Here’s another example of a massive regulatory failure by the Americans and Europeans. The reason the J&J vaccine is somewhat less efficacious then the mRNA vaccines is that it’s a one dose vaccine instead of two doses. The AZ vaccine was also less efficacious in one dose rather than two, which is why it’s now given in two shots spaced apart by weeks.
You can bet the house that the J&J vaccine will be even more effective as a two dose rather than a one dose vaccine. J&J is currently running a clinical trial to find out for sure; but here again is another example of regulators standing in the way of saving lives. Rather than wait until the summer for proof that the J&J vaccine is even more effective in two doses than one, it would make far more sense to run a safety trial which could be completed in a couple of months. Waiting to prove efficacy for the second dose is absurd; everyone with a brain knows that it will almost certainly be better. How many people have to become sick or die to satisfy the impulses of regulators with a civil service mentality?
What regulators should be insisting on for the adenovirus-vector vaccines is a trial with the first dose being the J&J vaccine with the second dose being AZ’s vaccine (or vice-versa; the order doesn’t matter)
As Dr. Zubrin pointed out in the first article in this series, giving second doses of the same vector can be problematic because the body mounts a immune response to the vector (which is, after all, a virus though a harmless one). If the vector is destroyed it can’t drop off its payload-the genetic instructions to produce spike protein.
J&J had exactly this problem with it Ad26 Ebola vaccine. It’s a two shot vaccine but J&J needed a different vector for the second shot. The problem was solved when J&J contracted with Bavarian Nordic A/S a company which produces a different viral vector.
The solution in the present circumstance is obvious; a two shot regimen consisting of the J&J and AZ vaccines. Would this work to increase the efficacy of the adenovirus vaccines? Probably yes. Will it ever be tried? Maybe some day in a galaxy far, far away. The problem is that the regulatory hurdle of proving efficacy (as opposed to safety) is so substantial that in the absence of a mandate from the regulators there’s no incentive to give it a try.
Other combinations are intriguing. How about a two shot regimen of the mRNA vaccines with the protein vaccines or the protein vaccines with the adenovirus vaccines. We need to test whether these combinations are safe, but if we wait to prove to a statistical certainty that they are efficacious, the trials will never happen. After all, how many 30,000 patient trials is it possible to run, especially if cases begin to plummet?
The other problem sure to arise is how long it will take to run trials of vaccines targeting emerging variants. If the FDA and European regulators require proof of efficacy of new vaccines targeting emerging variants it will be years before we put Covid-19 behind us.
Sadly, the regulators who should be protecting us have instead turned out to be the biggest problem of all.
There’s no surprise there; the administrative state strikes again and we are all poorer, sicker, angrier and less healthy as a result.
Something else to add is there appears to have been a Twitter fight that has broken out between Washington Post writer Anne Applebaum(and wife of EU Member of Parliament Radosław Sikorski) and the author of this article Robert Zubrin(both of whom I respect immensely) and there Twitter followers). Basically Anne is saying the EU is ahead of the UK looking at her interpretation of the data while Robert is saying the UK is ahead and Anne is telling a lie worthy of Goebbels(Anne I don't believe has ever written about Goebells but two of her books are "Gulag" and "Red Famine" so Anne knows a lot about the "Big Lie") Perhaps this is an an occasion for the Cosmopolitan Globalist to enlist Toomas Ilves as a neutral referee.
Almost everything the author says in this article is spectacularly correct. Actually, it’s not almost everything, it’s everything. At some future date, we need to figure out why the experts who work in pharma performed a miracle in creating several vaccines at warp speed while the experts who work for government couldn’t get out of their own way. Part of it is that private industry pays more (a lot more) so it can recruit more talented people; but it’s more than that. Government experts who’ve spent years or decades in a regulatory capacity have been stripped of all of their entrepreneurial tendencies-that is, if they ever had those tendencies in the first place.
The regulators in the United States and Europe condemned hundreds of thousands of people to an unnecessary death by refusing to grant approval to the vaccines based merely on safety data, this type of data could have been obtained in several weeks. Everyone (with an ounce of common sense) knew the vaccines would be efficacious based merely on the primate data obtained by the NIAID-NIH last March. That they turned out to be as efficacious as they are, is merely gravy.
There are so many other regulatory deficiencies that our friends at the “Cosmopolitan Globalists” didn’t mention.
(1) For one, the failure to execute “challenge trials” was immoral. Instead of needing 30,000 patients, challenge trials could have been run with 500-1,000. These trials wouldn’t have required a placebo arm. Patients would have been vaccinated and then exposed to SARS-CoV-2 via a nasal swab. Given the incredibly low death rate from Covid itself in people under 40 years of age, the risk of a challenge trial was extremely remote and certainly no worse than drug trials which routinely recruit healthy volunteers. We could have determined the efficacy of the vaccine (at least in younger people) in a matter of weeks while putting the experimental subjects at little to no risk. If the vaccine was efficacious in younger people it would be a reasonable extrapolation to assume that it would be effective (though perhaps less effective) in older people. Those who claim that challenge trials are unethical are ethically challenged themselves. Their obtuse attitude turned out to be a death sentence for tens of thousands of innocent people.
(2) The vast majority of people who contract Covid-19 recover fully from it. Most patients don’t need to be hospitalized, most never see the inside of an ICU, most are never hooked up to a ventilator and most never die. The long haul phenomenon is real but impacts a relatively small number of patients. The patients far and away at the highest risk are older (older than 60 but especially older than 80) and younger patients with comorbidities. In light of this, wouldn’t it have made sense to focus on these groups when running the trials seeking to determine safety and efficacy?Remarkably the regulators never insisted on it. The number of elderly patients in the trials was quite small and to this day, no one is quite sure of efficacy rates in the patients most at risk from Covid-19. And speaking of high risk patients; why are we vaccinating 20 year old waiters and grocery clerks before 64 year old smokers with Type II diabetes?
(3) Are the regulators so dense that it never occurred to them to mandate bake-off trials where the safety and efficacy of one vaccine technology is compared to another. The current crop of vaccines rely on three different technologies, mRNA (Pfizer and Moderna) Adenovirus-vector (J&J and AstraZeneca) and protein based (Novavax and maybe eventually Sanofi). Each technology has advantages and disadvantages in terms of cost, transport, administration, safety, side-effect profile and efficacy. Because all of the clinical trials were run separately using different entrance criteria and secondary endpoints (they all shared the same primary endpoint mandated by the FDA) it is impossible to get a clear and granular picture of exactly how one vaccine compares to another. Perhaps the more efficacious mRNA vaccines should be reserved for the elderly even though the two dose regimen is onerous while the one dose J&J vaccine should be reserved for younger people who are far less likely to die. Does this strategy make sense? We will never know. What we do know is that whether or not it makes sense, it will never be implemented. What a shame. This isn’t a failure of vaccine technology, it is purely a regulatory failure.
(4) Then there’s the issue of sterilizing immunity. Do the vaccines provide it? If you’re vaccinated, can you still be contagious? It seems like this is a pretty important question. Why aren’t there any answers? AstraZeneca has presented some extremely preliminary evidence that subjects who’ve received their vaccine are less contagious but the whole issue is a mess. Arriving at definitive answers is not easy, but getting reasonably good data is. How do you do it? You experiment with primates. Remember, every single vaccine currently approved or approaching approval was tested on primates at NIH. This work was paid for by the U.S. government (providing yet another example of Europe’s free-riding). It would be quick and easy to test whether the vaccines provide sterilizing immunity in primates. If the vaccines did, would that prove that the vaccines provide sterilizing immunity in humans? Of course not, but it would give a pretty good indication. To my knowledge, there has not been a single publication in a reputable medical journal about this.
There are many more failures that I could outline. Suffice it to say, the author of this article is right; the scope of the failure of American and European regulators is as enormous as the success of the pharmaceutical industry in producing vaccines in record time.
The epic failure of western governments is emblematic of so many of the problems that afflict us. The demise of the West has nothing to do with ignoring science. It has everything to do with cultural failure.
Obviously one model I can think of in the post the World War II era of the type of peace time mobilization you would require to solve in the timeframe being contemplated in the article was Charles De Gaulle's creation of "Force De Frappe" in the 1960s and the later civil nuclear power program in France under Pompidou and Messmer.
The problem with this analogy and perhaps the real problem with why we can't get Covid-19 solved is the pre-existing politics. You would never hear Wolfgang Munchau or Bruno Macaes say anything good about Charles DeGaulle. Munchau and Macaes hate with every fiber of there being everything DeGaulle stood for and hate DeGaulle's ungratefulness towards les Anglo-Saxons whom Munchau and Macaes have spent most of the adult life(probably since the Thatcher era) admiring. Thus we are all looked into the vice grip of using Covid-19 to fight the political fights we were already fighting pre-Covid and most of us I think in our heart of hearts really don't care what happens with Covid as long as Covid can be used to fight and win the political battles unrelated to Covid we were already fighting. This is also very much true in the US in terms of Trumpism vs Anti-Trumpism or Biden vs Trump.
Here’s another example of a massive regulatory failure by the Americans and Europeans. The reason the J&J vaccine is somewhat less efficacious then the mRNA vaccines is that it’s a one dose vaccine instead of two doses. The AZ vaccine was also less efficacious in one dose rather than two, which is why it’s now given in two shots spaced apart by weeks.
You can bet the house that the J&J vaccine will be even more effective as a two dose rather than a one dose vaccine. J&J is currently running a clinical trial to find out for sure; but here again is another example of regulators standing in the way of saving lives. Rather than wait until the summer for proof that the J&J vaccine is even more effective in two doses than one, it would make far more sense to run a safety trial which could be completed in a couple of months. Waiting to prove efficacy for the second dose is absurd; everyone with a brain knows that it will almost certainly be better. How many people have to become sick or die to satisfy the impulses of regulators with a civil service mentality?
What regulators should be insisting on for the adenovirus-vector vaccines is a trial with the first dose being the J&J vaccine with the second dose being AZ’s vaccine (or vice-versa; the order doesn’t matter)
As Dr. Zubrin pointed out in the first article in this series, giving second doses of the same vector can be problematic because the body mounts a immune response to the vector (which is, after all, a virus though a harmless one). If the vector is destroyed it can’t drop off its payload-the genetic instructions to produce spike protein.
J&J had exactly this problem with it Ad26 Ebola vaccine. It’s a two shot vaccine but J&J needed a different vector for the second shot. The problem was solved when J&J contracted with Bavarian Nordic A/S a company which produces a different viral vector.
The solution in the present circumstance is obvious; a two shot regimen consisting of the J&J and AZ vaccines. Would this work to increase the efficacy of the adenovirus vaccines? Probably yes. Will it ever be tried? Maybe some day in a galaxy far, far away. The problem is that the regulatory hurdle of proving efficacy (as opposed to safety) is so substantial that in the absence of a mandate from the regulators there’s no incentive to give it a try.
Other combinations are intriguing. How about a two shot regimen of the mRNA vaccines with the protein vaccines or the protein vaccines with the adenovirus vaccines. We need to test whether these combinations are safe, but if we wait to prove to a statistical certainty that they are efficacious, the trials will never happen. After all, how many 30,000 patient trials is it possible to run, especially if cases begin to plummet?
The other problem sure to arise is how long it will take to run trials of vaccines targeting emerging variants. If the FDA and European regulators require proof of efficacy of new vaccines targeting emerging variants it will be years before we put Covid-19 behind us.
Sadly, the regulators who should be protecting us have instead turned out to be the biggest problem of all.
There’s no surprise there; the administrative state strikes again and we are all poorer, sicker, angrier and less healthy as a result.
Something else to add is there appears to have been a Twitter fight that has broken out between Washington Post writer Anne Applebaum(and wife of EU Member of Parliament Radosław Sikorski) and the author of this article Robert Zubrin(both of whom I respect immensely) and there Twitter followers). Basically Anne is saying the EU is ahead of the UK looking at her interpretation of the data while Robert is saying the UK is ahead and Anne is telling a lie worthy of Goebbels(Anne I don't believe has ever written about Goebells but two of her books are "Gulag" and "Red Famine" so Anne knows a lot about the "Big Lie") Perhaps this is an an occasion for the Cosmopolitan Globalist to enlist Toomas Ilves as a neutral referee.
Almost everything the author says in this article is spectacularly correct. Actually, it’s not almost everything, it’s everything. At some future date, we need to figure out why the experts who work in pharma performed a miracle in creating several vaccines at warp speed while the experts who work for government couldn’t get out of their own way. Part of it is that private industry pays more (a lot more) so it can recruit more talented people; but it’s more than that. Government experts who’ve spent years or decades in a regulatory capacity have been stripped of all of their entrepreneurial tendencies-that is, if they ever had those tendencies in the first place.
The regulators in the United States and Europe condemned hundreds of thousands of people to an unnecessary death by refusing to grant approval to the vaccines based merely on safety data, this type of data could have been obtained in several weeks. Everyone (with an ounce of common sense) knew the vaccines would be efficacious based merely on the primate data obtained by the NIAID-NIH last March. That they turned out to be as efficacious as they are, is merely gravy.
There are so many other regulatory deficiencies that our friends at the “Cosmopolitan Globalists” didn’t mention.
(1) For one, the failure to execute “challenge trials” was immoral. Instead of needing 30,000 patients, challenge trials could have been run with 500-1,000. These trials wouldn’t have required a placebo arm. Patients would have been vaccinated and then exposed to SARS-CoV-2 via a nasal swab. Given the incredibly low death rate from Covid itself in people under 40 years of age, the risk of a challenge trial was extremely remote and certainly no worse than drug trials which routinely recruit healthy volunteers. We could have determined the efficacy of the vaccine (at least in younger people) in a matter of weeks while putting the experimental subjects at little to no risk. If the vaccine was efficacious in younger people it would be a reasonable extrapolation to assume that it would be effective (though perhaps less effective) in older people. Those who claim that challenge trials are unethical are ethically challenged themselves. Their obtuse attitude turned out to be a death sentence for tens of thousands of innocent people.
(2) The vast majority of people who contract Covid-19 recover fully from it. Most patients don’t need to be hospitalized, most never see the inside of an ICU, most are never hooked up to a ventilator and most never die. The long haul phenomenon is real but impacts a relatively small number of patients. The patients far and away at the highest risk are older (older than 60 but especially older than 80) and younger patients with comorbidities. In light of this, wouldn’t it have made sense to focus on these groups when running the trials seeking to determine safety and efficacy?Remarkably the regulators never insisted on it. The number of elderly patients in the trials was quite small and to this day, no one is quite sure of efficacy rates in the patients most at risk from Covid-19. And speaking of high risk patients; why are we vaccinating 20 year old waiters and grocery clerks before 64 year old smokers with Type II diabetes?
(3) Are the regulators so dense that it never occurred to them to mandate bake-off trials where the safety and efficacy of one vaccine technology is compared to another. The current crop of vaccines rely on three different technologies, mRNA (Pfizer and Moderna) Adenovirus-vector (J&J and AstraZeneca) and protein based (Novavax and maybe eventually Sanofi). Each technology has advantages and disadvantages in terms of cost, transport, administration, safety, side-effect profile and efficacy. Because all of the clinical trials were run separately using different entrance criteria and secondary endpoints (they all shared the same primary endpoint mandated by the FDA) it is impossible to get a clear and granular picture of exactly how one vaccine compares to another. Perhaps the more efficacious mRNA vaccines should be reserved for the elderly even though the two dose regimen is onerous while the one dose J&J vaccine should be reserved for younger people who are far less likely to die. Does this strategy make sense? We will never know. What we do know is that whether or not it makes sense, it will never be implemented. What a shame. This isn’t a failure of vaccine technology, it is purely a regulatory failure.
(4) Then there’s the issue of sterilizing immunity. Do the vaccines provide it? If you’re vaccinated, can you still be contagious? It seems like this is a pretty important question. Why aren’t there any answers? AstraZeneca has presented some extremely preliminary evidence that subjects who’ve received their vaccine are less contagious but the whole issue is a mess. Arriving at definitive answers is not easy, but getting reasonably good data is. How do you do it? You experiment with primates. Remember, every single vaccine currently approved or approaching approval was tested on primates at NIH. This work was paid for by the U.S. government (providing yet another example of Europe’s free-riding). It would be quick and easy to test whether the vaccines provide sterilizing immunity in primates. If the vaccines did, would that prove that the vaccines provide sterilizing immunity in humans? Of course not, but it would give a pretty good indication. To my knowledge, there has not been a single publication in a reputable medical journal about this.
There are many more failures that I could outline. Suffice it to say, the author of this article is right; the scope of the failure of American and European regulators is as enormous as the success of the pharmaceutical industry in producing vaccines in record time.
The epic failure of western governments is emblematic of so many of the problems that afflict us. The demise of the West has nothing to do with ignoring science. It has everything to do with cultural failure.
Obviously one model I can think of in the post the World War II era of the type of peace time mobilization you would require to solve in the timeframe being contemplated in the article was Charles De Gaulle's creation of "Force De Frappe" in the 1960s and the later civil nuclear power program in France under Pompidou and Messmer.
https://youtu.be/dcOT9pLSeUs
The problem with this analogy and perhaps the real problem with why we can't get Covid-19 solved is the pre-existing politics. You would never hear Wolfgang Munchau or Bruno Macaes say anything good about Charles DeGaulle. Munchau and Macaes hate with every fiber of there being everything DeGaulle stood for and hate DeGaulle's ungratefulness towards les Anglo-Saxons whom Munchau and Macaes have spent most of the adult life(probably since the Thatcher era) admiring. Thus we are all looked into the vice grip of using Covid-19 to fight the political fights we were already fighting pre-Covid and most of us I think in our heart of hearts really don't care what happens with Covid as long as Covid can be used to fight and win the political battles unrelated to Covid we were already fighting. This is also very much true in the US in terms of Trumpism vs Anti-Trumpism or Biden vs Trump.