Freedom of Information request on use of live animals in independent batch testing of COVID-19 vaccines (FOI 21-218)
Published 28 May 2021
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1st April 2021 FOI 21-218 Dear
Thank you for your information request, dated 3 March, where you enquired about the use of live animals in the independent batch testing of COVID-19 vaccines by the National Institute for Biological Standards and Control (NIBSC) as well as that of the manufacturers who have submitted data to the NIBSC for review.
I can confirm we have dealt with your request under the Freedom of Information Act 2000 (FOIA) and am pleased to provide you with the information below.
• are live animals used in the independent batch testing of Covid-19 vaccines conducted by the NIBSC? Live animals have not been required in the sets of tests conducted by NIBSC for the currently approved vaccines.
• are live animals used by the manufacturers of Covid-19 vaccines, who have submitted data to the NIBSC for review, in their own batch tests? Of the manufacturers who have submitted data to NIBSC for review to date, one indicates the use of “in vivo assay for adventitious viruses in suckling mice and embryonated hens’ eggs” in accordance with the requirements of the European Pharmacopoeia”. Here, “in vivo” means the use of live animals.
• if live animals are being used in routine batch tests for Covid-19 vaccines, could you please specify which species is/are being used and provide an explanation for why in vitro batch tests are not sufficient?
As stated above, live animals have not been required in the tests conducted by NIBSC. The use by the manufacturer of tests involving animals is the decision of that manufacturer, thus the NIBSC is not in a position to comment on the selection of in vitro or in vivo tests. Public Assessment Reports for each approved vaccine are available: Pharmacy - GOV.UK (www.gov.uk) - select the link ‘regulatory approval of [vaccine description]’ for the different vaccines. In each case there will be a document entitled ‘Public assessment report for [vaccine description]. Therein will be details of tests that require animals. For ease, the links to three documents relating to the assessment of adventitious agents are provided below.
Q5A Step 5 Viral safety (europa.eu) Q 5 D Quality of Biotechnological Products: Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products (europa.eu) 2.6.16. Tests for extraneous agents in viral vaccines for human use.pdf (njucm.edu.cn) In addition, the document below provides further background. https://www.edqm.eu/sites/default/files/medias/fichiers/COVID-19/updated_covid-19_vaccines_package_oct_2020.pdf
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