Quyết định 1210/QD-BYT

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.

Article 2. This plan shall provide the basis for formulation and launch of plans for receipt, storage, distribution and use of COVID-19 vaccines provided by COVAX Facility. This plan will be revised as appropriate to the pandemic’s situation and vaccine provision capacity of COVAX Facility.

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./. 

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

COVID-19 was first found in Wuhan City, Hubei, China in December 2019. To date, the disease is recorded in almost all countries around the world.

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.

- The Government’s Decree No. 155/2018/ND-CP dated 12/11/2018 on amendments to some Articles related to business conditions under state management of the Ministry of Health.

- 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

Reduce COVID-19 infection and mortality rates using free vaccines.

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.

- On 24/11/2020, the Ministry of Health promulgated Decision No. 4900/QD-BYT on establishment of COVID-19 vaccine working group, which includes WHO and UNICEF representatives, to request support from the COVAX Facility. Duties of this working group comprise formulating request for support from the COVAX Facility; reviewing and assessing Vietnam’s readiness for COVID-19 vaccination; advising the Minister on resolution of problems (if any) to meet GAVI and COVAX Facility requirements.

- 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.

- Strategies for COVID-19 prevention and control in Vietnam.

- 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

- People aged 65 and older

- 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.

+ Large and highly populated cities.

+ 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.

- Requiring few number of doses.

- 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.

4. Review of vaccine storage systems and vaccination staff

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.

The EPI is preparing to equip 174 TCW4000AC fridges, which is supported by GAVI via UNICEF under the CCEOP2 project. These fridges are expected to be handed over to the EPI in April 2021. In addition, WHO is purchasing and providing 212 TCW4000AC fridges for the EPI, which are expected to be delivered in April or May 2021.

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.

4.3. Tasks

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

Production records and samples of COVID-19 vaccine batches and vaccine inspection shall conform to regulations in Circular No. 11/2018/TT-BYT dated 04/5/2019 by the Ministry of Health on drug and drug ingredient quality. Below are the tests to be performed concurrently and time limit thereof:

- 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:

- At regional level: refrigerated trucks of Institutes of Hygiene and Epidemiology, Pasteur Institutes or distributors or importers shall deliver the vaccines to storage of provincial CDCs within 07 days starting from the date of receipt of the vaccines.

- 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.

- 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 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.

9. Communication about use of COVID-19 vaccines

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.

- 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 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.

- Cooperating units: General Department of Preventive Medicine, the EPI, provincial CDCs and communications centers of provinces.

- 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.

- 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 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

10.3. Organization of COVID-19 vaccination sessions

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:

- Organize the COVID-19 vaccination campaign on their premises and at mobile vaccination points.

- 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

a) Formulate guidelines for proactive monitoring of adverse events following immunization and adverse event of special interest (AESI):

- 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 .

- 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 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.

- Timeline: February - March 2021.

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.

- Timeline: February - March 2021.

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)

11.2. Local government funding

+ 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

Vaccines from other sources shall be purchased, received, stored and distributed in compliance with schemes approved by the Prime Minister.

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.

3.4. Department of Communication and Emulation, Commendation shall direct communications activities concerning COVID-19 vaccination.

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.

6. Central hospitals, provincial general hospitals, preventive medicine centers/ provincial CDCs, district-level preventive medicine centers, district-level hospitals, commune-level medical stations as well as public and private vaccination facilities shall implement vaccination plans.

(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:

2. Second quarter of 2021:

- Quantity: approximately 3,6 million doses, which is sufficient for 1,8 million people.

- Recipients:

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:

APPENDIX 2

IMPLEMENTING PLAN
(Promulgated together with Decision No. 1210/QD-BYT dated February 09, 2021)

APPENDIX 3

PROVISIONAL FUNDING FOR VACCINATION OF 20% OF INTENDED RECIPIENTS
(For vaccines provided by COVAX Facility)
(Promulgated together with Decision No. 1210/QD-BYT dated February 09, 2021)