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July 2021 • Version 1.0 International COVID-19 Vaccine Handling Guide COVID-19 Vaccine Information continues to evolve. Please scan the QR code to visit the website for the latest information.
International COVID-19 Vaccine Handling Guide
Background
Regulators around the world have authorized the use
of several COVID-19 vaccines to help mitigate the
devastating impact of the COVID-19 pandemic on
global communities and economies. As vaccination
campaigns are underway in many countries,
concerns have emerged with potential COVID-19
vaccine wastage at each stage of the supply chain.1
In February 2021, USP convened a group of experts
to develop and publish the USP COVID-19 Vaccine
Handling Toolkit, which includes general strategies,
as well as COVID-19 vaccine product-specific
information for vaccines available in the United
States to help address operational efficiency gaps
across U.S. states and territories.2 USP’s COVID-19
Vaccine Handling Toolkit and related guides (e.g.,
factsheets, videos, etc.) were designed to help
accelerate the pace of vaccination, expand the
available supply of vaccines by preventing waste,
and build healthcare practitioner confidence as
COVID-19 vaccine providers.
Disclaimer: This document is for informational
purposes only and is intended to address operational
considerations for COVID-19 vaccine preparation
during the COVID-19 pandemic. Where a particular
COVID-19 vaccine is mentioned, this identification is
furnished solely for informational purposes as a matter
of convenience, without implication of approval,
authorization, endorsement, or certification. This
document does not reflect the USP Healthcare Safety
and Quality Expert Committee’s opinions on future
revisions to official text of the USP–NF. Parties relying
on the information in this document bear independent
responsibility for awareness of, and compliance with,
any applicable laws and regulations of the applicable
regulatory jurisdiction and regulatory status of any
COVID-19 treatment. All product names, logos, and
brands are property of their respective owners.
2
International COVID-19 Vaccine Handling Guide
International COVID-19 Vaccine Handling Guide Development
This International COVID-19 Vaccine Handling Guide has vaccine trade name listed in Table 1: COVID-19 Vaccines
been developed based on the core concepts described in Described in the International COVID-19 Vaccine Handling
the USP COVID-19 Vaccine Handling Toolkit and provides Guide. Since the Janssen and Moderna COVID-19 vaccines
information related to several available COVID-19 vaccines do not yet have a vaccine trade name, these vaccines will be
currently used internationally. The selection of the vaccines referred to as the Janssen COVID-19 vaccine and Moderna
in this international guide is based on those which have COVID-19 vaccine, respectively.
received regulatory authorization, have been distributed and COVID-19 vaccine information varies worldwide. Resources
utilized in multiple countries, and based on the availability used to compile this information include publicly available
of published resources on the vaccines. The focus of this information from the vaccine manufacturers, the WHO, and
guide is on vaccines that have been granted Emergency other regulatory bodies.
Use Listing (EUL) by the World Health Organization (WHO)
The USP Healthcare Safety and Quality Expert Committee
for worldwide distribution through COVAX, and COVID-19
(HSQ EC), with experts from the Package and Distribution (PD
vaccines available in Brazil and India, where USP has offices
EC), Nomenclature and Labeling (NL EC), Health Information
and where COVID-19 variants bring a sense of urgency. This
and Technology (HIT EC), Complex Biologics and Vaccines
international guide is not intended to be an exhaustive guide
(BIO3 EC), and Compounding (CMP EC) Expert Committees
of all the COVID-19 vaccines that are utilized internationally.
developed this International COVID-19 Vaccine Handling
USP is actively monitoring the evolving situation and will Guide based on stakeholder input, and in anticipation of
continue to update this international guide as more vaccines challenges that may arise during the preparation of several
become authorized and additional information becomes available COVID-19 vaccines. See Appendix I: Independent
available. The inclusion of a COVID-19 vaccine in this guide Expert Volunteers and Other Contributors to the International
does not imply approval, authorization, endorsement, or COVID-19 Vaccine Handling Guide.
certification by USP or the Expert Committee.
Considering the public health emergency posed by
During the COVID-19 pandemic, manufacturers are COVID-19, this document was developed without a public
partnering with other manufacturers to ensure supply of comment period. This document is not a USP compendial
vaccines. For example, the COVID-19 vaccine developed by standard; rather, it reflects considerations developed by
AstraZeneca and University of Oxford [Vaxzevria] has the the USP HSQ EC and other EC members, based on their
same formulation as the COVID-19 vaccine manufactured scientific and professional expertise, as well as input
by the Serum Institute of India [Covishield]. For consistency from stakeholders.
in this document, the vaccine will be referred to by the
Table1: COVID-19 Vaccines Described in the International COVID-19 Vaccine Handling Guide
Manufacturer Vaccine Trade Name Alternative Name
AstraZeneca and University of Oxford Vaxzevria AZD1222
Beijing Bio-Institute of Biological Products (BBIBP) Sinopharm BBIBP-CorV
Bharat-Biotech and Indian Council of Medical Research Covaxin BBV152
Gamelaya Institute Sputnik V Gam-COVID-Vac
Janssen Biotech (Johnson & Johnson) Ad26.COV2.S
Moderna mRNA-1273
Pfizer-BioNTech Comirnaty BNT162b2
Serum Institute of India Covishield
Sinovac CoronaVac
Modified and adapted from https://covid19.trackvaccines.org/vaccines/
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International COVID-19 Vaccine Handling Guide
1 Preparation
Operational Considerations for COVID-19 Vaccine Preparation
Background • Items that are not necessary for vaccine preparation
should be removed from the vaccine preparation area
Preparing a conventionally manufactured COVID-19 vaccine (e.g., food, drinks, and other materials).
should be performed in accordance with the directions in the
• Whenever possible, there should be a sink, water, and
manufacturer’s authorized labeling, the laws and regulations
soap for hand hygiene in the proximity of the area for
of the applicable regulatory jurisdiction and the WHO. This
vaccine preparation. If not possible, alcohol-based
section focuses on considerations for the preparation of
hand sanitizer (see USP Hand Sanitizer Toolkit3, WHO
COVID-19 vaccines for administration and can be used to
guidance4) should be available. For alcohol-based hand
supplement a manufacturer’s authorized labeling, but not
sanitizers, the Centers for Disease Control & Prevention
replace them. In addition, this information should not replace
(CDC) recommends a concentration of 60% to 95%
a facility’s existing policies and procedures.
ethanol or isopropanol (i.e., isopropyl)5 alcohol.6
• Equipment available in the dedicated area or room may
Environmental Considerations include sharps containers, alcohol swabs, sink and/or hand
for Vaccine Preparation sanitizer, and materials for personnel hygiene and garbing.
• When manufacturer labeling permits, COVID-19 vaccines
Achieving and maintaining sterility and
can be prepared in ambient air without using a Primary
overall freedom from contamination of the vaccines is
Engineering Control (PEC) device (e.g., prepared outside
dependent on the environmental conditions under which
of an International Organization for Standardization (ISO)
the preparation process is performed. The following
Class 5 air environment).
considerations should be made when selecting an
environment for preparation of vaccines: • A PEC is defined as a device or zone that provides an
ISO Class 5 air environment which minimizes the risk of
• A dedicated area or room should be utilized for vaccine
microbial contamination.
preparation.
• ISO Class 5 describes the concentration of total
• The dedicated area or room should be a clean,
particulates per unit volume in the air.7 (See USP
uncluttered, functionally separate workspace.
General Chapter Microbiological control and
• Whenever possible, the dedicated area or room monitoring of aseptic processing environments).
should be away from windows, doors, air vents, etc., to
• Understanding that the vaccine preparation will take
minimize airflow disruptions.
place across a variety of practice settings, it is important
• Whenever possible, the area dedicated for vaccine to adhere to aseptic technique to ensure the quality and
preparation should not be in an area or close to an safety of the preparation of these vaccine products.
area where environmental control challenges could
• Clean and disinfect the surface where the vaccine
negatively affect the air quality (e.g., restrooms,
preparation will take place using a solution of at least
warehouses, or food preparation areas).
70% isopropyl alcohol or utilize clean preparation mats
per your facility’s policy and procedures.
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International COVID-19 Vaccine Handling Guide
Personnel Hygiene and Garbing • Inspect vials for cracks or leaks prior to proceeding further.
• Disinfect entry points on the diluent and vaccine vials (e.g.,
Healthcare workers who supervise the preparation
vial stoppers) by wiping the vials with single-use alcohol
of the vaccines should ensure that personnel are
swabs. Allow the alcohol to dry before piercing stoppers
adequately skilled, educated, and trained to correctly
with sterile needles.
perform preparation of COVID-19 vaccines. Before beginning
preparation of COVID-19 vaccines, personnel should consider • During preparation of the vaccine, personnel should avoid
the following aspects of hygiene and garbing: touching critical parts of the components being used for
preparation of the vaccines (e.g., needles, disinfected vial
• Personnel should remove hand, wrist, and other exposed stoppers) to minimize microbial contamination.
jewelry that could interfere with the effectiveness of
• Place all used syringes, needles, vials into puncture-proof
garbing or otherwise increase the risk of contamination of
containers (e.g., sharps container) and dispose of the
the vaccines.
containers according to regulatory requirements.
• Fingernails should be clean and neatly trimmed to minimize
• The disposal of COVID-19 vaccine vials should be
particle shedding and avoid glove punctures.
secured in a way that mitigates potential tampering.
• Personnel should perform hand hygiene by washing hands
with soap and water for at least 30 seconds or use hand
sanitizer rubbed between hands and fingers and then Withdrawing Doses
allowed to dry.
• Personnel should don powder-free gloves before preparing Manufacturer-supplied information on the steps for
vaccines for administration. Powder-free gloves should be preparation of the available COVID-19 vaccines is
inspected regularly for holes, punctures, or tears and must provided on the manufacturer’s COVID-19 resource webpages
be replaced immediately if such defects are detected. per country. For specific COVID-19 vaccine considerations,
see Appendix II: Considerations for Handling Specific
• Personnel should don and replace garb (e.g., masks,
COVID-19 Vaccine Products. Additional considerations,
freshly laundered lab coat, powder-free gloves, clean
applicable to all vaccines, on how to help ensure complete
scrubs) immediately if it becomes visibly soiled or if its
doses are withdrawn and safe practices include the following:
integrity is compromised.
• If applicable, ensure needle and syringe are tightly luer-
locked together.
Basic Aseptic Considerations • Consider using the smallest syringe appropriate for the
for Vaccine Preparation dose to improve dose accuracy. For example, a 0.3 mL or
0.5 mL dose should be drawn up using a 1 mL syringe or 3
Aseptic technique is a set of processes used to mL syringe, respectively, based on syringe availability.
keep objects and areas free of microorganisms and thereby
• The same needle should be used for withdrawal and
minimize infection risk to patients. Aseptic technique should
administration. This eliminates the need to change needles
be utilized to prepare vaccines for administration to prevent
and therefore reduces the risk of touch contamination to
the vaccines from being contaminated with microorganisms
the vaccine and potential loss of volume. More information
from the environment or from the persons preparing them.
is provided in the FAQ for Optimizing COVID-19 Vaccine
Manufacturer-supplied information on the steps for thawing,
Preparation and Safety accessible on page 14.8
storage temperatures, and preparation of the available
COVID-19 vaccines is provided on the manufacturer’s • Use the appropriate needle gauge and length for the
COVID-19 resource webpages per country. Aseptic technique recipient.
considerations for vaccine preparation should include • For example, see the U.S. Centers for Disease Control
the following: and Prevention (CDC) Vaccine Administration: Needle
Gauge and Length Guide which bases the selection
• Follow facility and regulatory requirements related
of needle gauge and length on patient age, gender,
to competency, training, or certification of vaccine
and weight.9
preparation and administration, as appropriate.
• Exercise care to avoid contaminating or bending the
• Combining vaccine in one syringe from more than one
needle if it is being used for both withdrawal and
vial to obtain a complete dose is not supported, due to
administration.
microbial contamination risks and the frequent absence of
preservatives.
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International COVID-19 Vaccine Handling Guide
• Refrain from using transfer devices (e.g., mini spikes,
Beyond-Use Dating
dispensing pins) or using one needle to prepare multiple
syringes, due to potential loss of vaccine in dead space, or Considerations for
damage to the stopper and loss of integrity of the vial. Pre-drawn Syringes
• Use a new needle, preferably a smaller needle (e.g., 25
gauge), for each vial puncture to preserve vial septum Opened Vials
integrity. Once a vial is punctured, it is considered an opened vial.
• Utilize safe practices when recapping the needle after Beyond-use dates and available information for healthcare
withdrawing and before administration. practitioners for opened vaccine vials vary across regions.
• While small air bubbles can be ignored, large air bubbles See Appendix III: Temperature and Maximum Allowable
can lead to underdosing and should be addressed (see Storage Times for Unopened and Opened COVID-19 Vaccine
example image of small versus large bubble in Figure 1 of Vials based on information from WHO, Brazil, and India.
the FAQ for Optimizing COVID-19 Vaccine Preparation and Open vial policies set by applicable health authorities
Safety accessible on page 14.)8 should be followed. For example, in India, open vial policies
• If diluent is required, slowly inject the diluent, aiming factor the presence of a vaccine vial monitor (VVM) for the
towards the wall of the vial to prevent excess foaming determination of beyond-use dates, and if a VVM is not used,
or bubbling. opened vials need to be discarded four hours after opening.11
VVMs are chemical-indicator labels that adhere to vaccine
• Minimize tapping or flicking of the syringe due to the
vials or ampules. They show the cumulative heat exposure
theoretical risk of inactivating the vaccine or degrading
an individual container of vaccine has received through a
its quality.
gradual and irreversible color change.12
• Slowly withdraw the vaccine to prevent excess foaming
or bubbling. Pre-drawn Syringes
• Rotate the insertion point of the needle across various Pre-drawing syringes is when a practice setting prepares
locations of the vial septum for each withdrawal to reduce and pre-draws the vaccine into syringes in one area and
leakage of vaccine. transports them to another area for administration. If
pre-drawn syringes are used, one must comply with laws
• Independent double check is preferred when resources are
and regulations of the applicable regulatory jurisdiction.
available. This is best practice to incorporate a process for
WHO guidance and several health authorities, including
checking that the correct dose and vaccine is prepared,
those of India and Brazil, do not recommend pre-drawing
particularly in a multi-vaccine environment (i.e., sites where
syringes.11,13,14 Physical stability, chemical stability, and
more than one vaccine type is administered). According to
microbial contamination studies are critical to support this
the Institute for Safe Medication Practices (ISMP), further
practice and some manufacturers have conducted them.
mix-ups have been reported between COVID-19 vaccines
Manufacturer-released supporting studies for beyond-
and COVID-19 specific monoclonal antibodies, which
use dates for Comirnaty, Janssen, and Moderna COVID-19
further highlights the importance of checking the correct
vaccines are provided in Appendix IV: Beyond-Use Dating for
dose and medicine.10
Pre-Drawn Syringes.
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International COVID-19 Vaccine Handling Guide
Labeling Considerations References
1. https://theconversation.com/covid-vaccine-some-waste-is-
If vaccines are pre-drawn and not administered normal-but-heres-how-it-is-being-kept-to-a-minimum-152772
immediately, the best practice is to adhere a 2. https://www.usp.org/covid-19/vaccine-handling-toolkit
label to the syringe or container(s) (e.g., a light protected,
3. https://www.usp.org/covid-19/hand-sanitizer-information
self-sealing bag in which the syringes are stored and
4. https://www.who.int/gpsc/5may/Guide_to_Local_Production.pdf
transported). Syringes prepared for administration must be
labeled with legible identifying information to prevent errors 5. https://www.cdc.gov/niosh/npg/npgd0359.html
during storage, dispensing, transport, and use. 6. https://www.cdc.gov/coronavirus/2019-ncov/hcp/hand-hygiene.
html
Personnel should consider adding the following labeling
7. https://www.iso.org/standard/53394.html
components to the containers in which the vaccine syringes
8. https://www.ashp.org/-/media/assets/pharmacy-practice/
are stored, as well as the vaccine syringe(s).
resource-centers/Coronavirus/docs/FAQ-optimizing-covid-
vaccine-prep-safety.ashx
Container labeling components:
9. https://www.cdc.gov/vaccines/hcp/admin/downloads/vaccine-
• Facility name and phone number administration-needle-length.pdf
• Quantity of syringes 10. https://www.ismp.org/resources/learning-errors-new-covid-19-
vaccines
• Name and amount of vaccine
11. https://www.mohfw.gov.in/pdf/COVID19VaccineOG111Chapter16.
• The exact beyond-use date and time pdf
• Lot number 12. https://www.who.int/immunization_standards/vaccine_quality/
• Initials of preparer(s) What%20is%20VVM%20and%20how%20does%20it%20work.pdf
13. https://www.who.int/publications/m/item/why-are-there-extra-
Example of syringe storage container labels doses-of-vaccine-in-the-vaccine-vial
14. http://bvsms.saude.gov.br/bvs/publicacoes/manual_
COVID-19 Vaccine product name procedimentos_vacinacao.pdf
Facility name and phone number
Quantity and syringes
Date & Time to discard (X hours after vial is opened)
Lot number
Initials of preparer(s)
Syringe labeling components:
• Name and amount of vaccine
• Route of administration
• The exact beyond-use date and time
• Lot number
• Initials of preparer(s)
Examples of pre-drawn syringe labels
COVID-19 Vaccine product name
Route of administration
Date & Time to discard (X hours after vial is opened)
Lot number
Initials of preparer(s)
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International COVID-19 Vaccine Handling Guide
Storage and
2 Transportation
Operational Considerations for Storing, Handling and
Transporting COVID-19 Vaccines
Background storage and handling SOPs (including those that address
Proper storage, handling, and transportation of COVID-19 inclement weather, natural disasters, and traffic disruptions).
vaccines are critical activities in their integrated supply Sample SOPs, for example purposes only, are available
chain. Failure to store and handle vaccines properly can online.1,2 The QMS, along with related SOPs, helps ensure
potentially reduce their potency, leading to inadequate proper procedures are followed and problems (e.g.,
immune response in patients and poor protection against damaged packages or vials) are identified, reported, and
COVID-19. Proper storage, handling, and transportation of corrected. SOPs should also provide direction for handling
the COVID-19 vaccines begins with an effective cold chain emergencies, such as equipment malfunctions or power
process, which is temperature-controlled, using related failures. All staff members who come in contact with the
equipment and procedures. It begins with cold storage at vaccines, or who administer the vaccines, should be trained
the manufacturing facility and extends to the proper on all relevant practices and procedures. The objective of the
receiving, storage, and handling of the vaccine at the training should be to reduce the gap between existing staff
provider facility, and in some situations, transportation off- competencies and those required to perform the job (see
site or to satellite facilities. USP General Chapter Risks and Mitigation Strategies
for the Storage and Transportation of Finished Drug Products).
Manufacturer-supplied information for storing and handling
COVID-19 vaccines is provided on the manufacturer’s
COVID-19 resource webpages per country. This document
focuses on considerations for storing, handling, and
Receiving Vaccine
transporting vaccines and can be used to supplement, but not When vaccines arrive at the facility, they should be
replace a manufacturer’s labeling. In addition, this document transferred as quickly as possible to a designated
should not replace a facility’s existing policies and procedures. storage area and stored at the recommended
temperature. Receiving areas should protect the product
from inclement weather during unloading. Access to the
Quality Management System receiving area should also be limited to authorized persons
(QMS) only. Deliveries should be examined at receipt to check that
shipping containers are not damaged, and that the shipment
Developing and maintaining clearly written, corresponds to the order. Check the temperature monitoring
detailed, and up-to-date receiving, storage, handling, and device, if applicable, for any indication of temperature
transporting standard operating procedures (SOPs) are excursion(s) during transit. Each organization should have a
essential. This occurs within the framework of a robust receiving procedure that determines the appropriate checks
QMS, which is a set of policies, processes, and procedures for this operation. A checklist can be used as a reminder of
required to execute core activities. Due to the risk associated what to inspect and what to record (see USP General Chapter
with vaccine transport caused by improper packing or Risks and Mitigation Strategies for the Storage and
storage unit failure, it is necessary to include detailed Transportation of Finished Drug Products).
packing and transport protocols in the organization’s
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International COVID-19 Vaccine Handling Guide
Vaccine Storage If your facility provides frozen vaccine, a separate freezer
unit is necessary.”3 Under no circumstance should a vaccine
Storage units are required to maintain the
be stored in a small combination refrigerator with a freezer
product temperature between the limits defined
located within the refrigerator compartment. Food and drinks
on the product label (see USP General Chapter
and/or biological specimens should not be stored in the
Packaging and Storage Requirements). Detailed information
same unit as the vaccine.
on vaccine storage and temperature monitoring equipment
is included in section 3 of the CDC Vaccine and Storage Standard operating procedures (SOPs) should be in place
Handling Toolkit.3 Manufacturer-supplied information for to ensure power supply or alternative options when power
storing the authorized COVID-19 vaccines is provided on the outage occurs. Routine maintenance should be conducted to
manufacturer’s COVID-19 resource webpages per country. ensure proper function of the refrigeration unit. Depending
on the time of year (e.g., summer, winter), thermostats may
The WHO recommends use of temperature monitoring
need to be reset, depending on room temperature.
devices, based on the specific cold chain equipment
application and intended purpose for temperature Typically, a refrigeration unit specification would be set to
monitoring. For more information on the various types 5°C (41°F) with an allowable range of ± 3°C (2°C to 8°C or
of devices and how they should be used, see the WHO 38°F to 44°F) to store products labeled 2°C to 8°C (36°F to
Guidance: How to Monitor Temperature in the Vaccine 46°F). Freezer temperatures may vary and typically range
Supply Chain.4 In addition, the WHO sets standards on from -25°C to -10°C (-13°F to 14°F). Most standard freezer
minimum, technical, and stability standards, and has a list of units do not meet ultra-cold freezer requirements for storing
prequalified devices and equipment on their website.5 vaccines between -60°C and -80°C (-76°F and -112°F).
According to the CDC Vaccine Storage and Handling Toolkit, If ultra-low freezer temperatures are required and the
COVID-19 Vaccine Addendum section, it is essential to utilize manufacturer provides or specifies the use of dry ice
continuous temperature monitoring systems to ensure that (e.g., Comirnaty COVID-19 vaccine), additional handling
the vaccines are stored within the correct temperature precautions should be taken, such as the following:
range. Use of a specific device, a digital data logger (DDL) 1. Store thermal shippers containing dry ice, as well as dry
with an external display, is preferred.3 A DDL is an electronic ice replenishment containers, in a well-ventilated area.
device that records data digitally over time or in relation Because frozen carbon dioxide changes phase (i.e., melts)
to location, either with a built-in or external instrument or into a gaseous state, elevated levels of carbon dioxide
sensor. Although automated systems monitor temperature can be dangerous to personnel operating within a poorly
continuously, manual checks must be performed as ventilated area, which may lead to asphyxiation.
appropriate to ensure functionality as well as when the 2. Because of the thermal expansion of dry ice as it changes
vaccine is removed from storage. Temperature monitoring phases from a frozen to gaseous state, it should never be
devices should be calibrated (in the United States - NIST stored in a tightly sealed device.
traceable)3 against nationally accepted standards to ensure
3. Wear impermeable loose-fitting gloves (e.g., leather,
accuracy of readings (see USP General Chapter
lined oven mitts, etc.) to protect from contact freezing
Monitoring Devices—Time, Temperature, and Humidity).
(similar to a burn). Gloves must be insulated to protect
Calibration testing should be done every one to two years, or
from general freezing temperatures (dry ice is -78.5°C or
according to the manufacturer’s suggested timeline. Alarm
-109.3°F).
systems may be part of the temperature monitoring system.
4. Wear goggles or a face shield to protect your eyes.
Pharmaceutical-grade refrigerators and freezers are
preferred because they are designed specifically for storing For maintaining temperatures at outdoor venues, keep
biopharmaceuticals, including vaccines. Per CDC guidance, opened vials or pre-drawn syringes at temperatures
“household-grade units can be an acceptable alternative at or below 25°C (77°F) within the beyond-use date
for refrigeration in some situations. However, the freezer timeframe until the time of administration to the patient.
compartment of household-grade units is not recommended For further information, see the USP Transporting COVID-19
to store vaccines and there may be other areas of the Vaccines Off-Site Guide accessible on page 14.
refrigerated compartment that should be avoided as well.
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International COVID-19 Vaccine Handling Guide
Temperature Excursions Vaccine Transport
Inclement weather, natural disasters, and traffic (Off-site or Satellite Facilities)
disruption can cause receiving delays and potential
Vaccine transport off-site or to satellite
temperature excursions. A temperature excursion is any
facilities involves the process of transporting vaccines
temperature reading outside of the recommended range for
over short distances and time frames in accordance with
vaccine storage as defined in the manufacturer’s package
practice setting SOPs. The total time for transport should
insert. Temperature excursions or inappropriate storage
be minimized to reduce potential risk for a temperature
conditions require immediate action. Each excursion
excursion due to a storage unit or thermal packaging
should be documented, including the magnitude of the
system failure. Sufficient transport supplies (e.g., materials
temperature excursion, and the total amount of time that
and equipment) are needed. These can include portable
temperatures were out of range. For refrigerated vaccines,
refrigerator/freezer units, qualified containers, coolant
Mean Kinetic Temperature may be calculated (see USP
materials, insulating materials, and the required temperature
General Chapter Mean Kinetic Temperature in the
monitoring devices.
Evaluation of Temperature Excursions During Storage and
Transportation of Drug Products). To determine the impact When vaccine transport is necessary, consider these storage
of an excursion, and whether the vaccines are still viable, recommendations:
contact the manufacturer for guidance on whether the • The manufacturer-supplied packaging can be used in
affected vaccines should be discarded or can be utilized. accordance with the directions in the manufacturer’s
While this determination is being made, the vaccines labeling.
should be maintained at the appropriate temperature with
• Transport the vaccines using a portable refrigerator and/or
temperature monitoring and clearly labeled “DO NOT USE
freezer unit with a temperature monitoring device.
pending guidance by the manufacturer.” Place them in a
separate container apart from other vaccines and do not • Appropriate measures should be taken to ensure the
discard these vaccines. The ability of the manufacturer vaccine is cushioned and protected from agitation
to determine the excursion impact will depend on the during transport.
information provided. Detailed information regarding • If a portable refrigerator and/or freezer unit is not available,
the excursion will enable the manufacturer to better qualified containers and packouts with a temperature
provide assistance. Each excursion event is unique and a monitoring device can be used. A container or packout
manufacturer’s recommendation for a specific excursion is ‘qualified’ through laboratory testing under controlled
event should not be applied to future events that appear conditions to ensure they achieve and maintain desired
to be similar. temperatures for a set amount of time. They are available
via packaging suppliers.
Temperature excursion labeling
DO NOT USE pending guidance by the manufacturer.
10International COVID-19 Vaccine Handling Guide
• For example, to prepare a packout for transportation of • Secure temperature monitoring device near
COVID-19 vaccine pre-drawn syringes or vials: container with pre-drawn syringes or vials for most
• The following materials are needed: accurate temperature monitoring.
• Temperature monitoring device, with continuous • Place the expanded polystyrene foam container in
monitoring being preferred. the hard-plastic container to protect the vaccine
during transport.
• Bubble wrap or corrugated cardboard cushioning
material (at least 1” thick) to provide barrier between • Close the hard-surface or hard-plastic container.
cooling agent and pre-drawn syringes.
When transporting the vaccine, the temperature should be
• Light-protected zip-lock bag or similar container for
validated whenever the storage container is opened.
pre-drawn COVID-19 vaccine syringes or vials.
Vaccines must be secured from theft and tampering
• Ice pack or other cooling agent.
when not under supervision of healthcare personnel,
• Expanded polystyrene foam container to maintain as with other medications. Strategies to ensure secure
temperature. transport can include the use of ‘tamper proof’ or ‘tamper
• Hard-surface or hard-plastic container to protect evident’ measures (e.g., locks, tape) on these containers as
from damage during transport. appropriate, per the healthcare professional’s judgment.
For additional information on tampering/damage, see the
• The following steps should be taken to prepare a Falsified COVID Vaccine Visual Inspection Guide accessible
packout for transportation: on page 14.
• Insulate the expanded polystyrene foam container The redistribution of vaccine supply to other in-network
with bubble wrap or corrugated cardboard settings for preparation and administration also requires the
cushioning. redistribution of adequate ancillary supplies for preparation
• Add ice pack or other cooling agent. and administration.
• Add bubble wrap or corrugated cardboard
cushioning.
• Add light-protected container with pre-drawn
syringes or vials to top of cushioning material and References
secure container.
1. https://www.healthvermont.gov/sites/default/files/documents/
pdf/ID_IZ_INFOHCP_S&H_VaccineManagementPlan.pdf
2. https://www.mass.gov/doc/sample-standard-operating-
procedure-sop-0/download
3. https://www.cdc.gov/vaccines/hcp/admin/storage/toolkit/
index.html
4. https://apps.who.int/iris/handle/10665/183583
5. https://apps.who.int/immunization_standards/vaccine_quality/
pqs_catalogue/index.aspx
11International COVID-19 Vaccine Handling Guide
Waste Minimization
3 and Ancillary
Supply Disposal
Operational Considerations for Waste Minimization and
Ancillary Supply Disposal for COVID-19 Vaccines
Background • Ensure cold chain is properly maintained with proper
storage conditions and continuous temperature monitoring
The variety of COVID-19 vaccines in the manufacturing to prevent the need to discard any product due to
pipeline will continue to pose challenges for the safe and temperature excursions. This includes implementing
proper minimization of waste of unused vaccines and effective procedures for preventative maintenance and
safe disposal of ancillary supplies (e.g., dry ice, syringes, repair of cold chain equipment and developing and
needles). Disposal of unused vaccines or ancillary supply rehearsing contingency plans in case of emergency
waste from a COVID-19 vaccine that has been authorized by situations.
local regulators should be performed in accordance with
• Ensure vaccine preparers are properly trained and
the directions in the manufacturer’s labeling. This document
demonstrate competency for proper aseptic technique to
focuses on considerations for disposal of unused or ancillary
minimize the risk of contaminating the product.
supply waste of COVID-19 vaccines and can be used to
supplement but not replace a manufacturer’s labeling. • Maximize doses withdrawn from vials by utilizing low dead-
In addition, this document should not replace a facility’s volume syringes/needles, whenever possible. A low dead-
existing policies and procedures. volume (LDV) syringe is designed to limit dead space that
exists between the syringe hub and needle.
COVID-19 Vaccine Waste • If pre-drawing is permitted, use pre-drawn syringes with
the earliest discard time first to avoid waste.
Minimization
• Carefully consider the number of pre-drawn syringes to
Given the critical shortage of COVID-19 vaccines
prepare to avoid drawing up unnecessary doses.
worldwide, sites should accordingly plan and build standard
operating procedures (SOPs) to minimize loss of doses • Carefully insert and withdraw needle from vial septum to
while following local regulatory guidance. The following not bend the needle, which could lead to wastage.
considerations should be made to minimize or control • Ensure safe practices when recapping the needle and
vaccine waste: appropriate closure of safety shield to reduce need to
• A site should have plans in place to minimize waste discard product due to microbiological risks.
of usable vaccine (e.g., a waiting list for vaccines,
plans to distribute vaccines if individuals do not keep
appointments, agreements with pharmacies and other
local centers for vaccine transport, etc.).
12International COVID-19 Vaccine Handling Guide
According to the WHO, “A variety of disposal methods can
Considerations for the be chosen, depending on the amount of waste, the location
Disposal of Vaccines and (rural or urban) and the availability of local disposal facilities.
The method should be safe, respect the environment,
Ancillary Supplies and comply with national laws and codes on health and
During this pandemic, a large volume of waste could be safety. Open-air incineration is not recommended due to
potentially generated due to the large amount of vaccine environmental risks.”1
use, usage of personal protective equipment (PPE) and other
ancillary supplies. The safe disposal of waste is essential to Items to be discarded immediately after use or a
eliminate the potential risks to healthcare workers and the recommended double check, or when the vaccine
public, and to protect the environment. Disposal of medical exceeds its beyond-use-date and time, may include:
waste is managed through national or local laws per country. • Empty vials
For information on how to assess, design, and implement • Vials with unused vaccine
appropriate waste management mechanisms, see this
• Vials with unused diluent
WHO interim guidance, COVID-19 Vaccination: Supply and
Logistics Guidance.1 • Pre-drawn syringes and needles
Medical waste is healthcare waste that may be contaminated • Used syringes and needles (e.g., post patient injection,
by blood, body fluids, or other potentially infectious materials.2 used in dilution process, etc.)
Medical waste disposal requirements are set by regulatory Facilities should have policies and procedures for security
agencies. Follow regulatory or facility policies for appropriate and storage for the COVID-19 vaccines. In addition, the
disposal, including for vaccines which contain genetically disposal of COVID-19 vaccine vials should be secured in a
modified organisms (Covishield/Vazevria). Empty vaccine vials way to mitigate potential tampering.
are usually not considered hazardous or medical waste and do
not require disposal in a biomedical waste container.3
References
Needles must be discarded in biohazard containers that are
closable, puncture-resistant, leakproof on sides and bottom, 1. https://www.who.int/publications/i/item/who-2019-ncov-
vaccine-deployment-logistics-2021-1
labeled, and color-coded (e.g., a sharps container). This is
important to help prevent an accidental needlestick, which 2. https://www.epa.gov/rcra/medical-waste
can lead to transmission of infection. Dispose of biohazard 3. https://www.cdc.gov/vaccines/hcp/admin/storage/toolkit/
containers according to facility and regulatory requirements. index.html
13International COVID-19 Vaccine Handling Guide
Supplemental content is also available
Handouts and related content intended to highlight key information and visually represent techniques discussed
in this toolkit are also available by clicking on the links below. These handouts include:
Maximizing Doses of Pfizer- Maximizing Doses of Moderna Beyond use date in vial or syringe for
BioNTech COVID-19 Vaccine COVID-19 Vaccine Max 15 dose vial COVID-19 Vaccines
Download the guide Download the guide Download the factsheet
View the Video
Transporting COVID-19 ASHP| ISMP | USP FAQs Falsified COVID Vaccine
Vaccines Off-Site for Optimizing COVID-19 Vaccine Visual Inspection Guide
Download the guide Preparation and Safety Download the guide
Download the FAQ
Your feedback helps us improve the content that we offer.
Please submit any questions or comments, including if this toolkit has been helpful to you, to HealthcareQuality@usp.org.
14International COVID-19 Vaccine Handling Guide
Appendix I: Independent Expert Volunteers and Other Contributors to the
International COVID-19 Vaccine Handling Guide
The Guide’s development was led by USP’s Healthcare Safety & Quality Expert Committee (HSQ), with input from other
USP Expert Committees, government liaisons, observers, and USP staff. Participants as of June 2021:
Healthcare Safety & Quality Expert Committee Nomenclature and Labeling Expert Committee
Melody Ryan, PharmD, MPH, (Chair) Professor and Associate Provost Sasha Beselman, PharmD, Investigational Drug Pharmacist,
for Global Health Initiatives, University of Kentucky Johns Hopkins
Danial Baker, PharmD, (Vice-Chair) Professor and Director of Drug Michael Cohen, MS, RPh, President, Institute for Safe Medication
Information Center, Washington State University Practices
Timothy Albertson, PhD, MD, MPH, Professor and Chair, Internal Ginette Pepper, PhD, RN, Professor Emeritus, University of Utah
Medicine, University of California, Davis College of Nursing
Bernard Appiah, DrPH, BS Pharm, Assistant Professor, Department of
Public Health, Syracuse University Packaging and Distribution Expert Committee
Nisha Bhide, PharmD, Senior Clinical Operations Manager, Capital Rx Chris Anderson, MA, Director, Quality Systems, Cardinal Health
Lakesha Butler, PharmD, Professor, Southern Illinois University, Glaucia Braga, PhD, Auditor of the Public-Private Partnership –
Edwardsville Senior Quality Assurance Analyst, FURP
Mark Decerbo, PharmD, Associate Professor of Pharmacy, Roseman
University of Health Sciences Government Liaison (HSQ)
Lauren Hoffman, PharmD, MPH, Senior Consultant, Linda Kim-Jung, PharmD, FDA Center for Veterinary Medicines (CVM)
Express Scripts, Inc.
Jo Wyeth, Surveillance Program Lead, FDA CDER, Division of
Raymond Love, PharmD, Professor and Director of Mental Health Medication Error Prevention and Analysis (DMEPA)
Program, University of Maryland, Baltimore
Joseph Lubega, MD, MPH, Assistant Professor, Baylor College Government Liaison (Observers)
of Medicine
Anita Patel, PharmD, Senior Advisor, Pandemic Medical Care and
Linda Pugh, PhD, Retired nurse professor Countermeasures Lead, Influenza Coordination unit, National Center
Michelle Then, PharmD, MBA, Pharmacy Manager-Medication Safety, for Chronic Disease Prevention and Health Promotion, CDC
Quality, Compliance, Denver Health Medical Center JoEllen Wolicki, BSN, Nurse Educator, National Center for Chronic
Dennis West, PhD, BS Pharm, Professor Emeritus of Dermatology and Disease Prevention and Health Promotion, CDC
Pediatrics, Northwestern University Sara Gagneten, PhD, Associate Division Director, Division of
Shonna Yin, MD, MS, Associate Professor of Pediatrics and Population Viral Products, OVRR, CBER, FDA
Health, NYU School of Medicine
Other Observers
Complex Biologics and Vaccines Expert Committee Michael Ganio, PharmD, Director Pharmacy Practice and Quality,
Mark van Ooij, PhD, Scientific Director, Janssen Vaccines (J&J), American Society of Hospital Pharmacists
Netherlands
Ganesh Barhate, PhD, Senior Technical Manager, MS&T, Novartis USP Staff
Technical Operations, Austria Farah Towfic, PharmD, MBA, Director, CEO Operations
Paul Stickings, PhD, Principal Scientist, National Institute for Biological Nurisha Wade, Vice President, Healthcare Quality & Safety Center
Standards and Control, United Kingdom for Excellence
Nakia Eldridge, PharmD, MBA, Senior Manager, Healthcare,
Compounding Expert Committee Patient Safety & Information
Lisa Ashworth, BS Pharm, Compounding Specialist and Clinical Brian Serumaga, PhD, RPh, MPH, Senior Manager, Personalized
Pharmacist, Children’s Health System of Texas Medicines, Compounding Expert Committee
Phil Ayers, PharmD, Chief, Clinical Pharmacy Services, Mississippi Desmond Hunt, PhD, Principal Scientific Liaison, Packaging &
Baptist Medical Center Distribution Expert Committee
Kevin Hansen, PharmD, MS, Assistant Director of Pharmacy, Diana Kwan, PharmD, Scientific Liaison, Healthcare Safety & Quality
Cone Health Expert Committee
Connie Sullivan, BS Pharm, President and CEO, National Home Donna Bohannon, B.S. Pharm, MS, Senior Scientific Liaison, Healthcare
Infusion Association Information and Technology Expert Committee
Misti Spann, PharmD, Scientific Liaison, Nomenclature and labeling
Health Information & Technology Expert Committee Expert Committee
Roy Guharoy, PharmD, MBA, Vice President, Chief Pharmacy Lindsey Clawson, MBA, Lead, COVID-19 Vaccine Strategy
Officer, Baptist Health Marissa Brykman, JD, United States Regulatory Affairs Policy Director
Shreya Parekh, PharmD, Clinical Informatics Specialist, Jeanne Sun, PharmD, JD, Counsel
Jefferson Health
Abigail Ammerman, Expert Committee Manager
James Austgen, PhD, Expert Committee Manager
15International COVID-19 Vaccine Handling Guide
Appendix II: Considerations for Handling Specific COVID-19 Vaccine Products
The selection of the vaccines in this international guide is based on those which have received regulatory authorization, distributed and utilized
in multiple countries, and availability of published resources. The focus of this guide is vaccines granted WHO Emergency Use Listing (EUL)
for worldwide distribution through COVAX and COVID-19 vaccines available in Brazil and India, where USP has local offices, and which are
areas where COVID-19 variants of concern bring a sense of urgency. The inclusion of a COVID-19 vaccine in this guide does not imply approval,
authorization, endorsement, or certification.
Comirnaty COVID-19 Step 2: Dilute the vaccine
Vaccine Considerations • Visually inspect vial for cracks and leaks.
• Wipe diluent vial stopper using sterile 70% isopropyl
Preparation alcohol swab and allow to dry.
• Maximize doses withdrawn from vials (at least 6 doses) • If applicable, ensure needle and syringe are tightly luer-
by utilizing low dead-volume (LDV) syringes/needles, locked together.
whenever possible. A low dead-volume syringe is designed
• Withdraw 1.8 mL 0.9% sodium chloride, preservative
to limit dead space that exists between the syringe hub
free, diluent into syringe. Discard vial after diluent
and needle.
withdrawal.
• Practice settings that may not have adequate quantities
• To prevent excess foaming or bubbling, slowly inject
of LDV syringes can maximize doses by utilizing a
1.8 mL of 0.9% sodium chloride, preservative free,
combination of LDV and non-LDV syringes (e.g., 3 LDV
diluent onto the wall of the vaccine vial.
syringes and 3 non-LDV syringes). The ratio of LDV to non-
LDV syringes should be dependent on the type of syringe • Before removing the needle from the vaccine vial,
and needle used. move the needle tip to the air headspace of the vial
and draw out 2.1 mL of air to optimize vial pressure.
• Regardless of diluent vial size, only a single needle
entry can be used to withdraw a single 1.8 mL volume of • Gently invert the diluted vial 10 times to mix. Do not shake.
preservative-free 0.9% sodium chloride diluent to prepare • Record dilution date and time on vaccine vial and
one vial of the Comirnaty COVID-19 vaccine. Any excess store diluted vaccine for up to 6 hours at 2°C to 25°C
diluent must be discarded. (35°F to 77°F).
• Preservative-free 0.9% sodium chloride diluent should not
be drawn up in advance as it is preservative-free. Step 3: Draw up each dose of the vaccine
• The manufacturer states that for dose preparation, a • Wipe vaccine vial stopper using sterile 70% isopropyl
21-gauge or narrower needle helps prevent leaking from alcohol swab and allow to dry.
the stopper when doses are withdrawn. • If applicable, ensure needle and syringe are tightly luer-
locked together.
Withdrawal • Inject 0.2 mL of air into the vial of reconstituted vaccine to
The following are steps for withdrawing doses, including optimize vial pressure.
optimizing vial pressure to ensure that the number of doses • Slowly withdraw 0.3 mL of vaccine into the administration
is maximized for each Comirnaty COVID-19 Vaccine vial. syringe.
Follow aseptic technique throughout vaccine preparation.
• While small air bubbles can be ignored, large air bubbles
Step 1: Prepare for dilution can lead to underdosing and should be addressed.
Minimize tapping of the syringe due to theoretical risk of
• A Comirnaty COVID-19 vaccine vial must reach room
inactivating the vaccine or degrading quality.
temperature before dilution and be diluted within 2 hours
of removal from frozen or refrigerated storage. • Utilize safe practices when recapping the needle after
withdrawing and before administrating.
• Inspect liquid to ensure it is a white to off-white suspension
which may contain white to off-white opaque amorphous • Rotate the insertion point of the needle across various
particles. locations of the vial septum for each withdrawal to reduce
leakage of vaccine.
• Invert vaccine vial gently 10 times. Do not shake.
16International COVID-19 Vaccine Handling Guide
Moderna COVID-19 Vaccine
Considerations
Preparation
• Maximize doses withdrawn from vials by utilizing low-dead
volume (LDV) syringes/needles whenever possible to
minimize drug loss in syringe/needles.
• Practice settings with adequate quantities of LDV syringes,
utilizing only LDV syringes, should consistently withdraw
the maximum number of extractable doses (11 or 15).
• Practice settings that may not have adequate quantities
of LDV syringes can consistently achieve 14 doses from
the Moderna COVID-19 vaccine Max 15 doses vial by
utilizing a combination of LDV and non-LDV syringes
(e.g., 7 LDV syringes and 7 non-LDV conventional or
luer-locked. needles/syringes). The ratio of LDV to
non-LDV syringes should be dependent on the type
of syringe and needle used.
Withdrawal
The following are steps for withdrawing doses, including
optimizing vial pressure to help maximize doses for
the Moderna COVID-19 vaccine multiple-dose vial with • Slowly withdraw 0.5 mL of vaccine into the
Max 15 doses. administration syringe.
Follow aseptic technique throughout vaccine preparation: • While small air bubbles can be ignored, large air bubbles
can lead to underdosing and should be addressed.
Step 1: Prepare Moderna Max 15 dose vial Minimize tapping of the syringe due to theoretical risk of
• Thaw each vial before use. Vials may be thawed: inactivating the vaccine or degrading quality.
• In the refrigerator at 2°C to 8°C (36°F to 46°F) • Rotating the insertion point of the needle across various
for 3 hours. locations of the vial septum for each withdrawal to reduce
leakage of vaccine.
• At room temperature at 15°C to 25°C (59°F to 77°F)
for 1 hour and 30 minutes. • Gently swirl and tilt the vial to withdraw the final dose to
maximize the volume of vaccine withdrawn. Be careful
Step 2: Draw up each dose of the vaccinea not to bend the needle.
• Visually inspect vial for cracks and leaks. • Utilize safe practices when recapping the needle after
withdrawing and before administering.
• Swirl vial gently after thawing and between each
withdrawal. Do not shake.
• Wipe vaccine vial stopper using sterile 70% isopropyl
alcohol swab. Allow to air dry before inserting needle.
• If applicable, ensure needle and syringe are tightly
luer-locked together.
• Inject 0.2 mL of air into the vial of vaccine to optimize
vial pressure.
17International COVID-19 Vaccine Handling Guide
Janssen COVID-19 Vaccine
Considerations
• Visually inspect vial for cracks and leaks.
• Wipe vaccine vial stopper using sterile 70% isopropyl
alcohol swab. Allow to air dry before inserting a needle.
• Before withdrawing each dose of vaccine, carefully mix
the contents of the multi-dose vial by swirling gently in an
upright position for 10 seconds.
• Do not shake the vial.
• The same needle should be used for withdrawal and
administration. This eliminates the need to change needles
and therefore reduces the risk of touch contamination to
the vaccine and potential loss of volume.
• Rotate the insertion point of the needle across various
locations of the vial septum for each withdrawal to reduce
leakage of vaccine.
• The product should be protected from light and ultraviolet
PHOTO: U.S. Army National Guard, Sgt. Sebastian Rothwyn
light.
Covishield/Vaxzevria COVID-19 Vaccine CoronaVac COVID-19 Vaccine
Considerations Considerations
• Visually inspect vial for cracks and leaks. • Visually inspect vial for cracks and leaks.
• Inspect the vial to make sure the liquid is clear to slightly • Do not use vaccine vial if it is cracked, has a badly printed
opaque, and colorless to slightly brown. or unlit label, or if there is a foreign body in the vaccine
• Inspect the vial for the presence of any particulate matter vial.
or other coloration prior to administration. Discard • Wipe vaccine vial stopper using sterile 70% isopropyl
if particulate matter or differences in the described alcohol swab. Allow to air dry before inserting a needle.
appearance are observed. • Shake well before administration. Unlike some of the other
• Wipe vaccine vial stopper using sterile 70% isopropyl COIVD-19 vaccines which should not be shaken, this
alcohol swab. Allow to air dry before inserting a needle. vaccine must be shaken.
• Do not shake the vial. • If precipitation is observed, disperse it by shaking.
• The same needle should be used for withdrawal and • The same needle should be used for withdrawal and
administration. This eliminates the need to change needles administration. This eliminates the need to change needles
and therefore reduces the risk of touch contamination to and therefore reduces the risk of touch contamination to
the vaccine and potential loss of volume. the vaccine and potential loss of volume.
• Rotate the insertion point of the needle across various • Rotate the insertion point of the needle across various
locations of the vial septum for each withdrawal to reduce locations of the vial septum for each withdrawal to reduce
leakage of vaccine. leakage of vaccine.
• The product should be protected from light and • The product should be protected from light and
ultraviolet light. ultraviolet light.
18International COVID-19 Vaccine Handling Guide
Sinopharm COVID-19 Vaccine
Considerations
• Visually inspect vial or pre-filled syringe for cracks and
leaks.
• Inspect the vial or pre-filled syringe to make sure that the
liquid is an opalescent suspension, milky-white in color.
• If precipitation is observed, disperse it by shaking. Unlike
some of the COVID-19 vaccines which should not be
shaken, this vaccine should be shaken.
• For manufacturer pre-filled syringes of Sinopharm:
• If applicable, ensure needle and syringe are tightly
luer-locked together.
• For single-dose vials of Sinopharm:
• Wipe vaccine vial stopper using sterile 70% isopropyl
alcohol swab. Allow to air dry before inserting a needle.
• The same needle should be used for withdrawal and
administration. This eliminates the need to change
needles and therefore reduces the risk of touch
Covaxin COVID-19 Vaccine contamination to the vaccine and potential loss
Considerations of volume.
• The product should be protected from light and
• Visually inspect vial for cracks and leaks.
ultraviolet light.
• Inspect the vial for the presence of any particulate matter
or other coloration prior to administration and discard
if particulate matter or differences in the described Sputnik V COVID-19 Vaccine
appearance are observed. Considerations
• Wipe vaccine vial stopper using sterile 70% isopropyl • Visually inspect vial for cracks and leaks.
alcohol swab. Allow to air dry before inserting a needle.
• Wipe vaccine vial stopper using sterile 70% isopropyl
• Shake vaccine vial to obtain a uniform, whitish translucent alcohol swab. Allow to air dry before inserting a needle.
suspension before administration. Unlike some of the
• Carefully mix the contents of the vial by swirling gently.
other COVID-19 vaccines which should not be shaken, this
Do not shake.
vaccine must be shaken.
• The same needle should be used for withdrawal and
• The same needle should be used for withdrawal and administration. This eliminates the need to change needles
administration. This eliminates the need to change needles and therefore reduces the risk of touch contamination to
and therefore reduces the risk of touch contamination to the vaccine and potential loss of volume.
the vaccine and potential loss of volume.
• Rotate the insertion point of the needle across various
• Rotate the insertion point of the needle across various locations of the vial septum for each withdrawal to
locations of the vial septum for each withdrawal to reduce reduce leakage of vaccine.
leakage of vaccine.
• The product should be protected from light and
• The product should be protected from light and ultraviolet light.
ultraviolet light.
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