Such a lot packed into a short phrase

However, the incremental trials required before a commercial vaccine could be rolled out are still a lengthy undertaking – and an essential one to ensure that even rare side-effects are spotted. A commercially available vaccine within a year would be quick.

Not really and not quite. There’s a rather large amount of bureaucratic form filling that is required. We can argue about how much is sensible with standard treatments. In fact, we do, I coming down on the side of the FDA etc being hopelessly, counter-productively, strict and expensive on such matters. More die because of the delays than are saved by the absence of side effects that is.

And sure, there are fast lanes for vaccines for something threatening to go pandemic and all that. But it’s still true that significant parts of the delay are imposed by the regulatory process, not the development one. And, you know, perhaps we should lift some chunk of that regulatory delay?

22 thoughts on “Such a lot packed into a short phrase”

  1. Well you seem to be suggesting lifting the “regulatory delay” of efficacy trials. Which is not a good idea.

    If it doesn’t work there is no point rolling it out to the world. If it does, the regulatory approval can be done, and would be in a case like this, pretty quickly.

  2. As Rappoport points out the vaccine may well be a POS itself.

    Heavy metals and possible genetic modification are only two little side effects that might prove to be little problems. As protection for something we don’t even have any decent facts about.

    They can inject the vaccs into their dicks. Anyone taking it cos some political piggy says its a good idea is a fool. But fostering panic and seeing how far they can push tyranny is what this mystery bug is all about.

  3. Bloke in North Dorset

    I appreciate it’s not that simple, but couldn’t they start the trials on health service staff who are most at risk?

    If it works some time has been saved if it doesn’t nothing lost.

  4. One form of regulatory delay that should indeed be abandoned for Coronavirus vaccines, and arguably other medicinal products is sequential geographic registrations. If a vaccine were to be properly approved in a country with first tier and well respected regulatory and safety processes, let’s say the US FDA, then mutual recognition of the approval should be fast tracked through other countries / regions. You could argue that mutual recognition exists in the EU via the European Medicines Agency, but the inherent complexity of that system still introduces administrative delays that can take several years to address which is wholly inappropriate when you are trying to prevent a pandemic via the vaccination route. What we need in this case is the mind set that if the Americans, British, Australian or other scientifically robust Health Agencies approve a vaccine, it should gain automatic temporary approval elsewhere. Of course, this would require bureaucratic abandonment of self-importance, so don’t hold your breath.

  5. Don’t forget the SARS vaccine that created a cytokine storm in the immune system, generally lethal.
    For testing use over 80s, those most likely to benefit from it.
    Swine flu: the remedy Tamiflu made billions for its manufacturers, was useless and caused idiosyncratic reactions, some potentially lethal in my daughters’ case.
    Caution, scepticism, cynicism all essential.

  6. ” scientifically robust”–there really aren’t any. They are an establishment of medical/bureaucratic hacks. Who know their own self interest and put it above public safety. They are slightly less self-serving than the media I suppose.

    I would take no chances on their concern or competence. Perhaps if inevitable death was an immediate alternative it might be worth the risk of taking whatever “vaccine” they produce.

    We are very very far from that.

  7. Bind, very likely what will happen. There will be no shortage of volunteers to trial this vaccine. And that’s usually the biggest bottleneck.

    No one in pharma has ever complained to me that regulatory reviews take too long. They do have a problem with the response phases being unmanageably short, but that’s pharma dithering.

    Mutual recognition isn’t necessary because the registration documentation is almost completely the same everywhere.

  8. Mr Worst, shouldn’t you currently be inveighing over the grotesque failure of the USA’s very own CDC’s failure to provide test kits?

  9. BiG “No one in pharma has ever complained to me that regulatory reviews take too long.“ – that may be the view of the regulatory affairs scientists preparing the dossiers, for whom it’s their bread and butter, but it’s not the view of the business. I agree that when the questions come from the agencies that the timeframe for responses is often unfeasibly short resulting in an all hands to the pump panic in some cases, but the real delays result from clock stops by the regulators to bypass legislative time limits on review times and overly lengthy agency review times often resulting from inadequate staffing of scientific reviewers.

    Mr Ecks: I share your cynicism about the managerial civil servants in the agencies, but there are some fine scientists amongst the reviewers “at the coal face” likewise in the R&D and regulatory / safety groups in the pharma companies.

    My point being, let the scientists do their jobs to satisfy legitimate safety and efficacy concerns, but have the political class and agency management facilitate rapid turnaround via true International mutual recognition.

  10. Mr in Germany, taking up your recent theme of governments making things worse by overreacting, would you consider that box ticked by relaxing regulation or by maintaining it?

  11. “The death toll so far is negligible- ordinary flu kills more people.”

    But I am enjoying the daily body counts from Quang Tri Province. It’s like I was 20 again.

  12. Will,
    Regulators don’t do clock stops, pharma does. Timelines are legally binding on the regulators, at least EMA.

    M’lud, vaccines really aren’t my thing, the science and the regulatory approvals are a bit different. For flu vaccine the approvals are already done very quickly, every year. You need at least evidence that the vaccine is safe before it can be distributed, most vaccines are very safe, and you need to show it works. The latter would probably be one of the fastest ever phase 3 trials if there were a product ready to tests which there is not.

    I guess the short answer is there is probably no need to reduce the box ticking. It will be fast enough to approve an effective product while keeping out the various Ecks ‘ Miracle Serums.

  13. Interestingly CVD drugs can be sold without any evidence that they stop heart attacks or extend life. It’s enough to prove they reduce cholesterol.

    (Or so I understand. Anyone?)

  14. Not quite true, there is good evidence that statins reduce cardiovascular mortality, but the effect is quite small (most patients receive no benefit from treatment, at least in terms of the endpoints looked at).

    Regs are very interested in clinically relevant endpoints, but the definition of a clinically relevant endpoint changes over time. For example, blood pressure, which is really a surrogate endpoint, is now effectively considered a clinically relevant endpoint, without having to go and show lower morbiditiy/mortality for every product, because it is so incontrovertibly established that lower BP means less damage to blood vessels in the kidney, brain, eyes, and lower risk of stroke and MI, the only question a new product that works in terms of BP control has to answer (at the point of marketing at least) is “Is it safe?”.

  15. “Not quite true, there is good evidence that statins reduce cardiovascular mortality,” Actually you have just confirmed my point. The competitors for statins are asked simply to reduce cholesterol, as I understand it.

  16. As a former statin taker* . . . as was explained by my doctor, statins reduce cardiovascular mortality, as BiG said, though it seems to have nothing to do with cholesterol (!).

    *Unbearable side effects. Dizziness, fatigue, cramping.

  17. “statins reduce cardiovascular mortality”: for most groups, though, they don’t extend life. The main exception, I understand, is people who already have symptoms of CVD e.g. have already had a heart attack.

    Everyone should read Malcolm Kendrick on the subject. His “Doctoring Data”, for instance, is an excellent book.

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