• Sun. Oct 24th, 2021

AstraZeneca Italia, second dose, leaflet and age: the news

Byeditorial

May 4, 2021

AstraZeneca vaccine in Italy, in the aftermath of the reassurances on the second dose of the CTS – and of the announcement on the ongoing revaluation for administration also to under 60s -, here is the latest news today with the voices of the experts: what the leaflet says what are the side effects, what are the age restrictions for the Covid vaccine at the moment. “There has never been a ban” on administration to the under 60s. The European Medicines Agency “Ema has not placed restrictions on age, while Aifa has only given an indication for preferential use to the over 60s. The suggestion was interpreted as a rule, but it is not “, clarifies in an interview with ‘Corriere della Sera’ Giorgio Palù, president of the Italian drug agency Aifa, after yesterday the coronavirus emergency commissioner, Francesco Paolo Figliuolo, explained that – as the prophylaxis campaign progresses – the use of the AstraZeneca vaccine will also be re-evaluated for the under 60 group. As proof that the use of this shield product has no age restrictions, there is the fact that ” Aifa suggests giving the second dose with AstraZeneca to those who have already done the first with the same vaccine, regardless of age – Palù recalls – We will discuss it again to better specify this point and avoid that, due to an unreasonable risk assessment, many sal appointments and miss opportunities to protect themselves and others “.” If we entered the order of ideas of vaccinating “against Covid-19” with AstraZeneca even under 60 years, and I would not be against it, maybe we could create limitations that are also understandable “, the thought expressed by Massimo Andreoni, scientific director of the Italian Society of Infectious and Tropical Diseases (Simit) and head of Infectious Diseases at the Tor Vergata Polyclinic in Rome, guest at ‘Agorà’ on Rai3. What kind of limitations? “It should be borne in mind that these exceptional events”, the rare thromboses that have been evaluated by the European Medicines Agency Ema, “substantially concerned the female gender and therefore one could try to give a technical explanation to the choices made. they do, trying to make people understand them. “” AstraZeneca even under the age of 60? Not for everyone. The risk of serious side effects “of this anti Covid vaccine” is rare, but it is greater in young women. On the other hand, young women have a lower risk than men of developing severe symptoms from Covid-19. The risk-benefit ratio therefore suggests that we vaccinate all men, even with J&J, but to keep the age limit in women. medicine that does not consider our sex “. This is how Antonella Viola, immunologist at the University of Padua, intervenes on social media, but what does the ‘leaflet’ say? While the AIFA recommendation – but not the obligation – of administration to over 60s is still valid in Italy, the package leaflet has been updated after rare thrombosis cases in Europe. In the sheet on the Aifa website (here the Pfd), which indicates 18 years as the minimum age limit for administration, the paragraph ‘Blood disorders’ reads: “Very rare blood clots, often in unusual sites (for eg brain, intestine, liver, spleen), in association with low levels of blood platelets, in some cases accompanied by bleeding, have been observed after vaccination with Vaxzevria. This condition included severe cases with blood clots at different sites or unusual as well as excessive clotting or bleeding throughout the body. Most of these cases occurred within the first fourteen days after vaccination and mainly occurred in women under 60 years of age. In some cases this condition resulted in death “. The section on ‘Possible side effects’ also reads:” Like all medicines, this vaccine can cause side effects, although not everybody gets them. If you notice any side effects not mentioned in this leaflet, please tell your doctor, pharmacist or nurse. Get urgent medical attention if symptoms of a severe allergic reaction occur. These reactions may include a combination of any of the following symptoms: – feeling faint or lightheaded – changes in heartbeat – shortness of breath – wheezing – swelling of the lips, face or throat – hives or rash – nausea or vomiting – stomach pain The following side effects may occur with Vaxzevria: Very common (may affect more than 1 in 10 people) – tenderness, pain, warmth, itching or bruising where the injection is given – feeling tired (fatigue) ) or general ill feeling – chills or feverish feeling – headache – feeling sick (nausea) – joint pain or muscle pain Common (may affect up to 1 in 10 people) – swelling or redness where it is given the injection – fever (> 38 ° C) – being sick (vomiting) or diarrhea – low blood platelet levels Uncommon (may affect up to 1 in 100 people) – sleepiness dizziness or feeling dizzy – decreased appetite – swollen lymph nodes – excessive sweating, itching or rash Very rare (may affect up to 1 in 10,000 people) – blood clots often in unusual sites (eg. brain, intestine, liver, spleen) associated with low blood platelet levels “.