As it conducted its analysis of the vaccine in December, the European Medicines Agency’s systems were targeted by unknown hackers.
Following this, more than 40 megabytes of classified information from the agency’s review were published on the dark web and several journalists, including those from the British Medical Journal, were sent copies of the leaks.
In a review of the documents, the BMJ said they showed concerns over unexpectedly low quantities of intact mRNA in batches of the vaccine developed for commercial production.
Early commercial batches of Pfizer/BioNTech’s COVID-19 vaccine had lower than expected levels of intact mRNA.
According to the BMJ EMA scientists ensuring the manufacturing quality of the product found “truncated and modified mRNA species present in the finished product”.
The information was in an email sent in late November by a high ranking EMA official, which outlined a raft of issues.
As a result the EMA filed two “major objections” with Pfizer about the discrepancy between clinical and commercial batches of the vaccine.
The email identified “a significant difference” in percentage of RNA integrity and “truncated species” between the clinical batched and proposed commercial batches – from around 78% to 55%.
However the issues seemed to have been resolved by 21st December when the EMA authorised the vaccine.
The documentation was not complete and the leaks did not show how the agency’s concerns were satisfied, the BMJ added.
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