On 2nd December 2020 Dr. June Raine, Chief Executive of the Medicines and Healthcare products Regulatory Agency (MHRA) and Professor Munir Pirmohamed, chair of an expert working group (of the Commission on Human Medicines) advising the MHRA held a press conference to announce that the MHRA had recommended that the Pfizer/BioNTech vaccine against Covid-19 should be given an emergency authorisation in the UK.
They were accompanied by Professor Wei Shen Lim chair of the subcommittee on Covid-19 vaccination of the Joint Committee on Vaccination and Immunisation (JCVI ) whose contributions were not relevant to the remainder of this post.
A video of the press conference is online here:
Coronavirus data briefing (2 December 2020)
One comment from Professor Pirmohamed stood out for me.
Beginning at around 9:40 on the video Professor Pirmohamed stated the following:
"The
committee also considered that no specific precautions were required on
administration of this vaccine in people who already have had Covid-19 and no
testing is required before receiving the vaccine.”
Professor Pirmohamed's statement puzzled me and worried me.
The question in my mind was what data existed to show that the Pfizer/BioNTech vaccine was safe and effective if given to people like me who might have had Covid-19 but didn't know for sure whether they had had Covid-19 or not.
Let me try to explain why I was both puzzled and worried.
The purpose of the Pfizer/BioNTech clinical trial was to show that the vaccine was both effective (in preventing Covid-19) and safe.
That led me to the assumption that people who had had Covid-19 were not recruited into the trial.
I found confirmation of that in a document online here:
REG 174 INFORMATION FOR UK HEALTHCARE PROFESSIONALS
On page 7 of that document, in a section entitled "Efficacy in participants 16 years of age and older" it is stated,
"The study excluded participants ... who had previous clinical or microbiological diagnosis of COVID-19 disease."
If we assume that my Covid-like symptoms in March were indeed due to Covid-19 then people like me were excluded from recruitment to the trial.
In other words, there is no evidence that the Pfizer/BioNTech vaccine confers any benefit on me.
Nor is there any evidence that it is safe for use in people like me who may have had Covid-19.
So I am puzzled.
Why would the Medicines and Healthcare products Regulatory Agency grant an authorisation for use of a product in people who had had (or might have had) Covid-19 when they had (so it seems to me) no evidence that it conferred any benefit nor any evidence that it was safe?
I am also worried.
Hundreds of thousands of people who had had Covid-19 or might have had Covid-19 (but were never tested) are likely to be given a vaccine that confers no benefit on them and might (because there is no data on safety in that group) cause serious adverse effects in that group.
Tomorrow vaccination begins.
I have serious concerns that the vaccination process is beginning on an unsound basis that could put at risk the health of hundreds of thousands of recipients of the vaccine - those who have had or may have had Covid-19.
Why give a vaccine to people for whom there is no demonstrated benefit?
Why give a vaccine to people when it is unknown whether or not it is safe to be given in that group?
If the MHRA has data that the Pfizer/BioNTech vaccine confers benefit on people who have had or may have had Covid-19 then that data should be published without delay.
If no such evidence exists then people who have had Covid-19 or may have had Covid-19 should be excluded from the vaccination program using the Pfizer/BioNTech vaccine.
A condition should be applied to the authorisation for the Pfizer-BioNTech to the effect that the vaccine should only be given to people not previously infected with the SARS-CoV-2 virus. For example, people who have had a negative antibody test for the SARS-CoV-2 virus (using an antibody test of known high sensitivity and specificity) within the previous, say, 24 or 48 hours.