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Biotech Innovations
April 13, 2021

Data Leak Exposes Early COVID-19 Vaccine Manufacturing Hiccups

JAMA. 2021;325(14):1385. doi:10.1001/jama.2021.5002

After a cyberattack late last year against the European Medicines Agency (EMA), anonymous emails dispatched a trove of classified documents to academics and journalists.

In a January 25 statement, the EMA said some of the hacked documents—which mainly concerned COVID-19 medicines and vaccines—were altered in a way that “could undermine trust in vaccines.”

“A closer investigation of the published material has revealed that not all of the documents were published in their integral, original form and may have been taken out of context,” the statement said.

According to The BMJ’s recent news investigation, the documents revealed that regulators reviewing vaccine candidates had concerns about truncated messenger RNA (mRNA) in early batches of Pfizer-BioNTech’s COVID-19 vaccine. These early batches developed for commercial production had about 55% intact mRNA, a lower percentage than in clinical trial batches, with uncertain implications.

Improved mRNA quality in subsequent batches may have resolved European, US, and Canadian regulators’ concerns, the report suggested. “Changes were made in [Pfizer’s] processes to ensure that the integrity was improved and brought in line with what was seen for clinical trial batches,” Health Canada told The BMJ.

According to the news story’s author, journalist Serena Tinari, Pfizer, the EMA, and Health Canada, as well as the US Food and Drug Administration and COVID-19 vaccine developers Moderna and CureVac, did not provide specifics about the percentage of mRNA integrity acceptable for a vaccine.