Covid, vaccine mix for second dose: what the experts say

The mix of vaccines, approved by AIFA for those under 60 who have already received the first dose of AstraZeneca and who will carry out the booster with an mRna vaccine, such as Pfizer BioNTech or Moderna, divides the experts, between those who consider this solution positive and who instead invites to a deepening. In particular for Luca Pani, former director general of the Italian drug agency, now a professor at the University of Miami in the States and Modena in Italy, the Aifa decision “is also dangerous because the same agency declares that the vaccine mix has a profile of reactogenicity which is characterized by greater frequency in terms of local and systemic side effects which appears to be ‘overall acceptable and manageable’. Systemic effects which appear acceptable and manageable? What does this mean? In what percentages and with what level of mild severity or moderate, respectively? With which management strategies? “, underlines in ‘Il Foglio’. “There are no studies on all this and the tendency to use impromptu research when it is convenient, instead of official trials with tens of thousands of patients will prove to be a dangerous boomerang at the first side effect which will instead be serious, very serious or potentially fatal – warns Pani. – At that point the association with the vaccine mix would be difficult if not impossible to defend and no one will have the courage to assume their responsibilities which really seems to be the only concern that drives certain otherwise incomprehensible choices “.” The thing is so complicated and illegitimate (because Ema approves vaccines and not Aifa) that the National Agency is in fact forced to use a legal quibble, invoking law 648 of 1996 because, otherwise, it would not have been possible to implement its decisions – observes – A very simple urgent appeal to the TAR by a citizen wishing to exercise his right to receive the second dose of a vaccine approved, and for which he has already expressed an informed consent that remains valid, would probably skip this umpteenth piece. I will be wrong, but it seems an emotional and decomposed reaction following the tragic death of Camilla Canepa – he concludes – and the concerns expressed by General Figliuolo that the vaccination campaign could not obtain the desired results “. For the virologist Fabrizio Pregliasco, the green light of ‘Italian Medicines Agency “was a political decision to calm the mind, with the hope of giving maximum reassurance to carry out the vaccination campaign”. “I say – says Pregliasco – that the scientific elements are there anyway. Other nations have done it, there are the data “. On the vaccine mix, the second heterologous vaccine doses,” we must be more than calm “, affirms instead the director general of Aifa, Nicola Magrini.” In the decisions taken in this phase of pandemic, less heavy than a few weeks ago, the choice was made – he explained – to avoid that at this stage young populations are potentially offered vaccines that have a very remote risk of a serious event, and therefore safety has been privileged to guaranteeing vaccines as safe as possible to all “. It is a” choice shared also by several countries, so I believe that trust and maximum peace of mind is the message to be given “, he added. At the basis of heterologous vaccination, underlined Magrini,” there are clinical studies that were done with the utmost ethical rigor, but they were not particularly problematic studies. The question was whether there would be more side effects and to what extent, and are mostly mild or moderate effects. Therefore, safety with regard to administration is very high “. Also with regard to” long-term safety, that is, whether the vaccine mix is ​​problematic – found Magrini – this is excluded in the light of the available data “. Therefore, “having preferred this ‘transfer’ over the second dose for utmost caution was also a mixed principle of fairness to guarantee everyone the best vaccine free of these very rare undesirable effects for which, when the pandemic was very serious, it was instead decided, on the population at greatest risk, to offer a highly effective vaccine that is also globally safe “. For Pierluigi Lopalco” in an emergency, unfortunately, health policy decisions must also be made based on weak evidence (not absent). The same rules of ordinary health management cannot be applied in a pandemic. “Institutional communication must resume its guiding role and explain well to the citizen the reason for certain choices”, adds the epidemiologist and health councilor of the Puglia Region . “I read what Luca Pani wrote today, but I wouldn’t be so critical of Aifa. The vaccine mix has been authorized in other countries, Canada and Germany: it is not a question of saying that it must always be done like this, but if in Italy there is a change of destination of a vaccine, the second dose can be done with a different vaccine. The studies, although preliminary, seem to me to say that it can be done. In medicine it is correct to change if the scientific evidence is changed, so I do not find anything wrong with what Aifa has done. We have known anti-Covid vaccines for eight months and it is right to deal with new evidence “, underlines to Adnkronos Salute Matteo Bassetti, director of the Infectious Diseases Clinic of the San Martino hospital in Genoa.” The fact that – he points out – the Minister of Health is not vaccinated is scandalous. First because it seems to me that in terms of age, it falls into that segment of the population that had to get vaccinated and second because it had to lead by example with AstraZeneca, which its technicians had recommended so much. A health minister who does not get vaccinated during the biggest vaccination campaign in history is hallucinating and perhaps should resign. We are at June 16th and the vaccination campaign started on December 27th, what do people have to think? Then one wonders why we doctors are attacked on social media. People unload anger on us because they see that a 40-year-old minister has not yet been vaccinated. While he had to be the first to put his arm in it. Public figures – he concludes – with a role in health, such as a minister, should lead by example in such a difficult time. He may have followed the official channels, but it is a matter of opportunity “‘” I am confident in the ability of regulators to make decisions that are supported by evidence. The AIFA decision to authorize the heterologous administration of anti-Covid vaccines is legitimate, based on the data we have, even if they are limited. The question is to frame this decision in a very particular situation, which does not lead to the establishment of a general rule “, says to the Adnkronos Salute is the virologist Giovanni Maga, director of the Institute of Molecular Genetics of the Cnr of Pavia.” The situation. particular that we are facing – analyzes Maga – is this: we have a highly polarized perception on the part of the public on the AstraZeneca vaccine. There are doubts and fears. And there are tragic cases, albeit extremely rare. At this time, moreover, we have a minimal risk in a population, the young, who in this epidemiological phase have an equally low risk of becoming infected. Faced with this, the choice may be to eliminate any doubt, fear or risk for that age group with an alternative. And the alternatives are supported by data that are still partial, but that are accumulating “.
Therefore, concludes the expert, “the booster with a different vaccine in the current state of things seems to be a viable path. It has already been used in other vaccination campaigns, such as polio, for example. There will certainly be a reasoning, upstream, from the regulatory point of view to frame this somewhat exceptional case, but to the state of our knowledge the heterologous call may have the function on the one hand of facilitating the achievement of full vaccination coverage and on the other eliminating that very low risk of which we are knowledge”.