• In December 2020, the European Medicines Agency (EMA) experienced a cyberattack.
• Leaked documents show that the EMA observed reduced integrity of the RNA portion of Pfizer-BioNTech’s COVID-19 vaccination during early commercial production.
• Maintaining RNA stability has been incredibly difficult during the manufacturing process.
• The EMA acknowledged that intact mRNA predicts vaccine efficacy yet cannot disclose the percentage of mRNA integrity they consider ‘acceptable’.
• The leaked documents were anonymously sent to various journalists and academics worldwide.

In December 2020, the European Medicines Agency (EMA) experienced a cyberattack which resulted in the exploitation of classified documents and emails. Among the documents was an email from a high-ranking EMA official who outlined various concerns about mRNA vaccine manufacturing.

The documents were anonymously sent to journalists and academics worldwide. The BMJ is one of the media outlets who received the documents and reported their findings.

The BMJ’s article says that the leaked email discussed the notion that “commercial manufacturing was not producing vaccines to the specifications expected, and regulators were unsure of the implications.” (1)

The article is specifically referencing a line from the email which reportedly identified “a significant difference in % RNA integrity/truncated species”. (2). The email also says that the impact of the decreased RNA integrity was “yet to be defined”. (3).

When inquired by The BMJ, regulators declined to disclose their requirements for an ‘appropriate’ percentage regarding RNA integrity.

Supposedly regulators were able to resolve the discrepancy without difficulty. However, the reluctance to share any details beyond ‘the problem was solved’ is seemingly incredulous. The BMJ says “the shortage of information may reflect the lack of certainty” and that “Experience with mRNA integrity is limited.” (4).

(1-4) 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