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.
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.
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.