Questions and answers on the AstraZeneca vaccine

Questions and answers on the AstraZeneca vaccine

Yet another change of course on the use of the AstraZeneca anti-Covid vaccine: following the probable link between vaccination and rare thrombotic events, the Ministry of Health recommends it over the age of 60. Here are our Faqs

(Image: Unsplash) Here we are at the latest installment of the saga starring Vaxzevria, the vaccine against Covid-19 developed by the University of Oxford and the pharmaceutical company AstraZeneca. In the light of new pharmacovigilance data, the European Medicines Agency (EMA) has recognized as probable the link between the rare thromboembolic events and vaccination with the Anglo-Swedish product. The experts, however, once again underline the substantial safety of the vaccine and how the benefits of vaccination far outweigh the risks, thus not indicating any limitations of use either by age or by gender. The European states, however, are free to give different indications, so much so that in the past few hours the Minister of Health Roberto Speranza has signed a new circular about it: here's what you need to know.

Is there a link between Vaxzevria vaccine and thromboembolic events?

The updated pharmacovigilance data that the Ema experts analyzed testify to a significant statistical association between anti-Covid vaccination with the Astrazeneca product 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 ”, reads the circular from the Ministry of Health.

The events of altered blood coagulation that could be a consequence of vaccination are not common either by type or by frequency. They appear to be an autoimmune reaction, similar to a condition that can occur in people taking heparin (an anticoagulant), when the immune system makes antibodies against this molecule. The manifestations are venous thrombosis in the brain or thrombosis at the abdominal level.

Based on the data available so far, it is estimated that these adverse events have a frequency of 4-7 cases in 1 million people vaccinated with Vaxzevria within 14 days from the first dose. By comparison, the risk of the same complication for other vaccines is less than 1 case in 1 million vaccinated people.

Our graphics to illustrate the potential benefits and potential harms of the AstraZeneca vaccine as announced by the MHRA this afternoon .

Benefits accrued over 16 weeks, at three different levels of exposure to the virus.

- Alexandra Freeman (@alex_freeman) April 7, 2021

Most of the reported rare thromboembolic events have occurred in women with less than 60 years, but it is not possible to establish with certainty whether age and gender are predisposing factors.

For whom is Vaxzevria recommended?

In the light of this information, Ema does not change its indications and confirms the use of Vaxzevria on adults in all age groups, without gender limitations.

Individual member states, however, have the possibility to impose limitations or give suggestions for use based on their vaccination strategies. Following the example of other European countries, including Germany and France, our Ministry of Health, in agreement with the CTS of Aifa and the Higher Health Council, recommends a preferential use of Vaxzevria in people over the age of 60.

What changes for those who have already received the first dose of Vaxzevria?

Nothing changes: in practice, as stated in the circular of the ministry, “by virtue of the data available to date , who has already received a first dose of the Vaxzevria vaccine, can complete the vaccination course with the same vaccine ".

To date there are no data indicating an association between the administration of the second dose of Vaxzevria and rare events Thromboembolic events.

After the first dose of Vaxzevria, what signs to watch out for?

The possibility of an adverse event of a thromboembolic nature within 14 days following the first administration of Vaxzevria of AstraZeneca is extremely rare. However, experts recommend that you immediately contact a doctor if signs such as headaches of an uncommon entity, widespread and persistent occur, especially if accompanied by neurological disorders such as vision problems, numbness of the limbs, confusion, etc; or persistent severe abdominal pain.

How does the Italian vaccination plan change?

For the moment, the new information on the AstraZeneca vaccine does not affect the Italian vaccination strategy. During the meeting with the Regions, the extraordinary commissioner for the Covid emergency Francesco Figliuolo declared that vaccinations for the 60-79 year old category will open at AstraZeneca from 8 April.

In short, the priorities remain the same : complete the vaccination of the older sections of the population, who are most at risk of developing severe forms of Covid-19 and appear not to be affected by serious adverse effects to the vaccine. For the under-60s we'll see.

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