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

(Source: European Parliament)

EN

E-001655/2021

E-001630/2021

E-001601/2021

Answer given by Ms Kyriakides

on behalf of the European Commission

(31.5.2021)

Security and trust in vaccines is key for vaccinations. The priority of the Commission has always been the safety and the efficacy of any COVID-19 vaccine authorised for use in the EU.

The Commission has full trust in the scientific assessment of the European Medicines Agency (EMA). An enhanced pharmacovigilance system is in place for COVID-19 vaccines. It allows a close monitoring of their safety after roll out, providing additional re-assurances for their safety. New information is included in the product information when relevant scientific evidence has been assessed.

The very rare side effect of blood clots combined with low levels of blood platelets was reviewed by EMA’s committee responsible for assessing and monitoring the safety of human medicines[1]. On 7 April 2021, the committee confirmed that the overall benefit of AstraZeneca’s COVID-19 vaccine remains positive. Moreover, additional safety information has been included in the product information to inform about possible adverse effects[2].

Following this assessment, the Commission requested EMA to carry out additional analysis of vaccination data and data on disease epidemiology (including infection rates, hospitalisations, morbidity and mortality)[3]. EMA’s human medicines committee[4] provided its interim analysis on 23 April 2021[5]. The analysis will inform national decisions on the roll out of the vaccine, taking into account the pandemic situation as it evolves and other factors, such as vaccine availability. The analysis could evolve as new data become available.


[1] Pharmacovigilance Risk Assessment Committee – PRAC.

[2] https://www.ema.europa.eu/en/news/astrazenecas-covid-19-vaccine-ema-finds-possible-link-very-rare-cases-unusual-blood-clots-low-blood

[3] https://www.ema.europa.eu/en/news/astrazenecas-covid-19-vaccine-ema-provide-further-context-risk-very-rare-blood-clots-low-blood

[4] Committee for Medicinal Products for Human Use- CHMP.

[5] https://www.ema.europa.eu/en/news/astrazenecas-covid-19-vaccine-benefits-risks-context

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