RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to raps@raps.org so that we can defer those challenges. Your health and safety are paramount to us.

Regulatory Focus™ > News Articles > 9 > EMA Takes Issue With BMJ Article on Pandemrix Vaccine

EMA Takes Issue With BMJ Article on Pandemrix Vaccine

Posted 26 September 2018 | By Zachary Brennan 

EMA Takes Issue With BMJ Article on Pandemrix Vaccine

A recent article in the BMJ suggested that one pandemic flu vaccine was less safe than others, though the European Medicines Agency (EMA) said Wednesday that the comparisons are “not scientifically valid.”

The BMJ article, titled “Pandemrix vaccine: why was the public not told of early warning signs?” suggests that GlaxoSmithKline’s Pandemrix vaccine was less safe than other pandemic flu vaccines based on a comparison of the number of suspected adverse reactions reports received.

“EMA’s view is that this comparison is not scientifically valid and the BMJ article’s consequent conclusions are flawed and misleading to its readers and the wider public,” the agency said.

The number of suspected adverse event reports spontaneously submitted by healthcare professionals and patients depends on the number of those receiving a vaccine, the agency explained, noting that it also depends on the organization of the local reporting system where the vaccine is administered, different target populations in different geographical regions, as well as any differences in the nature and frequency of adverse reactions to the vaccine itself.

“Therefore to conclude that one product is safer than the other, based on numbers of spontaneous suspected adverse reaction reports alone, without consideration of all other relevant data, including clinical trials and epidemiological studies, is in our view ostensibly simplistic, invalid and misleading,” EMA said.

EMA also explains how in August 2010, it learned of cases of narcolepsy in a small number of patients vaccinated with Pandemrix, and while the biological mechanism for the association between Pandemrix and narcolepsy remains unknown, the data available led EMA to restrict its authorized use to cases where alternative seasonal tri- and quadrivalent influenza vaccines are not available.

“Since that restriction by EMA, the marketing authorisation for Pandemrix has expired and it is currently not available in the EU,” EMA said.

Rapid response to BMJ


© 2022 Regulatory Affairs Professionals Society.