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Given that raw data of vaccine trials aren't even being made public I doubt that any reliable data is being collected, let alone analysed

by djbebs 5y ago

walterbell 5y ago
Progress is slowly being made on transparency. For the Omicron-specific Pfizer vaccine, the clinical trial in humans must be completed before approval and clinical trial data must be submitted at the same time (no 75-year delays). https://www.reuters.com/business/healthcare-pharmaceuticals/pfizer-biontech-launch-trial-omicron-targeted-covid-vaccine-2022-01-25/ https://www.reuters.com/business/healthcare-pharmaceuticals/... > recent study from Israel showed that while a fourth dose of an mRNA vaccine boosted antibodies, the level was not high enough to prevent infection by the Omicron variant ... the debate appears to have shifted with the European Medicines Agency (EMA) saying on Friday that international regulators now preferred clinical studies to be carried out before approval of a new vaccine ... it may not be possible to realise a current plan to launch an Omicron-targeting vaccine by the end of March ... Inclusion of clinical trial data in the regulatory filings may have an impact on the delivery of initial batches.
vkou 5y ago
At this point, given that the quantity and quality of the public data of vaccine rollouts dwarfs the data of vaccine trials in both scope and usefulness, anyone still grousing about vaccine trial data is just playing political football, for the sake of FUD. It's like arguing about the raw data of the Wright brothers flight, when millions of people are flying around the world on 747s. Was it relevant in the past? Yes. Is it relevant today? No. You want to know about vaccine safety? Look at excess mortality, hospital admissions, and long-term health problems of the vaccinated and unvaccinated populations, today. Ten billion COVID vaccines have been administered around the world in the past year. Any of the data we've gathered from that is about a thousand times more relevant to literally anything we could be doing, than raw study data on a few thousand people.
- xdennis 5y ago
  If a policeman breaks into your house without a warrant it's illegal even if he is right and you are a criminal. Procedures have to be followed.
  - vkou 5y ago
    Most legal systems do not agree with you. Fruit of the poisoned tree is a peculiarly American legal abberation, and even in the United States, it is not applicable in many cases. Most ethical and legal systems around the world, in fact, would use that evidence to both convict the criminal, and then independently recommend separate sanctions for breaking procedures. But we're not even talking about ethics or legality, here. We are talking about knowledge. People claim that we don't know about the safety of vaccines because we don't have data on trials conducted on thousands of people. ... Yet we have data about vaccines administered to billions of people. Why don't those critics look at that data, instead? It's because knowledge and fact-finding isn't the point of that complaint. The people asking about this don't actually care about having a data-driven argument about the safety or efficacy of vaccines, they just found a procedural problem, that they can play a political game with. The politics is the entire point.

Given that raw data of vaccine trials aren't even being made public I doubt that any reliable data is being collected, let alone analysed

by djbebs 5y ago

Given that raw data of vaccine trials aren't even being made public I doubt that any reliable data is being collected, let alone analysed

walterbell 5y ago

Progress is slowly being made on transparency. For the Omicron-specific Pfizer vaccine, the clinical trial in humans must be completed before approval and clinical trial data must be submitted at the same time (no 75-year delays). https://www.reuters.com/business/healthcare-pharmaceuticals/pfizer-biontech-launch-trial-omicron-targeted-covid-vaccine-2022-01-25/ https://www.reuters.com/business/healthcare-pharmaceuticals/... > recent study from Israel showed that while a fourth dose of an mRNA vaccine boosted antibodies, the level was not high enough to prevent infection by the Omicron variant ... the debate appears to have shifted with the European Medicines Agency (EMA) saying on Friday that international regulators now preferred clinical studies to be carried out before approval of a new vaccine ... it may not be possible to realise a current plan to launch an Omicron-targeting vaccine by the end of March ... Inclusion of clinical trial data in the regulatory filings may have an impact on the delivery of initial batches.

vkou 5y ago

At this point, given that the quantity and quality of the public data of vaccine rollouts dwarfs the data of vaccine trials in both scope and usefulness, anyone still grousing about vaccine trial data is just playing political football, for the sake of FUD. It's like arguing about the raw data of the Wright brothers flight, when millions of people are flying around the world on 747s. Was it relevant in the past? Yes. Is it relevant today? No. You want to know about vaccine safety? Look at excess mortality, hospital admissions, and long-term health problems of the vaccinated and unvaccinated populations, today. Ten billion COVID vaccines have been administered around the world in the past year. Any of the data we've gathered from that is about a thousand times more relevant to literally anything we could be doing, than raw study data on a few thousand people.

xdennis 5y ago
If a policeman breaks into your house without a warrant it's illegal even if he is right and you are a criminal. Procedures have to be followed.
- vkou 5y ago
  Most legal systems do not agree with you. Fruit of the poisoned tree is a peculiarly American legal abberation, and even in the United States, it is not applicable in many cases. Most ethical and legal systems around the world, in fact, would use that evidence to both convict the criminal, and then independently recommend separate sanctions for breaking procedures. But we're not even talking about ethics or legality, here. We are talking about knowledge. People claim that we don't know about the safety of vaccines because we don't have data on trials conducted on thousands of people. ... Yet we have data about vaccines administered to billions of people. Why don't those critics look at that data, instead? It's because knowledge and fact-finding isn't the point of that complaint. The people asking about this don't actually care about having a data-driven argument about the safety or efficacy of vaccines, they just found a procedural problem, that they can play a political game with. The politics is the entire point.