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White House demands to know how UK approved vaccine before FDA

BMJ 2020; 371 doi: https://doi.org/10.1136/bmj.m4725 (Published 03 December 2020) Cite this as: BMJ 2020;371:m4725

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Rapid Response:

Why being the first in vaccine approval is not necessarily winning

Dear Editors

The rapid approval of COVID-19 mRNA Vaccine BNT162b2 from Pfizer/BioNTech by UK's Medicines & Healthcare products Regulatory Agency (MHRA) has no doubt caught many by surprise, including the general public, healthcare professionals and even other respected heatlhcare regulatory agencies, including US's FDA and EU's EMA (Ref 1).

While there are suggestion within the MHRA's information document (Ref 2) that it had received more data from the manufacturers than what is reported in the corporate press release of November 18, 2020 (Ref 3), it is still not apparent to external observers to what extent the efficacy data in the Phase III was actually made to MHRA reviewers, who presumably are the same people involved in the rolling review promoted by the agency as a positive trait in keeping up to date with current evidence of the COVID-10 pandemic.

Perhaps other commentators (Ref 4) may have more detailed knowledge of what Phase III data MHRA did end up reviewing, before they gave the product temporary Authorisation under Regulation 174, but I do not share that confidence, knowing that the FDA commissioner Stephen Hahn pointed out FDA is "one of the few regulatory agencies in the world, if not the only one, that actually looks at the raw data from clinical trials" and did not know how the UK's MHRA managed to make their conclusion.

It is unclear to me if FDA (or indeed MHRA) has been given access to the Phase III raw data at the time of MHRA's announcement on the December 2 (Ref 5).

The circumstances of this pandemic made strange bedfellows: healthcare professionals may have similar reluctance and hesitancy as other vocal critics in considering whether MHRA's approval was performed with the usual due diligence.

Dr Anthony Fauci's (Director of the National Institute of Allergy and Infectious Diseases in the US) comment that: “If you go quickly and you do it superficially, people are not going to want to get vaccinated.” (Ref 6) may have drawn some flak, but nevertheless his views reflect many in the world and should not be discounted.

Until the MHRA and/or other agencies critically appraise raw trial data in this important healthcare measure, and this process is made transparent, otherwise there is certainly a case for caution before proceeding with it. Healthcare professionals in UK may have to carefully consider their position when they are tasked with carrying out the public health directive involving any novel product.

References
1. https://www.theguardian.com/world/2020/dec/04/how-vaccine-approval-compa...
2. https://assets.publishing.service.gov.uk/government/uploads/system/uploa...
3. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-an...
4. https://www.bmj.com/content/371/bmj.m4725/rr
5. https://assets.publishing.service.gov.uk/government/uploads/system/uploa...
6. https://www.sciencemediacentre.org/expert-reaction-to-comments-made-by-d...

Competing interests: No competing interests

08 December 2020
Shyan Goh
Orthopaedic Surgeon
Sydney, Australia