Update on Emergency Use Listing - Mariângela Simão Rogério Gaspar 25 November 2021
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
Update on Emergency Use Listing
Mariângela Simão
Rogério Gaspar
25 November 2021
EUL process
2WHO SARS-CoV-2 IVDs recommended for Emergency Use Listing (EUL)
update: as of 23 Nov 2021
Test types
Total Nucleic acid Antibodies Antigen
Pre-submission interest >200 (split not available)
EOIs 165 67 41 57
Under assessment 78 16 28 37
EUL listed 28 23 1 4
48 27 10 11
EUL not accepted
EUL Renewals Change Requests
EUL maintenance 24 under review 21 under review
3WHO SARS-CoV-2 IVDs: Increasing support for EUL assessment
update: as of 23 Nov 2021
• Expert assessors from trusted partners
Expanding expert • Leverage reliance mechanisms where appropriate
network • Support for EUL dossier screening & review
With collaborating
partners
ANVISA (Brazil)
• WHO PQ-IVD Team to host EUL Workshops for new CDC (USA)
Training for EUL assessors
FDA (USA)
assessment • EUL requirements; good assessment & reporting practice
• Q&A sessions with expert review teams HSA (Singapore)
MFDS (Rep Korea)
NRL (Australia)
PEI (Germany)
Increasing • Expanded pool of technical experts ready to support EUL
assessment from Q1 2022
capacity • Increased number of EUL applications reviewed
4WHO Emergency Use Listed Covid-19 vaccines update: as of 19 Nov 2021
Manufacturer /
Platform EUL holder / name NRA of Record Post-EUL commitments
BioNTech Manufacturing GmbH
mNRA-based vaccine BNT162b2 / COMIRNATY: EMA, US FDA • Chemistry Manufacturing
encapsulated in lipid Tozinameran Control (CMC) updates
nanoparticle (LNP) • Clinical
Moderna Biotech, mRNA-1273: elasomeran EMA, US FDA
• Updated data on the
Recombinant ChAdOx1 EMA, Health Canada, MFDS, efficacy/effectiveness
AstraZeneca, AB: AZD1222 Vaxzevria
adenoviral vector encoding MHLW-PMDA, TGA
• Updated Risk
the Spike protein antigen of Serum Institute of India Pvt. Ltd: Covishield Management Plan (RMP)
the SARS-CoV-2 DCGI
(ChAdOx1_nCoV-19)
• Monthly safety reports,
Recombinant, replication- and Periodic Benefit Risk
incompetent adenovirus type Janssen–Cilag International NV: Evaluation Reports
EMA
26 vectored vaccine encoding Ad26.COV2.S (PBRER) every 6 months
the SARS-CoV-2 Spike (S) protein
• Updated labelling,
Sinopharm / Beijing Institute of Biological shipping validation (if
NMPA
Products Co., Ltd. (BIBP) applicable) and data for
Inactivated, produced in Vero vaccine vial monitors
cells Sinovac Life Sciences Co., Ltd.: CoronavacTM NMPA (VVM)
Bharat Biotech: • Others
DCGI
BBV152 COVAXIN®Other Covid 19 vaccines under EUL update: as of 16 Nov 2021
6WHO Support to regions & countries
update: as of 23 Novemebr
WHO EUL assessment with designate lead NRAs in the region 2021
Facilitating national approvals by sharing regulatory dossiers
1. Sharing dossier and EUL reports
• >400 reports shared with >100 countries
(both LMIC & HIC)
• Product Evaluation group (PEG):
Roster of regulatory experts from all 6 regions 2. Discussion on outcome of review:
• Facilitated workshops
• Technical Advisory group (TAG-EUL): • One-on-one discussions with countries
Risk benefit assessment
ToR and list of members 3. Additional guidance for decision
making on expedited authorization
• Collaboration agreement with NRAs of • Support to RO and agencies providing
references and others on regulatory relevant docs for actual shipments
oversight 4.Post listing changes:
• > 152 changes (clinical, CMC, labelling,
packaging, shelf-life, new sites, etc.)
7Emergency regulatory authorizations issued by 122 LMICs
update: as of 16 Nov 2021
1,600
59
42
107
1,400
Regulatory authorizations issued
1,200
413
1,000 53 BIBP
38 28
Sinovac
203
130 Moderna
800
26
Janssen
185
83 Pfizer
600
150 AZ/SK-Bio/SII
23
400 78 763
56 132 585
461
200 112
208
146
0
31 July 31 Aug 30 Sept 19 Oct 16 Nov
(source: COVAX platform) 8WHO Therapeutics and COVID-19: Living Guideline*
Latest update issued on 24 Sept 2021
conditional recommendation to use a combination of neutralizing in non-severe COVID-19 patients at the
monoclonal antibodies (casirivimab & imdevimab)** highest risk of severe disease
2021 09 24
conditional recommendation to use a combination of neutralizing in severe and critically ill COVID-19
monoclonal antibodies (casirivimab & imdevimab)** patients with seronegative status
strong recommendation to use IL-6 receptor blockers (tocilizumab or
2021 07 06 in patients with severe or critical COVID-19
sarilumab)**
in patients with COVID-19 except in the
2021 03 31 recommendation not to use ivermectin
context of a clinical trial
strong recommendation against hydroxychloroquine in patients with COVID-19 of any severity
2020 12 17
strong recommendation against lopinavir/ritonavir in patients with COVID-19 of any severity
2020 11 20 conditional recommendation against remdesivir in hospitalized patients with COVID-19
in patients with severe and critical COVID-
strong recommendation for systemic corticosteroids**
19
2020 09 02
conditional recommendation against systemic corticosteroids in patients with non-severe COVID-19
*WHO Therapeutics and COVID-19: Living Guideline
**Expression of interest for Prequalification 9Therapeutics: The 5th and current EOI for prequalification (PQ)
EoI issued for PQ applications
Molnupiravir 15 Nov 2021 One application received
generic/biosimilar
Casirivimab and imdevimab 21 Sep 2021
versions invited
generic/biosimilar
Tocilizumab and sarilumab 19 May 2021 One application under assessment
versions invited
Dexamethasone 10 July 2020 2 FPPs and 2 APIs prequalified in 2020/2021
Ongoing engagement with innovator and generic/biosimilar manufacturers to clarify requirements and address
questions (examples below)
• Whether the safety/efficacy of generic products can be supported with biowaiver data instead of bioequivalence
• If PQ would accept less stability data than usual at the time of submission
• for biotherapeutics approved by SRAs, how to adapt packaging, transport conditions and pharmacovigilance risk
management plans to LMIC settings
• for biosimilars, how to show biosimilarity, how to characterize the molecule etc.
• how to facilitate country approvals of prequalified or SRA approved products
10Therapeutics: Next steps
• All therapeutics invited are eligible for submission for prequalification.
EUL to be activated when needed.
• Continuing monitoring of pipelines (Paxlovid, other antibodies) and interaction with ACT-
A and WHO Clinical Management Team in preparation for possible invitation of new
therapeutics, including engagement with the respective manufacturers.
• Preparations ongoing with GF and UNICEF to use the ERP risk assessment mechanism
for molnupiravir generic products - to make products available promptly while they
progress towards prequalification.
11You can also read
