Leaked Documents Questioned Pfizer Vaccine Manufacturing: BMJ
Leaked documents from a cyberattack at the European Medicines Agency (EMA) late last year provide a rare glimpse into how the regulatory agency and regulators at FDA and Health Canada collaborated on a review issue involving Pfizer-BioNTech’s Covid-19 vaccine. The hacked documents were anonymously sent to The BMJ and a subsequent review revealed that “regulators had major concerns over unexpectedly low quantities of intact mRNA in batches of the vaccine developed for commercial production,” according to the medical journal.
EMA reviewers raised concerns about “truncated and modified mRNA species present in the finished product,” The BMJ reports. Among the many files leaked, the journal says the concern was that “commercial manufacturing was not producing vaccines to the specifications expected.” One email identified “a significant difference in % RNA integrity/truncated species” between the clinical batches and proposed commercial batches — from around 78% to 55%, it says. According to another leaked email dated 11/25/2020, positive news eventually came from an undisclosed source in the U.S: “The latest lots indicate that % intact RNA are back at around 70-75%, which leaves us cautiously optimistic that additional data could address the issue.”
Health Canada told The BMJ that Pfizer had conducted “root cause” investigations into the reduced integrity in the commercial vaccine batches, and “changes were made in their processes to ensure that the integrity was improved and brought in line with what was seen for clinical trial batches.” Health Canada also said the three regulatory agencies subsequently determined that “there was no concern with the RNA integrity or any other product specifications.” Correspondence in the leaked documents suggested that FDA, Health Canada, and EMA were on the same page as to the clinically qualified specifications of percentage mRNA integrity. Health Canada confirmed to The BMJ that regulators “have worked together to align those requirements.”
While Pfizer declined to comment to The BMJ on what percentage mRNA integrity is an acceptable range, it did say: “Each batch of vaccines is tested by the official medicinal control laboratory — the Paul Ehrlich Institute in Germany — before final product release. As a result, the quality of all vaccine doses that are placed on the market in Europe has been double tested to ensure compliance with the specifications agreed upon with the regulatory authorities.”
Meanwhile, Pfizer says new real-world evidence collected by Israel’s Ministry of Health shows that two weeks after the second vaccine dose the product’s effectiveness was at least 97% in preventing symptomatic disease, severe/critical disease and death. The data also show the vaccine is 94% effective against asymptomatic Covid-19 infections.