The verdict of the European Medicines Agency (Ema) on the potential link between the anti-Covid vaccine developed by AstraZeneca and the risk of thromboembolic events will soon arrive. As of March 10, 30 cases out of 5 million vaccinated have been reported. But for which several European countries, including Italy, have decided as a precaution to suspend the administration of the drug.
Meanwhile, there are those who wonder if it is not appropriate to stop the birth control pill, a pro-thrombotic drug, in order to receive the vaccination. The alert arose from the fact that in Germany, according to reports from the German agency that deals with drug safety, the Paul Ehrlich Institute (Pei), seven cases (3 fatal) of the rare cerebral venous thrombosis, associated with to a drop in platelets, of which six women and one man. The thrombosis, specify from the German agency, can also occur in women who take the contraceptive pill, as evidenced by the leaflet of this pro-thrombotic drug, which also requires a medical prescription, and it is for this reason that it is suggested, in the event that a cause-and-effect link was confirmed, to mention it in the vaccine package insert.
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In recent days, some experts like Giorgio Palù, president of the Italian Medicines Agency (Aifa), reported that in case of confirmation, more attention should be paid to certain categories of people, such as theand women who are on birth control pills or who have blood clotting defects. We therefore asked to clarify the possible link between vaccine, birth control pill and thrombosis a Gianfranco Parati, full professor of cardiovascular diseases at the University of Milan Bicocca, Director of the Department of Cardiology and Scientific Director at the Italian Auxological Institute, S. Luca Hospital in Milan.
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Referring to the AstraZeneca vaccine, the Pei mentioned the contraceptive pill and its relationship, also reported in the package insert, with thrombotic events. Could the risk be the same for the vaccine?
“Vaccines in general, and also anti-Covid vaccines, prepared according to different methodologies, do not have the appearance of thrombotic events as side effects. The AstraZeneca vaccine showed no evidence of an increased risk of pulmonary embolism, deep vein thrombosis (Tvp) or thrombocytopenia, in any age group, gender. To date, about 17 million people have been vaccinated with AstraZeneca without significant side effects ”.
What risks are there for women who take birth control pills, other pro-thrombotic drugs, or who may have blood clotting defects?
“Currently, cause-and-effect relationships between the administration of anti-Covid vaccines and contraceptives have not been demonstrated. Any thrombotic events are independent and are due to the use of the contraceptive itself. The American drug regulator (FDA) estimates that of the 842 million women who take contraceptives, the risk of thrombosis is three to nine in 10,000 each year. The AstraZeneca vaccine has been administered to patients with coagulation disorders, such as heterozygous prothrombin positive mutation G20210A and homozygous MTHFRC677 positive, without any side effects. In summary, the risk given by vaccination is currently estimated at 0.00003%. On the contrary, the thromboembolic risk for those who take contraceptives can in some cases reach 6-10% “.
Even in these cases, therefore, does the benefit-risk ratio of the vaccine remain positive?
“For a patient who has an increased thrombotic risk of any kind, including taking birth control pills or drugs that confer an increased risk of TE, it is much more dangerous to get Covid-19, because recent literature data indicates that the incidence of thromboembolic complications in Covid-19 patients is 15% of cases, with percentages ranging from 3 to 40% depending on age and other factors “.
If the EMA were to confirm a slight increase in the risk of thrombotic events, what consequences could there be? Could the vaccine be discouraged?
“The risk-benefit ratio should always be weighed. The data available to date indicate a very low risk for the vaccine which therefore would weigh little on the overall risk. Before modifying the methods of administration of anti Sars-Cov-2 vaccines, it is necessary to have solid evidence that they cause thrombotic events. To date, the EMA has not yet communicated significant data on the cause-and-effect link between vaccination and thrombotic events. If scientifically certain data should emerge for the risk of related diseases, re-evaluations on how to administer it will be made, with what methods and with what precautions “.
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In Germany they observed that thromboembolic events are related to a decrease in platelets, what is the relationship with these adverse events?
“Thrombi, which constitute the etiopathogenetic mechanism of thromboembolic events, are made up of aggregates of platelets. If the thromboembolic event is massive, a decrease in the number of platelets may therefore be found ”.
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