Translation of a-t 2021; 52: 31
Do not shake COMIRNATY ...but why?
With the mRNA vaccine BNT162b2 (COMIRNATY; a-t 2020; 51: 92, 101-2 and 2021; 52: 21-3) by BioNTech, it is not just challenging to store the vaccine as it must be stored at temperatures below 60 °C, the preparation of the vaccine is also difficult. The frozen multiple-dose vials must be thawed and rotated carefully ten times before dilution with 0.9% sodium chloride solution and then again ten times afterwards. Six doses then need to be extracted from the vial using syringes or needles with a low dead volume. The vaccine may not be shaken throughout the entire process. Even strong vibrations, for example those that occur when transporting syringes that have been drawn up, need to be avoided.1 We cannot, however, find any reason for the ban on shaking and why the vaccine becomes "unusable" 2 as a result of vibrations in either the summary of product characteristics (SPC)3 for the vaccine, the administration information,4 the US Fact Sheet5 or any other announcements. The Paul Ehrlich Institute referred us to the marketing authorisation holder, BioNTech, which issued the ban on shaking,6 but the company did not respond to our enquiries. However, the chance of bans such as "do not shake" being followed might be greater if an understandable reason is given. We believe the problem lies in the sensitivity of the lipid nanoparticles in which the messenger [m]RNA of the vaccine is embedded and which are used to get the mRNA into the cells, thus making the vaccine effective. We think it is plausible that the lipid shells of the mRNA may agglutinate as a result of shaking, clumping into larger lipid conglomerates and losing their function, -Ed.
|1||BioNTech: website, undated; http://www.a-turl.de/?k=ilie|
|2||BioNTech: stability data, version of 15 January 2021; http://www.a-turl.de/?k=ordg|
|3||EMA: SPC for COMIRNATY, version of 13 April 2021; http://www.a-turl.de/?k=oxst|
|4||BioNTech: COMIRNATY - Posology and Administration. 2021; http://www.a-turl.de/?k=etsc|
|5||Pfizer, BioNTech: Fact Sheet Pfizer-BioNTech COVID-19 vaccine, version of 6 April 2021; http://www.a-turl.de/?k=ogre|
|6||PEI: Letter of 16 April 2021|
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