AWERB Minutes 23 November 2021

National Institute for Biological Standards and Control

Animal Welfare and Ethics Review Body

Minutes of a meeting held on Tuesday 23 November 2021 at 2:00pm

1. 

The minutes for the June and September meetings were accepted without amendment

February 2021

21-02: A questionnaire was drafted, but will have to be discussed at an AWERB committee meeting. ONGOING

June 2021

21-08: Engaging the PELH with regard to agenda item 12 (AOB: size & shape / BSD staffing levels) has a higher priority. The chair will invite the PELH to the next AWERB committee meeting. CLOSED

September 2021

21-09: NVS to distribute list of criteria for fast-tracking of amendments by e-mail; AWERB members to review & complete the list. CLOSED

21-10: HOLC/Chair to initiate review of the ‘AWERB guidelines for submission of new PPL applications and amendments’ to reflect the agreed changes regarding fast-tracked amendments. CLOSED

21-11: Chair to draft letter to the PELH on the committee’s concerns about how size & shape will impact animal work at NIBSC. CLOSED

21-12: The concerns raised towards the PELH (21-11) should also be submitted as part of the formal size & shape consultation process by the Chair. CLOSED

The PPL Holder gave an overview over the work performed under this licence. The licence contains one protocol for control testing of vaccines as requested by regulatory bodies.

It was noted that less mice and rats than estimated had been used under the licence. In part this was a consequence of several vaccines that had been tested using this protocol in the past were no longer tested in this in vivo assay (e.g. HepA and yellow fever vaccine). The remaining vaccines undergoing this test when requested by regulatory bodies are HepB and inactivated polio vaccines.

For specific combined HepB vaccines, unexpected adverse effects (lethargy, pinched waist and orbital tightening 30 minutes after vaccination) were observed in several studies and the mild severity limit of the protocol was exceeded. A subsequent investigation identified the Diluent used in the NIBSC SOP being the source of these adverse events.

In the renewal PPL application for this work, the PPL Holder may include a second protocol with moderate severity level to cover similar combined HepB vaccines undergoing this test. Alternatively, an alternative less reactive diluent may be validated to be used under the renewed PPL in the future.

The AWERB committee approved the mid-term review without any revisions required.

The renewal PPL application will be ready for AWERB review soon. The PPL Holder will contact NVS, HOLC and BSD Head for drafting of specific humane endpoints associated with this protocol.

The PPL Holder gave an overview over the work performed under this licence. The work initially was funded by REDACTED and the aim of the project was to establish a NHP model for chikungunya virus infection which is suitable to perform protection studies. The work went well and allowed the team to establish the use of telemetric devices in NHP studies. Furthermore, the model proved suitable for protection studies using passive transfer of antibodies and active immunisation. Furthermore, the study established that NHP infected with chikungunya virus unlike humans do not show clinical signs of neuralgia, but inflammation of the joints could be observed in histology sections. The last study undertaken on the REDACTED grant was cut short by the SARS-CoV2 pandemic. The company then continued their project with a third party provider and publication of the data has so far been blocked by the company.

However, since establishing the chikungunya model, REDACTED has expressed an interest to further develop the model for vaccine testing. Sera from clinical trials will be used in NHP protection studies. Since the initially forecast number of animals (90 NHP) has been used, the PPL Holder will have to submit an amendment of the licence with increased number of animals used under the licence in order to continue the work.

The AWERB committee approved the mid-term review without any revisions required.

The HOLC clarified that the PELH report is now better aligned with the dates of the AWERB committee meeting. The last meeting with the PELH took place on 2^nd November and the PELH report reflects what has been reported to and discussed with the PELH.

The standards in Virology PPL has been granted on 20^th October 21. The Novel Biologics for Tumour Immunotherapy PPL has undergone AWERB review and should be ready to be submitted within the next week. The Viral Vaccines (Research) PPL and the Viral Vaccines (Batch Release) PPL have undergone pre-AWERB review and should soon be submitted for AWERB review. Extra AWERB meetings will be scheduled for the discussions of these PPL applications as required. The aim is to submit before Christmas.

Two amendments were processed since the last HOLC update with the second one being distributed to all AWERB committee members as agreed under new the fast-tack amendment process.

Two PILs were revoked (staff members leaving).

8. NVS report

The primary NVS gave a verbal report. There were no specific incidents to report.

9. 3Rs / welfare initiatives

The NACWO reported on 3Rs. Ladders have been attached to the roof of individually caged animals to enrich their environment. Other adjustments were made to the feeding structures in hamster cages in order to prevent mouth lesions (see PELH report).

10. Any other business

2022 meeting dates should be agreed:

Tuesday afternoons work best for NVS and BSD staff. Five regular committee meetings will be identified for February, March, June, September and November. In addition, another date in June will be identified for the next general AWERB meeting, which will be held via Teams as either a virtual or a hybrid meeting. The Large Meeting Room is now equipped for hybrid meetings.

Action: HOLC/Chair to identify dates and Chair to distribute meeting invites to the committee members. 

The meeting concluded at 15:39 pm.

END

These Minutes have been viewed and approved by the Establishment Licence Holder (Director of NIBSC).

Signature: REDACTED