Violations in Pfizer/BioNTech vaccine studies not casting doubt on safety: EMA
Amsterdam, Nov 4 (UNI/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.
Earlier this week, the BMJ peer-reviewed journal reported that researchers involved in the clinical trials engaged in poor scientific practices that compromised the integrity of the data.
“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.
“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,” the agency added.