and track records. Granted, these are things that the US and EU possess at least partially from unearned advantages due to historical inequities rooted in colonialism, but that is not a perspective that I consider when rating meds.
This is a good example of how social breakdown and creeping neoliberal policies force everyone – even those adamantly opposed in principle – to consider taking personal decisions that are at odds with the greater good, like getting a booster when there are third world countries begging for first doses. Because a functioning society with a robust ethos of social cohesion would not put individuals in that position.
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Hear Hear.
That’s exactly what I came to when feeling out my initial blood boil when my momma told me about everyone she knows up there already getting booster shots. Da fuk you gonna do?
I also think sometimes about how neoliberal mindset messed up mitigation guidance in the USA - that whole mess where an emerging elite fully vaccinated population was going to be privileged with not wearing masks anymore. I mean, how was that supposed to be more encouraging to get vaccines than a more social - cohesion approach which would be: we can stop with the itchy masks when everyone has the dose. We’re seeing that all the democrat’s carrots don’t hold a candle to the negative social pressure of the republican’s stick.
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= any market that is not the USA or EU
ymmv
Correct. Those are the biggest markets. If a drug is marketed elsewhere, but not authorized in the biggest markets, that raises a red flag as far as I am concerned.
I think we are talking past each other. I respect your point of view, I carefully considered your remarks, but clearly my perspective is offensive to you. Our point of dispute is much closer to home for you than it is for me, so I am going to politely step out of this conversation. I am not going to ignore you, because you do have a lot of great and interesting comments, but I am going to respect your space.
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Just got my third dose, because I have a compromised immune system and don’t want to die from COVID. Nor do I want to spread it to others. If it bothers you that I’m doing what I need to do to stay healthy, tough shit.
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I would gently ask you to please read a post to the end before you come all aggro at me, cussing and challenging. It makes me feel attacked and I wasn’t attacking any individual person who gets boosters - I was talking about a generalized angry desperation as my loved ones who are worth as much as you are, wait in line for 2nd doses, and our teens wait for the 1st, while agreeing that I’d probably do the same thing in your shoes. So please step back from me; thank you.
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Yep, you’re right - I checked out after that line. Apologies, and no hard feelings.
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None harbored. Appreciate you taking the time to apologize. 
I truly hopeyou stay safe up there in such a scary situation.
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Not to mention the fact that people are powerfully influenced by social norms.
You can bet your ass that the moment a certain proportion of vaccinated folks started showing up in stores not wearing masks – as they had been told they were good to do by the powers that be – most of the unvaccinated didn’t interpret that with the higher cognition nuance of “Oh those lucky folks who don’t have to wear masks, I should really get vaxxed so I can do the same” but instead with the much more basic human social brain thought process of “Looks like masks are no longer the norm in this setting, so I’m good to take mine off as well.”
The strategy you mention would have reduced that stupidity as well.
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