Coronavirus Vaccine, Garattini: “It would be a disaster to authorize it without completing the last phase of testing. We do not confuse hopes with facts”

A great march in forced stages. The development of an active and effective vaccine to prevent Sars on 2 It is already a challenge that has gone from the workshops to the button rooms, two in particular: those of the White House and those of Kremlin. One leak however, it could have devastating effects on public health. Donald trump, which had conceived the operation called Warp Speed ​​in May, could apply to the Food and Drug Administration to clear one of the possible candidates before phase III of the trials is completed. At the same time also from Oxford / AstraZeneca comes the news that the compound, whose viral vector occurs in Pomezia, could be available in November. Ilfattoquotidiano.it I ask Silvio Garattini, pharmacologist and president ofMario Negri InstituteWhat are the risks of investigating at the speed of light? without completing the last phase of experimentation, one in which a large number of people (30,000 in the case of the vaccine) are administered the compound to verify its safety and efficacy.

Professor, what do you think?
It would be disastrous because a vaccine would somehow be licensed before there is scientific evidence to do so. I think phase III should be finished because only all the data will be able to tell us if the vaccine is valid or not. Above all, phase III must be robust in terms of people’s participation because what we want to see is not only efficacy, which of course was seen in phase I and II, but above all safety: because we administer the vaccine healthy subjects and therefore we must be sure that we are not causing damage that may exceed the expected benefits. Only by testing a large number of people can the percentage of effectiveness be established and, on the other hand, what is the percentage of side effects and what type they are. We can only know if the number is large enough. It is one thing to have a serious side effect in 100 people, one in 1000

However, the FDA seems willing to move on. A directive was sent to health officials to prepare to distribute a possible vaccine in late October. It also provided planning scenarios to help states prepare.
Scientist Eric Topol sent a letter to Stephen Hahn, commissioner appointed in December to lead the FDA, inviting him to say what the situation is or to resign, citing three cases: hydroxychloroquine (which Trump took, ed) authorized and revoked, the drug therapy. plasma in which he had to make a correction, and then the announcement that he would approve the vaccine even though Phase III was not completed. In the United States we know that there are presidential elections.

But Anthony Fauci pointed to the possibility that a vaccine will be available before all the necessary tests are completed, if the results are largely positive.
Whether it can be expedited is a matter of willingness and resources available for the people you examine to work immediately. It can be done relatively quickly. I reasonably believe that vaccines are available at the beginning of the year. Hopefully, they don’t confuse hopes with facts. However, it depends on the recruitment of people: it may be that today 30 thousand tests have already been reached and therefore we would have the vaccine in October. We must not forget that for the first time in the history of vaccines, since a great abundance of economic resources has been made available, there are some pharmaceutical companies that are already producing the vaccine regardless of the result. If it is active it is ready, if it is not active we throw everything away. This only supports the idea that there may be some acceleration: because the vaccine is already being prepared (AstraZeneca started in June, ed)

So is it possible?
Theoretical possibility. If all goes well, if there is no setback, it may be that at the end of October there is the possibility of starting to vaccinate someone. But there is a whole series of if that should go well. It is more reasonable to think that it will happen in early 2021, starting to vaccinate those most at risk.

Russia also launched the “Sputnik” vaccine and Putin did it himself.
This is not our concern, it is in phase I and the Russian health minister has spoken of limited production. It is only from Russia and will not be exported. However, it cannot be used without the permission of EMA, the European Medicines Agency.

But Venezuelan President Maduro says he will and offer 500 volunteers …
A boutade.

Italy has also started the tests and the scientific director of Spallanzani said that “we entered this war as protagonists, so as not to be slaves of other countries that I will say first.”
The idea of ​​who comes first is an idea that in the field of science has a meaning and there is because we are in an emergency, because we want to provide a solution to this pandemic as soon as possible. What matters is to start having one, perhaps the others that are coming will be more refined. This type of pandemic doesn’t seem destined to go away quickly, and even if we can’t use vaccines, we will learn new things. The good news is that this situation can help improve awareness of an infectious disease problem that is expected to grow. We had a time when infectious diseases were the leading cause of death, antibiotics somehow solved most of these diseases, and it was surprising that someone died of pneumonia. Infections are now affected by globalization: we travel, we travel goods and viruses and bacteria also travel, and therefore we are more exposed than 30 years ago.

What do we have to do?
I address and I did with Doctors Without Borders a few months ago an appeal to the government. It would be important not to focus on a single horse and beyond the vaccine if we had an effective therapy we could compensate it, independently and pending the vaccine, with an active drug. We should also participate in this.

Do we need to prepare for other emergencies?
It is a problem, of which we do little because we are caught in the pandemic, but resistance to antibiotics causes a thousand deaths a year. We will increasingly need new weapons against virus and bacterial infections because we have passed the phase in which we believed that infectious diseases were now a legacy of the past and instead are becoming a very important problem again, also because not we have proceeded to have new agents. The performance of these monoclonal antibodies should be strongly encouraged. It must be said that Italy is not at the forefront because research is penalized and reduced to misery. I hope these events make it clear that without research there is no development. We need research to return to the role it should play in solving health and other problems. This pandemic and also other infections by viruses and bacteria – we saw the case of citrobacter (the case of the hospital in Verona, ed) is not a problem that we can ignore. Diseases will not leave us, the scenario has changed and now many tools are much less active. We must be aware that we are in a period in which we must change our attitude, think much more about prevention than we have done so far.

Twitter @ trinchella

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