Stop vaccinations for young people with AstraZeneca and Johnson & Johnson and do it quickly. This is the sense of an appeal that a group of scientists and doctors has addressed to the government, in the light of the data relating to the administration of these two drugs, and to the serious side effects connected to them.
These days the Regions have chosen to launch several ‘Open Day’, to open vaccinations also to the age groups hitherto excluded from the vaccination campaign, and in particular to children who have to face maturity. In this way a vaccine such as AstraZeneca is used for the immunization of young people. A choice on which the government has not pronounced itself – also because health is the responsibility of the Regions – and which goes in the opposite direction to the recommendations of the Aifa, which suggested, but not imposed, the administration of these two serums in priority way for subjects over 60. However, it is a question of making us who have been approved in an emergency, for which the pharmacovigilance activity must continue.
Specifically, the data cited by the scientists in the letter, an initiative of the Coscioni Association, concern analyzes carried out by the English Medicines Agency and the Health Service on adenoviral vector vaccines, which can cause thrombocytopenic venous thrombosis (VITT is the English acronym) in subjects predisposed for unknown reasons, a rare disorder that occurs 5-15 days after inoculation of the drug, and which can also lead to to death.
The age group most at risk is between 20 and 55, especially women. Aifa did not provide enough data on vaccinations with AstraZeneca and Johnson & Johnson: we do not have data disaggregated by age group and by sex. For the moment, however, we have more data on AstraZeneca and less on J&J.
According to what the scientists write in the letter, if in the first studies on these vaccines the incidence was 1: 100,000, with a third of fatal cases, the latest data provided by the English Medicines Agency and Health Service, updated in half May, show that the incidence of adverse events is higher. The AstraZeneca vaccine fact sheet says VITT is a possible side effect that may affect up to 1 in 10,000 people.
But are the risks associated with vaccinating younger people greater than the benefits? Is it useful to continue vaccinating the under 40s to try to achieve community immunity? Or perhaps it would be better to allocate vaccines to them exclusively mRNA like Pfizer and Modern? We asked the Professor Valeria Poli, full professor of Molecular Biology at the University of Turin and president of the Italian Society of Biophysics and Molecular Biology (SIBBM), who signed the appeal.
Among the signatories of the letter are also Michele De Luca, co-president of the Coscioni Association, Full Professor in the Department of Life Sciences and Director of the ‘Stefano Ferrari’ Center for Regenerative Medicine of the University of Modena and Reggio Emilia; Gilberto Corbellini, full professor of the history of medicine and professor of bioethics at La Sapienza in Rome; Anna Rubartelli, professor of Cellular and Molecular Biology; Gennaro Ciliberto, President of the Italian Federation of Life Sciences and immunologists Anna Mondino and Giulia Casorati.
Professor Poli why did you write this letter?
The letter was written by absolutely pro vax doctors and scientists, I want to clarify it. We started with the observations that have been made on the rare but potentially very serious side effects of adenoviral vector vaccines. This is recent data, released from Great Britain. For Italy, however, we do not know exactly how many people have been vaccinated with AstraZeneca by age group and by sex, because Aifa has not provided the data in a disaggregated way until now.
Why should vaccinations with AstraZeneca and Johnson & Johnson for under 60s be suspended immediately?
The risk is that an adverse reaction occurs, very well documented by German scientists above all. It is a disease that has nothing to do with normal thrombosis, for example those caused by the pill, which in fact do not seem to increase after vaccines. VITT, vaccine-induced thrombocytopenic venous thrombosis, is a particular disease that occurred only with the AstraZeneca and J&J vaccines – while we still don’t know anything about the Russian one – and not with mRNA vaccines. It occurs in at least one case out of 50 thousand, but more likely in 2. It can therefore occur in 4 cases out of 100 thousand, among the under 55s, especially in women, for reasons that are not yet clear. The lower the age range is, the more the frequency of VITT increases, which has potentially lethal effects in 25-30% of cases.
What causes this pathology?
Adenoviral vectors somewhat facilitate the formation of auto-antibodies against platelets, which are involved in the blood clotting process. Auto-antibodies recognize a platelet protein, called FP4, attach themselves to platelets and activate them, causing a chain of events that lead to thrombus formation. These clots are particularly frequent in the deep venous vessels and concentrated especially in the vessels of the spleen and brain. For a drug, especially in the experimental phase, the risk-benefit ratio must always be analyzed. In recent days we have had three cases of VITT: a 40-year-old from Lucca, for which her parents have also presented a complaint; then an 18 year old student from Genoa and a 45 year old carabiniere from Catanzaro. For the latter two, a laboratory diagnosis has not yet been made, but the picture is worrying.
In this case, do you think the risks outweigh the benefits?
The risk-benefit ratio compared to the potential effects of Covid until death for people over 60 years is very much to the advantage of the vaccine. Among other things, VITT is less frequent for this segment of the population. Those between 40 and 60 are a bit gray. For healthy 18-40 year-olds, without other pathologies, there would instead be a truly laughable risk of suffering major damage from Covid, if they fell ill. While they have a definite, albeit rare, risk of contracting VITT. And of these, as we said, 25-30% can also die, in a totally useless way.
So isn’t it a good idea for you to vaccinate 500,000 graduates?
Young people must absolutely be vaccinated. We have always said that 30-50 year olds must be vaccinated immediately after securing fragile ones, because they are the ones who are much more likely to act as reservoirs, because they have many more social contacts. I am also in favor of vaccination for teenagers, but with the right vaccine. Vaccines are not all the same. This message was conveyed to overcome the distrust of AstraZeneca, after adverse cases were recorded, after the drug was suspended and then restarted. Vaccines are all effective, but they are not all the same. There are those that are good for the over 60s and those that are good for the young.
But is this not in danger of missing the objective of achieving community immunity?
If an 18-year-old has to wait two more weeks to get vaccinated, nothing happens, he doesn’t risk dying like an 80-year-old. Community immunity will necessarily have to involve vaccination of children, and when it is permitted, even younger children.
On Astrazeneca and Johnson & Johnson, however, Aifa limited herself to making a recommendation. Why does the government not comment on this?
In my opinion, both the EMA and Aifa have been very close to the circle, perhaps they did not want to frighten potential vaccinators. They should have been more peremptory in their indications, which, moreover, have been broken by the regional presidents. The government let it go, it almost gave the impression of wanting to run out of AstraZeneca. Maybe behind the scenes he also encouraged the use of Open Days open to all age groups, which obviously were filled with young people who cannot yet be booked at this stage. But even just risking a death I consider it totally unethical.
Would you have your 20-year-old son vaccinated with these vaccines?
No, if I can avoid it. But she is of age, so if she decided to get vaccinated I couldn’t do anything about it.
And does this also apply to boosters, i.e. for those who have already received the first dose of AstraZeneca?
Yes, this also applies to the second dose, for those age groups. While there are still no known real predisposing conditions for VITT, such as having had other thrombosis previously or taking the pill. The latter can cause venous thrombosis, which has absolutely nothing to do with the pathology we are talking about.
But are there any tests that can be done to understand if a person is at risk of VITT?
There are currently no preventive examinations. There is only one laboratory test that can show the presence of these antibodies, but it is done after drug administration. However, it would be much easier to only make Pfizer under a certain age. Even in England, who are the real producers of AstraZeneca, they are no longer giving it under the age of 40 in the last couple of months. Even those who took the first dose with Oxford serum are given Pfizer or Moderna as a second dose, there is no contraindication from the point of view of efficacy, because they are the same antigen. Vaccines can be mixed, there are studies that prove it.
Ema and Aifa have authorized the Pfizer vaccine for 12-year-olds. What do you think?
I am in favor, the data are very clear. Some cases of myocarditis have come out, especially in young males vaccinated with Pfizer, but they are easily controlled, not serious diseases.