Here’s something for the Covid Inquiry to investigate.
In January, I wrote about the possibility of the ‘blame game’ starting between MHRA and Health Ministers. I had got hold of a letter dated November 17th 2020 from Professor Van Tam, then Deputy Chief Medical Officer (England), to June Raine, Head of MHRA, seeking her view on the suitability of the Pfizer/BioNTech Covid vaccine Batch EJ0553 for Regulation 174 emergency authorisation. I had asked MHRA for a copy of June Raine’s reply to Van Tam but it said there wasn’t one and that ministers had taken all decisions regarding the Covid vaccines.
It’s taken me a while to find out what actually happened and I think it’s really odd. Judge for yourself.
In a normal world, MHRA would just have replied to Van Tam and copied it to ministers, given the significance of the issue. Instead, Lord Bethell, one of the Health Ministers, intervened and instructed MHRA to draft a reply for him to send to Van Tam, which he did on December 1st 2020.
That’s beyond weird. We’ve got a senior DHSC official – Van Tam – writing to the head of the MHRA asking for advice about invoking emergency approval of a new medicine after less than one year of trials (compared with the normal 10 years). But MHRA doesn’t reply. Instead, a Health Minister – Lord Bethel – intervenes and, in effect, tells Van Tam to get on with it. Really? I’m not a fan of MHRA, but it really makes me wonder if MHRA actually had safety reservations but were overruled by Ministers.
One possibility is the ‘bait and switch’ issue. The approved batch (EJ0553) came from large-scale ‘Process 2’ manufacture. The clinical trials had been done using product from the different, small-scale ‘Process 1’ manufacture. There was supposed to have been some safety testing of ‘Process 2’ product prior to approval (bottom of page 46 here) but there is a strong possibility that this didn’t happen in time. That would open up a whole can of worms. I submitted an FOI to MHRA on July 13th asking for a copy of Pfizer’s report of that testing but its is being evasive. Perhaps MHRA was aware of the associated risks but was overruled by ministers.
Either way, the Covid Inquiry must get to the bottom of why MHRA wasn’t allowed to reply to Van Tam. I would suggest the Inquiry gets hold of MHRA’s ‘Background Brief’ – these briefs always accompany draft letters for Ministers to send. I know because I used to be a Senior Civil Servant and I did hundreds of them over the years.
But that’s not all. There are some concerning issues in Lord Bethell’s reply:
- It says: “Pfizer/BioNTech must provide a robust root cause analysis on the visible lipid particles as soon as this is available.” Has anyone seen this ?
- It says that NHS Trusts do not need a manufacturing licence even though hospitals, GPs and Health Centres would be involved in unpacking and thawing of the product. These are legally considered part of the manufacturing process and therefore subject to licensing. There is an exemption if they are conducted under the supervision of a qualified pharmacist but I would be amazed if that happened in all cases.
For anyone interested, it was the same story for the subsequent Regulation 174 emergency authorisations of the AstraZeneca and Moderna Covid vaccines: Van Tam wrote each time to MHRA but the Minister intervened and replied himself.
All very odd. But I’m sure the Covid Inquiry will get to the bottom of it. Or maybe not.
Until Nick retired a few years ago, he was a Senior Civil Servant in the Ministry of Defence responsible for the safety and effectiveness of ammunition used by the Armed Forces. He is co-author of the Perseus Group report on U.K. medicines regulator the MHRA.