Post on 11-Oct-2020
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Accelerating COVID-19 Vaccine Development in Taiwan: Regulatory Adjustment andClinical Trial Considerations
Regulatory Challenges against COVID-19
8th Joint Conference of Taiwan and Japan
Mei-Chen Huang,Section Chief
Division of Medicinal Products, TFDA
15 Oct. 2020
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Content
Current Status of COVID-19 Pandemic
Actions Against COVID-19 in Taiwan
Strategies for Accelerating COVID-19 Vaccine Development
Challenges for Clinical Trials of COVID-19 Vaccines in Taiwan
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Current Status of Coronavirus Pandemic
Global Status
Status in Taiwan
34,899,831cases confirmed
1,034,786deaths
2.97%case fatality rate (CFR)
517cases confirmed
7deaths
484recovered
Cumulative Cases
Cumulative Cases
(updated 4 Oct 2020)
(updated 4 Oct 2020)
no locally acquired COVID-19 cases for over 4 months
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Status of COVID-19 in Taiwan
Timely Response and Precautionary Approaches
>1.5m
Public Health Management of COVID-19 through Non-Pharmaceutical Interventions: Public masking Social distancing Early and aggressive identification,
isolation, and contact tracing
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Actions Against COVID-19 in Taiwan
Biotechnology National Teams
Government Resources Integration
Consolidate and Strengthen Industrial Chain
Enhance Research Capacity and Technology Transfer
• Inter-agencies collaborations• Resources integration• Research funding and
consultation
• Invest in therapeutics and vaccines development and manufacturing
• Support development of research teams and facilitate technology transfer at early stage
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Biotechnologies in Fighting COVID-19
Rapid test kitsDiagnostic tools
MedicationInnovative drugs
Preventive vaccines
Personal protective equipment (PPE)
Technical support
platform
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Global Race for COVID-19 Vaccines
Aim for Early Access of Effective Vaccines targeting SARS-CoV2 virus
Challenges for vaccine development: Regulatory adjustment Technical platform Financial support
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Potential COVID-19 Vaccine Candidates Worldwide
42 in clinical evaluation; 151 in preclinical evaluation; 10 at Phase 3 stage
Candidates Type Developer
mRNA-1273 RNA Moderna (US)
BNT162b2 RNA Pfizer/BioNTech (GE)
AZD1222non-replicating viral vector
AstraZeneca/Oxford (UK)
Ad5-nCoVnon-replicating viral vector
CanSino Biological/Beijing Institute of Biotechnology (CN)
Sputnik Vnon-replicating viral vector
Gamaleya (RU)
Ad26.COV2.Snon-replicating viral vector
Janssen Pharmaceutical Companies
NVX-CoV2373 Protein subunit Novavax (US)
CoronaVac Inactivated Sinovac (CN)
SARS-CoV2 vaccine (vero cell)
InactivatedWuhan Institute of Biological Products/Sinopharm (CN)
SARS-CoV2 vaccine (vero cell)
InactivatedBeijing Institute of Biological Products/Sinopharm (CN)
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Strategies for Accelerating COVID-19 Vaccine Development in Taiwan
Acceleration for COVID-19 vaccine development
Pre-clinical
Post-approval requirementsR&D
Rolling Review
Phase 1, 2
Regist.
Pre-clinical Phase 1, 2, 3Post-approval
surveillanceRegistrationR&D MA
2-5yrs 1.5yrs 5-7yrs
2-3yrs
Typical timeline for vaccine development(>10 yrs)
Scale up, Specification, GMP, Lot release
Scale up, Specification, GMP, Lot release
MA
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Integrate Resource from Government
To facilitate the development of COVID-19 vaccines and drugs in TW
Project teamconsultation
Review optimization measures
Technical supportplatform
Government subsidies
TFDA
CDENHRI
CDC
DOIT
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Regulatory Adjustment
Implementation of EUA approach Article 48-2 of the Pharmaceutical Affairs Act
The central competent health authority may approve to manufacture and import the specific drugs as special case:
– For the purpose of prevention, diagnosed as life-threatening, severely disability diseases, and there is no domestic appropriate drug or alternative treatment.
– In responding to the necessity of emergency public health circumstances
Article 51 of Communicable Disease Control Act
When communicable disease occur or are expected to occur, the central competent authority for the reason of emergency, may procure pharmaceuticals and equipment, provided that the relevant documents shall be filled within six months and complete the test.
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Review Optimizing Measures
Review flexibilities
Accelerated Approval approach
Pilot program of accelerated review for domestic new drugs
Rolling submission and review
On-site audit for GMP compliance
GMP inspectors on-site checking for the quality of production.
Develop analytical methods
Develop validated analytical methods for vaccine development
Set up national reference standard for the analysis of vaccine efficacy
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Project Team Consultation
Timely communication on regulatory, manufacturing process development, clinical and Pharm/Tox issues
Weekly progress checking
CDE Can HelpRegulatory science guidance program for the development of domestic COVID-19 medicinal products
► Project team set up for each selected application
► Provide free and active consultation.► Quick response (initial response in 3~7 days) for
inquiries.► Aim for shortening the time required for the
development of COVID-19 medicinal products, including drugs, vaccines and medical devices.
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Technical and Financial Supports
Technical Support Platform
Support by National Health Research Institute (NHRI)
Provide technical platform for vaccine development, including various analysis for vaccine efficacy.
Review of applications for the use of blood samples from clinical COVID-19 confirmed cases.
Government Subsidies
Subsidy program for domestic potential COVID-19 vaccines
Supported by Taiwan Center for Disease Control (CDC), MOHW
Grants for the R&D and Clinical Trials of potential COVID-19 vaccines
A+ Industrial Innovation R&D Program
Supported by Department of Industrial Technology (DOIT), MOEA
Subsidies for industries to get involved in innovation, development and research programs.
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COVID-19 Vaccine Development in Taiwan
3 Potential vaccine candidates at clinical trial stage
Adimmune Corp.
AdimrSC-2f Vaccine
Protein subunit vaccine
Phase 1 initiated on 17 Aug
2020 (60 Subjects)
Phase 2 expected before the
end of 2020 (~3000 Subjects)
United Biomedical, Inc. Asia.
UB-612
Protein subunit vaccine
Phase 1 initiated on 30 Aug
2020 (45 Subjects)
Phase 2 expected before the
end of 2020 (~3000 Subjects)
Medigen Vaccine Biologics Corp.
MVC-COV1901 Vaccine
Protein subunit vaccine
Phase 1 initiated on 28 Aug
2020 (60 Subjects)
Phase 2 planning (~3000
Subjects)
Other candidates
DNA vaccine of NHRI/Enimmune
Protein subunit vaccine with nano-vector
of NTU/Tanvex Biopharma
Self-amplifying mRNA vaccine of Abnova
Protein subunit vaccine of PhamaEssentia
…, etc.
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Challenges for Clinical Trials of COVID-19 Vaccines in Taiwan
Evaluating safety and efficacy of COVID-19 vaccines
Lack of standard parameter for evaluating vaccine protectivity
Take reference from the lead vaccine candidates in the world.
Recommend to check vaccine immunogenicity using common analytical method, which is validated by a common reference standard.
Number of subjects required for representing vaccine safety.
For the need of early access to COVID-19 vaccines, MA or EUA might be granted before the initiation of Phase 3 trials.
How many subjects could be representative for vaccine safety and efficacy?
No locally acquired COVID-19 cases since May, 2020 in Taiwan
MRCT will be recommended for better proving the protectivity of vaccines.
Need to define checkpoints for progressing the vaccine development to next stage.
Developing Checklists (review requirements) of Phase 1 and Phase 2 applications for COVID-19 vaccines.
Developing Checklists (review requirements) of EUA application for COVID-19 vaccines
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Future Challenges
International cooperation on vaccine development
MRCTs for recruiting high risk populations.
Safety and efficacy information of current developing COVID-19 vaccines in the world
Experience sharing on the development of COVID-19 vaccines
Large scale confirmatory study for COVID-19 vaccines
Unknow efficacy and the uncertainty of SARS-CoV-2 characteristics
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THANK YOU
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