Operations Instruction for the administration of Pfizer-BioNTech/Comirnaty Omicron XBB.1.5 monovalent vaccine for children aged 6 months to 4 years
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Last updated on 27 February 2024

Purpose

1. This Operations Instruction seeks to inform Vaccination Providers on the instructions to operationalise the COVID-19 vaccination for children aged 6 months to 4 years who are receiving the Pfizer-BioNTech/Comirnaty XBB.1.5 Monovalent vaccine.

Intended Audience

2. The intended audience are as follows

  • Children aged 6 months to 4 years

  • Early Intervention Programme for Infants and Children (EIPIC) Centres

Introduction

3. MOH will adopt a phased approach to vaccination operations, with the end intent to vaccinate the entire Singapore resident population.

Principal Considerations

4. The principal considerations are as follows:

a) Client Safety

   i. Minimum age of eligible client to receive the mRNA COVID-19 vaccination should be calculated based on the date of birth, not just the birth year. The authorised minimum age specified for each vaccine type can be found on the respective MOH Guidance document for Vaccination Providers.

    ii.  For clients who are receiving the vaccines for the first time, the second dose of the primary series could be offered to be received at the same venue as the first dose, and the vaccine should be from the same manufacturer as the first dose. Vaccination Providers should pay attention to the interval between the doses.

b) Minimise Vaccine Supplies Wastage

Due to the short shelf-life of the vaccines after opening of vials and reconstitution, Vaccination Providers should take reasonable efforts to minimise vaccine wastage.

Concept of Operations

5. Health Appointment System

a) Vaccinations will be administered to individuals aged 6 months to 4 years at designated Joint Testing and Vaccination Centres (JTVCs) or any designated vaccination sites if the vaccine is made available to them.  

b) Parents/Legal guardians of eligible children may schedule their child's/ward's vaccination appointment using the Health Appointment System (HAS) at https://book.health.gov.sg/. 

c) Vaccination Providers will continue to achieve the throughput as per MOH's latest instructions.

(Note: Clinics who wish to register for the Health Appointment System may do so here.)


Updates to Clinical Guidance

6.1  Individuals who have not been vaccinated against COVID-19 with effect from 1 March 2024 are now recommended to receive two initial vaccine doses. This includes children aged 6 months to 4 years who were previously recommended to receive 3 doses for their primary series vaccination.

Vaccine

Eligible Age

Dose(s) and Recommended Intervals

Pfizer-BioNTech/Comirnaty XBB.1.5 monovalent COVID-19 Vaccine

6 months to 4 years

Primary series vaccination

  • 2 doses of 3mcg (0.2mL)
  • 8 weeks apart

2023/2024 additional dose

  • 1 dose of 3mcg (0.2mL)
  • 1 year after the last dose

6.2  The advice to avoid strenuous physical activity after vaccination is updated to apply to only male vaccinees aged 12-29 years, for a duration of 1 week.

 

6.3  COVID-19 vaccines can now be administered concurrently with other non-COVID-19 vaccines across all ages eligible for the vaccine.

 

6.4  There is no longer a stipulated period of observation after COVID-19 vaccination, other than for persons at increased risk of anaphylaxis who should be observed for 30 minutes. These individuals include those who had a past history of:

  1. Allergic reactions (that is, immediate hypersensitivity reactions) to other COVID-19 vaccines, OR,

  2. Any anaphylaxis

 

6.5  Emergency drugs/equipment requirements for COVID-19 vaccine providers is now aligned to that required under prevailing regulatory requirements relevant to the licensable healthcare service which the licensee is licensed for and is stipulated in the "Licence Conditions for Providing or Intending to Provide Emergency Life Saving Measures".

 

6.6  There is no more restriction of nonsteroidal anti-inflammatory drugs (NSAIDs) use after COVID-19 vaccine administration.

 

Administration of Vaccine to Children Aged 6 Months to 4 Years

6.7  Vaccination centres should refer children with conditions listed in Table 1 to the hospital for their COVID-19 vaccination.

Table 1: Referral for vaccination in hospital

Specialty

Consider Vaccination in Hospital

Cardiology

  • Persistent fluid overload or pulmonary hypertension and/or in NYHA class 3 or 4 symptoms
  • Severe, symptomatic stenotic valvular heart disease (with angina, faints, shortness of breath)
  • Hypertrophic cardiomyopathy with outflow tract obstruction

Respiratory

  • Advanced neuromuscular conditions with chronic respiratory failure, especially those on prolonged BiPAP support
  • Chronic lung disease with need for respiratory support (i.e., on supplemental oxygen or requiring suctioning)

 

6.8  Table 2 provides a non-exhaustive list of conditions that can be vaccinated at community vaccination sites.

Table 2: Non-exhaustive list of conditions that can be vaccinated at community vaccination sites

Specialty

Can be safely vaccinated in community vaccination sites

Allergy

All patients with non-vaccine related allergies can be safely vaccinated in a community vaccination centre.

Cardiology

Except for conditions in Table 1, all other patients can be safely vaccinated in a community vaccination centre.

Nephrology

Haemodialysis and peritoneal dialysis patients

Transplant patients

Complex renal patients with comorbidities

Patients on immunosuppression

Neurology and Rehabilitation Medicine

Patients with neuroimmunological conditions (e.g.​ MS, NMOSD, autoimmune encephalitis etc) can be safely vaccinated in community vaccination centres

Patients on immunosuppression should discuss with their attending physician before COVID-19 vaccination

Oncology

See paras 6.4 and 6.5.

Patients with stem cell transplants should discuss with their primary specialist before COVID-19 vaccination.

Respiratory

Except for conditions in Table 1, all other patients can be safely vaccinated in a community vaccination centre

Cystic fibrosis and other forms of severe bronchiectasis can be vaccinated.

Rheumatology

Patients on Rituximab should discuss with their primary rheumatologist before COVID-19 vaccination.

Cardiothoracic and Vascular Surgery

Safe to vaccinate in a community vaccination centre.

Psychological Medicine

Safe to vaccinate in a community vaccination centre.

 

6.9  It is safe for children currently on cancer treatment (chemotherapy/immunotherapy/ radiotherapy) to be vaccinated. However, they may be advised to consult their oncologist on the optimal timing, weighing better vaccine effectiveness against the risks of delay in view of their vulnerability to COVID-19 infection.

 

6.10  Children with cancer who have not been on chemotherapy/immunotherapy/radiotherapy for the past 3 months can be vaccinated. This includes children currently on hormonal therapy. Hormonal therapy is not considered chemotherapy or immunotherapy. There is no need for a memo from the oncologist.

 

6.11  There may be instances where Community Vaccination Centres may refer children for vaccination at a hospital in-situ vaccination site for non-medical reasons, for example, unwillingness to be vaccinated at a Community Vaccination Centre due to heightened parental concerns over their child/ward's pre-existing medical condition, or children who are uncooperative in a community vaccination centre setting. In such instances, it should be emphasised to parents that this referral is specifically for COVID-19 vaccination and there is no scheduled review with any paediatrician at the hospital's in-situ vaccination site on the day of the vaccination.


6.12  MOH has provided the following clinical guidance materials to support vaccination provider staff who are carrying out vaccinations. Personnel who are carrying out vaccinations should ensure that they are familiar with the materials before carrying out vaccinations.

COVID-19 Recovered Persons

6.13  Recovered persons who had not completed COVID-19 vaccination previously can complete 2 doses of the vaccine to finish their primary vaccination series. They are recommended to receive the vaccine 3 months or more after the date of infection.

 

6.14  Recovered persons who had not completed COVID-19 vaccination previously are considered to have completed their primary vaccination series if they received at least one dose of mRNA/Novavax vaccines or two doses of Sinovac vaccine at a minimum interval of 28 days after the date of infection.


Parent Consent for Vaccination 

7.1 Children below 13 years old are required to have the consent of their parent or legal guardian in order to be administered with the vaccine. The parent or legal guardian must also be present on the vaccination day.

Requirements on Granting of Consent and Consent Verification (including in person parent/guardian presence) 

7.2 The Vaccination Providers will verify the following before administering the vaccine to the client: 

a) HAS Appointment. Verify the HAS appointment​ status of the client to ensure that he/she has a valid appointment booked when present. If there is a valid HAS appointment, consent was given at the point the appointment was made and there is no need for written consent. If the client does not have any valid appointments, Vaccination Providers shall facilitate the client's vaccination on site and ensure that consent has been obtained. 

b) Verify the identification document of the client to ensure that he/she is the correct person for whom the parent/legal guardian had booked the vaccination appointment. 

c) Vaccination Providers shall verify the parent's/legal guardian's signed letter of consent either in hardcopy or softcopy form which is produced by the client. If the client is unable to produce the signed letter of consent either in hardcopy or softcopy form, the Vaccination Providers will verbally verify consent with the parent/legal guardian whose presence is required in-person and record the consent in GPConnect-lite/Patient Risk Profile Portal (PRPP) or the vaccination provider's IT system. 

For foreign clients with foreign identification documents or whose birth certificates indicate they were not Singaporean at time of birth, Vaccination Providers shall register the clients with their FIN number. 

Vaccination Providers are not required to retain the hardcopy of the signed letter of consent​. However, the Vaccination Providers should document the parent's/legal guardian's consent in GPConnect-lite/PRPP or vaccination provider's IT system by capturing the following details for every client whose parent/legal guardian consent​ needs to be verified:

  1. ​Name of the parent/legal guardian 

  2. Contact number of the parent/legal guardian 

  3. Consent obtained from parent/legal guardian 

  4. <Mode of consent obtained> from parent/legal guardian 

  5. Relationship between parent/legal guardian and client 

d) For any subsequent dose appointments, the Vaccination Providers onsite will again verify that the client has the required parent/legal guardian consent and captured the same details in GPConnect-lite/PRPP​ or vaccination provider's IT system, before administering subsequent doses. 

e) The Vaccination Providers will capture the required data under the “Clinical Notes" area and in accordance with the template shown below as a guide. 

Clinical Notes in GP Connect Lite.jpg

7.3  Hospitals and other healthcare institutions that provide vaccination services to their existing clients should obtain consent from a parent/legal guardian for their clients who are below 18 years old, using the hospital/institution's existing processes. Hospitals/institutions should document the parent/legal guardian's consent obtained in an appropriate EMR/IT system. 


Medical Screening for Children 

7.4  Vaccination Providers must obtain answers and seek clarifications, if necessary, from parent/legal guardian to the relevant questions before administering vaccine to the client. 

7.5  The Vaccination Providers will ask the parent/legal guardian the screening questions, for the parent/legal guardian to answer on behalf of the client. 

7.6  The vaccination will generally follow the processes below: 

a) Pre-vaccination – Parents/legal guardian of the client will make an appointment for vaccination. 

b) On-Site Registration and Triaging – Upon the client's arrival at the vaccination site, the client will be triaged and screened in the presence of the parent/legal guardian based on the client's updated information and age. For organisations with access to National Electronic Health Record (NEHR), the Doctor/Nurse should also access the client's NEHR via GPConnect Lite/Staff Surveillance System (S3)/Electronic Medical Record (EMR)/Patient Risk Profile Portal (PRPP) or vaccination provider's IT system to verify the client's medical history. COVID-19 vaccines can now be administered concurrently with other non-COVID-19 vaccines across all ages eligible for the vaccine. The Doctor/Nurse should also check the client's COVID-19 vaccination records, if any, via GPConnect Lite/S3/EMR/PRPP or vaccination provider's IT system. 

c) Vaccination - Vaccination and data capture. 

d) Post-vaccination – Monitoring of the client and reporting of adverse effects, if necessary. 


Referral to Public Healthcare Institutions (KKH/NUH) for In-Situ Vaccination 

7.7  The default posture is for vaccination to take place in the community. Most clients can and should be safely vaccinated in the Vaccination Centres. There are rare exceptions who may require vaccination in a hospital setting. The workflow for such referrals and documents required during the vaccination process are as follows:

  • ​​For referral to KK Women's and Children's Hospital (KKH) Paediatric Vaccination Clinic for in-situ vaccination of children aged 6 months to 5 years.

  • For referral to National University Hospital (NUH) Paediatric Vaccination Clinic for in-situ vaccination of children aged 6 months to 5 years.

7.8  The following documents are required during the vaccination process:

  • ​Vaccination Information Sheet: Vaccine information and post-vaccination advice for client, if necessary.

  • Vaccination Screening Form: Reference of the minimum dataset for various uses, including registration, declaration of contraindications, indication of consent, medical record documentation, and vaccination procedure medical record documentation.

  • Vaccination Card​:  To be issued to client's parent/legal guardian after the vaccination is administered, if required. Vaccination Card is not meant to be used for travel purposes/proof of vaccination. Client's parent/legal guardian may request for a digital vaccination certificate from the Notarise website.​


Vaccination Screening Form​

7.9  If a client has been assessed to be ineligible or has to be deferred for vaccination, the screening Doctor/Nurse should reflect the associated reason/medical conditions on the GPConnect Lite/S3/EMR/PRPP or vaccination provider's IT system as follows:

a) The reasons/medical conditions1 should be aligned to the latest recommendations on contraindications and indications to the respective COVID-19 vaccine.

b)  The screening Doctor/Nurse should clearly communicate the said reasons to the client.

7.10  Vaccination Providers should continue to exercise due diligence to assess clients during screening/triaging. This includes questioning the parent(s)/legal guardian as to whether the client experienced anaphylaxis after previous doses. The Vaccination Batch Number should continue to be recorded, as new batches would be distributed to institutions in future.

1The reasons/medical conditions are codified in GPC as: fever, acute respiratory infections, general unwell, immunosuppression, platelet count abnormality, allergy to vaccine product, history of drug-induced anaphylaxis, others, cancer treatment.

​Daily Reporting Requirements

7.11  Vaccination Providers are required to submit daily reports  to MOH. The reporting requirements are as follows:

  • ​Data reporting is to be submitted through PRPP, the cut-off time for data submission each day is 2359 hrs each day.

  • ​PRPP Reporting Module: Clinics are only required to key in the information below under the reporting module. Other necessary information will be auto-populated by PRPP for reporting to MOH:

    • ​Doses administered/ Number of persons vaccinated

    • Number of Vials used

    • Efficiency Ratio (Total doses administered/ Number of vials used)

    • Inventory at the end of the day (In vials)

    • Wastage (In doses) 

    • Wastage reason (if any)

Please refer to the PRPP COVID-19 Vaccination Module Quick Start Guide here​.


Vaccine Handling and Storage

8.1  Vaccination Providers should adhere to the following vaccine storage guidelines.

a) Undiluted vaccine vials should be stored in a refrigerator with the temperature maintained between 2°C and 8°C and must be monitored. For refrigerators that do not have a temperature data logger, the internal temperature of the refrigerator where vaccine vials are stored should be recorded twice daily, e.g. in the morning and evening.

b) Care should be taken to protect the vaccine vials from light if the refrigerator door/window panel is transparent.

c) Adopt a first-expire-first-out system when retrieving vaccine vials from the refrigerator.


8.2 Vaccination Providers should adhere to the following vaccine handling guidelines.

a) Vaccine vials should always be protected from light when not being handled. Handling refers to the process of preparation (when diluting or pre-filling the syringe) and administration of the vaccine.

b) Vaccine vials should be visually inspected for discolouration, or particulates before dilution, after dilution and before each syringe is filled during preparation.

c) When filling the syringe, the dose in each syringe should be visually inspected by lifting up each syringe to check for (I) the correct final dosing volume, (ii) no discolouration and no particulates, and (iii) no air bubbles.

Disposal of Used/Empty Vaccine Vials, Syringes and Needles​

8.3  Used/empty vaccines vials are considered pharmaceutical waste. They should be collected in containers that are non-reactive, tamper-proof and designed to resist impact rupture and labelled with the proper colour code and symbol before disposal by a licensed biohazard waste collector.

8.4  As COVID-19 vaccines delivered to vaccination sites are considered controlled consumables, used/empty vials should be properly accounted for and stored in a controlled environment before disposal to prevent unauthorised possession.

(Reference:https://www.straitstimes.com/singapore/consumer/surgical-masks-vaccines-among-counterfeit-goods-on-the-rise-online)


8.5  Vaccination Providers should adhere to the following guidelines to prevent needle-stick injuries.

a) Used needles and syringes should be disposed as one single unit into a Sharps Disposal Container immediately after they have been used.

b) Used needles should not be removed from the syringe, bent or broken by hand manipulation/removal device/port to prevent accidental needle sticks which may cause serious infections.

c) Used needles and syringes should not be left protruding from Sharps Disposal Containers, and Sharps Disposal Containers should not be more than two-thirds full.

d) Sharps Disposal Containers should be located in a safe and secure position such that they cannot be easily tipped over. Sharps Disposal Containers should not be stored on the floor or above shoulder level.

e) There should not be any form of crossing over of hands/clients when disposing used needles and syringes into Sharps Disposal Containers.

f) When Sharps Disposal Containers are not in use, the temporary closure mechanism must be used.

g) If recapping of needles is necessary or required as part of the vaccine preparation workflow, the needle should be recapped with the aid of a pair of forceps, using a cap-holding device, or using a “one-handed scoop" technique to scoop the cap.


8.6  Vaccination Providers should ensure that Sharps Disposal Containers used are properly, securely, and safely stored in a controlled area that is not accessible by any unauthorised personnel. Proper storage and handling of Sharps Disposal Containers before disposal must be adhered to as part of workplace safety management (i.e., Sharps Disposal Containers must not be stacked hazardously.)

8.7  Please refer to the National Infection Prevention and Control Guidelines​ for more information.


Inventory Management​​

8.8  Vaccination Providers should account for the vaccines issued. Proper recording of vaccine inventory and stock movement (e.g. stock balance/usage/received/transferred/wastage/disposed) should be maintained. Vaccination service providers are recommended to adopt the good practice of counting empty/used/damaged vaccine vials before disposal, to ensure that the quantity discarded tallies with that taken out of the fridge.


8.9  Vaccination Providers must have a system to monitor the stock expiry and transfer any excess stock to fellow Vaccination Providers at the first instance, to reduce wastage. If necessary, Vaccination Providers may seek assistance from your operations lead (PHPCs should contact their AIC Account Manager​) at least 2 weeks before expiry for MOH redistribution of the excess stock, subject to availability of vaccination sites that are able to consume before expiry.


8.10  Vaccination Providers are recommended to hold sufficient supply for 5 to 7 days to keep the vaccine fresh, and to manage the supply and re-supply properly to keep wastage to a minimum.

 

Pfizer-BioNTech/Comirnaty XBB.1.5 Monovalent (6 months to 4 years)

8.11  The Pfizer-BioNTech/Comirnaty XBB.1.5 monovalent (6 months to 4 years) vaccine will be thawed by MOH's vaccine distributors and delivered to Vaccination Providers at the temperature range of 2°C and 8°C. The shelf-life of the vaccine is 10 weeks once removed from the freezer at the central warehouse. The expiry date of the vaccine at 2°C and 8°C will be labelled on the vaccine vial.


8.12  Each Pfizer-BioNTech/Comirnaty XBB.1.5 monovalent (6 months to 4 years) vaccine vial is a multi-dose vial sufficient for 10 clients to be vaccinated. Pfizer-BioNTech/Comirnaty XBB.1.5 monovalent (6 months to 4 years) vaccine requires dilution and must be used within 12 (twelve) hours from the time of dilution.


8.13  Vaccination Providers are required to submit vaccine orders via Zuellig Pharma's Online Ordering Portal.
(Note: If the portal is temporarily not available or experiencing issues, vaccination providers may email Zuellig Pharma at SGZPSCSOrdersMailbox@zuelligpharma.com​ their COVID-19 Vaccine order form​ and cc MOH at MOH_SRMD_Supply@moh.gov.sg.)

8.14  Vaccination Providers should note the order cut-off time, and the expected delivery when requesting for top-up of vaccines.

Order Placed on Working Day Vaccine Delivery
Day 1; Before 10am By Day 4; Within 3 working days

Day 1; After 10am

(Processed as Next Working Day; Day 2)

 By Day 5; Within 4 working days

Orders placed on Friday and Eve of Public Holiday (By 10am)

 Next 3 working days
​Note: No order processing on​ weekends and public holidays. ​

 

8.15  Please refer to the detailed work instructions for the requisition of vaccine and medical supplies.

8.16  Medical supplies such as needles and syringes may also be ordered from MOH via ST Logistics, if the medical service provider is unable to obtain the supplies from their usual sources.

 

Low Dead Volume (LDV) Needles & Syringes

8.17  Vaccination sites can order the MICSAFE NIPRO Slip Tip 1cc LDS syringe and NIPRO Hypodermic 25G needle (as a set). Users should attempt to extract 10 doses from the Pfizer-BioNTech/Comirnaty XBB.1.5 monovalent (6 months to 4 years) vial.​


9.1  The broad approach for IT systems is to provide a unified and integrated system to complement the appointed Vaccination Providers with the administrative and clinical functions to handle the operations' requirements.

Health Appointment Booking System (HAS)

9.2  The COVID-19 vaccination appointment booking function had been incorporated into the HAS​ to enable MOPs to schedule their COVID-19 vaccination appointments at the respective vaccination sites. This system will enable notifications and reminder functions to facilitate appointment attendance.

 

Vaccination Operations EMR System

9.3  GP Connect Lite (GPC Lite) has been identified to be the EMR System to manage the Vaccination Providers operations.

Mobile Vaccination Team (MVT) Deployments

9.4  MVTs would be deployed to vaccinate those with special needs (i.e., EIPIC Centres) OR for specific purposes (i.e., Temp VCs). Such setups would not be connected to HAS.

Updating of COVID-19 Vaccination Records in the National Immunisation Registry (NIR)

9.5  Updating of Vaccination Records into NIR will be done via GPC Lite automatically. Vaccination Providers and MVTs are to ensure that all clients' Vaccination Records accumulated within each operational day are entered into GPC Lite by 2200H on the same day.

Manual Updating of Vaccination Records into National Immunisation Registry (NIR)

9.6  There are currently 2 main methods to manually update Vaccination Records into NIR Web Portal. Vaccination Providers performing the updating of Vaccination Records via this route are to login using their Corp Pass account using this internet link​.

9.7  Data Entry Method: Vaccination Providers may choose one of the following relevant modes to perform the data entry function on NIR Web Portal. 'Individual Record Entry (18 Years Old and Above)', 'Individual Record Entry (Below 18 Years Old)' and “Multiple Record Entry".

9.8  Batch (Excel) Upload Method: Vaccination Providers may choose to batch Vaccination Records and pre-populate them into the .xls excel template provided on NIR Web Portal. The completed templates should be uploaded into NIR Web Portal within the daily stipulated timing. Vaccination Providers should not develop the template on their own.

9.9  To perform the operations specified in this section efficiently, Vaccination Providers are advised to apply for an appropriate number of NIR “User" accounts within their respective organisations to assist with the updating requirements.

9.10  The collective instructions for manual updating of Vaccination Records into NIR are prescribed in this document​.

​
10, MOH seeks Vaccination Providers' adherence to the requirements stipulated in this Operations Instruction when carrying out vaccination service for their clients.

11.  Please feel free to email MOH Vaccination Operations Centre (VOC) at COVID_Vaccination_Ops@moh.gov.sg with any queries.​