1

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

2

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

3

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

4

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

5

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

6

Biotechnologies in Fighting COVID-19

Rapid test kitsDiagnostic tools

MedicationInnovative drugs

Preventive vaccines

Personal protective equipment (PPE)

Technical support

platform

7

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

8

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)

9

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

10

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

11

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.

12

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

13

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.

14

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.

15

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.

16

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

17

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

18

THANK YOU

*Background vector created by freepik and Slidego