Aifa and AstraZeneca, when science bends to politics

Aifa and AstraZeneca, when science bends to politics

Aifa and AstraZeneca

The decision to approve the combined AstraZeneca first and second dose strategy of an mRna vaccine is based on promising but very preliminary data. Rather than managing and communicating the risk, it was preferred to follow the emotion

(photo: Ipa) In this world, on the contrary, it is the technical body, the Italian Medicines Agency (Aifa), that accepts the choices of the policy, and not vice versa, by approving the mix of two different vaccines against Covid-19. Do we want to reassure the population by also depriving those who have already received the first dose of AstraZeneca of the second? Let's do it. And it does so by citing a letter to the Lancet, not even a paper, in which 110 people (one hundred and ten) received the mixed AstraZeneca + Pfizer treatment and a phase 2 study in pre-print (i.e. not yet peer-reviewed) that in Spain involved about 600.

What can be drawn, in an absolutely preliminary way, from these works, is that this scheme works, in the sense that it induces an even greater antibody response than with the double dose of Vaxzevria by AstraZeneca. Consistently with this finding, however, it causes more unwanted effects (the usual, common, such as fever, headache, muscle pain, index of the inflammatory reaction). Nothing serious, however, at least on this sample of less than a thousand people in all. The few and preliminary data available therefore tell us that probably (also for biological plausibility, the spike protein is the same) the new heterologous scheme will work as much as the homologous one, which however has been studied in trials on 30-40 thousand people.

Moreover, in addition to having completed phase 3 of experimentation, it was then subjected to post marketing surveillance demonstrating its safety (we are no longer talking about efficacy, which I do not discuss, but safety) on hundreds of millions of people. No less than a thousand, then. Only in this way, on a very large population, the risk of abnormal thrombosis and thrombocytopenia could emerge, estimated in about one case in 100 thousand people vaccinated at the first dose, one in 600 thousand at the second, which has prompted today for prudence to introduce this protocol. br>
This is, it should be emphasized, a much lower risk than that due to the use of the pill or cigarette smoke. Young girls like the one from Genoa take oral contraceptives very frequently, and often prefer third and fourth generation products that reduce water retention, but are at greater thrombotic risk. Each year, each of them has one in 1,000 risk of venous thrombosis - obviously not all serious cases, which in any case are rare -, one hundred times more frequent therefore than the rare form linked to AstraZeneca (Altroconsumo data updated to February 2019). And if you smoke (and you don't say that no one does, if you take the pill), the risk increases even more, so even the severe forms increase in proportion.

Every now and then the newspapers, since well before the pandemic , report the news of the death from pulmonary embolism of a young woman like Camilla, but nobody even remotely thinks of withdrawing the contraceptive pills from the market. Unfortunately it happens, and we turn the page. However, if we talk about a vaccine, the same calculated risk that is accepted for a non-essential, non-life-saving drug, such as the contraceptive pill, in which it is considered balanced by the benefit, becomes a coincidence, and affects the choices on many other people.

The example of the pill serves just to explain how we metabolize the concept of very rare risk in a different way, depending on the case, our values ​​and our starting prejudices. We therefore now have a treatment on a plate of the scales, two doses of AstraZeneca, which on the basis of what has been said we can consider safe, with very rare serious side effects, which emerged only after the treatment of hundreds of millions of people. On the other hand, there is a mixed protocol, which will most likely work well and which in theory should not create problems, even if it has given some signals of greater reactogenicity. We don't know if this is a red flag for something that will show up in large numbers. It is not known. It has not been authorized by the European Medicines Agency (Ema), nor by the manufacturers. The Technical Scientific Committee, and now AIFA, however, say that it must be done. That it is not possible to opt for the tried and tested scheme, which is known and authorized by the EMA. That a completely unknown risk is better than one quantified at such low levels. And then some countries already do it. But is there any data? No, no one has collected a case history equivalent to that of the double dose of Vaxzevria, such a large number of administrations that such rare complications can be seen. There are those 700 cases treated in the two studies cited. So far, so good.

However, it is not just a question of logic, safety, or public health, but of method. How will we defend ourselves in the next Stamina case? Do you remember the slogans? Hope cannot be taken away. Do you remember the pictures of sick children? The life of a single child is worth more than all your scientific method, they told us. Today, it is the life of an 18-year-old, with a still unclear medical history, which is worth more than the vaccination campaign as a whole. More than the basic idea that treatments must be preceded by experimentation, and then used only if they prove to be safe and effective. That the exceptions to this rule must be exceptions, certainly legitimate in a pandemic, but only out of urgent necessity, as when the United Kingdom was overwhelmed by the winter wave and dared to choose to lengthen the timing of the second dose.

This is not the case. The vaccine cocktail was not decided because AstraZeneca is no longer available. Because we don't have enough doses. Nor why Ema suspended him. The vaccination campaign is being changed in the wake of the news case, on the emotionality of the moment. Method, peer review, breadth of studies, all the concepts that we have explained to Italians for a year and a half no longer count. The sweet face of Camilla, which now seems familiar to us, cancels that of dozens (hundreds?) Of other people who could die from the inevitable delays in the vaccination campaign resulting from this decision. Those are numbers, they say, this is an 18-year-old girl. As if they did not have names, faces, loved ones who will miss them terribly.

Dossiers to be submitted to regulatory agencies are no longer needed. Those who advocate the use of Sputnik, or Chinese vaccines, are right. Why should we wait for the approval of the EMA or the FDA? On the other hand, even agencies are now evidently often forced to follow politics, ignoring scientific evidence. We saw it with bamlanivimab, the monoclonal antibody initially authorized in Italy as monotherapy, despite negative studies, because a well-known scientist, or maybe two, wanted it so. History repeated itself a few days ago with the US FDA, which came to deny the opinion of the technical committee and ignore the inconsistency of scientific data, in order to support the lobbies and authorize the "drug against Alzheimer's".

If the data no longer count for anything, if the treatments do not have to prove safety and efficacy (and not out of necessity, but by choice), because for a year we have used these arguments as a club against family doctors who are struggled with therapies not supported by controlled trials in order not to send their patients to hospital?

We explained to those who listened to us that scientific evidence can change over time, but at any moment it is the most solid foothold we have . We believed in all of this, and we still believe in it. Many times we have fought to defend these principles from hordes of charlatans. Was it all a joke? Didn't we understand anything?

(The comment is an adapted version,

with the author's approval,

of a post that originally appeared

on the Facebook page of Roberta Villa,

author of Vaccini, never so feared, never so expected)

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