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Parliamentary question - P-000303/2022(ASW)Parliamentary question

Answer given by Ms Kyriakides on behalf of the European Commission

In the EU a marketing authorisation is granted to a medicinal product only after its quality, safety and efficacy have been evaluated and a positive benefit-risk balance related to its use has been concluded. For EU authorisations of COVID-19 vaccines this assessment is carried out by the European Medicines Agency (EMA).

EMA has analysed reports describing the analysis of several vials of COVID-19 vaccines suggesting the presence of graphene and concluded that the currently available data do not show presence of graphene in the vaccines concerned. The analysis by EMA’s working party for biological medicines included an input on the Raman spectroscopy from the European Directorate for Quality of Medicines and the independent national testing laboratories responsible for batch release (OMCLs).

Graphene oxide is not used in the manufacture or formulation of any of the COVID-19 vaccines or other medicines, so it would not be present at manufacturing facilities and there is no obvious way that it could get into the vaccines. Quality control testing and quality assurance review, by the vaccine manufacturers and OMCLs responsible for batch release, confirm that each batch met all quality standards prior to release. No product complaints have been received for the batches mentioned in the paper. The presence of graphene or graphene derivatives in the vaccines therefore are not plausible.

The Commission and EMA do not consider that any further actions are necessary at this stage.

Last updated: 8 March 2022
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