Reports on vaccine safety from Pfizer, obtained under FOI request, reveal concerning safety signals in a major U.K. primary care database, but the MHRA is refusing to release the data to the public.
As side-effects of the Covid vaccines piled up, the MHRA expanded its advice lists for patients but took no action. Why is there no safety threshold for medicine, unlike in all other safety sectors, asks Nick Hunt.
Freedom of Information requests have revealed that the MHRA did not follow up on nearly half of the reports of deaths following the Moderna Covid vaccine.
Covid vaccine-makers Pfizer, Moderna and AstraZeneca were required to publish multiple post-authorisation safety studies. So where are they, asks Nick Hunt.
In a new FOI release the MHRA has finally come clean that it failed to test the safety of mass manufactured Covid vaccine batches, in contravention of its own regulations and public statements.
The MHRA has admitted that it doesn’t have a process for assessing the cause of Covid vaccine adverse events. Nor does it hold any information on the assessments it has carried out.
When the Government asked the MHRA to grant emergency approval to the Covid vaccines, a Minister intervened to reply on its behalf, cutting the licensing authority out of the loop. Why, asks Nick Hunt.
Nick Hunt diagnoses the U.K. medicines regulator's shortcomings relative to other industries, and the prognosis looks bleak. Root and branch reform is needed, but he's not holding his breath.
Safety professional Nick Hunt has written to the Health Secretary to raise his deep concerns about the MHRA, which consistently misses safety signals from dangerous medicines.
Product safety expert Nick Hunt suggests two simple changes MHRA should make if it actually wants to make sure the medicines it approves for release to the public are safe.
The MHRA was so flooded with Yellow Card adverse event reports for Covid vaccines that its statistical analysis was skewed and safety signals were buried, a new FOI release has revealed.
If you're considering participating in a clinical trial in the U.K., maybe don't, says Nick Hunt. Trials are regulated by the MHRA, and its failures here are no less extensive and serious than elsewhere.
