December 3, 2020

expert reaction to comments made by Dr Anthony Fauci on the approval of the Pfizer/BioNTech COVID-19 vaccine by the MHRA

Dr Anthony Fauci, the Director of the National Institute of Allergy and Infectious Diseases, commented on the UK’s speed in approving the Pfizer-BioNTech vaccine, saying “If you go quickly and you do it superficially, people are not going to want to get vaccinated.”

Prof Stephen Evans, Professor of Pharmacoepidemiology, London School of Hygiene & Tropical Medicine, said:

“Dr Fauci has been and still is an extremely good scientist and his advice has been of very high quality throughout this pandemic.

“However, I think it is possible that he has over-stated concerns about the UK assessment process for the Pfizer/BioNTech vaccine.

“The processes carried out by the FDA and the MHRA are basically very similar. The only major difference is that the FDA may reproduce all the tables submitted by a company by re-analysing the data. This has been a notable difference between the FDA and other regulatory authorities around the world. Virtually no other regulator will regularly reanalyse from raw data to verify the analysis carried out by a company. We do not know how often there are substantive differences between an FDA analysis and a company analysis. We may well see differences in interpretation of the data between a regulator and a company, but this type of difference is regularly seen by all regulators, whether they reanalyse the data or not.

“It is very important to state that the reason the UK has been able to be so quick is not because we are no longer in the European regulatory system because we are. Every EU country has the same option of carrying out its own assessment in a public health emergency. Hungary has also effectively followed this option as I understand it.

“What is a unique situation is that The UK, while being governed by the EU regulatory laws and decisions, has not been carrying out assessment work for new vaccines or medicines intended for the whole EU for about 18 months and the work that would usually be done by the MHRA for Europe, is being shared out by the other 27 member states. Consequently, the UK has almost undoubtedly had greater capacity to respond to a new application for authorization of a vaccine than any other country. This temporary situation will change from January 1st 2021 when the UK MHRA becomes responsible for doing all applications for new drugs and vaccines to be authorised in the UK. It will have to do work that previously would have been shared among all the other 28 member states.

“It is very clear that the UK assessment of this has followed all the usual processes, but has been working incredibly long hours and seven days a week both with MHRA staff and with their academic advisors for quite a long time on initial and interim data before the final data were submitted. It is entirely possible that had this pandemic occurred in a year’s time when the MHRA was fully or more than fully occupied with work for the UK, then the speed with which they would have been able to authorise a new vaccine would have been longer than others rather than shorter. It will be important to have some evidence that the UK assessment process was deficient in some regard and I think that is very unlikely. In my judgement the assessment of this new vaccine will have been done more rigorously currently then a routine assessment in a non-pandemic situation. There is a spotlight on this whole process and if it were to be the case that a problem appears with the vaccine that had been missed by the MHRA and its advisors, then their reputation would be damaged very severely so the incentive to get it right now is very high. It is easy to say the speed means not careful, but it is also possible to understand other reasons for the speed than lack of care.”

Declared interests

Prof Stephen Evans: “No conflicts of interest. I am funded (one day per week) by LSHTM. They get funding from various companies, including Astra Zeneca and GSK but I am not funded by them, I have no involvement in obtaining funding from them and I am not an investigator on any grants obtained from them. I am the statistician to the ‘meta-Data Safety and Monitoring Board’ for CEPI. I am paid for my attendance at those meetings and will be paid expenses for travel if that occurs.”