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SWAT Team Description: The Manufacturing SWAT team focuses on resolving technical cross-project questions and challenges, promotes harmonization and comparability across projects and brings together different stakeholders to coordinate players across the ecosystem. The SWAT provides cross-cutting support to COVID-19 vaccine developers in the areas of Drug Substance (DS) and Drug Product (DP) scale-up and scale-out, supply chain and release assays. Co-Leads: Ingrid Kromann and Matthew Downham (CEPI), David Robinson (BMGF) |
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Workshops:
- April 14, 2021 | Multivalent COVID-19 vaccines to help address emergence of variants: CMC and Clinical implications - Presentation | Report
- March 3, 2021 | Best practices for post approval changes - Presentation | Minutes | Recording
- January 27, 2021 | Best practices for tech transfer workshop - Presentation | Minutes
- December 9, 2020 | Best practices for determining and updating storage temperate and shelf life Workshop - Presentation | Minutes
- October 26, 2020 | Accelerated vaccine development and experiences with regulatory pathways for vaccines
in emergency situations Workshop - Presentation | Minutes - September 28, 2020 | CMC Comparability Workshop - Presentation | Minutes
- September 2, 2020 | WHO Presentation of NRL - Presentation | Minutes
- August 3, 2020 | DP Workshop Follow Up - Presentation | Minutes
- July 27, 2020 | DP Workshop - Presentation | Minutes
Resources:
- The COVAX Marketplace Newsletter – February 2022 edition
- The COVAX Marketplace Newsletter – November 2021 edition | 17 Nov 2021
- The Medicine Quality Research Group, Centre of Tropical Medicine & Global Health, Nuffield Department of Medicine, University of Oxford have issued the following Medical Product Quality Reports (Issue 12. Data from June & July 2021): Main Text Annex D
- COVID-19 VACCINES Part A, a summary of public domain reports on quality issues with COVID-19 vaccines.
- OTHER COVID-19 MEDICAL PRODUCTS Part B, discusses diagnostics, Personal Protective Equipment, sanitisers & disinfectants, medicines, and ventilation & oxygenation equipment and consumables.
- Multi-dose COVID-19 vaccines required globally, before single dose vials for the few | 23 Sep 2021
- Facilitation Council objectives of the COVAX Manufacturing Task Force presented to the ACT-A Facilitation Council
- Objectives of the COVAX Manufacturing Task Force presented to the ACT-A Facilitation Council | May 12, 2021 | More on COVAX Manufacturing Taskforce
- Medical Product Quality Report – COVID-19 vaccine issues | 16 Apr 2021
- WHO Policy paper on traceability of medical products | 18 Mar 2021
- Infectious Diseases Data Observatory (IDDO) 'Medical Product Quality Report: COVID-19 vaccines'
- CEPI and INTACT Solutions: Rapid Pandemic Response for turning Vaccines into VaccinationsNEW Webinar on MedInstill held on January 29, 2021
- WHO working position on vial, carton label and QR, barcodes
- 21st WHO Regulatory Update on COVID-19 – October 30, 2020
- Annex – Barcodes, QR codes and Vaccine Vial Monitors in the context of COVID-19 vaccines
- Guidance document on QC testing of viral vectored vaccines:
- Text on recombinant viral vectored vaccines
- Press release November 3, 2020
- Temptime newsletter July 27, 2020 | Temptime expands Vaccine Vial Monitor (VVM) types for COVID-19 candidate vaccines
- WHO Roadmap for evaluation of AstraZeneca AZD1222 Vaccine against Covid-19