Johnson & Jonshon’s Covid vaccine continues to be effective and safe, but it is now proven that, although still low, it produces the possibility of cases of blood clotting disorders. The European Medicines Agency’s (EMA) Risk Assessment Committee found a clear correlation in the incidence of immune thrombocytopenia, the condition where the immune system mistakenly attacks and destroys blood cells called platelets necessary for normal blood clotting.
For this reason, the expert body recommended an update of the risk management plan of the Janssen vaccine to reclassify immune thrombocytopenia, currently ‘an important potential risk’, as ‘an important identified risk’.
The Italian Medicines Agency (AIFA) clarifies and clears the field of unjustified fears. Alla Stampa reminds us that the potential risk is “a harmful event for which there are well-founded suspicions of an association with the drug in question, but for which the evidence is insufficient to conclude that there is a causal relationship”. The identified risk, on the other hand, is “a harmful event for which there is adequate evidence of the association with the medicinal product in question”.
Therefore, it is now shown that Johnson & Johnson’s Covid vaccine can produce immune thrombocytopenia. This does not imply the danger of the drug, since overall the risk-benefit ratio remains the prerogative of the latter. So much so that for the Janssen vials this correlation “remains unchanged”, assures the EMA.
The threshold of cases in percentage of the vaccinated population that undergoes collateral problems of this type remains low, but the ascertained correlation forces the revision of the accompanying sheet of the pharmaceutical product and the invitation to information between patients and medical-health personnel .
Those who are more exposed to certain pathologies must notify the doctor, or must be warned by the hospital staff themselves of this possible side effect. In this way it is possible to evaluate the administration of the vaccine or the use of other sera.
Currently, the European Medicines Agency has authorized the marketing and administration of the VaxZevria (formerly Astrazeneca), Pfizer-BioNtech, Moderna and Janssen vaccines.
Then there is an aspect of the all-pink vaccination campaign. The European Medicines Agency’s (EMA) Risk Assessment Committee also reviewed reported cases of menstrual disturbances that occurred after puncture. “So far no causal association has been established between anti-COVID vaccines and menstrual disorders”, the results of the tests.