Violations in Studies of Pfizer/BioNTech Vaccine Not Casting Doubt on Vaccine Safety - EMA

11:39 GMT, 4 November 2021

BRUSSELS (Sputnik) - Information about violations allegedly recorded during studies of the Pfizer/BioNTech vaccine against COVID-19 do not call into doubt the conclusions on vaccine safety and effectiveness, the European Medicines Agency (EMA) told Sputnik on Thursday.

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"EMA experts and international regulators scrutinised all the data on the safety, effectiveness and quality of the vaccine before concluding that it was safe and effective and could be authorised for use in vaccination campaigns worldwide. Although serious, these allegations do not call into doubt the conclusions on the safety, effectiveness and quality of the vaccine itself", EMA said.

Coronavirus disease (COVID-19) vaccination in Nantes

"We are aware that an article in the BMJ has reported poor practices that allegedly occurred at one of the US research organisations involved in the main study supporting the authorisation of Comirnaty (Pfizer/BioNTech's COVID-19 vaccine) both in the United States and in the EU. EMA takes all allegations questioning subjects' safety and data integrity very seriously. We are working closely with the US FDA [Food and Drug Administration] and international partners to investigate the issues raised, and will take regulatory actions as necessary", EMA added.

Earlier this week, the peer-reviewed journal BMJ reported that researchers involved in clinical trials engaged in poor scientific practices that compromised the integrity of the results.

BMJ cited Brook Jackson, a former exec from the Ventavia Research Group and subcontractor for the vaccine's phase 3 clinical trial. According to her, the company "falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events". Jackson added that she had repeatedly notified the company about the issues, and later sent a complaint by email to the US Food and Drug Administration (FDA).