Re: Covid-19 vaccines and treatments: we must have raw data, now
Dear Editor
I very much welcome the BMJ editors’ call for free access of doctors, researchers and the public to the trial data on experimental vaccines collected by the vaccine manufacturers [1]. However, I believe there is an even stronger case for similar release to the same constituency of the anonymised individual patient data collected in the UK under the Yellow Card covid-19 vaccine adverse events reporting scheme [2]. The aim of this scheme is to ensure the earliest detection of possible adverse reactions to the experimental covid-19 vaccines, and plays a vital role in protection of the UK public from medical harm.
The Yellow Card scheme is administered by the MHRA, a government body funded by the UK public. The data is largely gathered by NHS staff, again paid for by the UK public. However, despite public finance being crucial to the generation of Yellow Card data, the MHRA have repeatedly refused to release the anonymised individual patient data from this scheme for independent analysis (FOI 21/640). The MHRA argue that release of these data would be too onerous, yet paradoxically these same data are passed on to the vaccine manufacturers for analysis as a matter of routine (FOI 21/942). All that the public can access from Yellow Card is a rudimentary summary of the total numbers of adverse events recorded for each vaccine type in particular medical categories. In the absence of anonymised individual patient data linked to vital information collected under the scheme, such as age, sex of the individual etc., no rigorous scientific analysis of the data can be undertaken. Consequently, there is no opportunity for those outside the MHRA either to provide fresh and innovative perspectives on the data, or to challenge scientifically the conclusions stated in the MHRA’s reports concerning the rarity and innocuousness of vaccine adverse effects.
The MHRA’s attitude to data sharing stands in stark contrast to the situation in the USA, where the VAERS reporting system [3] provides anonymised individual patient data, and the detailed analyses that this allows has been crucial for recognising important safety signals [4]. The MHRA’s refusal to share the information that they hold within the Yellow Card database would also not be tolerated in the general science community where access to raw data is now a prerequisite for publication in peer reviewed journals. It is of vital importance that the safety profiles of the experimental covid-19 vaccines are kept under strict and independent surveillance by as many observers as possible during their period of emergency use. A simple means of facilitating this would be the immediate release by the MHRA of the anonymised raw data collected under the Yellow Card reporting scheme to doctors, researchers and the public.
[1] Doshi P, Godlee F, Abbasi K. Covid-19 vaccines and treatments: we must have raw data, now BMJ 2022; 376 :o102 doi:10.1136/bmj.o102
[2] https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-...
[3] https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/vaers/index....
[4] https://jessicar.substack.com/p/a-report-on-myocarditis-adverse-events
Rapid Response:
Re: Covid-19 vaccines and treatments: we must have raw data, now
Dear Editor
I very much welcome the BMJ editors’ call for free access of doctors, researchers and the public to the trial data on experimental vaccines collected by the vaccine manufacturers [1]. However, I believe there is an even stronger case for similar release to the same constituency of the anonymised individual patient data collected in the UK under the Yellow Card covid-19 vaccine adverse events reporting scheme [2]. The aim of this scheme is to ensure the earliest detection of possible adverse reactions to the experimental covid-19 vaccines, and plays a vital role in protection of the UK public from medical harm.
The Yellow Card scheme is administered by the MHRA, a government body funded by the UK public. The data is largely gathered by NHS staff, again paid for by the UK public. However, despite public finance being crucial to the generation of Yellow Card data, the MHRA have repeatedly refused to release the anonymised individual patient data from this scheme for independent analysis (FOI 21/640). The MHRA argue that release of these data would be too onerous, yet paradoxically these same data are passed on to the vaccine manufacturers for analysis as a matter of routine (FOI 21/942). All that the public can access from Yellow Card is a rudimentary summary of the total numbers of adverse events recorded for each vaccine type in particular medical categories. In the absence of anonymised individual patient data linked to vital information collected under the scheme, such as age, sex of the individual etc., no rigorous scientific analysis of the data can be undertaken. Consequently, there is no opportunity for those outside the MHRA either to provide fresh and innovative perspectives on the data, or to challenge scientifically the conclusions stated in the MHRA’s reports concerning the rarity and innocuousness of vaccine adverse effects.
The MHRA’s attitude to data sharing stands in stark contrast to the situation in the USA, where the VAERS reporting system [3] provides anonymised individual patient data, and the detailed analyses that this allows has been crucial for recognising important safety signals [4]. The MHRA’s refusal to share the information that they hold within the Yellow Card database would also not be tolerated in the general science community where access to raw data is now a prerequisite for publication in peer reviewed journals. It is of vital importance that the safety profiles of the experimental covid-19 vaccines are kept under strict and independent surveillance by as many observers as possible during their period of emergency use. A simple means of facilitating this would be the immediate release by the MHRA of the anonymised raw data collected under the Yellow Card reporting scheme to doctors, researchers and the public.
[1] Doshi P, Godlee F, Abbasi K. Covid-19 vaccines and treatments: we must have raw data, now BMJ 2022; 376 :o102 doi:10.1136/bmj.o102
[2] https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-...
[3] https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/vaers/index....
[4] https://jessicar.substack.com/p/a-report-on-myocarditis-adverse-events
Competing interests: No competing interests