• AstraZeneca, Locatelli: "Recommended preferential use over 60"

  • Vaccini, Zingaretti: Lazio could double injections, if there were doses

  • Ema on Astrazeneza: "Possible link to very rare thrombosis".

    "Benefits outweigh the risks"

  • Veneto, Zaia: "If AstraZeneca stops, there is a risk of delaying the vaccination campaign"

  • AstraZeneca suspends vaccine testing on very young people

  • EU, 70% vaccinated at the end of June is a realistic goal

Share

08 April 2021 "In the light of the data currently available, it is not possible to make recommendations regarding the identification of specific risk factors, and at the same time preventive treatments for thrombotic episodes are not identifiable".



This was stated by the Technical Scientific Commission CTS of the Italian Medicines Agency Aifa in the opinion on the AstraZeneca vaccine, in relation to the cases of rare thrombosis reported following the administration of the same vaccine.



The opinion is attached to the Ministry of Health circular which updates the vaccine recommendations.



"There are no data on risk related to second dose"

The association between the AstraZeneca vaccine "and very rare cases of thromboembolism, even severe, in unusual locations (including rare cases of venous thrombosis of the cerebral sinuses, splanchnic and arterial thrombosis) associated with thrombocytopenia", to date "in most of the Cases have been reported in subjects less than 60 years of age and predominantly in women. These events were mostly observed within 14 days after administration of the first dose of the vaccine. There is currently no data on the risk related to the second dose as to the at the moment it was administered only to a limited number of subjects ".



Benefit / risk balance is confirmed positive

"On the basis of current incidence estimates that indicate the extreme rarity of the events described, the benefit / risk balance of the Vaxzevria vaccine is confirmed overall positive, as the vaccine is certainly effective in reducing the risk of serious illness, hospitalization and death related to Covid-19.



Currently, this balance appears progressively more favorable with increasing age, both in consideration of the greater risks of developing serious Covid-19, and for the lack of an increased risk of thrombotic events described above in vaccinated subjects over the age of 60 ".



This is what the AIFA Technical Scientific Commission, meeting yesterday evening, writes in an opinion on the cases of thrombosis related to the AstraZeneca vaccine, specifying that "AIFA in collaboration with the EMA will continue the careful evaluation of any safety signal even in order to formulate any further recommendations ".



No signs of rare thrombosis risk for Mrna vaccines

"At the moment similar signs of" rare thrombosis "risk have not been identified for mRna vaccines" against Covid-19, such as those of Pfizer / BioNTech and Moderna, the Commission specifies scientific technician in the annex to the circular with which the Ministry of Health updates the indications for the use of the AstraZeneca anti-Covid vaccine, now recommended as a preferential option for those over 60.