The EMA covid-19 data leak, and what it tells us about mRNA instability

Dear Editor

We have read the article “The EMA covid-19 data leak, and what it tells us about mRNA instability” [1], published in BMJ on 10/03/2021 with steadily growing concern.

This article questions an EMA decision, and this criticism is based on data unlawfully obtained from EMA. While EMA should do everything to prevent data leaks, computer hacking is a criminal offence. EMA states that the information was partially doctored, and that the perpetrators selected and aggregated data from different users and added additional headings [2]. The data published on the dark web are not verifiable, extremely questionable and thus, the propagators of such information should not be provided with a legitimate platform.

It is unclear to us why a respected journal chose to present unverifiable information, in the process damaging an institution that has worked for 25 years in a transparent and successful manner. Evaluation of new medicinal products is difficult; it requires competence, and it takes time to go through all the information supplied by applicants. Therefore, it is part of the procedure and perfectly acceptable that after the first reading, the authorities pose numerous questions to applicants. However, the responses to these questions, which were adequate to reassure the regulator as reported in the public assessment report [3], have not been taken into account in the BMJ article. Besides, EMA is not the only regulatory authority which has looked at these data. The vaccine has been approved and is now in use in more than 40 countries, including many European countries but also Australia, Canada, the United States, Chile, Singapore and a number of Middle Eastern countries.

We now have data on the use of the Pfizer-BioNTech vaccine in a real-world setting. In the UK, data from the SIREN study, a prospective cohort study among staff working in publicly funded hospitals, were used to determine vaccine effectiveness of the vaccine. The study demonstrates that the vaccine effectively prevents both symptomatic and asymptomatic infection in working age adults [4]. Similarly, all newly vaccinated persons in Israel during the period from December 20, 2020, to February 1, 2021, were matched to unvaccinated controls. Estimated vaccine effectiveness at 7 or more days after the second dose was higher than 90% for all outcomes assessed, including documented infection, symptomatic Covid-19, hospitalization, and severe disease [5]. In the US, where tens of millions of doses of the Pfizer vaccine have been administered, a retrospective cohort analysis of a high-risk population, residents of skilled nursing facilities, found that even with partial vaccination, Pfizer-BioNTech COVID-19 vaccine provided protection to the residents [6].

We believed that the BMJ promotes Evidence-Based Medicine, and would only publish articles based on hard, verifiable data. We can only imagine that this editorial somehow escaped your vigilance and professional scrutiny.

Sincerely yours,

Pieter Neels, International Alliance for Biological Standardization - IABS, Geneva, Switzerland

Elizabeth Miller, Department of Infectious Disease Epidemiology, Faculty of Epidemiology & Population Health London School of Hygiene & Tropical Medicine, United Kingdom

Pierre Van Damme, Centre for the Evaluation of Vaccination, Vaccine & Infectious Diseases Institute, University of Antwerp, Universiteitsplein 1, 2610, Wilrijk, Belgium.

Joris Vandeputte, International Alliance for Biological Standardization - IABS, Geneva, Switzerland

Thomas Verstraeten, P95 Epidemiology & Pharmacovigilance, Leuven, Belgium

Albert Osterhaus, University of Veterinary Medicine, Hannover, Germany

Steffen Thirstrup, Affiliate Professor, Department of Drug Design and Pharmacology, Translational Pharmacology Faculty of Health, University of Copenhagen, Denmark

Marc Baay, P95 Epidemiology & Pharmacovigilance, Leuven, Belgium

Stanley Plotkin, University of Pennsylvania and Children's Hospital of Philadelphia, Philadelphia, United States

1. Tinari S. The EMA covid-19 data leak, and what it tells us about mRNA instability. Bmj 2021;372:n627. doi: 10.1136/bmj.n627 [published Online First: 2021/03/12]
2. European Medicines Agency. Cyberattack on EMA - update 6 2021 [Available from: https://www.ema.europa.eu/en/news/cyberattack-ema-update-6March 15, 2021.
3. European Medicines Agency. Comirnaty - COVID-19 mRNA vaccine (nucleoside-modified) 2020 [Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/comirnatyMarch 15, 2021.
4. Hall VJ, Foulkes S, Saei A, et al. Effectiveness of BNT162b2 mRNA Vaccine Against Infection and COVID-19 Vaccine Coverage in Healthcare Workers in England, Multicentre Prospective Cohort Study (the SIREN Study). Lancet preprint 2021 doi: http://dx.doi.org/10.2139/ssrn.3790399
5. Dagan N, Barda N, Kepten E, et al. BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Mass Vaccination Setting. N Engl J Med 2021 doi: 10.1056/NEJMoa2101765 [published Online First: 2021/02/25]
6. Britton A, Jacobs Slifka K, Edens C, et al. Effectiveness of the Pfizer-BioNTech COVID-19 Vaccine Among Residents of Two Skilled Nursing Facilities Experiencing COVID-19 Outbreaks — Connecticut, December 2020–February 2021. Morb Mortal Wkly Rep 2021;ePub: 15 March 2021 doi: http://dx.doi.org/10.15585/mmwr.mm7011e3