Pfizer COVID-19 Vaccine Emails Hacked?

mRNA percent integrity

Nolte Alexis
Mon 23/11/2020 10:48
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Korakianiti Evdokia;
Evdokia,

One way to understand how the lower mRNA level in the finished product translates to efficacy would be to measure whether it affects significantly levels of protein expression. It could be that the level of antigenic protein expressed is not significantly affected. However, I don’t know whether there is a test that would allow to predict impact on efficacy without clinical trial for comparability.

Alexis

Classified as internal, Medicines A‘
Korakianiti Evdokia

Mon 23/11/2020 10:38

Inbox

Dear Colleagues,

by the Europ

This email is for awareness and to flag an important comparability issue with the BioNTech
vaccine that needs to be addressed prior to approval.

Issue: A significant difference in %RNA integrity / truncated species has been observed
between the clinical batches ( ~ 78% mRNA integrity) based on which the Interim analysis
was performed and the proposed commercial batches (~ 55%).

The company claims that the efficacy of the drug product is dependent on the expression of
the delivered RNA, which requires a sufficiently intact RNA molecule. The root cause for
for the lower %RNA integrity at commercial batches has not yet been identified

Impact: The potential implications of this RNA integrity loss in commercial batches
compared to clinical ones in terms of both safety and efficacy are yet to be defined.
Whether or not the observed comparability issues could be a blocking point will depend on
the relevance of these observations to safety and efficacy and the company will be
requested to fully justify the lower %RNA integrity (and other differences noted).

Point for discussion will be whether the comparability issues can be solved only by Quality
data (additional functional/ in vitro biological data + available non-clinical) or that further
clinical data (bridging studies are/will be performed) will be needed. It is difficult to make
any projections on this

Way forward: This issue and other MO ( but in our view not blocking to a potential
approval) have been raised at ETF and are being discussed at BWP this week and in a TC
with FDA on Wednesday

With many thanks to Ton who’s is the Quality specialist for this vaccine together with Brian
looking after the chemical elements

Best regards
Evdokia
Ext. 7150