Vaccination Guidelines for Sinopharm Vaccine

By Federal EPI
 Basic information about Sinopharm Vaccine (Vero Cell)
Developed by: Sinopharm and BBIPS

Name: SARS-CoV-2 Vaccine (Vero Cell), inactivated

Composition: The Vaccine (Vero Cell), inactivated,

formulated with SARS-CoV-2 strain which is inoculated
on the Vero cells for culturing, virus harvesting, 8-
propiciactone-inactivation, concentration and purification,
then adsorbed with aluminium adjuvant to form the liquid
vaccine

Appearance: Semi-transparent turbid suspended with

slight white colour

The vaccine is used for people aged 18 years old and

above
Source: Vaccination Guide for Pakistan - Sinopharm Vaccine (Vero Cell) 2
Agenda for training

Target Population and Vaccination Stages

Vaccine cold chain and storage

Administration of vaccine, injection safety and

waste disposal
COVID-19 vaccine safety, warnings and
contraindications

Potential AEFI management and reporting

Post vaccination counselling, evaluation and

handling of emergencies

3
 Target population and phases

Stage 1a:
- Frontline essential health care workers

Stage 1b:
- Remaining Health care workers
- Population over 60 - 64yrs

Stage 2:
- A defined proportion of remainder population (18
and above)

Note: As per the Cabinet’s decision

Agenda for training

Vaccination strategy

Vaccine cold chain and storage

Administration of vaccine, injection safety and

waste disposal
COVID-19 vaccine safety, warnings and
contraindications

Potential AEFI management and reporting

Post vaccination counselling, evaluation and

handling of emergencies

5
 Vaccine storage

Storage and transportation in refrigerated (2-8 ͦ C) condition,

1 protected from light

2 Do not freeze the vaccine in any circumstance

3 Protect the vaccine from sun-light

4 Expiry is approximately 2 years

Source: Vaccination Guide for Pakistan - Sinopharm Vaccine (Vero Cell) 6

Agenda for training

Vaccination strategy

Vaccine cold chain and storage

Administration of vaccine, injection safety and

waste disposal
COVID-19 vaccine safety, warnings and
contraindications

Potential AEFI management and reporting

Post vaccination counselling, evaluation and

handling of emergencies

7
Inter-personal Communication (Provider to recipient)

You are receiving this vaccine as you agreed by registering in

Consent
the system

This will be an injection into the upper part of your arm and will
The procedure cause the usual slight pain. Do let us know if you experience
something unusual.

SOP following After the injection, you are requested to stay here for
the injection observation of any problems, for a period of 30 minutes

Do you have any question, or shall we go ahead with the

Confirmation
injection?

This is your first dose. Please revisit AVC for your second dose
Retention
after 3 weeks.

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 Vaccine administration and needle selection

Administration:
The recommended administration is through
intramuscular route.

The deltoid muscle of the non-dominant side is

the preferred site of injection.

Needle selection:
The injection is placed at an angle of 90
degree using a 25-gauge needle (22-25
may be used). The length of the needle is
(5⁄8 – 1 1⁄2 inch).

Source: Vaccination Guide for Pakistan - Sinopharm Vaccine (Vero Cell) 9

 Vaccine dosage

Dosage:

A pre-filled syringe containing 0.5mL of product will be used for

administration. Each dose contains 6.5U of inactivated SARS-CoV-2
antigen.

Individuals should receive 2 doses (0.5 mL each), 21 days apart (2~4

weeks).

Day 0: Day 21:

1st dose 2nd dose
0.5ml 0.5ml

Source: Vaccination Guide for Pakistan - Sinopharm Vaccine (Vero Cell) 10

Agenda for training

Vaccination strategy

Vaccine cold chain and storage

Administration of vaccine, injection safety and

waste disposal
COVID-19 vaccine safety, warnings and
contraindications

Potential AEFI management and reporting

Post vaccination counselling, evaluation and

handling of emergencies

11
 Vaccine safety

Safety in
different Safe and well tolerated from 18 years and above
age groups

Most
Most common AEFI are pain at injection site and fever
common
(mild/low grade)
AEFI

Vaccine
immuno- Tolerable and immunogenic in healthy people.
genicity

Source: Vaccination Guide for Pakistan - Sinopharm Vaccine (Vero Cell) 12

 Special Warnings
1. Intravascular (IV) injection is strictly prohibited
2. The patient should be under observation for at least 30
minutes after vaccination.
3. Health care workers who are under quarantine for recent
exposure with COVID-19 case should not be allowed to
vaccinate
4. Co-administration of Sinopharm vaccine with other
vaccines should be avoided
5. Do not put the vaccine in contact with disinfectant or
injection (when the protective cap is pulled off)
6. This vaccine should be used immediately after opening
7. Do not use the vaccine if foreign objects, unclear label,
out of expiry and cracks in the syringe are seen

Source: Vaccination Guide for Pakistan - Sinopharm Vaccine (Vero Cell) 13

 Groups to which vaccine should not be administered

Cancer patients, Immunodeficient Children <18 Individuals who have

those who had organ Patients, individuals years received any vaccine
transplant in past 1 with anaphylaxis in the past 14 days
year history

Patients who received Lactating mother Individuals who are

Pregnant mother
SARS-CoV-2 allergic to any
monoclonal component (active,
antibodies excipients) of this
/convalescent plasma vaccine

Source: Vaccination Guide for Pakistan - Sinopharm Vaccine (Vero Cell) 14

Agenda for training

Vaccination strategy

Vaccine cold chain and storage

Administration of vaccine, injection safety and

waste disposal
COVID-19 vaccine safety, warnings and
contraindications

Potential AEFI management and reporting

Post vaccination counselling, evaluation and

handling of emergencies

15
 Occurrence of adverse event following immunization (AEFI)

Very
• pain at the injection site
common
• transient fever,
• fatigue,
• headache,
• diarrhoea, If there are any
Common
• redness,
adverse events not
• swelling,
• itching, mentioned here,
• hardening at the injection site
please inform your
• skin rash at the injection site,
• nausea and vomiting, physician in time.
• itching at the non-injection site,
Uncommon • muscle pain,
• arthralgia,
• drowsiness,
• dizziness, etc.

Note: No vaccine-related serious adverse reaction was observed

Source: Vaccination Guide for Pakistan - Sinopharm Vaccine (Vero Cell) 16
 Adverse event following immunization (AEFI) reporting
National Immunization Management System (NIMS) has a section to
indicate any AEFI immediately

After vaccine administration a feedback SMS after 48-72 hours will be

auto-generated through NIMS, citizen can reply to register for any
adverse event.

• First SMS will be fired to ask whether the citizen has any adverse event
or not (response will be either Yes or No)

• If Yes; a second SMS will contain possible side effect with an IVR
Code. Citizens can register for the adverse event through an IVR
selection

• The citizen can also report any untoward effect through the web-portal
of NIMS or by calling to 1166 helpline.

• The callers and doctors in the helpline have been trained to deal such
emergency
Source: Vaccination Guide for Pakistan - Sinopharm Vaccine (Vero Cell) 17
 Role of AEFI focal persons in hospitals with Adult
Vaccination Counters (AVCs)

AEFI focal person should be notified in AVCs for emergency

management of AEFI cases

Requirements for the AEFI focal person:

1. A senior physician should be appointed as the AEFI focal person

2. The AEFI focal person must be oriented on AEFI management, include the
following:
• Serious AEFIs
• Immunization errors
• Clusters of AEFI (≥2 same AEFIs related in time, place & vaccine)
• Concern of parents/caregivers and community regarding any minor or
major AEFIs

3. Contact details of every AEFI focal person must be available with every
Adult Vaccination Team (AVT)

Source: Vaccination Guide for Pakistan - Sinopharm Vaccine (Vero Cell) 18

 Management of AEFI in hospitals with AVCs
1. Early detection 2. Reporting
• Each and every AEFI
to be reported in the
AEFI reporting form
and AEFI case
• AEFI focal investigation form by
persons/doctors the AEFI focal person
should be oriented • Any serious AEFI
on AEFI must be immediately
management notified to the
Provincial AEFI focal
• Each and every person
serious AEFI case • Death related to
should be thoroughly vaccination should be
investigated reported immediately
following the national • Data needs to be
AEFI guidelines entered in the EPI-
MIS for further
investigation by the
National AEFI review
committee
Source: Vaccination Guide for Pakistan - Sinopharm Vaccine (Vero Cell)
3. Clinical 4. Reassurance of
management the target
(if required) population
• Avoid possible
• The AVC must be
rumours and
prepared and well-
misinformation
equipped to manage
• Only the designated
any emergency case:
AEFI focal person or a
 a qualified medical
designated
doctor
spokesperson should
 adequate stock of
respond to the media
life saving medical
and address rumours
supplies (with
through social media
readable date of
• Crisis
expiry)
communication /risk
 functional oxygen
communication
cylinder
strategy developed by
• Ambulance
Federal EPI must be
arrangements must be
adapted by DoH/
in place and contact no.
Provincial EPI prior to
of the ambulance driver
vaccine administration
must be posted in the
• Post-vaccination
health facility and
counselling is essential
shared with the AEFI
to provide accurate
focal persons and team
information
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Agenda for training

Vaccination strategy

Vaccine cold chain and storage

Administration of vaccine, injection safety and

waste disposal
COVID-19 vaccine safety, warnings and
contraindications

Potential AEFI management and reporting

Post vaccination counselling, evaluation and

handling of emergencies

20
 Post-vaccination counselling

HCWs should encourage the target population to complete 2-doses

1 for maximum vaccine efficacy and benefit

Vaccinated individuals should be encouraged to report any adverse

2 events following immunization

After vaccination, individuals should be advised to remain in waiting

3 area of adult vaccination counter for at least 30 min to avoid any AEFI

Antipyretic or analgesic medication may be taken in case of

4 fever/pain after vaccination

Source: Vaccination Guide for Pakistan - Sinopharm Vaccine (Vero Cell) 21

 Handling of post-vaccination emergencies (anaphylaxis)

Patients should be managed as soon as possible and in an intensive

care setting
1. Assess adequacy of ventilation and provide the patient with
sufficient oxygen to maintain adequate oxygen saturation of at
least 92% (pulse oximetry)
2. Equipment for endo-tracheal intubation should be available
for immediate use in event of respiratory failure and is indicated
for poor mentation, respiratory failure, or stridor not responding
immediately to supplemental oxygen and epinephrine
3. Administer an isotonic solution such as normal saline
4. Patient should be kept under close observation for at least 6-8
hours after initial reaction

Source: Vaccination Guide for Pakistan - Sinopharm Vaccine (Vero Cell) 22

 Vaccination should not be considered an
alternate for:

1 Wearing a mask

2 Physical distancing

3 Observing other SOPs for COVID-19 prevention

Source: Vaccination Guide for Pakistan - Sinopharm Vaccine (Vero Cell) 23

Thank You

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