The European Medicines Agency (EMA) monitors “closely” eleven cases of blood coagulation reported after vaccination with Pfizer and two with Moderna, although there is no alarm signal at the moment because these figures are “extremely low and do not generate concern”, I assure Efe of a source from the regulator.
When these cases “are observed in the context of the exposure of people to vaccines”, the EMA does not consider these signs to be worrying nor does it see the need to initiate a thorough investigation as it did with AstraZeneca and Janssen, when what was known as “safety signal”
Putting these data into perspective, of the 60 million doses of Comirnaty, the Pfizer-BioNtech preparation, administered in the European Economic Area (EEA), formed by the 27 states of the EU, together with Iceland, Liechtenstein and Norway, Eleven cases of thrombosis with thrombocytopenia have been recorded coinciding with the days after vaccination.
These figures about Pfizer, notified until April 13 , amount to 25 cases worldwide, according to reports collected by EudraVigilance, the European database that collects the side effects of drugs authorized or studied in clinical trials.
At Moderna, there have been two reported cases of blood clotting with a low level of plateletsamong the more than 5 million doses administered to the same date, which rises to 5 cases if those reported after vaccination outside the EEA zone are also added.
“By way of comparison, with Vaxzevria (AstraZeneca’s vaccine trade name), 142 cases of thrombosis with thrombocytopenia had been reported in the EEA as of April 13 and more than 17 million doses had been administered. reported 287 cases” globally, underlines the same source.
Close monitoring of cases
For this reason, the EMA stresses that it is “closely following the cases of blood clots reported after the use of the covid-19 Comirnaty and Moderna vaccines, and considers at this stage that there are no safety signs of (possible risk of developing ) blood coagulation” because these figures ” are extremely low and do not cause concern ” at the moment.
Study with AstraZeneca and Janssen
AstraZeneca and Janssen, both investigated in depth by the EMA for the risk of coagulation, are based on the same technique: adenoviral vector derived from an adenovirus that causes the common cold in chimpanzees and humans, respectively, genetically modified so that it cannot replicateand cause disease, so it has been transformed to express the SARS-CoV-2 Spike protein in cells.
However, the Pfizer and Moderna preparations use a new technology called messenger RNA, ribonucleic acid molecules that contain instructions with which the human body can produce the virus and at the same time the antibody that neutralizes it.
Both the EMA and the EU Member States “will continue to monitor and evaluate any new information, including reports of suspected side effects, of all Covid-19 vaccines” authorized in the community zone, says the source, promising that “measures will be taken when necessary to protect public health”.
Always more benefits than risks
In the results of a specific investigation published last week by the EMA, it was shown that the benefits of vaccinating with AstraZeneca outweigh its risks (including those of developing thrombi) in all age groups, although the older the person and the figures of contagion, the clearer are those effects of its protection against covid-19.
As an example, the safety committee (PRAC) showed in graphs how, in people over 80 years of age with high exposure to the virus, 1,239 hospitalizations, 110 admissions to intensive care units and 733 deaths from covid-19 had been prevented by per 100,000 people, in an age group in which only 0.4 cases of blood coagulation with a low level of blood platelets have been detected.
This means that, despite the existence of some cases of thrombi that could be linked to the vaccine, vaccination against Covid-19, a disease with a risk of hospitalization and death , continues to have many more benefits when it comes to protecting against the virus and save lives, than the possible risks of developing coagulation disorders, which in themselves already occur much more frequently beyond the use of these vaccines.
As of today, the EMA has a real-time analysis process openof the American vaccine Novavax since last February 3; the German CureVac from February 12, and the Russian Sputnik V from March 4, but none has a set schedule for them to take the step of requesting a conditional license for use in the EU, and be used in European campaigns of vaccination.
