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MINISTRY OF HEALTH
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SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
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No. 3659/QD-BYT
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Hanoi, August 21, 2020
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DECISION
PROMULGATING GUIDELINES FOR COVID-19 VACCINE RESEARCH,
CLINICAL TRIALS, MARKETING AUTHORIZATION AND USE
MINISTER OF HEALTH
Pursuant to the Law on Prevention and Control
of Infectious Diseases No. 03/2007/QH12 dated 21/11/2007;
Pursuant to the Law on Pharmacy No.
105/2016/QH13 dated April 06, 2016;
Pursuant to the Government’s Decree No.
75/2017/ND-CP dated June 20, 2017 on functions, duties, powers and
organizational structure of the Ministry of Health;
Pursuant to the Government's Decree No.
54/2017/ND-CP dated May 08, 2017 elaborating Law on Pharmacy;
Pursuant to the Government’s Decree No.
104/2016/ND-CP dated July 01, 2016 on vaccination;
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Pursuant to the Circular No. 32/2018/TT-BYT
dated November 12, 2018 by the Minister of Health on marketing authorization of
drugs and medicinal ingredients;
Pursuant to the Circular No. 35/2018/TT-BYT
dated November 22, 2018 by the Minister of Health on Good Manufacturing
Practices for pharmaceutical products and pharmaceutical starting materials;
At the request of the Director General of
Administration of Science Technology and Training, Director General of Drug
Administration of Vietnam and Director General of General Department of
Preventive Medicine of the Ministry of Health.
HEREBY DECIDES:
Article 1. Promulgated together with this Decision are the guidelines
for COVID-19 vaccine research, clinical trials, marketing authorization and
use.
The guidelines for COVID-19 vaccine research,
clinical trials, marketing authorization and use promulgated together with this
Decision are applicable during the COVID-19 pandemic.
Article 2. This Decision takes effect from the date on which it is
signed.
Article 3. Director General of Administration of Science Technology and
Training, Director General of Drug Administration of Vietnam, Director General
of General Department of Preventive Medicine, Head of Office of the Ministry of
Health, heads of relevant regulatory bodies and organizations, and relevant
individuals shall implement this Decision./.
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P.P. THE MINISTER
THE DEPUTY MINISTER
Tran Van Thuan
GUIDELINES
FOR COVID-19 VACCINE RESEARCH, CLINICAL TRIALS, MARKETING
AUTHORIZATION AND USE
Section 1. VACCINE RESEARCH
AND QUALITY CONTROL
Article 1. Research on
COVID-19 vaccines
1. Every COVID-19 vaccine
must undergo preclinical assessment of its safety, immunogenicity and ability
to protect animal models from challenge, which shall be carried out by its
manufacturer.
2. The manufacturer shall
provide sufficient vaccine samples, typical chemicals and documents according
to regulations for National Institute for Control of Vaccine and Biologicals to
inspect the quality of its vaccine and certify that the vaccine meets quality
requirements.
Article 2. Inspection of
quality of vaccine batches undergoing clinical trial
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2. National Institute for Control
of Vaccine and Biologicals shall conduct new tests and regular tests necessary
for COVID-19 vaccine quality control on its premises or assign officials to
conduct these tests independently/concurrently on the premises of the
manufacturer or supervise the testing procedures of the manufacturer to ensure
that these tests are carried out in an accurate, scientific and impartial
manner.
Section 2. VACCINE CLINICAL
TRIALS
Article 3. General
regulations on COVID-19 vaccine clinical trials
1. Clinical trial
procedures, requirements for language, presentation and legality of documents,
and organization of clinical trials are provided for in Articles 18, 20 and 24
of the Circular No. 29/2018/TT-BYT dated October 29, 2018 by the Minister of
Health on clinical trial of drugs (hereinafter referred to as “Circular No.
29/2018/TT-BYT”).
2. Rights and
responsibilities of the sponsor, the institution, investigators and the
principal investigator as well as rights and obligations of clinical trial
participants are provided for in Articles 3, 4, 5, 6 and 7 of the Circular No.
10/2020/TT-BYT dated June 11, 2020 by the Minister of Health on bioequivalence
studies for drugs (hereinafter referred to as “Circular No. 10/2020/TT-BYT”).
3. Conducting of clinical
trials, recording, reporting, statistical analysis, monitoring and supervision,
and audit of clinical trials, remedial actions for adverse events, reporting of
adverse events in clinical trials in Vietnam, finance and remuneration for
trial participants, clinical trial termination, and reporting and announcement
of clinical trial results are provided for in Articles 13, 17, 18, 19, 20, 21,
22 and 23 of the Appendix enclosed with Circular No. 10/2020/TT-BYT .
Article 4. Documents
required for COVID-19 vaccine clinical trials
1. Application for
permission for clinical trial, which is prepared in compliance with regulations
in Clause 1 Article 19 of Circular No. 29/2018/TT-BYT .
2. Application for approval
for clinical trial, which is prepared according to regulations in Clause 2
Article 19 of Circular No. 29/2018/TT-BYT and documents about the clinical
trial in previous phases (mentioned in Point b Clause 2 Article 19 of Circular
No. 29/2018/TT-BYT) included in which shall be prepared as follows:
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b) Application for permission for phase 2 of the
clinical trial may use results of interim assessment of the safety and
immunogenicity (if any) of phase 1 instead of results of assessment of the
whole phase 1 while phase 1 is not yet completed.
c) Application for permission for phase 3 of the
clinical trial may use results of interim assessment of the safety and
immunogenicity (if any) of phase 2 instead of results of assessment of the
whole phase 2 while phase 2 is not yet completed.
3. Application for approval
for change to clinical trial, which is prepared in compliance with regulations
in Clause 3 Article 19 of Circular No. 29/2018/TT-BYT .
4. Application for approval
for clinical trial results, which is prepared in compliance with regulations in
Clause 4 Article 19 of Circular No. 29/2018/TT-BYT .
Article 5. Clinical trial
application procedure
Procedure for application for permission to
conduct a COVID-19 vaccine clinical trial is provided for in Article 21 of
Circular No. 29/2018/TT-BYT .
Article 6. Protocol approval
and clinical trial result approval
1. Procedures for protocol
approval, approval for amendment to protocol and approval for results of
COVID-19 vaccine clinical trials are provided for in Articles 22, 23 and 25 of
Circular No. 29/2018/TT-BYT .
2. The national research
ethics committee shall validate the applications in emergency meetings
according to regulations in Article 26 of Circular No. 04/2020/TT- BYT dated
March 05, 2020 by the Minister of Health on establishment, functions, tasks and
rights of research ethics committees.
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Article 7. Clinical trial
protocol
Clinical trial protocol is provided for in
Article 8 of the Appendix enclosed with Circular No.10/2020/TT-BYT.
Article 8. Clinical trial
design
Clinical trial design is provided for in Article
9 of the Appendix enclosed with Circular No.10/2020/TT-BYT, in which:
1. Phase 1 may be designed
as an independent trial or together with phase 2 in one protocol. Phase 2 may
be designed together with phase 3 in one protocol.
2. Phase 1 may be conducted
in one or more than one center; phase 2 shall be a double-blind, randomized
comparison study conducted at one or more than one center; phase 3 shall be a
double-blind, randomized comparison study conducted at multiple centers.
3. The protocol must
specify the standards applied to the interim assessment results if these
results are used to consider transitioning to the following phase or apply for
marketing authorization following the emergency procedure applicable to
vaccines against pandemics.
4. In case Vietnam does not
have sufficient COVID-19 cases to design vaccine efficacy assessment (phase 3,
case-based assessment), a study may be designed to compare the immunogenicity
of the vaccine in question with that of a vaccine which belongs to a country
with a WHO-recognized national regulatory authority (NRA) and the efficacy
assessment results of which are available.
Article 9. Sample size is provided for in Article 10 of the Appendix of
Circular No. 10/2020/TT-BYT , in which, recommended total sample size of phase 1
is 30-150 subjects. Recommended minimum total sample size of phase 2 used for
result analysis is 200 subjects. Recommended minimum total sample size of phase
3 used for result analysis is 800 subjects. In case of phase 3 study for
assessment of a vaccine’s protection effectiveness, minimum total sample size
shall be 800 subjects, who must be monitored for at least 01 year after the
date of administration of the last dose.
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Article 11. Technical documents and quality control for clinical trials
are provided for in Clause 1 Article 15 of the Appendix of Circular No.
10/2020/TT-BYT .
Article 12. Technical standards for personnel are provided for in
Article 16 of the Appendix of Circular No. 10/2020/TT-BYT , excluding the
regulation restricting every principal investigator from taking charge of more
than 03 clinical trials at the same time.
Section 3. ASSESSMENT OF
COMPLIANCE WITH GMP REQUIREMENTS
Article 13. Compliance with GMP requirements of domestic COVID-19
vaccine production lines shall be directly assessed according to regulations of
Circular No. 35/2018/TT-BYT dated 22/11/2018 by the Minister of Health on Good
Manufacturing Practices for pharmaceutical products and pharmaceutical starting
materials (hereinafter referred to as “Circular No. 35/2018/TT-BYT”) for the
purpose of granting of registration numbers.
Article 14. Compliance with GMP requirements of overseas COVID-19
vaccine production facilities shall be assessed according to regulations of the
Government’s Decree No. 54/2017/ND-CP dated 08/5/2017 on guidelines for
implementation of Law on Pharmacy (hereinafter referred to as “Decree No.
54/2017/ND-CP”).
Section 4. MARKETING AUTHORIZATION
Article 15. Drug Administration of Vietnam shall submit a report to the
marketing authorization advisory council, which will provide the basis for the
marketing authorization advisory council to consider and approve use of phase 1
and phase 2 results and results of interim assessment of phase 3 of safety and
immunogenicity for application for marketing authorization based on validation
of documents on safety and efficacy by validation specialists. Based on
opinions of the marketing authorization advisory council, Drug Administration
of Vietnam shall submit a report to the Minister of Health, which will provide
the basis for the Minister of Health to consider and decide to exempt one or
more than one clinical trial phase according to regulations in Clause 1 Article
18 of Circular No. 32/2018/TT-BYT dated 12/11/2018 by the Minister of Health on
marketing authorization of drugs and medicinal ingredients (hereinafter
referred to as “Circular No. 32/2018/TT-BYT”).
Article 16. Applications for issuance, renewal and revision of
marketing authorization for COVID-19 vaccines are provided for in Articles 23,
24, 25, 26, 27 and 28 of Circular No. 32/2018/TT-BYT , including the following
documents, which require much time for preparation:
- Test report, specifications
and test method certified by National Institute for Control of Vaccine and
Biologicals, which may be added after results are available.
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- Data on clinical trial
results, which may be updated during the application validation process.
Article 17. Marketing authorization for a COVID-19 vaccine shall be
granted following the simplified procedures provided for in Article 41 of
Circular No. 32/2018/TT-BYT to shorten the procedure while ensuring the safety,
quality and efficacy of the vaccine based on benefit/risk analysis.
Section 5. VACCINE USE AND
IMPLEMENTING RESPONSIBILITY
Article 18. COVID-19 vaccines shall be prioritized for localities and
individuals facing high risk as appropriate to real-world situation and vaccine
provision capacity.
Article 19. General Department of Preventive Medicine shall take charge
and cooperate with Drug Administration of Vietnam, Department of Planning and
Finance and relevant departments of the Ministry of Health, Institutes of
Hygiene and Epidemiology, Pasteur Institutes and relevant units in formulating
and proposing plans for COVID-19 vaccine receipt, preservation, distribution
and use to Ministry leaders for consideration and approval.
Article 20. Implementing
responsibilities
1. Administration of
Science Technology and Training shall:
a) Provide guidance on implementation of these
Guidelines and monitor such implementation.
b) Act as the body in charge of receiving and
processing applications for permission for COVID-19 vaccine clinical trial,
approving and carrying out commissioning of COVID-19 vaccine clinical trials
according to Circular No. 29/2018/TT-BYT as soon as practicable.
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2. Drug Administration of
Vietnam shall organize assessment of compliance with GMP requirements of
COVID-19 vaccine production lines according to Decree No. 54/2017/ND-CP and
Circular No. 35/2018/TT-BYT as soon as practicable; and organize validation of
applications for COVID-19 vaccine marketing authorization according to Circular
No. 32/2018/TT-BYT as soon as practicable.
3. General Department of Preventive
Medicine shall formulate a plan for use of authorized COVID-19 vaccines and
supervision of vaccine reactions.
4. National Institute for
Control of Vaccine and Biologicals shall inspect quality of COVID-19 vaccines
to ensure quality of vaccines used in clinical trials, ensure that vaccines are
registered as soon as practicable and exercise after-sales supervision of
vaccines granted marketing authorization.
5. National Institute of
Hygiene and Epidemiology, Pasteur Institute of Ho Chi Minh City, Pasteur
Institute of Nha Trang and Vietnam Military Medical University shall cooperate
with and assist vaccine manufacturers in COVID-19 vaccine research,
manufacturing and clinical trials as soon as practicable.
6. The national research
ethics committee and internal research ethics committees shall carry out
validation and commissioning of applications for permission for COVID-19
vaccine clinical trial as soon as practicable; and monitor and inspect COVID-19
vaccine clinical trials to ensure the safety of trial participants and the
accuracy and trustworthiness of research data.
7. Organizations and
individuals involved in COVID-19 vaccine research and manufacturing shall
comply with these guidelines and relevant laws during COVID-19 vaccine clinical
trial, marketing authorization and use processes.