AstraZeneca vaccinations resume. Gynecological scientific societies: no risk for women who take the contraceptive pill.
In a meeting on 18 March 2021, The European Medicines Agency (EMA) ruled out a link between cases of thrombosis and the COVID-19 vaccine. The Pharmacovigilance Risk Assessment Committee (PRAC) therefore confirms the favourable benefit/risk ratio of AstraZeneca's COVID-19 vaccine. Vaccinations have resumed in all health districts of the Region of Sardinia. In a position paper yesterday, March 22, the Gynecological Scientific Societies Sigo-Aogoi-Agui, in agreement with Sim, Sic and Sigite, stated that there are no contraindications to the vaccination of women taking estrogen-progestin contraceptives or using hormone replacement therapy. They further stressed that there are no data in the literature regarding an increased risk of blood clots in those receiving anti-COVID vaccines - including the serum AstraZeneca - compared to the general population.
EMA’s safety committee, PRAC, concluded its preliminary review of a signal of blood clots in people vaccinated with COVID-19 Vaccine AstraZeneca at its extraordinary meeting of 18 March 2021. The Committee confirmed that:
- the benefits of the vaccine in combating the still widespread threat of COVID-19 (which itself results in clotting problems and may be fatal) continue to outweigh the risk of side effects;
- the vaccine is not associated with an increase in the overall risk of blood clots (thromboembolic events) in those who receive it;
- there is no evidence of a problem related to specific batches of the vaccine or to particular manufacturing sites;
However, the vaccine may be associated with very rare cases of blood clots associated with thrombocytopenia, i.e. low levels of blood platelets (elements in the blood that help it to clot) with or without bleeding, including rare cases of clots in the vessels draining blood from the brain (CVST). In view of this, having consulted the Minister of Health, the Directorate-General for Prevention and the Consiglio Superiore di Sanità, AIFA (Italian Medicines Agency) announces that the reasons behind the precautionary ban on vaccine batches, issued on 15 March 2021 (Attachment 1), are no longer valid.
Therefore, the Vaccination Campaign has been fully resumed in all Health Districts throughout the region.
Vaccinarsinsardegna.org also highlights the important statement made today by the Scientific Societies Sigo-Aogoi-Agui in a position paper, also shared by Sim, Sic and Sigite in which it reiterates that there are no contraindications to the vaccination of women who take estrogen-progestin contraceptives or who use hormone replacement therapy. This is a very important aspect of vaccination communication, as the Astra Zeneca vaccine is most suitable for the age groups in which the contraceptive pill is most widely used.
Vaccinarsinsardegna.org, wishes to remind users that during the recent suspension of the AstraZeneca vaccine pending the EMA’s decision, the anti-COVID-19 vaccination campaign has continued throughout the region with the Pfizer vaccine administered in particular to health care personnel, staff of companies authorised to work in our hospitals, vulnerable patients, staff of schools and law enforcement agencies considered "fragile" due to underlying clinical conditions.
In addition, the University Hospital of Sassari informs us that following authorisation from the Region of Sardinia, the vaccination of interns in Medicine and Surgery, Dentistry and Dental Prosthetics, Pharmacy and Health Professions enrolled at the University of Sassari has been approved. Vaccination will begin today, 22 March, in the vaccination centre on the ground floor of the Medicine building in Viale San Pietro.
Finally, we wish to inform our users that:
- As of today, the Azienda Ospedaliero-Universitaria Sassari (Sassari University Hospital) will proceed with the administration of Pfizer-Biotech doses to fragile categories, starting with nephropathic patients undergoing dialysis at AOU-SS. In this case, the AOU vaccination centre will begin carrying out assisted vaccination directly in the ward.
- From Tuesday, 23 March 2021, the administration of the vaccine to teaching and non-teaching staff in the province's schools will also resume. Their vaccination, which was interrupted due to the suspension of the AstraZeneca vaccine, will be scheduled following the same daily order and timetable given in the lists provided previously.
We urge users to stay connected to our website so as not to miss further updates. updates.
Also attached are the EMA press statement (Att 2) and the Circular on the Revocation of the AstraZeneca ban (Att 3).