Written Question: Pharmacovigilance strategy concerning the AstraZeneca vaccine and recent statements by the National Institute of Allergy and Infectious Diseases (NIAID)

(Source: European Parliament)

Date submitted: 24 March 2021

Question for written answer E-001655/2021
to the Commission
Rule 138
Simona Baldassarre (ID), Matteo Adinolfi (ID), Rosanna Conte (ID), Francesca Donato (ID), Stefania Zambelli (ID)

Subject: Pharmacovigilance strategy concerning the AstraZeneca vaccine and recent statements by the National Institute of Allergy and Infectious Diseases (NIAID)

With regard to the 25 cases of a rare type of thrombosis following the inoculation of the AstraZeneca vaccine, the EMA has not been very clear. On the one hand it has stated that the vaccine ‘is not associated with an increase in the overall risk of blood clots (thromboembolic events)’ and, on the other, ‘we still cannot rule out definitively a link between these cases and the vaccine’.

Pharmacovigilance in relation to thrombotic effects remains essential: after around 1.6 million vaccinations with the AstraZeneca vaccine in Germany, seven cases of cerebral venous sinus thrombosis were reported, which is a higher-than-normal incidence. It also needs to be clarified whether there are any correlations with the use of contraceptive drugs or with cases of inherited thrombophilia(1).

Moreover, we have learned from the US NIAID that the 79% efficacy rate for the AstraZeneca vaccine is the result of ‘outdated’ information dating back to before 17 February and therefore does probably not consider the new variants(2). Naturally, this uncertainty only undermines citizens’ trust in the vaccination campaign.

Can the Commission therefore answer the following questions:

  1. What specific pharmacovigilance protocol is being implemented with regard to the complications?
  2. How does the Commission intend to shed light on this serious situation reported by the NIAID?

(1) A number of genetic factors are widespread in the population, such as Factor V Leiden which is estimated to be present in 4.4 % of the population – Gregg JP, Yamane AJ, Grody WW, ‘Prevalence of the factor V-Leiden mutation in four distinct American ethnic populations’, American Journal of Medical Genetics, Vol. 73, No 3, December 1997, pp. 334-6.
(2) ‘NIAID Statement on AstraZeneca Vaccine’; 23 March 2021; (https://www.nih.gov/news-events/news-releases/niaid-statement-astrazeneca-vaccine).

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