Appendix C: Janssen COVID-19 Vaccine - Minnesota ...
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
MINNESOTA DEPARTMENT OF HEALTH
Appendix C: Janssen COVID-19
Vaccine
7/19/2021
Read the full provider guide: Interim COVID-19 Vaccine Provider Guide
(www.health.state.mn.us/diseases/coronavirus/vaccine/guide.pdf).
Summary of Johnson & Johnson’s Janssen COVID-19 vaccine
Age indication Dose route Schedule Presentation/preparation Storage and handling Notes
Refrigerator: 2°C to 8°C (36°F
Multi-dose vial: 5 doses to 46°F):
per vial • Unpunctured vials: until Not
expiration date. interchangeable
18 years and Single • Punctured vials: 6 hours.
0.5 mL IM No reconstitution with other
older dose required. COVID-19
Room temperature: up to 12 vaccines.
No preservative. hours (unpunctured vials).
• Punctured vials: 2 hours.
Shipping
Janssen COVID-19 vaccine is initially stored frozen by the manufacturer, then shipped at 2 to 8 degrees
Celsius (36 to 46 degrees Fahrenheit). If vaccine is still frozen when it arrives, place it in the refrigerator
at 2 to 8 degrees Celsius (36 to 46 degrees Fahrenheit) to thaw. If needed immediately, thaw vaccine at
room temperature (maximum 25 degrees Celsius/77 degrees Fahrenheit). A carton of ten vials will take
about two hours to thaw; an individual vial will take about one hour. Do not refreeze vaccine once
thawed.
A signature will be required when the vaccine is delivered. When you receive the vaccine, unpack the
shipment and confirm the quantity is correct and there are no damaged vials. Janssen vaccine is in
preservative-free multi-dose vials (MDVs), with five doses per vial. Each carton has ten vials (total of 50
doses). The minimum order is 100 doses (two cartons). Ancillary supply kits will be delivered separately
from the vaccine. If you need additional ancillary supplies, email health.mdhvaccine@state.mn.us. Do
not return the shipping container.
1 of 10
APPENDIX C: JANSSEN COVID-19 VACCINE
Storage
Refrigerated
Store unpunctured multi-dose Janssen vials between 2 to 8 degrees Celsius (36 to 46 degrees
Fahrenheit) and protect them from light. Vaccine may be stored at refrigerated temperatures until the
expiration date. Do not freeze vaccine.
Room temperature
Unpunctured vials may be stored between 9 to 25 degrees Celsius (47 to 77 degrees Fahrenheit) for up
to 12 hours.
Punctured vials
After the first puncture of the vial, vaccine can be held within the vial at 2 to 8 degrees Celsius (36 to 46
degrees Fahrenheit) for up to six hours or at room temperature (maximum 25 degrees Celsius or 77
degrees Fahrenheit) for up to two hours. Discard vaccine if it is not used within these timeframes.
Expiration dates for vials
There is no expiration printed on the vaccine carton or vial. Go to Expiry Checker: Janssen COVID-19
Vaccine Under Emergency Use Authorization (vaxcheck.jnj/) to look up the expiration date for your
Janssen vaccine. Locate the lot number, which is printed on the carton and vial, enter it in the expiry
checker field, and click “check lot.” Write the expiration date on the carton(s)/vial(s).
Temperature monitoring and documentation
Use a continuous temperature monitoring device (e.g., digital data logger) to monitor vaccine. Learn
more at COVID-19 Vaccine Temperature Monitoring Devices
(www.health.state.mn.us/diseases/coronavirus/vaccine/devices.pdf).
At the start of each workday:
Document minimum (lowest) and maximum (highest) temperature in the storage unit.
Record date, time, and staff name or initials.
Document electronically or on a paper log (keep temperature documentation for three years).
If the temperature goes out of range, take action immediately. Do not use the vaccine until the
manufacturer is contacted about the viability of the vaccine. Refer to the Managing out-of-range
temperatures (excursions) section in the provider guide.
2 of 10
APPENDIX C: JANSSEN COVID-19 VACCINE
Redistribution
If you redistribute vaccine, you must sign a redistribution agreement. Sites must strictly follow the
components of the agreement during redistribution and off-site vaccination. Learn more at COVID-19
Vaccine: Redistribution and Off-site Vaccination Guide
(www.health.state.mn.us/diseases/coronavirus/vaccine/vaxredistribution.pdf). For information on
transporting COVID-19 vaccine, refer to Transporting COVID-19 Vaccines
(www.health.state.mn.us/diseases/coronavirus/vaccine/transport.pdf).
Vaccine recommendations for Janssen COVID-19
vaccine
Janssen COVID-19 vaccine is administered in a single dose (0.5 milliliter) for people ages 18 years
and older.
Janssen COVID-19 vaccine is not interchangeable with other COVID-19 vaccine products.
Coadministration of COVID-19 vaccines and other vaccines: Refer to CDC’s interim clinical
considerations (link below).
Report vaccine errors to the Vaccine Adverse Event Reporting System (VAERS)!
Find the full listing of vaccine recommendations at CDC: Interim Clinical Considerations for Use of
COVID-19 Vaccines Currently Authorized in the United States (www.cdc.gov/vaccines/covid-
19/clinical-considerations/covid-19-vaccines-us.html).
Contraindications and precautions
CDC considers people with a known history of severe allergic reaction (e.g., anaphylaxis) or known
(diagnosed) allergy to any component of the Janssen COVID-19 vaccine to be a contraindication to
vaccination with the Janssen COVID-19 vaccine.
The full listing of contraindications and precautions are at CDC: Interim Clinical Considerations for Use
of COVID-19 Vaccines Currently Authorized in the United States: Contraindications and precautions
(www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-
us.html#Contraindications).
Ingredient listing for Janssen COVID-19 vaccine
Each dose of the Janssen COVID-19 vaccine includes the following ingredients:
0.14mg citric acid monohydrate
2.02mg trisodium citrate dihydrate
3 of 10APPENDIX C: JANSSEN COVID-19 VACCINE
2.04mg ethanol
25.50mg 2-hydroxypropyl-β-cyclodextrin (HBCD)
0.16mg polysorbate-80
2.19mg sodium chloride
May also contain residual amounts of host cell proteins (≤0.15mcg) and/or host cell DNA (≤3ng)
Janssen COVID-19 vaccine does not contain a preservative.
The vial stoppers are not made with natural rubber latex.
Appropriate medical treatment used to manage immediate allergic reactions (e.g., epinephrine)
must be immediately available in the event an acute anaphylactic reaction occurs following
administration of the vaccine.
Warnings
Thrombosis with thrombocytopenia syndrome: Reports of adverse events following use of the Janssen
COVID-19 vaccine under emergency use authorization suggest an increased risk of thrombosis involving
the cerebral venous sinuses and other sites (including but not limited to the large blood vessels of the
abdomen and the veins of the lower extremities) combined with thrombocytopenia. Onset of symptoms
is approximately one to two weeks after vaccination. Most cases of thrombosis with thrombocytopenia
syndrome (TTS) reported following the Janssen COVID-19 vaccine have occurred in females ages 18
through 49 years; some have been fatal. Specific risk factors for TTS following the Janssen COVID-19
vaccine, and the level of potential excess risk due to vaccination, are under investigation. Based on
currently available evidence, a causal relationship between TTS and the Janssen COVID-19 vaccine is
plausible.
Health care professionals should be alert to the signs and symptoms of TTS in people who receive the
Janssen COVID-19 vaccine. The clinical course shares features with autoimmune heparin-induced
thrombocytopenia. In people with suspected TTS following the Janssen COVID-19 vaccine, the use of
heparin may be harmful and alternative treatments may be needed.
Clinicians should consult the CDC HAN Archive: Cases of Cerebral Venous Sinus Thrombosis with
Thrombocytopenia after Receipt of the Johnson & Johnson COVID-19 Vaccine
(emergency.cdc.gov/han/2021/han00442.asp), MDH’s Health Alert Network
(www.health.state.mn.us/han): Health Advisory: Cerebral Venous Sinus Thrombosis After Johnson &
Johnson Vaccine published on April 13, 2021, and The American Society of Hematology Thrombosis with
Thrombocytopenia Syndrome (www.hematology.org/covid-19/vaccine-induced-immune-thrombotic-
thrombocytopenia) for more information on the diagnosis and treatment of suspected cases of TTS.
Consultation with hematology specialists is strongly recommended.
It is critical to educate providers and patients (Janssen COVID-19 Vaccine EUA Fact Sheet for Recipients
and Caregivers [www.fda.gov/media/146305/download]) about this warning to ensure that all
recipients, especially women under 50 years of age, are aware of the increased risk for TTS after receipt
4 of 10APPENDIX C: JANSSEN COVID-19 VACCINE
of the Janssen COVID-19 vaccine and the availability of other FDA-authorized COVID-19 vaccines (i.e.,
mRNA vaccines).
Recipients of Janssen COVID-19 vaccine should be instructed to seek immediate medical attention if
they develop shortness of breath, chest pain, leg swelling, persistent abdominal pain, neurological
symptoms (including severe or persistent headaches or blurred vision), or petechiae beyond the site of
vaccination.
For additional information, go to:
CDC: Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Authorized in the
United States: Contraindications and precautions (www.cdc.gov/vaccines/covid-19/clinical-
considerations/covid-19-vaccines-us.html#Contraindications)
CDC: Updated Recommendations from the Advisory Committee on Immunization Practices for Use
of the Janssen (Johnson & Johnson) COVID-19 Vaccine After Reports of Thrombosis with
Thrombocytopenia Syndrome Among Vaccine Recipients — United States, April 2021 | MMWR
(www.cdc.gov/mmwr/volumes/70/wr/mm7017e4.htm?s_cid=mm7017e4_w)
CDC: Talking to Patients about Safety of the Janssen COVID-19 Vaccine
(www.cdc.gov/vaccines/covid-19/downloads/talking-patients-Janssen-COVID-19-Vaccine-safety.pdf)
Guillain Barré syndrome (GBS): Reports of adverse events following use of the Janssen COVID-19
vaccine under emergency use authorization suggest an increased risk of GBS (a neurological disorder in
which the body’s immune system damages nerve cells, causing muscle weakness and sometimes
paralysis) during the 42 days following vaccination. These cases have largely been reported about two
weeks after vaccination and mostly in males, many age 50 years and older.
Health care professionals should be alert to the signs and symptoms of GBS in people who receive the
Janssen COVID-19 vaccine. It is critical to educate providers and patients (Janssen COVID-19 Vaccine EUA
Fact Sheet for Recipients and Caregivers [www.fda.gov/media/146305/download]) of the risk of GBS
after receiving the Janssen COVID-19 vaccine and to seek medical attention right away if they have any
of the following symptoms:
Weakness or tingling sensations, especially in the legs or arms, that’s worsening and spreading to
other parts of the body.
Difficulty walking.
Difficulty with facial movements, including speaking, chewing, or swallowing.
Double vision or inability to move eyes.
Difficulty with bladder control or bowel function.
Altered immunocompetence: Immunocompromised people, including those receiving
immunosuppressive therapy, may have a diminished response to Janssen COVID-19 vaccine.
The Janssen COVID-19 vaccine may not protect all vaccine recipients.
5 of 10APPENDIX C: JANSSEN COVID-19 VACCINE
Adverse reactions (side effects)
Adverse reactions reported in a clinical trial following administration of the Janssen COVID-19
vaccine include injection site pain, redness, and or swelling; headache; fatigue (feeling tired);
myalgia (muscle pain); nausea; and fever.
In clinical studies, severe allergic reactions, including anaphylaxis, have been reported following the
administration of the Janssen COVID-19 vaccine.
Post authorization use: Severe allergic reactions (including anaphylaxis), thrombosis with
thrombocytopenia, Guillain Barré syndrome, and capillary leak syndrome have been reported
following administration of the Janssen COVID-19 vaccine during mass vaccination outside of clinical
trials.
Additional adverse reactions, some of which may be serious, may become apparent with more
widespread use of the Janssen COVID-19 vaccine.
This information is taken from the full Emergency Use Authorization (EUA) prescribing information for Janssen
COVID-19 vaccine, found in Janssen COVID-19 Vaccine – EUA Fact Sheet for Healthcare Providers Administering
Vaccine (www.janssenlabels.com/emergency-use-authorization/Janssen+COVID-19+Vaccine-HCP-fact-sheet.pdf).
Vaccine preparation
Overview
Janssen COVID-19 vaccine is preservative-free and comes in a multi-dose vial (MDV). There are five
0.5 milliliter doses per vial. Do not pool excess vaccine from multiple vials.
Schedule: One 0.5 milliliter dose for ages 18 years and older.
No reconstitution required.
Protect multi-dose vials from light.
Administer via intramuscular (IM) route.
Preparing individual doses
Follow strict aseptic technique when preparing the vaccine doses for administration.
Gather ancillary kit supplies.
Janssen COVID-19 vaccine is a colorless to slightly yellow, clear to very opalescent suspension.
Visually inspect the vial for particulate matter and discoloration prior to administration and if found,
do not administer the vaccine.
6 of 10APPENDIX C: JANSSEN COVID-19 VACCINE
Photo from Janssen Scientific Affairs, LLC
Before withdrawing each dose of vaccine from a vial, carefully mix the contents of the multi-dose
vial for ten seconds by gently swirling the vial in an upright position. Do not shake.
Photo from Janssen Scientific Affairs, LLC
Clean the stopper of the Janssen COVID-19 vaccine multi-dose vial with a single-use alcohol swab.
Using a 1 milliliter or 3 milliliter syringe, withdraw a 0.5 milliliter dose from the Janssen COVID-19
vaccine multi-dose vial.
Photo from Janssen Scientific Affairs, LLC
7 of 10APPENDIX C: JANSSEN COVID-19 VACCINE
After the first dose has been withdrawn from the multi-dose vial (i.e., pierced with a needle), store
the punctured vial between 2 to 8 degrees Celsius (36 to 46 degrees Fahrenheit) for up to six hours
or at room temperature (maximum 25 degrees Celsius or 77 degrees Fahrenheit) for up to two
hours. Discard the vial if vaccine is not used within these times. Record date and time of first use on
the Janssen COVID-19 vaccine vial label.
Photo from Janssen Scientific Affairs, LLC
When withdrawing additional doses from the same vial, clean the vial stopper each time with a new
single-use sterile alcohol swab. Insert the needle into a different place on the vial stopper. Do NOT
use the same insertion point every time or the vial may leak.
Since there is no preservative in the Janssen multi-dose vial, discard the vial when there is not enough
vaccine to obtain a complete dose. Do not “pool” or combine residual vaccine from multiple vials to
obtain a dose.
Administration
Follow strict aseptic technique when administering vaccine.
Visually inspect each dose of the Janssen COVID-19 vaccine in the dosing syringe prior to
administration.
During the visual inspection:
Verify the final dosing volume of 0.5 milliliters.
Confirm there are no particulates and that no discoloration is observed.
Do not administer if vaccine is discolored or contains particulate matter.
8 of 10APPENDIX C: JANSSEN COVID-19 VACCINE
Administer the Janssen COVID-19 vaccine by the intramuscular (IM) route.
Photo from Janssen Scientific Affairs, LLC
Do not miss an opportunity to vaccinate
Ensuring that everyone has an opportunity to receive vaccine should be balanced with vaccine wastage.
Use these strategies to minimize wastage, but do not miss an opportunity to vaccinate someone, even if
that means not every dose in a vial can be used.
In a clinic setting, look ahead at your schedule and the patients’ records and/or MIIC to assess the
need for COVID-19 vaccine. This will help anticipate how much vaccine will need to be used on a
daily or weekly basis.
Once you have punctured the vial:
Make a plan to administer all the doses in the vial.
Consider having a waiting list.
Be aware of people who may be able to come on short notice to get vaccinated.
▪ All the doses must be administered within six hours if stored at refrigerated temperatures or
two hours if stored at room temperature. If not administered in these specific timeframes,
the vaccine must be discarded.
Do not open another vial until you have used all the doses in the current vial.
Keep multi-dose, labeled vials in a central location, so multiple vaccinators have access to the same
vial to increase the likelihood of all doses being used.
Resources
CDC: Interim Considerations: Preparing for the Potential Management of Anaphylaxis after COVID-
19 Vaccination (www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-
anaphylaxis.html)
9 of 10APPENDIX C: JANSSEN COVID-19 VACCINE
CDC: Morbidity and Mortality Weekly Report (MMWR): The Advisory Committee on Immunization
Practices’ Interim Recommendation for Use of Janssen COVID-19 Vaccine — United States, February
2021 (www.cdc.gov/mmwr/volumes/70/wr/mm7009e4.htm)
Janssen: The U.S. FDA Has Granted the Janssen COVID‑19 Vaccine an Emergency Use Authorization
(www.janssencovid19vaccine.com)
EUA Fact Sheet for Healthcare Providers; EUA Fact Sheet for Recipients and Caregivers.
Check expiration; storage, dosage, and administration; adverse event reporting; resources.
Janssen contact information (i.e., temperature excursions, vaccine shipment problem): 1-800-
565-4008 or 1-908-455-9922. Email: JSCCOVIDTEMPEXCURSION@its.jnj.com.
Janssen MD Search Medical Information: Stability Information (www.janssenmd.com/janssen-
covid19-vaccine/interactive-content/stability-information): You may use this online tool, but please
continue to contact MDH (or CDC after-hours) regarding temperature excursions.
CDC: Janssen COVID-19 Vaccine (Johnson & Johnson) (www.cdc.gov/vaccines/covid-19/info-by-
product/janssen/index.html)
Janssen EUA Fact Sheets, Interim Clinical Considerations, FAQs, ACIP recommendations, vaccine
administration resources, storage and handling resources, and more.
Vaccine protocol template: COVID-19 Janssen Ad26.COV2.S Vaccine
(www.health.state.mn.us/people/immunize/hcp/protocols/covidjanssen.docx)
Minnesota Department of Health | health.mn.gov | 651-201-5000
625 Robert Street North PO Box 64975, St. Paul, MN 55164-0975
Contact health.communications@state.mn.us to request an alternate format.
10 of 10You can also read
