Date: 21April 2021Document Code: 63-01Version: 01Guidelines and Standard Operating Procedures (SOPs)Sinovac Vaccine (CoronaVac)1
Target Audience All the concerned national, provincial & district health authorities and health care workers who areinvolved in the COVID-19 vaccine operations, establishment, and management of COVID-19Vaccination Counters both at public and private health facilities.Objective of this document To provide guidance on Sinovac COVID-19 Vaccine (CoronaVac) storage, handling,administration and safe disposal along with recommendations for vaccine recipients. Vaccinationshould not be considered as an alternate for wearing a mask, physical distancing and observing otherSOPs for COVID-19 prevention.Vaccine Basic Information CoronaVac manufactured by Sinovac Biotech Ltd. is an inactivated virus COVID-19 vaccine.Active ingredient: Inactivated SARS-CoV-2 Virus (CZ02 strain).Adjuvant: Aluminum hydroxide.Excipients: Disodium hydrogen phosphate dodecahydrate, sodium dihydrogen phosphatemonohydrate, sodium chloride.CoronaVac is a milky-white suspension. Stratified precipitate may form which can be dispersed byshaking.Vaccine Dose Two doses should be administered by intramuscular injection in the deltoid region of the upper arm.The second dose is preferably given 28 days after the first dose.Each vial (syringe) contains 0.5 mL of single dose containing 600S8U of inactivated SARS-CoV-2virus as antigen.Who should receive CoronaVac: Individuals who are above 18 years of age.Who should NOT receive CoronaVac: Individuals who are below 18 years of age. The safety and efficacy of CoronaVac in children andadolescents below 18 have yet to be established.People with history of allergic reaction to CoronaVac or other inactivated vaccine, or anycomponent of CoronaVac (active or inactive ingredients, or any material used in the process).2
Previous severe allergic reactions to the vaccine (e.g. acute anaphylaxis, angioedema, dyspnea, etc.).People with severe neurological conditions (e.g. transverse myelitis, Guillain-Barré syndrome,demyelinating diseases, etc.).Patients with uncontrolled severe chronic diseases.Special Warnings and Special Precautions: Patients with acute diseases, acute exacerbation of chronic diseases, severe chronic diseases, atopyand fever may delay or defer vaccination after doctor's evaluation.Caution may be observed in patients with uncontrolled diabetes, or history of convulsions, epilepsy,encephalopathy or mental illness.In patients with thrombocytopenia or hemorrhagic diseases, intramuscular injection of this productmay cause local bleeding.There is a limited experience with the use of CoronaVac in pregnant women. Administration inpregnancy should only be considered when the potential benefits outweigh any potential risks forthe mother and fetus.It is unknown whether CoronaVac is excreted in human milk. However, adverse events are unlikely.Shelf life The expiry date of vaccine is indicated on the label and packagingThe shelf life is 12 monthsVaccine Storage: Store in a refrigerator ( 2 C to 8 C).Do not freeze. Protect from light.The outside refrigerator (room) temperature should not be more than ( 25 C).Pre-Vaccination Phase Designated Nurse/Skilled Immunization Staff/Vaccinator/ Doctor should administer the vaccineThe CVC staff should have prior training on vaccine handling, cold chain, Infection PreventionProtocols, Reporting Tools / MIS and Adverse Events Following ImmunizationVaccination PhaseAdministration Precautions3
o CoronaVac for intramuscular (IM) injection only, in the deltoid muscle.o The vaccine should be inspected visually prior to administration and discarded if particulate matteror differences in the described appearance are observed.o Contraindications, warnings and precautions to injection must be checked prior to administering thestudy injection.o This vaccine is strictly prohibited by intravascular injection. There are no data yet on the safety andefficacy of this vaccine by subcutaneous or intra-dermal injection.o Before use, check whether the packaging container, label, appearance, and expiration date meet therequirements. It should not be used under following circumstances: damage or crack, spots, stains,scratches on the outer surface of the vaccine container, unclear label, expired vaccine, or abnormalappearance.o Adequate treatment provisions, including epinephrine injection and emergency treatment, should beavailable for immediate use. Individuals should be observed for at least 30 minutes on site aftervaccination.o Avoid exposing CoronaVac to the disinfectant during use.o Do not freeze. It should be administered immediately after opening the vial.o Avoid contact with vaccine fluid when opening.o The vaccine does not contain any preservativeo To facilitate the traceability of the vaccine, the name and the batch number of the administeredproduct must be recorded for each recipientStepsoooooooooooooWear mask and observe COVID-19 SOPsGreet the clientComplete verification process in the National Immunization Management System (NIMS)Take consent. Since vaccine may be administered to both walk-in and previously registered patients,consent should be worded accordingly, e.g “I agree to receive this COVID-19 vaccine because Ihave registered myself in the system” or “ I agree to receive this COVID-19 vaccine to avail walkin vaccination facility”. (Annex)Expose site (deltoid of non-dominant arm) for administrationExplain the procedure and inform that some pain on giving injection, discomfort at the site ofinjection or fever after the injection, may happenTake vaccine vial out of the vaccine carrierOpen the vial by removing plastic cover/capTake out 22G-25G 0.5ml syringe and remove needle capDiscard the needle and syringe in safety boxInsert the syringe needle through the top rubber pad of vaccine vialDraw 0.5ml of diluted vaccine from the vialInject intra muscularly at the site of injection at an angle of 90⁰ (right angle) following “No-touchtechnique”4
During vaccination, do NOTo Touch the rubber pad of vaccine vial (causes contamination and result in AEFI)o Recap needle of syringes (can cause needle stick injuries)Post Vaccination PhaseVaccine Related Wastage and Disposal Guideline Syringes, needles, and empty vaccine vials should be placed in an FDA-approved sharps container.Such containers are made from rigid, puncture-proof plastic and prevent injury and spread ofinfectious waste.Never discard needles or other sharp objects in the trash or loose into the bio-hazardous wastebox/container.Remaining doses of vaccine is not hazardous and does not contain any viral material. Leftover dosesof vaccine, may be disposed off in accordance with state regulation requirements for non-hazardouspharmaceuticals.After administration of vaccine, remove gloves and perform hand hygiene. Gloves may be discardedin a regular bin if they are not overtly contaminated. If there is bleeding, contaminated gloves shouldbe discarded in biohazardous waste bin.General Measures Post Vaccination Complete entry in the NIMSSend the client for observation area for 30 minutesAfter 30 minutes if no acute adverse events are experienced by the client, explain the next steps onfollow up visit for second dose and to report to health facility/1166 helpline if any adverse event isexperiencedAdverse Events Following Immunization (AEFI)According to the grading standard of adverse reaction incidence from Council for InternationalOrganizations of Medical Sciences (CIOMS), i.e. very common (10%), common (1%-10%), uncommon(0.1%-1%), rare (0.01%-0.11%) and very rare ( 0.01%). All adverse reactions are summarized anddescribed as follows:5
Local adverse reaction at injection siteo Very common: pain.o Common: swelling, pruritus, erythema, induration.o Uncommon: burn at injection site.Systemic adverse reactionsVery common: headache, fatigueo Common: myalgia, nausea, diarrhea, arthralgia, cough, chills, pruritus, loss of appetite, rhinorrhea,sore throat, nasal congestion, abdominal paino Uncommon: vomiting, hypersensitivity, fever, tremor, flushing, edema, dizziness, drowsinesso Rare: muscle spasms, eyelid edema, nose bleeds/epistaxis, abdominal distension, constipation,hyposmia, hot flashes, hiccup, conjunctival congestionoSeverity of adverse reactionso The severity of adverse reactions observed in these clinical trials is mainly Grade 1 (mild), theincidence rate of adverse reactions for Grade 3 and the above was 1.31%.o Grade 3 and above adverse reactions include pain at injection site, cough, fever, headache, sorethroat, abdominal pain, dizziness and drowsiness.oSerious adverse event (SAE)o No serious adverse event related to vaccination was identifiedVaccination should not be considered an alternate for:Wearing a maskPhysical distancingObserving other SOPs for COVID-19 preventionFor more information, please contact:Expanded Program on Immunization, PM National Health Complex, a.edu.pk/ rg.pk/ https://www.youtube.com/NHSRC-PK6
The second dose is preferably given 28 days after the first dose. Each vial (syringe) contains 0.5 mL of single dose containing 600S8U of inactivated SARS-CoV-2 virus as antigen. Who should receive CoronaVac: Individuals who are above 18 years of age. Who should NOT receive CoronaVac: Individuals who are below 18 years of age. The safety and efficacy of CoronaVac in children .