Make you ill to test the vaccines. Is it ethical?
Today, as never before, the world is waiting with bated breath for a remedy against the pandemic.
At the moment, there are 78 projects on vaccines that are already approved. Here. There are dozens and dozens of the therapies used off – label on the ill that are returning in the new experiments. By monoclonal antibodies to the anti-malarial, by the anti viral to stem cells, from pesticides to anticoagulants, from cortisone to the ozone therapy. In each Country, there is a swarm of proposals. In Japan you are trying to achieve a product formulated with antibodies of plasma of people healed. Click here and here and here and here.
There is too much – understandable – in a hurry. One wonders, therefore, if you desire to do soon, and in the case of vaccines, to get to the first, not the ports then to the “other” public health problem, the lack of safety rules. On Sciences, of 27 march, Seth Berkley, chief executive officer of Gavi, the Vaccine Alliance, wonders if the first vaccine to cross the finish line will also be the safest and most effective. “Or – question – are vaccines the most funded to become available for the first time, or perhaps those that use the technologies of the vaccines with the fewest number of regulatory obstacles?”
Our attention has fallen on the work entitled: “Studies on the human challenges to speed up the approval of vaccines against coronavirus” , proposed by the university of Harvard here, and taken over by Nature, here.
In practice, a vaccine, tested first safety and then effectiveness. It starts from the in vitro test, does not always pass through the trials on animals and then comes to the man. At first, with numbers representative, gradually with more and more participants. It takes from eighteen months to two years. When we talk about the effectiveness of a vaccination refers to the presence of antibodies in the vaccinated people. It is assumed that a certain level of antibodies induced face as a shield against the infection (when it will, if you will). The estimated efficacy is reported on the package insert of each vaccine. In the past, studies conducted on guinea pigs to find a vaccine against other coronavirus have been disappointing (it is verified in some cases the death of the guinea-pigs. Olsen CW. A review of feline infectious peritonitis virus: molecular biology, immunopathogenesis, clinical aspects, and vaccination. Vet. Microbiol. 36(1-2),1-37 (1993).).
After 16 years since the appearance of SARS, there is still no vaccine.
The human challenge
Also, the work of the american university suggests a way to speed up the approval process of the vaccines. How? By proposing a “human challenge ” trial”. To recruit a hundred healthy volunteers, between 20 and 45 years of age, making them ill “under observation”. A first group is administered the new vaccine to be tested, a second group a placebo. The tests are “blind”, i.e. the participants must ignore what to assume.
Then everyone would be exposed to virus infection Sars Cov-2.
It also speaks of a third group of volunteers, who should contract the virus in a progressive manner to understand what the minimum dose of the infecting. This group should be subjected to an escalation of the infection growing. In order to understand if the vaccine, if you are not able to protect from disease, can reduce some symptoms.
The researchers at this point point out that “the healthy young adults are at relatively low risk of severe disease following natural infection” and that “during the trial would receive frequent checks and as a result of disease would have the best care”.
Such treatment, one wonders. But here it is. Nature in the present, the challenge seems almost to justify the …sacrifice of the young. It is written: “it May also be curiously more secure for some to adhere to the study rather than wait for a probable infection, and then try to rely on the health system in general”.
Nature goes on to explain that “normally, you let the humans volunteer to do risky stuff. For example, you agree that people do volunteer in emergency medical services during this period. This significantly increases the risk of being infected.”
The author concludes with a clarification: it is important not to pay too much for the volunteers to ensure “a high level of confidence in the public.”
It is described, finally, a third phase of the project. After the escalation, and the challenge trial testing the vaccine on 3,000 volunteers to understand if the product is harmless and effective (releases antibodies in subjects) under normal conditions, i.e., without inducing the infection. However, according to the investigators, this phase may also arrive after the release of the vaccine due to the rush generated by the pandemic.
Is it ethical to cause disease to test a vaccine?
We asked for more opinions on the ethics of the proposal of the University of At already supported by the journal Nature. At the moment they have replied Silvio Garattini, professor of Pharmacology, researcher and doctor, Ivan Cavicchi, professor of Medicine, Sociology of health organizations and of the Philosophy of medicine and Luciano Eusebi, professor of criminal Law, a member of the national Committee for bioethics and the present (even these days) and in ethics committees of two hospitals.
“I don’t think that is feasible because the virus is not harmless. What you do in these cases is to inject the vaccine to healthy subjects, and see if after a few weeks to form antibodies. At this point, you use antibodies to see if they are able to inactivate the virus in vitro and in animals of experiment”.
“The first thing you need to ask yourself how much time you would gain in proceeding in this way. If they were only two weeks, it’s not worth it.
The times of the trials are unavoidable. To test the safety on animals and on men, it takes time. As an expert of medical ethics does not comprimerei even for one day. It’s already happened in the past that you were to neglect this aspect. And the fallout has been huge, for the biological damage, and economic. The companies were forced to withdraw the medication.
And if it were to speed up, only the phase that evaluates the efficacy?
“This second phase needs to test on animals and men must always be time. I am opposed to omitting the guarantees. The pursuit of a vaccine within a year is already a discount. Serve at least 18 months”.
In times of emergency does not comply with all the rules.
“True. We’re already living in a period of deregulation, the complete (we think of the amount of money that is coming from each part without rules, or to the fact that the new doctors hired have not taken the State examination). One of the problems that we will face will be to bring back the system within the rules. It is not difficult to set up beds and cars, but where are the anesthesiologists and nurses?”.
Returning to the human challenge?
“In theory, on a scientific level, it is not impossible that you face. How many prisoners have been enrolled in the past to test drugs or vaccines? It is, however, an exception to the rule and, as a rule, needs a specific authorisation, usually political. However, it is not enough to establish that one thing you can do, you need some guarantees…Always of life it is.”
“I am somewhat suspicious when, referring to the emergency in the act, it is proposed to abandon some of the policies have been widely recognised in research and medical practice, according to evaluation of efficiency that it is not said to lead to the same results. Only think of the idea, that someone left to emerge in the past few weeks, to the exclusion “a priori” of certain categories of sufferers from the therapy (for example according to age), when, instead, here (I live in Brescia) hospitals have always acted in the past few weeks, as far as I understand, on the basis of the criteria of proportionality related to all the parameters in the game, as it should be, of a person, trying to dilate to the utmost the tools available (especially intensive and subintensivi).
On the research and the vaccines, we, in Italy, on the basis of international and european standards, we never allowed trials on the basis of the simple consent (and, in fact, on the basis of a salary of poor people), but the start of the trials only on the basis of the assessment between the risks and benefits to the parties involved and many scientific parameters, in this way, also ensuring the quality of the experiments and the trust for the precisely scientific of their outcomes. In front of the emergency, can be sped up some of the steps of the experimentation phase, but may not be tools to create the hinges of the latter. There is, moreover, a wide experience on the validation of vaccines. Among other things, it seems that it is favoured also by the fact that the present virus also infects animals. And I think that in those modes you should refer to. Obviously looking for in a short time to experience the best, as you are doing, medications that can be used for anyone who is currently infected”.
What do you think about the WHO? On the contrary, professors Garattini, Toggles and Eusebi, the World Health Organization will approve. In 2016, in fact, he had assumed a human challenge trial similar to the one proposed today by the university of havard, even without the epidemic.