AstraZeneca vaccine: what the AIFA data say

AstraZeneca vaccine

The tone of the discussion about vaccines has flared up again as a result of the blockade of a batch coming from the AstraZeneca plants. The company itself in a press release refers to a decision taken as a result of some "serious adverse events" manifested "in conjunction with the administration". The collaboration with the health authorities has started for the investigation of the case.

An analysis of our safety data on over 10 million administrations has not revealed any evidence of an increased risk of pulmonary embolism or venous thrombosis deep in any age group, sex, batch or any country where AstraZeneca vaccine against COVID-19 was used. The number of these events observed is significantly lower in vaccinated subjects than the number observed in the general population.

Inevitably (and legitimately) the news has raised concern, especially among those who have already undergone or are injecting to do. The tam tam on social media and the methods chosen by a part of the local press did the rest. The only effective vaccine against information distortion is once again the one made available by the data. Let's look at those of AIFA so that we can eliminate the background noise generated by clickbait and sensationalism that frankly no one now feels the need for.

AIFA data on AstraZeneca and other vaccines

The Italian Medicines Agency has issued a press release on the matter with explicit reference to lot ABV2856. Here are the most important passages.

AIFA has decided as a precaution to issue a ban on the use of this lot throughout the national territory and reserves the right to take further measures, where necessary, also in close coordination with the EMA.

Called into question EMA, the European agency, which in turn has ruled on similar cases registered elsewhere, so much so as to lead some countries such as Austria to suspend the administration of the AstraZeneca vaccine.

At the moment not there are indications that the vaccine caused these conditions, not present among the side effects.

The cases referred to are those of a man who died ten days after the injection from thrombosis and another instead in the healing phase after being hospitalized for pulmonary embolism. Both had been inoculated with batch ABV5300, distributed in 17 countries in over one million doses.

Returning to AIFA, it is emphasized that at the moment no causal link has been established between the administration of the vaccine and these events. The agency is carrying out all the necessary checks, acquiring clinical documentation in close collaboration with the NAS and the competent authorities. The samples of batch ABV2856 will be subjected to analysis by the Istituto Superiore di Sanità.

In recent days, the Italian agency also published the "Second AIFA Report on the surveillance of COVID-19 vaccines" with data updated as of February 26, 2021. Interested are those of Pfizer, Moderna and AstraZeneca. Out of a total of 4,118,277 doses administered, 30,015 reports were evaluated (729 per 100,000), defined as a higher rate than that which is usually observed for other vaccinations, such as influenza, but consistent with the results of clinical studies and indicative of the special attention paid to this vaccination.

93.6% of the reports refer to non-serious events, in line with the information in the "Summary of Product Characteristics" of the vaccines, ie fever, headache, muscle and joint pain, injection site pain, chills and nausea: the reported events occurred mainly on the same day as vaccination or the day after (87% of cases). , for which the "evaluation of the causal link with vaccinations" is underway, correspond to 6.1% of the total (44 per 100,000), regardless of the type of vaccine and the if administered.

AIFA concludes by recalling that a large number of reports do not imply a greater danger of the vaccine, but indicate the high ability of the pharmacovigilance system to monitor safety.