Provision Language
8. Quality Requirements and Responsibilities
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8.5 Pharmacovigilance meetings with sub-awardees. Awardee will keep CEPI informed about any official meetings between Awardee and Sub-Awardees, or Sub-Awardees and any regulatory authority, concerning significant Pharmacovigilance matters related to the Product. Awardee will schedule regular meetings with each Sub-awardee’s Pharmacovigilance Team and with CEPI’s Pharmacovigilance Team to share a routine safety update on the Product and to discuss any significant safety related issues, as applicable.
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11. Regulatory Activities
For the purposes of this section, where an LMIC Manufacturer will be undertaking regulatory activities for a particular Product, Awardee will use commercially reasonable endeavours to ensure that the relevant LMIC Manufacturer adhere to the obligations applicable to Awardee, mutatis mutandis.
11.1 Meetings with Regulatory Authorities. Awardee will keep CEPI informed about any product related official meetings with regulatory authorities (including WHO PQ). In case Awardee is participating in the meeting with the relevant regulatory authority, the Awardee shall provide an opportunity to have a CEPI representative in the meeting as a silent observer, provided the regulatory authority and the LMIC Manufacturer so accept. At CEPI’s reasonable request, Awardee will request a meeting with regulatory authorities to address any significant unresolved issues.
11.2 Regulatory Filings. Awardee will regularly inform CEPI regarding its, and the LMIC Manufacturer’s, regulatory strategy for the Product and will inform CEPI of any discussions with regulatory authorities that may have a significant impact on future development of the Product through the bilateral and multilateral meetings referred to in the Team Charter. Awardee will provide CEPI with copies of:
11.2.1 key regulatory filings and submissions in respect of the Product, including M1 and M2 of the Common Technical Document (CTD), clinical study reports, proposed product specifications and product label information;
11.2.2 official meeting minutes of meetings between the regulatory authority and Awardee/LMIC Manufacturer relating to the Product, and any written communications from the regulatory authority on significant matters related to the Product which may impact the Project.
11.3 Cross Referencing. Awardee will co-operate with CEPI to allow CEPI to cross-reference specific parts of Awardee’s Project Results in order to support regulatory pandemic preparedness, to be further discussed and agreed upon between the Parties.
11.4 Regulatory Approvals in LMICs. Awardee will ensure the LMIC manufacturer will use commercially reasonable endeavours to obtain regulatory approvals and licensure for the Product in Non-Traveler’s Market countries where there is a demand for the Product. The Parties, through the JMAG, may discuss and agree on a list of such Non-Traveler’s Market countries in which to seek such approvals and licensure and on a schedule for seeking such approvals and licensure, and Awardee will, or will obligate its Sub-Awardee(s) to, use commercially reasonable endeavours to meet such schedule in such countries.
11.5 WHO Prequalification. Awardee will ensure that the LMIC manufacturer will use commercially reasonable endeavours to obtain WHO prequalification for the Product.
Annex C: Integrated Product Development Plan (IPDP)
1. Project Description
1.1. Introduction and Background
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The Butantan-Valneva partnership also enables significant development synergies, whereby data generated with Valneva’s chikungunya vaccine VLA1553 will be supporting LMIC partners to achieve licensure. For example, Valneva’s pivotal Phase 3 studies with VLA1553 in US adults, complemented by data generated in adolescents in Brazil with VLA1553 and enabled through CEPI funding, have served as the basis for the ANVISA submission of IXCHIQ, and will continue to support future licensure submission of VLA1555 (which is locally produced after tech-transfer of VLA1553 lyophilisation and packaging to Instituto Butantan). Physical-chemical comparability between the products can be leveraged to ensure that data generated for either vaccine can be used from a regulatory perspective for the other vaccines. FDA has from a scientific perspective agreed to that concept, and also EMA has agreed to this concept. Therefore, any clinical data generated by Valneva for VLA1553 will support any regulatory submission in LMIC, and vice versa. In the case of the post marketing commitments under the accelerated approval, however, FDA has determined during its review process that from a legal perspective, these studies must be carried out with the same (regulatory-wise) product as the one registered under the accelerated approval. Therefore, the post marketing effectiveness studies will be carried out with VLA1553, which, to achieve that, has been submitted for licensure review in Brazil.
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In order to make Valneva’s, Butantan (IB)’s and Serum Institute of India (SII)’s chikungunya vaccines broadly accessible, all efforts will be made to continue submitting and registering the CHIKV products in HIC and LMIC countries. Health Canada and EMA applications were filed in May and October 2023, respectively, aiming to receive approval in the second half of 2024. For MHRA/UK approval, VLA will follow the reliance route from EMA. The strategy for Brazil submission recently changed; VLA1553 was submitted in December 2023, to comply with FDA’s legal requirements to perform the Phase 4 studies with an identical product. This will get the vaccine to the Brazil market earlier. ANVISA agreed that VLA1555 will be submitted under a separate license, planned in 2024. VLA1555 multidose is to be developed with plans to be submitted to ANVISA in 2026. VLA1556 will be submitted to India and Asian Key Countries by Serum Institute of India.
2. Pharmacovigilance Strategy
The Corporate Pharmacovigilance Team at Valneva is responsible for managing all pharmacovigilance tasks and activities worldwide. […]