Two million dead, but that is God's will!

 Two steps could dramatically speed up the recovery from the coronavirus: immediately approve the AstraZeneca vaccine and switch (temporarily) to a single dose regimen.

 

 Mikk Salu

 mikk.salu@ekspress.ee

 

 DEATH WHICH COULD NOT HAVE BEEN: August 20, 2020. Kathmandu Hospital staff transports a person who died of a coronavirus to a crematorium.

 Photo: NARENDRA SHRESTHA

 It is even strange to think that the Moderna coronary vaccine, which was approved by the European Union Medicines Agency last week, was ready a year ago.  On January 10, 2020, the Covid-19 genome became public, and the following weekend, the vaccine was completed in two days in the Moderna laboratory.  The same that has now been approved and will soon be injected in Estonia.

 The same can be said of other vaccine developers - Sanofi, Johnson & Johnson, AstraZeneca, Pfizer-Biontech - whose vaccines were completed a year ago in January.  The Pfizer-Biontech vaccine, which is currently used in Estonia, was developed in the Biontech laboratory in Germany in January 2020 and was called BNT 162b2 at the time.

 Vaccines already existed, but few had heard of any new Covid-19 virus at the time.  According to the Delfi archives, the first laconic news button mentioning the new virus appeared in Estonia at the end of January last year.  It took a few more weeks for more coverage, and initially in a ridiculous and skilful key: what a virus, there is no reason to panic, the flu is worse.  And no one had thought about the emergency.

 This is not a special feature of Estonia.  New York Magazine recently recalled in the same context that the vaccines we are now using were ready before China acknowledged that the virus was spreading from person to person.  Long before the first coronary incident was recorded in the United States.  No coronary deaths had yet been recorded in America when the same Moderna vaccine was produced, transported to a national laboratory, and coordination began so that the vaccine could be tested.

 A more advanced society would have had the vaccine ready a long time ago

 Professor Scott Aaronson (who specializes in quantum computing and theoretical informatics) wrote a few days ago in his blog that someday many doctoral dissertations will be written on how it is possible that life-saving vaccines were developed in a matter of days, but then sat down for years.  die and infect tens of millions so that they can carefully fill out paperwork, signatures, convene committees and tick boxes "phase 1", "phase 2", "phase 1/2", and so on.

 Of course, Aaronson does not say that if the vaccines were already available in January 2020, they could have been injected into the masses immediately.  However, he says that a more developed society would have been able to reduce the annual waiting period several times, complete the testing and approval process sometime in March-April, and at the same time increase production capacity to start vaccinating in May.

 So that the statement does not remain theoretical, let us give examples (the list is far from exhaustive) where we could have saved weeks and months.

 Moderna, which completed the vaccine in mid-January, immediately began producing and coordinating it.  It took two months to coordinate, and in mid-March last year, the first tests could begin.

 It took an insane amount of time for all vaccine developers to conduct phase III clinical trials.  That in itself is very simple - you take a few tens of thousands of people, divide it into two groups, inject one with the vaccine, the other with the placebo and then watch what happens.

 Finding, managing, injecting and tracking such a large mass is time consuming, but it takes the most time to wait.  Since both groups are sent back to so-called normal life, it takes months and months, because most people do not pick up the virus.  However, infections are needed because otherwise an efficacy analysis cannot be performed.

 Thousands of adults agree to participate in the study in the full knowledge that something could happen to some of them - unethical!  At the same time, two million die in the crown - it has nothing to do with ethics!

 For example, the AstraZeneca vaccine, which was approved in the UK a few days ago, began a phase III study at the end of May, and it was not until the second half of October that researchers registered a sufficient number of illnesses to make statistical calculations as required.  (However, some officials believe that AstraZeneca still does not have enough data and wants to continue the study.)

 But there are also faster options, such as Human Challenge Trial (HCT) type trials.  Subjects are first vaccinated, waiting for antibodies to develop, and then the live virus is blown into the nose or throat (or another method of infection is chosen).  And then it is monitored whether the person becomes ill or not.  Does the vaccine work or not?

 HCT requires tens of times fewer subjects (this is already a time winner), but the main acceleration comes from not having to wait until a sufficient number of subjects are exposed to the virus.  There is not even anything revolutionary about HCT research, just as smallpox vaccines, the first flu vaccines, a cholera vaccine were ever developed.  All vaccine scientists know how to do this.

 Even more.  As early as March last year, there were several organizations that were ready to launch HCT trials immediately.  Check out the www.1daysooner.org website: the team consists exclusively of professors and researchers from top US universities.  These are not flat people, but it is a serious attempt to speed up vaccine testing.  Solid team, solid funding, tens of thousands of volunteers.

 However, the HCT studies did not receive permission.  In recent decades, little has been done at all because they are considered unethical.  How do you intentionally expose someone to a virus?  Maybe something happens to someone, maybe someone gets seriously ill.

 Thousands of adults agree to participate in the study in the full knowledge that something could happen to some of them - unethical!  At the same time, two million die in the crown - it has nothing to do with ethics!

 It takes two months to investigate one case

 In September last year, the AstraZeneca vaccine study was paused because one of the participants became ill.  It took the British regulator about a week to investigate the case - it had nothing to do with the vaccine - and was allowed to continue.

 However, the US regulator FDA investigated the matter three months before reaching the same conclusion - there is no connection with the vaccine.  Did the FDA use horse-drawn carriages to drive to see the patient?  One hundred years ago, in three months, Waldemar Haffkine made the world's first plague vaccine from scratch in India, assisted by a secretary and three laboratory assistants.  Thank God that AstraZeneca performed experiments in the UK and Brazil in addition to the United States, otherwise vaccine development would have stalled altogether.

 Johnson & Johnson was not lucky like that.  In these cases, a couple of infected subjects were found in October.  The study was stopped.  It took the FDA two months (two months!) To decide that the disease was not vaccine-related, and on December 17, Johnson & Johnson was allowed to continue testing.  In the same two months, more than 50,000 people died in Covid in the United States.  The J&J vaccine, however, is highly anticipated because, unlike others, it is a single-dose vaccine.  But as you can see, time is widely distributed.

 Finally another example, but from a slightly different angle.  On September 17 last year, the German pharmaceutical company Biontech issued a press release that it has bought production land and buildings in Marburg and wants to build a plant there to start producing the vaccine.  However, the press release also stated that although the purchase and sale agreement has been entered into, the transaction will not take effect until the end of the year.  And that the plant could be completed at some point in the first half of 2021, depending on permits and approvals.

 

 OLD PICTURE: This photo was not taken during the current vaccination wave, but on March 16 last year, when a participant in the first phase of clinical trials was injected with Moderna.

 Photo: Ted S. Warren / AP / Scanpix

 Those who are better acquainted with the German legal system can describe what promises were needed there.  After all, it is not just a matter of approvals from medical regulators, but a number of other authorities are still at play.

 It is now said that vaccines went extremely fast.  Wrong!  They went slowly.  There is no point in comparing it to the normal pace of drug development.  The only thing this comparison shows is the incredibly slow and inefficient "normal pace".

 However, in the case of an exponentially growing virus, speed is the most important thing ever.  A previously developed vaccine with 80% efficacy produces herd immunity faster than a vaccine with 90% efficacy, which is delayed.  Not to mention that all these worries in Britain, South Africa and who knows what else the strains would have been missing if the vaccines had been launched earlier.  The pandemic would have been suppressed and the virus would not have had time to mutate.

 Perfection or who is to blame?

 Economics professor Miles Kimball wrote a few weeks ago that the search for perfection made the pandemic worse.  Kimball lists a number of examples of decisions being postponed or not made at all during the pandemic, as better and more complete information was expected all the time.  The masks could not be approved because there were no perfect studies (in fact, so far) to prove their effectiveness.

 It took an insane amount of time to approve the cheap, fast and ready-to-use crown tests, because more and more accurate and better tests were expected, but they did not want to arrive.  The requirement for vaccine effectiveness was raised from 30 percent to 50 percent, and in the summer there was talk of a 70-75 percent requirement.  And so on.

 A modern risk-averse society is carried by Kantian ethics.  If something happens as a result of your active activities - for example, you do a vaccine test and one of the subjects becomes seriously ill - it is possible to identify the culprits by following your finger.

 Economist Arnold Kling, while agreeing with Kimball's examples, disputes the diagnosis.  According to Kling, it is not a question of perfection, but the main operator of the system is the motive for avoiding guilt.  When two million people die in the crown - it is God's will, no one is to blame!  But if you do something a little differently or faster and something happens, you get guilty, Kling discusses.

 A colleague from the editorial board recently expressed a similar idea.  A modern risk-averse society is carried by Kantian ethics.  If something happens as a result of your active activities - for example, you do a vaccine test and one of the subjects becomes seriously ill - it is possible to identify the culprits by following your finger.  Who injected?  Who gave permission?  Who approved the budget?  Who approved the study protocol?  Who selected the test phrases?  In any case, someone is to blame.  Two million people will die in the crown?  Whatever, the virus is a natural phenomenon, a colleague said.

 Whether the reason is "pursuit of perfection" or "avoidance of guilt", in any case it takes a huge amount of time.  There are so many blocks, companies, institutions in the system, many departments and committees within them, everyone slows down and in the end months and months disappear.

 Last week, entrepreneur Kristjan Maruste wrote about a few simple ideas on how to improve the pace of vaccination in Estonia with the help of better logistics.  Interesting suggestions, however, would speed up the process in just a few days.

 However, there are two major things that can be used to make rapid progress in overcoming the coronavirus.  At the same time, typical of the coronary age, making them simply requires a decision.  The information needed to make a decision (even if it is not perfect) has been around for a long time.

 First, approve the AstraZeneca vaccine immediately.  Information is available.  The vaccine is safe.  The vaccine is effective.  Yes, there is some statistical debate about exactly how effective the AstraZeneca vaccine is, but this exact number to one decimal place is less important.  Or, as Marty Makary, a medical professor at Johns Hopkins University in Baltimore, USA, put it a few days ago: safe, cheap, easy logistics, immediately distributable.

 Second: switch to single dose mode.  Both Pfizer-Biontech and Moderna require two injections.  Postponing the second injection would now allow twice as many people to be vaccinated.  Britain has already made that decision.  Joe Biden's (future) administration also announced three days ago that when they come to power in two weeks, they will change their current policies and go into First Dose First mode.  The German, Danish and Dutch Ministries of Health announced last week that they were also investigating the issue.

 Neither of these issues - the fate of the AstraZeneca vaccine and the single dose regimen - requires further information.  Information is available.  You just have to decide.