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MINISTRY OF
HEALTH
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SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
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No. 1210/QD-BYT
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Hanoi, February
09, 2021
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DECISION
APPROVING
PLAN FOR RECEIPT, STORAGE, DISTRIBUTION AND USE OF COVID-19 VACCINES PROVIDED
BY COVAX FACILITY FOR 2021 - 2022
MINISTER OF HEALTH
Pursuant to the Government’s Decree No.
75/2017/ND-CP dated 20/6/2017 on functions, duties, powers and organizational
structure of Ministry of Health;
Pursuant to Decision No. 3659/QD-BYT dated
21/8/2020 by the Ministry of Health on guidelines for COVID-19 vaccine
research, clinical trials, marketing authorization and use;
At the request of the General Director of
General Department of Preventive Medicine, Ministry of Health,
HEREBY DECIDES:
Article 1. Approved together with this Decision is the plan for
receipt, storage, distribution and use of COVID-19 vaccines provided by COVAX
Facility for 2021 - 2022.
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Article 3. This Decision takes effect from the date on which it is
signed.
Article 4. Heads of Office of the Ministry of Health, General
Department of Preventive Medicine, Drug Administration of Vietnam,
Administration of Science Technology and Training, Medical Services
Administration, Department of Planning and Finance, Department of Communication
and Emulation, Commendation, National Institute for Control of Vaccines and
Biologicals, Institutes of Hygiene and Epidemiology, Pasteur Institutes, Departments
of Health and relevant units shall implement this Decision./.
P.P. THE
MINISTER
THE DEPUTY MINISTER
Do Xuan Tuyen
PLAN
RECEIPT,
STORAGE, DISTRIBUTION AND USE OF COVID-19 VACCINES PROVIDED BY COVAX FACILITY
FOR 2021 - 2022
(Promulgated together
with Decision No. 1210/QD-BYT dated 09/02/2021 by Minister of Health)
I.
NECESSITY OF PLAN FORMULATION
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Vietnam reported its first SARS-CoV-2 infection on
23/01/2020. As of 08/02/2021, Vietnam has recorded 2.050 confirmed cases
(including 923 imported cases and 1.127 internal cases) and 35 deaths, which
are patients with serious underlying conditions in Da Nang (31 cases), Quang
Nam (03 cases) and Quang Tri (01 case).
As of 08/02/2021, 11 vaccines have been authorized
for emergency use by other countries or approved by the European Medicines
Agency (EMA). In addition, according to the World Health Organization (WHO), as
of 08/02/2021, there are 237 other COVID-19 vaccines in research (63 undergoing
clinical trials, 174 in research and not yet clinically studied). The 63
vaccines that are undergoing clinical trials include 15 vaccines in phase III,
10 in phase II and 38 in phase I with 01 vaccine from Germany, 6 from China, 3
from the United States, 01 from Kazakhstan, 02 from India, 01 from Russia and
01 from the United Kingdom. Most vaccines require two intramuscular doses that
are at least 14 days apart and storage at 2 - 8 degrees Celsius.
Vietnam currently has 04 COVID-19 vaccine
producers, namely Institute of Vaccines and Medical Biologicals (IVAC), Company
for Vaccine and Biological Production No.1 (VABIOTECH), Center for Research and
Production of Vaccines and Biologicals (POLYVAC), and Nanogen Pharmaceutical
Biotechnology JSC.. The 04 vaccines are produced using recombinant protein
technology and 02 of them are undergoing clinical trials. If the trials are
successful, the vaccines may be put on the domestic market in the second
quarter of 2022.
The COVAX Facility (initiative for global access to
COVID-19 vaccines) was founded by GAVI and WHO with the aim of providing
COVID-19 vaccines for 190 countries. On 10/12/2020, GAVI recognized Vietnam as
one of the initiative’s participants and eligible for vaccine support. GAVI and
COVAX Facility plan to provide vaccines for 20% of participating countries’
populations. However, according to current estimation, the initiative will
supply free vaccines and vaccination materials for about 15-16% of the
populations of 92 countries, including Vietnam. On 29/01/2021, the COVAX
Facility notified that approximately 4,8 million doses of the AstraZenecca
vaccine would be delivered to Vietnam in the first and second quarters of 2021,
and provision of the remaining amounts would be informed at a later date. For
timely receipt and use of vaccines provided by the COVAX Facility, Vietnam
needs to formulate a plan for receipt, storage, distribution and use of
COVID-19 vaccines on the basis of Vietnam’s situation and vaccine provision
capacity of the COVAX Facility.
II.
LEGAL GROUNDS
- Law on Prevention and Control of Infectious
Diseases No. 03/2007/QH12 dated 21/11/2007.
- Law on Pharmacy No. 105/2016/QH13 dated
06/4/2016.
- Telegram of standing members of the Secretariat
dated 05/01/2021 on enhancement of COVID-19 prevention and control.
- The Government’s Decree No. 104/2016/ND-CP dated
01/7/2016 on vaccination.
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- Notification No. 164/TB-VPCP dated 31/12/2020 by
the Office of the Government on the Prime Minister’s conclusions in meeting of
standing Government members on COVID-19 vaccines.
- Circular No. 34/2018/TT-BYT dated 12/11/2018 by
the Ministry of Health elaborating some Articles of the Government’s Decree No.
104/2016/ND-CP dated 01/7/2016 on vaccination.
- Circular No. 38/2017/TT-BYT dated 17/10/2017 by the
Ministry of Health introducing lists of infectious diseases, scope and
recipients of compulsory vaccines and biologicals.
- Decision No. 3659/QD-BYT dated 21/8/2020 by the
Ministry of Health on guidelines for COVID-19 vaccine research, clinical
trials, marketing authorization and use.
- Letter of the COVAX Facility dated 10/12/2020 on
approval for Vietnam's participation in the COVAX Facility and commitment to
provide Vietnam with COVID-19 vaccines for 15-16% and up to 20% of Vietnam's
population.
- Letter of the COVAX Facility dated 29/01/2021 on
distribution of AstraZenecca vaccines to Vietnam.
III. OBJECTIVES
In order to ensure herd immunity, Vietnam must
strive to have 80% of the population vaccinated against COVID-19. However,
based on current vaccine availability, objectives for the 2021 - 2022 period
are as follows:
1. General objectives
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2. Specific objectives
- Ensure 20% of the population is vaccinated
against COVID-19 when there are sufficient vaccines.
- 95% of at-risk individuals are vaccinated against
COVID-19.
- Promptly receive, provide and administer COVID-19
vaccines according to the COVID-19 situation.
- Ensure safe and efficient use of COVID-19
vaccines.
IV. ACTIVITIES
1. Establishment of national
COVID-19 vaccine distribution system (done)
- On 30/1/2020, the Prime Minister promulgated
Decision No. 170/QD-TTg on establishment of National Steering Committee
for COVID-19 Prevention and Control.
- On 25/3/2020, the Ministry of Health promulgated
Decision No. 1338/QD-BYT by the Ministry of Health on strengthening of steering
committees for epidemic prevention and control with specific functions and
duties and establishment of epidemic surveillance, prevention and treatment,
communication, logistics and international cooperation subcommittees.
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- On 25/01/2021, the Ministry’s leader signed and
promulgated the Decision on strengthening of the COVID-19 vaccine working group
to prepare for deployment of vaccines provided by the COVAX Facility.
- Notify relevant ministries and central
authorities, national advisory committee on immunization (NITAG), partners and
other relevant parties of COVID-19 vaccine introduction and the role of each
unit. Regularly provide and exchange information and share global/ regional
guidelines with NITAGs and RITAGs and support technical groups of NITAGs with
matters concerning COVID-19.
2. Identification of COVID-19
vaccine recipients and scope of vaccination
2.1. Selection of
vaccine recipients
a) Rules: ensure that many population groups
receive vaccines, the vaccination rate is high and people have equitable access
to vaccines.
b) Grounds:
- 2007 Law on Prevention and Control of Infectious
Diseases.
- Recommendations of the Strategic Advisory Group
of Experts on Immunization of WHO (SAGE).
- Propositions of the NITAG in the meeting on
16/11/2020.
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- Guidelines for epidemic surveillance, medical
quarantine and response to epidemic prevention and control in Vietnam.
c) COVID-19 vaccine recipients
Below is the list of COVID-19 vaccine recipients
organized in order of priority according to the COVID-19 situation and
considering limited vaccine availability in Vietnam:
- Healthcare workers
- COVID-19 prevention and control participants
(steering committees at all levels, staff of quarantine areas, reporters, etc.)
- Diplomatic staff, customs staff, officials
involved in entry and exit operations
- Military forces
- Police forces
- Teachers
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- Essential service providers such as aviation,
transport, tourism; power supply, water supply, etc.
- People having chronic diseases.
- People wishing to work or study abroad.
- People in epidemic zones per epidemiological
indications.
(Appendix 1:
Vaccine recipients per vaccine provision plan)
2.2. Scope of
vaccination
- Administer vaccines nationwide.
- Priority level shall be determined based on high
to low level of risk according to the following criteria:
+ Areas/ provinces/ districts recording community
infections or deaths of COVID-19.
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+ Provinces having important transport hubs.
3.
Vaccine selection criteria
Below are the criteria for COVID-19 vaccine
selection organized in order of priority. Vaccines are not required to meet all
of these criteria.
- High safety and effectiveness (issued with a
registration number or import license by the Ministry of Health).
- Having undergone WHO prequalification.
- Approved by a stringent regulatory authority
(SRA).
- Stored at 2 - 8°C.
- Inactivated vaccines.
- Produced using vector technology.
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- Affordable.
- Added to emergency use list of WHO.
- Low number of doses per vial (under 10 doses).
- Cold storage conditions (-20°C).
- Produced using mRNA technology.
- Deep freezing storage conditions (-70°C).
Vietnam shall prioritize vaccines meeting the
following criteria:
- High safety and effectiveness (issued with a registration
number or import license by the Ministry of Health).
- Stored at 2 - 8°C.
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4.1. Cold chain systems
4.1.1. Vaccine transport
The vaccine receipt, storage and distribution
system of Vietnam’s Expanded Program on Immunization (EPI) is deployed at 04
levels, including the national level (National Institute of Hygiene and
Epidemiology); regional level (EPIs in the North, in the Central, on the
Central Highlands and in the South); provincial level (CDCs of 63 provinces);
and district level (district-level medical centers). The commune level mostly
receives vaccines from the district level and administers vaccines on
vaccination dates. Communes in remote and isolated areas are equipped with small
refrigerators to store vaccines.
Vaccines are usually imported and kept in national
or regional storage before they are distributed to provincial storage,
district-level storage and commune-level medical stations (communes in remote
and isolated areas have vaccine storing fridges). Vaccines are imported mostly
via Noi Bai and Ho Chi Minh airport; and received and kept in national storage
or Ho Chi Minh City storage. After being inspected, vaccines will be delivered
from national or regional storage to provincial CDCs by refrigerated trucks and
then kept in cold boxes and delivered to district-level medical centers before
they are delivered to commune-level medical stations by cars or motorcycles.
The amount of vaccine remaining after each vaccination session at commune-level
medical stations will be delivered to district-level storage or stored directly
at commune-level medical stations having vaccine storing fridges.
4.1.2. Current state of cold chain systems
Results of the survey on current state of cold chain
systems conducted by General Department of Preventive Medicine in cooperation
with UNICEF and relevant units using the UNICEF-developed tools for current
cold chain state assessment are as follows:
a) Storage at 2-8°C
Vietnam’s available cold chain systems mostly
consist of equipment for vaccine storage at 2 - 8°C, which is estimated to be
able to store 122 million doses of COVID-19 vaccines. To be specific: total
available capacity at central level is 253.000 liters, capable of storing 54
million doses; at provincial level is 156.000 liters, capable of storing 33
million doses; and at district level is 160.000 liters, capable of storing 35
million doses. However, 26 provinces need to expand their cold chains by 14.358
liters and 92 districts need to expand theirs by 8.829 liters.
According to the annual report on cold chain
stocktaking of the EPI, 1.158 TCW3000 fridges equipped in 2008 are damaged or
have been repaired many times after more than 10 years of use. In addition,
since 2003, the EPI has equipped commune-level medical stations with 3.988
RCW50EG small fridges. At present, these fridges no longer work properly and
require replacement to maintain high annual vaccination coverage and equality
in vaccination, especially with vaccination against COVID-19.
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In conclusion, Vietnam is capable of receiving,
storing and distributing COVID-19 vaccines with storage conditions at 2-8°C at
central, provincial and district levels. However, it is necessary to equip
remote and isolated areas with at least 2,197 fridges.
b) Storage at -25 to -15 °C
Regarding equipment for vaccine storage at -25 to
-15°C, total available capacity is 72.000 liters, which is estimated to be able
to store 16 million doses. To be specific: total available capacity at central
level is 54.730 liters, capable of storing almost 12 million doses; at
provincial level is 9.531 liters, capable of storing 2 million doses; and at
district level is 8.271 liters, capable of storing 1,8 million doses.
Therefore, EPI’s capacity for vaccine storage at -25 to -15°C is limited and
requires upgrade.
c) Deep freezing storage at -80 to -70°C
EPI currently cannot support storage at these
temperatures.
Vietnam Vaccine JSC. has deep freezing storage
(-70°C) capable of storing 3 million doses of COVID-19 vaccines.
4.2. Current state of workforce of vaccination
systems
There are more than 13.000 vaccination facilities
across the country, including more than 11.000 EPI facilities and 2.000 state-owned
and private facilities. Healthcare establishments having maternity wards
administer hepatitis B infant vaccine doses and TB vaccines under the EPI.
There are 49.000 EPI staff members and 10.000 people working for private-sector
vaccination services. Commune-level medical stations mostly comprise health
officials, communication officials and technical staff. Each EPI level has
vaccination units and officials in charge of vaccination under the EPI. EPI and
private-sector vaccination workers are trained in vaccination and have
experience in organizing vaccination sessions. However, as COVID-19 vaccines
are new vaccines, vaccination officials require training in administration,
monitoring of adverse events following immunization, etc.
According to EPI’s annual report and the EPI Review
of 2020, all vaccination officials have received training and possess
vaccination planning skills. Most vaccine and cold chain managers are trained
in cold chain management and vaccine storage. Vaccine storage in 63 provinces
store vaccines according to regulations of good storage practices (according to
Circular No. 36/2018/TT-BYT). However, as there is change of vaccination
officials and vaccine and cold chain managers at EPI levels due to merging of
provincial CDCs and district-level medical centers, new officials need further
training in vaccination planning as well as vaccine and cold chain management.
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The EPI shall formulate and propose a cold chain
improvement plan for its levels to the Ministry of Health to ensure capacity
for COVID-19 vaccine storage and transport, and mobilize support from
Vietnamese and foreign organizations.
Timeline: February - March 2021
5.
COVID-19 vaccine receipt
- The vaccine that the COVAX Facility provided for Vietnam
in the first and second quarters of 2021 is the vaccine produced by AstraZeneca
and distributed by SK Bioscience (SKBio).
- Drug Administration of Vietnam shall carry out
procedures for marketing authorization or import licensing according to regulations
in Decision No. 3659/QD-BYT dated 21/8/2020 by the Ministry of Health on
guidelines for COVID-19 vaccine research, clinical trials, marketing
authorization and use and existing regulations. To be specific:
+ Regarding import licensing according to regulations
in Clause 1 Article 67 of the Government's Decree No. 54/2017/ND-CP dated May
08, 2017: a COVID-19 vaccine may be granted the import license only when it has
obtained marketing authorization in at least one foreign country and meets any
of the following conditions: a) The Ministry of National Defense proposes that
the vaccine be imported for urgent national defense; b) The Ministry of Public
Security proposes that the vaccine be imported for urgent security assurance;
or c) The vaccine is approved by the Ministry of Health for urgent use in the
event of epidemic prevention or disaster recovery. Import licensing procedures
are provided for in Clause 2 Article 77 of Decree No. 54/2017/ND-CP and may be
completed within 03 days after receipt of an application adequate according to
regulations. After a vaccine is granted the import license, it may be used in
Vietnam.
+ Regarding marketing authorization of COVID-19
vaccines according to regulations in Section 4 of Decision No. 3659/QD-BYT by
the Ministry of Health: 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
available clinical trial results; 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. Applications for
marketing authorization issuance, renewal and amendment for COVID-19 vaccines
shall be prepared according to regulations in Articles 23, 24, 25, 26, 27 and
28 of Circular No. 32/2018/TT-BYT, and some documents that require more time to
prepare as mentioned in Article 16 of Decision No. 3659/2020/QD-BYT may be
added to the applications when they are available. Granting of the marketing
authorization following simplified procedures shall require a maximum of 6
months starting from the date of receipt of an adequate application according
to regulations in Article 41 of Circular No. 32/2018/TT-BYT. Drug
Administration of Vietnam is formulating guidelines for marketing authorization
of COVID-19 vaccines based on WHO and COVAX Facility guidelines. According to
regulations in Section 11 of Article 3 of Circular No. 32/2018/TT-BYT, Drug
Administration of Vietnam requests vaccine manufacturers to implement the
approved risk management plan in the application for issuance or renewal of the
marketing authorization for their vaccines.
- The EPI shall take charge and cooperate with
General Department of Preventive Medicine and relevant units in completing
import procedures and procedures for receipt of aid being vaccines and
vaccination materials.
6.
Vaccine quality assurance
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- Some chemical and physical tests shall be performed
within 03 days.
- General safety assessment shall be performed on
test animals within 07 days.
- Effectiveness testing and laboratory
identification testing shall be performed within 15 days.
7.
Transport, storage and distribution of vaccines and materials
Vaccines provided by the COVAX Facility will be
imported free-of-charge via Noi Bai or Ho Chi Minh City airport and granted
customs clearance immediately upon their arrival at the airport and then
transported to national or regional storage. After undergoing an inspection (if
any), vaccines will be delivered from national or regional storage to
provincial and district-level storages by specialized vehicles or cold boxes,
and then delivered to commune-level storage or commune-level medical stations
by thermos flasks on vaccination dates. Temperature monitors will be used
throughout the delivery process at all levels. Vaccine delivery from the
central level to commune level shall be carried out by vaccination officials
trained in vaccine transport and storage.
All vaccine storages at central, provincial and
district levels are in compliance with regulations of good storage practices
according to Circular No. 36/2018/TT-BYT. These storages are located on the
premises of provincial CDCs and district-level medical centers under 24/7
supervision of security guards and officials.
Quantities of vaccines, syringes and safety boxes
received and dispatched at all levels will be recorded and monitored via
vaccine dispatch and receipt books and delivery records according to
regulations. Vaccine dispatch and receipt books will be updated on a monthly
basis at all levels.
In addition, Vietnam is employing the national
vaccination information management system at all levels. This system enables
management of vaccine recipients, vaccination coverage, vaccines, syringes,
safety boxes, etc. and will be used or adjusted as appropriate to manage
COVID-19 vaccine recipients, vaccination coverage and vaccination materials
used.
As notified, the vaccine provided by COVAX Facility
for Vietnam is the AstraZeneca vaccine, which requires storage at 2 - 8°C.
Thus, the EPI shall formulate a plan for distribution, transport and storage of
vaccines and vaccination materials in its cold chain system. Vaccine delivery
at EPI levels shall be carried out as follows:
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- At provincial level: provincial CDCs shall
receive and store the vaccines in provincial storages and dispense the vaccines
as follows:
+ Dispense the vaccines to district-level medical
centers at least 03 days before vaccination date.
+ Dispense the vaccines to hospitals at the
central, regional and provincial levels and hospitals of sectors in their
provinces 01 day prior to vaccination date or immediately before a vaccination
session. Hospitals fully equipped with cold chains for vaccine storage may keep
the vaccines in their storages on vaccination dates. For hospitals not fully
equipped with a cold chain system, provincial CDCs shall provide the vaccines
for each vaccination session or temporarily equip these hospitals with cold boxes
and vaccine carriers. Unused vaccines shall be returned to provincial
preventive medicine centers.
- At district level: district-level medical centers
shall deliver the vaccines from storages of their provinces to district-level
storages and dispense the vaccines to communes and district-level hospitals or
private-sector vaccination locations requesting the vaccines 01 days prior to
vaccination date or immediately in a vaccination session.
- The commune level or facilities permitted to
administer the vaccines shall receive vaccines from the district level, store
the vaccines and deliver them to vaccination locations in vaccination sessions.
In case where the available cold chain systems of
the EPI could not meet vaccine transport and storage demand, the EPI shall
cooperate with General Department of Preventive Medicine and Drug
Administration of Vietnam in proposing a plan to mobilize cold chain systems of
distributors, importers and public and private vaccination facilities across
the country.
8.
Training in use of COVID-19 vaccines for health officials
Activity 1: review documents and guidelines
on training in COVID-19 vaccine administration of WHO and vaccine storage.
- In-charge unit: the EPI and National Institute of
Hygiene and Epidemiology.
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- Timeline: within 07 days starting from the date
of issuance of WHO training documents.
Activity 2: formulate plans and documents
concerning training in COVID-19 vaccine administration, monitoring of adverse
events following immunization for vaccination facilities and vaccine storage.
- In-charge unit: the EPI and National Institute of
Hygiene and Epidemiology.
- Cooperating units: General Department of
Preventive Medicine, Institutes of Hygiene and Epidemiology, Pasteur Institutes
and provincial CDCs.
- Timeline: within 07 days starting from the date
upon which the Ministry of Health gives direction on the vaccine to be used.
Activity 3: organize training in COVID-19
vaccine administration, monitoring of adverse events following immunization for
vaccination facilities and vaccine storage.
- In-charge unit: the EPI and National Institute of
Hygiene and Epidemiology.
- Cooperating units: General Department of
Preventive Medicine, Medical Services Administration, Institutes of Hygiene and
Epidemiology, Pasteur Institutes and provincial CDCs.
- Timeline: the EPI shall provide training for its
regional units, Departments of Health and provincial CDCs at least 10 days
before vaccination starts. Provincial CDCs shall cooperate with regional EPI
units in providing guidance on COVID-19 vaccination plans for EPI levels in
their provinces at least 07 days before vaccination starts.
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Activity 1: formulate plans to communicate
about use of COVID-19 vaccines to raise awareness, share information and
encourage people to get vaccinated.
- In-charge unit: General Department of Preventive
Medicine.
- Cooperating units: Department of Communication
and Emulation, Commendation, Institutes of Hygiene and Epidemiology, Pasteur
Institutes and provincial CDCs.
- Timeline: January - February 2021
Activity 2: develop messages, news reports
and documents informing about COVID-19 vaccines and recipients thereof.
- In-charge unit: General Department of Preventive
Medicine.
- Cooperating units: Department of Communication
and Emulation, Commendation, Institutes of Hygiene and Epidemiology, Pasteur
Institutes and the EPI.
- Timeline: From February 2021
Activity 3: inform health officials and
communication officials about COVID-19 vaccines and recipients thereof.
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- Cooperating units: General Department of
Preventive Medicine, Department of Communication and Emulation, Commendation,
Institutes of Hygiene and Epidemiology, Pasteur Institutes and the EPI.
- Timeline: From February 2021
Activity 4: launching communications activities
a) Collect information on COVID-19 vaccine use from
social network sites and communities to promptly devise plans for recovery from
and response to communication crises over vaccination.
- In-charge unit: National Center for Health
Communication and Education.
- Cooperating units: General Department of
Preventive Medicine, Department of Communication and Emulation, Commendation,
Institutes of Hygiene and Epidemiology, Pasteur Institutes, Departments of
Health, provincial CDCs/ provincial Centers for Health Communication and
Education.
- Timeline: From January 2021.
b) Carry out communications activities according to
approved communication plans. To be specific: inform press agencies of
prioritized vaccine recipients, type of vaccine used, vaccination benefits,
vaccination schedule, vaccine safety, adverse events following immunization and
vaccination plans, which will provide this information to people and
communities.
- In-charge unit: Department of Communication and
Emulation, Commendation and National Center for Health Communication and
Education.
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- Timeline: at least 07 days before vaccination
starts.
c) Monitoring of and
support for communication about COVID-19 vaccination:
- In-charge unit: National Center for Health
Communication and Education.
- Cooperating units: provincial CDCs and
communications centers of provinces.
- Timeline: before, during and after vaccination.
10.
Vaccination organization
10.1. Local COVID-19 vaccination need
determination and plan formulation
- Activity content: Departments of Health shall
take charge and cooperate with regulatory bodies and governments of districts
in their provinces in formulating plans for local COVID-19 vaccine use and
directing development of lists of vaccine recipients by risk group and lists of
persons agreeing or disagreeing to get vaccinated using the opinion collection
form of the Ministry of Health.
- In-charge units: Departments of Health.
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- Timeline: within 07 days starting from the date
upon which the Ministry of Health promulgates the COVID-19 vaccination plan.
(The plan shall be formulated according to the
vaccine provision plan in Appendix 1 enclosed therewith).
10.2. Formulation of guidelines for vaccination
session organization
The EPI has formulated and adopted the guidelines
on planning for vaccination in remote and isolated areas. Vaccination officials
of all levels, especially in remote and isolated areas, have received training
and possess skills in applying these guidelines. These guidelines will be
implemented to planning for COVID-19 vaccination to ensure that those living in
remote and isolated areas have access to COVID-19 vaccines.
In 2020, the Ministry of Health has formulated and
implemented guidelines for vaccination organization during the COVID-19
pandemic at all levels (Official Dispatch No. 2251/BYT-DP dated 22/4/2020),
which provide guidance on COVID-19 prevention, including vaccination planning,
provision of protective clothing, face masks and hand sanitizer, vaccine
recipients in a vaccination session, etc.
- Activity content: formulate guidelines for
vaccination session organization, including organizing vaccination according to
existing regulations, arranging vaccination locations in compliance with
requirements for COVID-19 prevention and safety of vaccination officials, etc.
- In-charge unit: General Department of Preventive
Medicine.
- Cooperating units: Departments of Health,
Institutes of Hygiene and Epidemiology, Pasteur Institutes and provincial CDCs.
- Timeline: January - February 2021
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The AstraZeneca vaccine shall be administered to
persons aged 18 or above in a series of 02 intramuscular doses 21 days apart.
One vaccine vial contains 08-10 doses.
10.3.1. Injection route
COVID-19 vaccination shall be organized in the form
of a campaign that takes place in the shortest possible amount of time. Employ
the existing EPI system and, where necessary, Departments of Health shall
mobilize state and private vaccination facilities to organize vaccination sessions.
10.3.2. Vaccination facilities
For units eligible for vaccination, CDCs shall
provide them with guidelines on vaccinating the intended recipients according
to regulations. For healthcare establishments without eligible vaccination
units, provincial CDCs shall formulate plans and organize mobile vaccination
points according to regulations.
a) Central and provincial hospitals and
district-level hospitals and medical centers shall:
- Administer the vaccine to their healthcare
workers, COVID-19 prevention participants, patients and other persons according
to the plans of the localities where they are located.
- Set up emergency teams and provide assistance for
hard-to-access communes (at least 01 mobile emergency team every 3-4 communes)
b) Commune-level medical stations shall:
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- Administer the vaccine to healthcare workers,
COVID-19 prevention participants, national defense forces, police forces and
teachers in their communes, essential service providers and people aged 65 or
above in their communes and other chronic disease outpatients according to the
plans of their communes; after the campaign ends, administer the vaccine to
those yet to receive it in hospitals.
- Set up their emergency teams.
c) Hospitals, infirmaries, healthcare
establishments, etc. affiliated to ministries and central authorities shall:
- Formulate plans and administer the vaccine to
workers of the ministries and central authorities to which they are affiliated
and support the healthcare sector with vaccinating other recipients (where
necessary).
- Set up emergency teams in vaccination facilities.
d) Private-sector vaccination clinics
- Administer the vaccine in accordance with
directions of Departments of Health.
- Set up emergency teams in vaccination facilities.
10.4. Monitoring and handling of adverse events
following COVID-19 vaccination
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- In-charge unit: General Department of Preventive
Medicine.
- Cooperating units: Institutes of Hygiene and
Epidemiology, Pasteur Institutes, Departments of Health, provincial CDCs.
- Timeline: January - February 2021.
b) Proactively monitor adverse events following
immunization: vaccination facilities shall proactively monitor adverse events
following immunization according to the Ministry of Health’s guidelines. The
system for monitoring of adverse events following immunization includes
monitoring units and cooperating units from central to local government
(provincial). Procedures for investigation, reporting and announcement of
investigation result, and response to post-vaccination serious injuries are
provided for in Article 6 of Decree No. 104/2016/ND-CP dated 01/07/2016.
- Monitoring units: vaccination facilities.
- Cooperating units: General Department of
Preventive Medicine, Departments of Health, Institutes of Hygiene and
Epidemiology, Pasteur Institutes, provincial CDCs, district-level medical
centers.
- Timeline: during vaccine use.
- The units shall receive training in proactive
monitoring of adverse events following immunization on an annual basis.
c) Periodic monitoring: vaccination facilities
shall monitor post-vaccination common side effects and serious injuries
according to regulations in Decree No. 104/2016/ND-CP and Circular No.
34/2018/TT-BYT.
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- Cooperating units: General Department of
Preventive Medicine, Departments of Health, Institutes of Hygiene and
Epidemiology, Pasteur Institutes, provincial CDCs, district-level medical
centers.
- Timeline: during vaccine use.
- The units shall receive training in monitoring of
post-vaccination common side effects and serious injuries on an annual basis.
d) Advisory councils on assessment of causes of
serious vaccine injuries: advisory councils on assessment of causes of serious
vaccine injuries from central to provincial level shall be established and organized
and operate according to Circular No. 24/2018/TT-BYT and Circular No.
05/2020/TT-BYT, and receive annual training in professional operations of
assessment of causes of serious vaccine injuries.
e) Response to vaccine anaphylaxis: procedures for
anaphylaxis diagnosis and response are provided for in Circular No.
51/2017/TT-BYT dated December 29, 2017 by the Ministry of Health on guidelines
for anaphylaxis prevention, diagnosis and response. Officials participating in
vaccination at all levels and healthcare establishments shall receive training
in these procedures on a periodic basis.
10.5. Management of syringes and biomedical
waste after vaccination sessions
a) Formulate guidelines for handling of syringes
and biomedical waste after vaccination sessions according to regulations in
Joint Circular No. 58/2015/TTLT-BYT-BTNM dated 31/12/2015 by the Ministry of
Natural Resources and Environment stipulating regulations on biomedical waste
management as well as characteristics of the COVID-19 vaccine.
- In-charge unit: Health Environment Management
Agency.
- Cooperating units: General Department of
Preventive Medicine, Departments of Health, Institutes of Hygiene and
Epidemiology, Pasteur Institutes, provincial CDCs.
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b) Collect and handle syringes and biomedical waste
at vaccination points according to regulations of the Ministry of Health
- In-charge units: vaccination facilities.
- Cooperating units: Health Environment Management
Agency, Departments of Health, Institutes of Hygiene and Epidemiology, Pasteur
Institutes, provincial CDCs, district-level medical centers.
- Timeline: during vaccine use.
10.6. Vaccination monitoring and reporting
a) Formulate vaccination monitoring and reporting
forms
- Activity content: develop forms, format, content
and procedures for reporting on vaccine use and adverse events following
vaccination.
- In-charge unit: General Department of Preventive
Medicine.
- Cooperating units: Departments of Health,
Institutes of Hygiene and Epidemiology, Pasteur Institutes and provincial CDCs,
district-level medical centers.
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b) Prepare reports:
Vaccination facilities shall prepare reports on a
daily, periodic and ad hoc basis according to guidelines of the Ministry of Health.
c) Inspect and supervise before, during and after
the campaign: General Department of Preventive Medicine and the EPI and
regional units thereof shall supervise administration of the vaccine.
11.
Funding
11.1. Central government funding
+ Transport and storage of vaccines from the
manufacturers to Vietnam (if any) and at central level; improvement of cold
chain systems of all levels.
+ Training for provincial level.
+ Development of communication messages, launching
of communications activities, etc.
(Appendix 3. Estimated funding)
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+ Transport and storage of vaccines from central
level to local levels and at local levels.
+ Training for district-level medical centers and
local vaccination points.
+ Communications activities.
+ Printing of forms and reports.
+ Remuneration for vaccination, inspection and
monitoring activities, payment for vaccination materials, etc.
(Appendix 3. Estimated funding)
11.3. Funding from
Vietnamese and foreign organizations and other legal funding sources
(Appendix 3. Estimated funding)
12. For
imported and/or domestically manufactured vaccines
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V.
IMPLEMENTATION
1. Provincial People’s Committees shall allocate
funding and direct organization of vaccination in their provinces.
2. Ministries and central authorities shall cooperate
in the following tasks:
2.1. The Ministry of Finance shall take charge and
cooperate with the Ministry of Health in stipulating remuneration for
vaccination activities.
2.2. The Ministry of Public Security, Ministry of
National Defense, Ministry of Education and Training, Ministry of Foreign
Affairs and Ministry of Transport shall organize administration of vaccines to
their workers or cooperate with the Ministry of Health in this task and support
the Ministry of Health where necessary.
3. Units affiliated to the Ministry of Health
shall:
3.1. General Department of Preventive Medicine
shall take charge and cooperate with relevant units in formulating guidelines
for vaccination session organization; guidelines for monitoring of adverse
events following immunization, plans to communicate about COVID-19 vaccination;
vaccine recipient opinion collection forms, and forms for reporting on vaccine
use and adverse events following immunization, and monitoring implementation of
approved plans.
3.2. Medical Services Administration shall direct
adoption of this plan at healthcare establishments.
3.3. Department of Planning and Finance shall
advise and submit proposals to the Ministry of Health to ensure funding for
activities of COVID-19 vaccination plans; and provide provincial governments
with guidelines on funding distribution in their provinces.
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3.5. Drug Administration of Vietnam shall import
COVID-19 vaccines, provide guidance and carry out procedures for issuance of
the marketing authorization or import license for the vaccines as soon as
practicable to ensure that the vaccines are administered promptly and in
compliance with the law.
3.6. Administration of Science Technology and
Training shall provide guidelines on clinical testing of COVID-19 vaccines
promptly and in accordance with regulations.
3.7. Health Environment Management Agency shall
formulate guidelines for and direct handling of waste from COVID-19 vaccination
as per the law.
3.8. Institutes affiliated to the preventive
medicine system shall receive, transport and store vaccines; engage in
vaccination training, communication and monitoring as assigned; and monitor and
respond to post-vaccination reactions. National Institute for Control of
Vaccines and Biologicals shall inspect vaccines’ quality promptly and in
compliance with approved procedures.
3.9. The EPI shall develop detailed COVID-19
vaccination plans; formulate and launch plans to improve cold chain systems at
all levels; receive, store and distribute vaccines from central to local EPI
level; prepare communication messages about use of COVID-19 vaccines; and
organize training in and monitoring of use of COVID-19 vaccines.
3.10. National centralized drug procurement center
shall procure COVID-19 vaccines as per the law.
3.11. National Center for Health Communication and
Education and press agencies shall cooperate with the Ministry of Health in
raising awareness about COVID-19 vaccines and organize monitoring of
communications activities.
4. Departments of Health shall formulate and
propose detailed vaccination plans to the People's Committees of their
provinces for approval and provision of resources for these plans, and direct
relevant units to launch approved plans.
5. Vaccine distributors and importers shall
formulate vaccine import, storage and transport plans at the request of the
Ministry of Health or Departments of Health; take responsibility for vaccine
storage and transport and sufficient vaccine provision according to plans; and
prepare adequate documents for validation when registering or importing
vaccines.
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(Appendix 2: Implementing plan)
APPENDIX 1
PROVISIONAL VACCINE PROVISION PLAN
(Promulgated together with Decision No. 1210/QD-BYT dated February 09, 2021)
The COVAX plans to provide 4.886.600 doses for
Vietnam (25-35% in the first quarter of 2021 and 65-75% in the second quarter
of 2021).
1. First quarter of 2021:
- Quantity: approximately 1,2 million doses, which
is sufficient for 600.000 people.
- Recipients:
No.
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Estimated
number of prioritized persons
Vaccination
coverage
Number of
recipients
1
Healthcare workers
500.000
0,95
475.000
2
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116.000
0,95
110.200
Total
616.000
585.200
2. Second
quarter of 2021:
- Quantity: approximately 3,6 million doses, which
is sufficient for 1,8 million people.
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No.
Prioritized
persons
Estimated number
of prioritized persons
Vaccination
coverage
Number of
recipients
1
Customs officials
9.200
0,95
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2
Diplomatic officials
4.080
0,95
3.876
3
Military forces
1.027.000
0,95
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4
Police forces
304.000
0,95
288.800
5
Teachers
550.000
0,95
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1.799.566
3. Third and fourth quarters of 2021
As notified, the COVAX Facility will provide
vaccines for a maximum of 20% of participating countries’ populations. The
COVAX Facility will provide the remaining amount of vaccines for Vietnam from
the third quarter of 2021. To be specific:
- Quantity: approximately 33 million doses, which
is sufficient for 16 million people.
- Recipients:
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Prioritized
persons
Estimated
number of prioritized persons
Vaccination
coverage
Number of
recipients
1
Teachers
750.000
0,95
712.500
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People aged 65 and older
7.600.000
0,95
7.220.000
3
Essential service providers such as customs,
foreign affairs, aviation, transport and tourism
1.930.000
0,95
1.833.500
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Adults having chronic diseases
7.000.000
0,95
6.650.000
Total
17.280.000
16.416.000
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IMPLEMENTING PLAN
(Promulgated together with Decision No. 1210/QD-BYT dated February 09, 2021)
Activities
according to plans
Timeline
In-charge unit
Cooperating
unit
Results according
to plans
2020
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2022
Q1
Q2
Q3
Q4
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X
General Department
of Preventive Medicine
Drug Administration of Vietnam, Expanded Program
on Immunization, UNICEF, provincial CDCs
A report on detailed assessment of cold chain
systems for vaccine storage at all levels
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Formulate a cold chain improvement plan
X
Expanded Program
on Immunization
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
A cold chain improvement plan is available and a
proposal for support for GAVI and relevant units is adopted
Apply for import license for COVAX-provided
vaccines
X
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Drug
Administration of Vietnam
Expanded Program on Immunization, General Department
of Preventive Medicine, applicants, NICVB
Obtain the marketing authorization or import
license
Import and receive COVAX-provided vaccines
X
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Expanded Program
on Immunization
General Department of Preventive Medicine, importers,
distributors, Institutes of Hygiene and Epidemiology, Pasteur Institutes,
provincial CDCs.
Vaccines are imported to Vietnam.
Transport, store and distribute vaccines and
vaccination materials
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
X
X
X
X
Expanded Program
on Immunization
General Department of Preventive Medicine, Drug
Administration of Vietnam, distributors, importers, Institutes of Hygiene and
Epidemiology, Pasteur Institutes, CDCs.
Vaccines are delivered to vaccination facilities
in compliance with requirements.
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
X
X
Expanded Program
on Immunization
General Department of Preventive Medicine, Institutes
of Hygiene and Epidemiology, Pasteur Institutes, CDCs.
Officials receive training in COVID-19
vaccination and safety thereof.
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Formulate plans to communicate about use of
COVID-19 vaccines
X
X
General Department
of Preventive Medicine
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Plans to communicate about use of COVID-19
vaccines
Develop communication messages about use of
COVID-19 vaccines
X
X
X
X
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
General Department
of Preventive Medicine
General Department of Preventive Medicine,
Department of Communication and Emulation, Commendation, Institutes of
Hygiene and Epidemiology, Pasteur Institutes, CDCs.
Communication messages about use of COVID-19
vaccines
Provide training in vaccine recipients for health
officials and communication officials
X
X
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
National Center
for Health Communication and Education
General Department of Preventive Medicine,
Department of Communication and Emulation, Commendation, Institutes of
Hygiene and Epidemiology, Pasteur Institutes, Expanded Program on
Immunization
Health officials and communication officials
receive training.
Carry out communications activities
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
X
X
X
X
National Center
for Health Communication and Education
General Department of Preventive Medicine,
Department of Communication and Emulation, Commendation, Institutes of
Hygiene and Epidemiology, Pasteur Institutes, Expanded Program on
Immunization
Communications activities are carried out.
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
X
X
X
Departments of
Health
CDCs, units affiliated to Departments of Health
The plans are promulgated.
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Formulate guidelines for vaccination session
organization
X
General Department
of Preventive Medicine:
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Guidelines for vaccination session organization
Organize COVID-19 vaccination sessions
X
X
X
X
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Vaccination points
CDCs, district-level medical centers
Vaccinate the correct recipients and ensure
vaccination safety
Formulate guidelines for proactive monitoring of
adverse events following immunization
X
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
General Department
of Preventive Medicine
Departments of Health, Institutes of Hygiene and
Epidemiology, Pasteur Institutes, CDCs
Guidelines for proactive monitoring of adverse
events following immunization
Monitor and handle adverse events following
COVID-19 vaccination
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
X
X
X
X
Vaccination points
Departments of Health, CDCs, district-level medical
centers, General Department of Preventive Medicine, central and provincial
hospitals
All adverse events and common side effects are
promptly managed and handled.
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
X
Health Environment
Management Agency
General Department of Preventive Medicine,
Departments of Health, Institutes of Hygiene and Epidemiology, Pasteur
Institutes, provincial CDCs
Guidelines for handling of syringes and
biomedical waste after vaccination sessions are provided.
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Collect and handle syringes and biomedical waste
at vaccination points
X
X
X
X
X
Vaccination
facilities
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Collect and handle syringes and biomedical waste
at vaccination points according to regulations.
Formulate monitoring and reporting forms
X
X
X
X
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
General Department
of Preventive Medicine
Departments of Health, Institutes of Hygiene and
Epidemiology, Pasteur Institutes, CDCs
Vaccination monitoring and reporting forms
Monitor and report on COVID-19 vaccination
X
X
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
X
X
General Department
of Preventive Medicine
Expanded Program on Immunization, National
Institute of Hygiene and Epidemiology, Institutes of Hygiene and
Epidemiology, Pasteur Institutes, provincial CDCs
Campaign monitoring and summary reports are
promulgated.
APPENDIX 3
...
...
...
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No.
Activity
Provisional funding
Amount (VND)
COVAX
Central government budget
Provincial budget
Remaining funding requiring mobilization
1
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
6.322.072.974.000
6.322.072.974.000
-
-
-
2
Vaccine transport
16.100.000.000
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
11.500.000.000
3
Training
39.721.000.000
6.900.000.000
32.821.000.000
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Communications
16.100.000.000
4.600.000.000
11.500.000.000
5
Supervision
23.225.515.000
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
4.600.000.000
18.625.515.000
6
Recipient
identification
9.900.005.000
-
9.900.005.000
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
7
Remuneration for
vaccination activities
78.535.064.000
-
78.535.064.000
8
Extra-station
vaccination
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
-
-
35.200.005.000
9
Vaccine injury
compensation according to regulations in Decree No. 104/2016/ND-CP
3.450.000.000
-
3.450.000.000
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
-
10
Procurement of
refrigerated trucks
5.520.000.000
5.520.000.000
-
-
-
11
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
7.590.000.000
7.590.000.000
-
-
-
12
Procurement of
additional fridges for vaccine storage at 2 - 8°C (TCW4000AC)
14.490.000.000
14.490.000.000
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
-
-
13
Replacement of
fridges in use for 10 years or more at district level (TCW4000AC)
61.099.500.000
-
-
-
61.099.500.000
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Provision of
fridges for commune-level medical stations in disadvantaged areas (HBC 80)
106.115.100.000
-
-
-
106.115.100.000
Total
6.739.119.163.000
6.349.672.974.000
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
162.881.584.000
202.414.605.000