More under the heading of not-crazy shit...
Another article grabbed and Google translated (then tweaked) from Spiegel Online. I think it's a fairly clear and not too technical account of the prospects for a workable SARS Cov-2 vaccine. What the possibilities and problems are in terms of medicine, technology, finance and politics. Some may still find the article too long but I didn't feel I could usefully cut out bits.
My own thoughts regarding the question "will a workable vaccine ever be produced at all?"
--> Many people point to the fact that a vaccine for the common cold (also a coronavirus) and a vaccine for HIV (a retrovirus, not a coronavirus) still haven't been produced, after all these years. That's true, and there is no guarantee that a SARS Cov-2 vaccine will succeed, but the need for such a virus is being seen as a priority in the way that these other potential vaccines never were. And correspondingly, huge resources in terms of facilities, researcher working hours and money are being directed at the problem in a way that the common cold and even HIV never attracted. The common cold is a bummer and certainly causes a (minor) degree of economic damage, and occasional deaths if a person's health is already severely compromised, but in the huge majority of cases it's basically just an annoyance. HIV, as we know, is far more deadly but even without a vaccine there are, nowadays, many very effective methods of prevention: avoid having 'unprotected' sex with different partners, or use condoms generally; don't share needles; at-risk health workers use protective measures; hospitals screen donated blood supplies. Applying behavioural changes / life decisions like these will ensure that your chance of getting HIV nowadays is pretty much zero. And even when HIV was more rampant back then, it wasn't really (generally perceived as) the kind of threat that could infect and even kill just about anyone going about their daily, 'sensible' business. So no huge pressure in the Western world to develop a vaccine. The situation was and to some extent still is more dramatic in parts of Africa, but hey, if it doesn't seriously affect the rich countries then it's not really a problem... 
So on that basis, pointing to the non-appearance of vaccines for some other viral diseases is not necessarily a strong argument..............................................................................
Why vaccine production is so difficultThe world is hoping for a vaccine to fight the corona virus. Which candidates are promising? Who pays for it? And why does development take so long? Answers to the most important questions.How many potential vaccines are currently under investigation?As of May 11, 2020, the WHO lists 110 candidate vaccinesagainst Sars-CoV-2 that are being researched and tested by different pharmaceutical companies around the world. There are also projects by universities that have never made a vaccine themselves. Ten of these are already in phase I or II of the so-called clinical trial. That means: they are already being tested on humans.
What are the requirements for vaccine approval?In order for the Paul Ehrlich Institute in Germany to approve a potential vaccine for a clinical trial in humans, a manufacturer must first submit data that the substance has already been tested sufficiently preclinically - for example in animal experiments. Then the vaccine must be clinically tested in three phases:
Phase I: The vaccine is given to a small group of healthy volunteers. It is observed whether the agent reaches the target area in the body and there are no acute side effects.
Phase II: Only if phase I was successful can the vaccine be administered to a larger number of participants in the phase II, which come from the risk group. In the case of Covid-19, this would be the elderly or people with previous illnesses. In this phase it is checked whether the vaccine works, i.e. prevents the disease and which dosage is suitable.
Phase III: Afterwards, the vaccine can be tested on a representative group of volunteers - up to ten thousand test subjects are vaccinated. In phase III the effectiveness, safety and dosage of the vaccination are confirmed. Adverse events, such as a particularly severe course of the disease due to the administration of the vaccine, can thus be observed and excluded.
What basic approaches are currently in clinical trials?mRNA vaccinesTwo of the ten companies whose candidate vaccines are already in clinical trials - the German pharmaceutical company Biontech and the US Moderna - are researching so-called mRNA vaccines. Messenger RNA are messengers in the human body that carry information about the blueprint of proteins to the cell machinery, where the proteins are built.
In the case of an mRNA vaccine against Sars-CoV-2, the blueprints for a shell protein of the virus are injected into the human body so that the cells produce it. As a result, the body recognizes them as foreign and produces, among other things, antibodies in a precisely tailored defense process. When in contact with the real virus, the immune system can quickly activate this protective patrol and eliminate the pathogens.
So far, not a single mRNA vaccine has been approved, and there is a lack of experience worldwide. "The fact that RNA vaccines have not yet been approved is not necessarily due to the fact that the technology is bad, but depends on various factors," said the chairman of the German Standing Vaccination Commission (Stiko), Thomas Mertens, in an SPIEGEL interview. It is also a question of money, because research into new technologies has to be financed.
Tried and tested models for the mass production of mRNA vaccines are also lacking. However, experts rely on the fact that mRNAs could be produced relatively easily because they are not complex biomolecules.
Inactivated virus (dead vaccine)The Chinese companies Sinovac and Sinopharm are testing the safety and effectiveness of so-called dead vaccines in three institutes in the fight against Covid-19. The Sars-CoV-2 viruses are isolated from infected persons and propagated in cell cultures that are approved for the production of vaccines. Then they are chemically and physically inactivated so that they can no longer reproduce and injected into humans. The immune system recognizes the inactivated viruses as foreign and produces antibodies. Many important vaccines are based on this principle, for example against tetanus or hepatitis B.
Vector vaccinesUsing genetic engineering, researchers can "disguise" harmless viruses as the novel corona virus. To do this, they exchange certain proteins on their surface for typical components of the pathogen. These so-called vector viruses ‘persuade’ the body that it is infected, but they do not make you sick. The idea: Those who are vaccinated with such vector viruses then form antibodies that also protect against a real infection. The first approved Ebola vaccine works like this.
However, vector vaccines are "regulated, genetically modified medicines, which are associated with a long approval process," writes the "Science Media Center" (SMC). "Above all, the risk potential of the vector used must be explored."
In the fight against Sars-CoV-2, the University of Oxford and the Chinese company Cansino Biological are already testing their candidate vaccines in humans in the first two clinical phases.
DNA vaccinesIn another approach, which the US company Inovio is already investigating in humans, a DNA section is introduced into human cells using a bacterial plasmid. This DNA sequence stimulates the immune system to produce antibodies. However, this usually requires potentiators that can have undesirable side effects. "So far, DNA vaccines have only been approved in veterinary medicine," writes the SMC.
Why is this all taking so long?It usually takes more than a decade to get a new vaccine ready for the market. Because it is later to be administered to healthy people, it has to undergo particularly strict security checks. Even under the very optimistic assumption that one or more candidate vaccines will have successfully completed the approval process by the end of the year, there are likely to be problems providing people with comprehensive coverage. Because the vaccines have to be mass-produced. However, there is no capacity for this.
Assuming that people would need two doses, there is a need for almost eight billion doses of vaccine if half of the world's population is to be vaccinated. Experts speak of the greatest challenges in the history of vaccine manufacture. Giant companies like Sanofi are currently able to produce one billion doses a year - across all of their vaccine groups. The other vaccines would have to continue to be manufactured - and bottlenecks have always been a problem across the industry, even with standard vaccines.
Who pays for vaccine development?The vaccine business has been dominated by four manufacturers for years: GlaxoSmithKline, Merck & Co., Pfizer and Sanofi. Unlike pharmaceuticals, Europe is a leader in vaccine research; 80 percent of the production also takes place in Europe. It’s unlikely there will be many new providers appearing because the market entry hurdles are very high. The high investment costs for setting up production facilities are responsible for this. The business with vaccines is lucrative for the remaining suppliers: many have announced that they will increase their production capacities as much as possible.
The current problem is that preparations have to be made for the production without knowing exactly what vaccine will ultimately be produced. The pharmaceutical industry is therefore demanding cost sharing and promises from politicians to guarantee certain purchase quantities.
Vaccine development is currently also being promoted through product development partnerships; these are alliances that organize joint projects by foundations, government and aid organizations, research groups and companies. In this way, active ingredients can be developed that would not be economically feasible for a single company. Germany is involved in the CEPI project through the Federal Ministry of Research.
And who will get the vaccine first?To eradicate the virus, as many as possible of the 7.8 billion people worldwide would have to be vaccinated. With earlier epidemics such as swine flu, richer countries were always first vaccinated, while the poorer countries received it much later. This situation should be prevented this time around, politicians, the World Health Organization and pharmaceutical experts demand. "To firstly completely vaccinate the population in one country and not in other countries at all: that’s inconceivable in the sense of global solidarity," said Paul Cichutek, head of the Paul Ehrlich Institute, at the beginning of May to SPIEGEL.
A promise by the French pharmaceutical manufacturer Sanofi to the US government to grant the United States special rights when ordering vaccines against the novel coronavirus is being criticized. Sanofi's justification for the exception is that the Americans were willing to take financial risks in vaccine development.
It could be conceivable that there will be further geopolitical disputes: Countries that have been heavily involved in the financing could require that they have a prerogative to the first wave of vaccine deliveries. In any case, it can be expected that not all people can be vaccinated immediately if and when a vaccine becomes available because the capacities will not be sufficient.
Pandemic plans provide for medical personnel and risk groups to be vaccinated first. However, other system-relevant professions such as police officers or registrars (they must still be able to certify the death of people in the event of a pandemic) could also be among the first recipients.
Source: Spiegel Online, 15 May 2020
https://www.spiegel.de/wirtschaft/unternehmen/coronavirus-was-die-impfstoffherstellung-so-schwierig-macht-a-f1365987-0a22-4358-be3c-b3d15e9bc0ad
by everything on Wed May 13, 2020 6:34 am 
