Janssen COVID-19 Vaccine: Package Insert and Label Information (Page 4 of 5)

18.2 Immunogenicity of a Booster Dose following Primary Vaccination with Janssen COVID-19 Vaccine

In Study 2, individuals 18 through 55 years of age and 65 years and older received a booster dose of the Janssen COVID-19 Vaccine approximately 2 months after the primary vaccination. Immunogenicity was assessed by measuring neutralizing antibodies to SARS-CoV-2 Victoria/1/2020 strain using a qualified wild-type virus neutralization assay (wtVNA). Immunogenicity data are available from 39 individuals, of whom 15 were 65 years of age and older, and are summarized in Table 13. Based on a limited number of individuals from this study, a similar fold-rise in neutralizing antibody titers from pre-booster to 14 and 28 days post-booster was observed between individuals 18 through 55 years of age and individuals 65 years of age and older.

Table 13. Study 2 — SARS-CoV-2 Neutralization Wild Type VNA-VICTORIA/1/2020 (IC50), , Per Protocol Immunogenicity Set *
Baseline(Day 1) 28 Days Post-Primary Vaccination(Day 29) Pre-Booster Dose(Day 57) 14 Days Post-Booster Dose (Day 71) 28 Days Post-Booster Dose (Day 85)
LLOQ = lower limit of quantification
*
PPI set: The per protocol immunogenicity population includes all randomized and vaccinated participants for whom immunogenicity data are available excluding participants with major protocol deviations expected to impact the immunogenicity outcomes. In addition, samples obtained after missed vaccinations or participants with SARS-CoV-2 infection occurring after screening were excluded from the analysis.
N 38 39 39 39 38
Geometric mean titer (95% CI) <LLOQ (<LLOQ, <LLOQ) 260 (196, 346) 212 (142, 314) 518 (354, 758) 424 (301, 597)
Geometric mean fold increase (95% CI) from baseline n/a 4.4 (3.3, 5.7) 3.7 (2.6, 5.2) 8.8 (6.1, 12.8) 7.4 (5.4, 10.2)
Geometric mean fold increase (95% CI) from day 29 n/a n/a 0.9 (0.7; 1.1) 2.0 (1.5; 2.7) 1.6 (1.2; 2.1)
Geometric mean fold increase (95% CI) from pre-booster n/a n/a n/a 2.3 (1.7, 3.1) 1.8 (1.4, 2.4)

When evaluated descriptively among a limited number of study participants using an ELISA assay, increases in anti-Spike protein binding IgG antibodies post booster were not lower for an interval of 6 months compared with an interval of 2 months between primary vaccination and booster dose. These data support the effectiveness of a booster dose when administered at an interval of longer than 2 months after primary vaccination.

18.3 Immunogenicity of a Booster Dose Following Primary Vaccination with Another Authorized or Approved COVID-19 Vaccine

Effectiveness of a Janssen COVID-19 Vaccine booster dose in individuals who completed primary vaccination with another authorized or approved COVID-19 Vaccine (heterologous booster dose) is inferred from immunogenicity data supporting effectiveness of a Janssen COVID-19 Vaccine booster dose administered following completion of Janssen COVID-19 Vaccine primary vaccination and from immunogenicity data from an independent Phase 1/2 open-label clinical trial (NCT04889209) conducted in the United States that evaluated a heterologous booster dose of the Janssen COVID-19 Vaccine. In this study, adults who had completed primary vaccination with a Moderna COVID-19 Vaccine 2-dose series (N=151), a Janssen COVID-19 Vaccine single-dose (N=156), or a Pfizer-BioNTech COVID-19 Vaccine 2-dose series (N=151) at least 12 weeks prior to enrollment and who reported no history of SARS-CoV-2 infection were randomized 1:1:1 to receive a booster dose of one of three vaccines: Moderna COVID-19 Vaccine, Janssen COVID-19 Vaccine, or Pfizer-BioNTech COVID-19 Vaccine. Neutralizing antibody titers, as measured by a pseudovirus neutralization assay using a lentivirus expressing the SARS-CoV-2 Spike protein with D614G mutation, were assessed on Day 1 prior to administration of the booster dose and on Day 15 after the booster dose. A booster response to the Janssen COVID-19 Vaccine was demonstrated regardless of primary vaccination.

19 HOW SUPPLIED/STORAGE AND HANDLING

Janssen COVID-19 Vaccine is supplied in a carton of 10 multi-dose vials (NDC 59676-580-15). A maximum of 5 doses can be withdrawn from the multi-dose vial.

The storage and handling information in this Fact Sheet supersedes the storage and handling information on the carton and vial labels.

Storage Prior to First Puncture of the Vaccine Vial

Store unpunctured multi-dose vials of the Janssen COVID-19 Vaccine at 2°C to 8°C (36°F to 46°F) and protect from light. Do not store frozen.

Unpunctured vials of Janssen COVID-19 Vaccine may be stored between 9°C to 25°C (47°F to 77°F) for up to 12 hours.

The Janssen COVID-19 Vaccine is initially stored frozen by the manufacturer, then shipped at 2°C to 8°C (36°F to 46°F). If vaccine is still frozen upon receipt, thaw at 2°C to 8°C (36°F to 46°F). If needed immediately, thaw at room temperature (maximally 25°C/77°F). At room temperature (maximally 25°C/77°F), a carton of 10 vials will take approximately 4 hours to thaw, and an individual vial will take approximately 1 hour to thaw. Do not refreeze once thawed.

Storage After First Puncture of the Vaccine Vial

After the first dose has been withdrawn, hold the vial between 2° to 8°C (36° to 46°F) for up to 6 hours or at room temperature (maximally 25°C/77°F) for up to 2 hours. Discard the vial if vaccine is not used within these times.

20 PATIENT COUNSELING INFORMATION

Advise the recipient or caregiver to read the Fact Sheet for Recipients and Caregivers.

Instruct Janssen COVID-19 Vaccine recipients to seek immediate medical attention for 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 [see Warnings and Precautions (5.2)].

In individuals with a history of ITP, discuss the risk of ITP and the potential need for platelet monitoring following vaccination with the Janssen COVID-19 Vaccine [see Warnings and Precautions (5.3)].

The vaccination provider must include vaccination information in the state/local jurisdiction’s Immunization Information System (IIS) or other designated system. Advise recipient or caregiver that more information about IISs can be found at: https://www.cdc.gov/vaccines/programs/iis/about.html.

21 CONTACT INFORMATION

For general questions or to access the most recent Janssen COVID-19 Vaccine Fact Sheets, scan the QR code using your device, visit www.janssencovid19vaccine.com or call the telephone numbers provided below.

QR CodeFact Sheets WebsiteTelephone numbers

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www.janssencovid19vaccine.com.US Toll Free: 1-800-565-4008 US Toll: 1-908-455-9922

This Full EUA Prescribing Information may have been updated. For the most recent Full EUA Prescribing Information, please see www.janssencovid19vaccine.com.

Manufactured by:
Janssen Biotech, Inc.
a Janssen Pharmaceutical Company of Johnson & Johnson
Horsham, PA 19044, USA

Revised: May/05/2022

© 2021 Janssen Pharmaceutical Companies

FACT SHEET FOR RECIPIENTS AND CAREGIVERS

EMERGENCY USE AUTHORIZATION (EUA) OF
THE JANSSEN COVID-19 VACCINE TO PREVENT CORONAVIRUS DISEASE 2019 (COVID-19)

The Janssen COVID-19 Vaccine is authorized for use in individuals 18 years of age and older for whom other FDA-authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and for individuals 18 years of age and older who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine. The Janssen COVID-19 Vaccine can cause blood clots with low levels of platelets (blood cells that help your body stop bleeding), which may be fatal.

You are being offered the Janssen COVID-19 Vaccine to prevent Coronavirus Disease 2019 (COVID-19) caused by SARS-CoV-2 because there is currently a pandemic of COVID-19.

This Fact Sheet contains information to help you understand the risks and benefits of receiving the Janssen COVID-19 Vaccine.

The Janssen COVID-19 Vaccine may prevent you from getting COVID-19.

Read this Fact Sheet for information about the Janssen COVID-19 Vaccine. Talk to the vaccination provider if you have questions.

The Janssen COVID-19 Vaccine has received EUA from FDA to provide the following doses in individuals 18 years of age and older for whom other FDA-authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and in individuals 18 years of age and older who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine:

  • A single dose primary vaccination.
  • A single booster dose after completing a primary vaccination with the Janssen COVID-19 Vaccine.
  • A single booster dose after completing primary vaccination with a different authorized or approved COVID-19 vaccine.

The Janssen COVID-19 Vaccine may not protect everyone.

This Fact Sheet may have been updated. For the most recent Fact Sheet, please visit www.janssencovid19vaccine.com.

WHAT YOU NEED TO KNOW BEFORE YOU GET THIS VACCINE

WHAT IS COVID-19?

COVID-19 is caused by a coronavirus called SARS-CoV-2. This type of coronavirus has not been seen before. You can get COVID-19 through contact with another person who has the virus. It is predominantly a respiratory illness that can affect other organs. People with COVID-19 have had a wide range of symptoms reported, ranging from mild symptoms to severe illness. Symptoms may appear 2 to 14 days after exposure to the virus. Common symptoms may include: fever or chills; cough; shortness of breath; fatigue; muscle or body aches; headache; new loss of taste or smell; sore throat; congestion or runny nose; nausea or vomiting; diarrhea.

WHAT IS THE JANSSEN COVID-19 VACCINE?

The Janssen COVID-19 Vaccine is an unapproved vaccine that may prevent COVID-19.

Under an EUA, the FDA has authorized the emergency use of the Janssen COVID-19 Vaccine to prevent COVID-19 in individuals 18 years of age and older for whom other FDA-authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and in individuals 18 years of age and older who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine.

For more information on EUA, see the “What is an Emergency Use Authorization (EUA)?” section at the end of this Fact Sheet.

WHAT SHOULD YOU MENTION TO YOUR VACCINATION PROVIDER BEFORE YOU GET THE JANSSEN COVID-19 VACCINE?

Tell the vaccination provider about all of your medical conditions, including if you:

  • have any allergies,
  • have a fever,
  • have a bleeding disorder or are on a blood thinner,
  • have ever had a low level of platelets (blood cells that help your body stop bleeding),
  • are immunocompromised or are on a medicine that affects your immune system,
  • are pregnant or plan to become pregnant,
  • are breastfeeding,
  • have received another COVID-19 vaccine,
  • have ever fainted in association with an injection.

WHO SHOULD GET THE JANSSEN COVID-19 VACCINE?

FDA has authorized the emergency use of the Janssen COVID-19 Vaccine in individuals 18 years of age and older for whom other FDA-authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and in individuals 18 years of age and older who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine.

WHO SHOULD NOT GET THE JANSSEN COVID-19 VACCINE?

You should not get the Janssen COVID-19 Vaccine if you:

  • had a severe allergic reaction after a previous dose of this vaccine.
  • had a severe allergic reaction to any ingredient of this vaccine.
  • had a blood clot along with a low level of platelets (blood cells that help your body stop bleeding) following Janssen COVID-19 Vaccine or following AstraZeneca’s COVID-19 vaccine (not authorized or approved in the United States).

WHAT ARE THE INGREDIENTS IN THE JANSSEN COVID-19 VACCINE?

The Janssen COVID-19 Vaccine includes the following ingredients: recombinant, replication-incompetent adenovirus type 26 expressing the SARS-CoV-2 spike protein, citric acid monohydrate, trisodium citrate dihydrate, ethanol, 2-hydroxypropyl-β-cyclodextrin (HBCD), polysorbate-80, sodium chloride.

HOW IS THE JANSSEN COVID -19 VACCINE GIVEN?

The Janssen COVID-19 Vaccine will be given to you as an injection into the muscle.

Primary Vaccination

The Janssen COVID-19 Vaccine is administered as a single dose.

Booster Dose

  • A single booster dose of the Janssen COVID-19 Vaccine may be administered at least two months after primary vaccination with the Janssen COVID-19 Vaccine.
  • A single booster dose of the Janssen COVID-19 Vaccine may be administered after completing primary vaccination with a different authorized or approved COVID-19 vaccine. Please check with your health care provider regarding timing of the booster dose.

HAS THE JANSSEN COVID-19 VACCINE BEEN USED BEFORE?

The Janssen COVID-19 Vaccine is an unapproved vaccine. In clinical trials, more than 61,000 individuals 18 years of age and older have received the Janssen COVID-19 Vaccine. Millions of individuals have received the vaccine under EUA since February 27, 2021.

WHAT ARE THE BENEFITS OF THE JANSSEN COVID-19 VACCINE?

The Janssen COVID-19 Vaccine has been shown to prevent COVID-19. The duration of protection against COVID-19 is currently unknown.

WHAT ARE THE RISKS OF THE JANSSEN COVID-19 VACCINE?

Side effects that have been reported with the Janssen COVID-19 Vaccine include:

  • Injection site reactions: pain, redness of the skin and swelling.
  • General side effects: headache, feeling very tired, muscle aches, nausea, and fever.
  • Swollen lymph nodes.
  • Blood clots.
  • Unusual feeling in the skin (such as tingling or a crawling feeling) (paresthesia), decreased feeling or sensitivity, especially in the skin (hypoesthesia).
  • Persistent ringing in the ears (tinnitus).
  • Diarrhea, vomiting.

Severe Allergic Reactions

There is a remote chance that the Janssen COVID-19 Vaccine could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of the Janssen COVID-19 Vaccine. For this reason, your vaccination provider may ask you to stay at the place where you received your vaccine for monitoring after vaccination. Signs of a severe allergic reaction can include:

  • Difficulty breathing,
  • Swelling of your face and throat,
  • A fast heartbeat,
  • A bad rash all over your body,
  • Dizziness and weakness.

Blood Clots with Low Levels of Platelets

Blood clots involving blood vessels in the brain, lungs, abdomen, and legs along with low levels of platelets (blood cells that help your body stop bleeding), have occurred in some people who have received the Janssen COVID-19 Vaccine. In people who developed these blood clots and low levels of platelets, symptoms began approximately one to two weeks after vaccination. Blood clots with low levels of platelets following the Janssen COVID-19 Vaccine have been reported in males and females, across a wide age range of individuals 18 years and older; reporting has been highest in females ages 30 through 49 years (about 8 cases for every 1,000,000 vaccine doses administered), and about 1 out of every 7 cases has been fatal. You should seek medical attention right away if you have any of the following symptoms after receiving the Janssen COVID-19 Vaccine:

  • Shortness of breath,
  • Chest pain,
  • Leg swelling,
  • Persistent abdominal pain,
  • Severe or persistent headaches or blurred vision,
  • Easy bruising or tiny blood spots under the skin beyond the site of the injection.

Immune Thrombocytopenia (ITP)

Immune Thrombocytopenia (ITP) is a disorder that can cause easy or excessive bruising and bleeding due to very low levels of platelets. ITP has occurred in some people who have received the Janssen COVID-19 Vaccine. In most of these people, symptoms began within 42 days following receipt of the Janssen COVID-19 Vaccine. The chance of having this occur is very low. If you have ever had a diagnosis of ITP, talk to your vaccination provider before you get the Janssen COVID-19 Vaccine. You should seek medical attention right away if you develop any of the following symptoms after receiving the Janssen COVID-19 Vaccine:

  • Easy or excessive bruising or tiny blood spots under the skin beyond the site of the injection,
  • Unusual or excessive bleeding.

Guillain Barré Syndrome

Guillain Barré syndrome (a neurological disorder in which the body’s immune system damages nerve cells, causing muscle weakness and sometimes paralysis) has occurred in some people who have received the Janssen COVID-19 Vaccine. In most of these people, symptoms began within 42 days following receipt of the Janssen COVID-19 Vaccine. The chance of having this occur is very low. You should seek medical attention right away if you develop any of the following symptoms after receiving the Janssen COVID-19 Vaccine:

  • 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.

These may not be all the possible side effects of the Janssen COVID-19 Vaccine. Serious and unexpected effects may occur. The Janssen COVID-19 Vaccine is still being studied in clinical trials.

WHAT SHOULD I DO ABOUT SIDE EFFECTS?

If you experience a severe allergic reaction, call 9-1-1, or go to the nearest hospital.

Call the vaccination provider or your healthcare provider if you have any side effects that bother you or do not go away.

Report vaccine side effects to FDA/CDC Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1-800-822-7967 or report online to https://vaers.hhs.gov/reportevent.html. Please include “Janssen COVID-19 Vaccine EUA” in the first line of box #18 of the report form.

In addition, you can report side effects to Janssen Biotech, Inc. at the contact information provided below.

e-mailFax numberTelephone numbers
JNJvaccineAE@its.jnj.com 215-293-9955US Toll Free: 1-800-565-4008 US Toll: (908) 455-9922

You may also be given an option to enroll in v-safe. V-safe is a new voluntary smartphone-based tool that uses text messaging and web surveys to check in with people who have been vaccinated to identify potential side effects after COVID-19 vaccination. V-safe asks questions that help CDC monitor the safety of COVID-19 vaccines. V-safe also provides live telephone follow-up by CDC if participants report a significant health impact following COVID-19 vaccination. For more information on how to sign up, visit: www.cdc.gov/vsafe.

WHAT IF I DECIDE NOT TO GET THE JANSSEN COVID-19 VACCINE?

Under the EUA, there is an option to accept or refuse receiving the vaccine. Should you decide not to receive the Janssen COVID-19 Vaccine, it will not change your standard medical care.

ARE OTHER VACCINES AVAILABLE FOR PREVENTING COVID-19 BESIDES JANSSEN COVID-19 VACCINE?

COMIRNATY and SPIKEVAX are FDA-approved COVID-19 vaccines. Other vaccines to prevent COVID-19 may be available under EUA. The Janssen COVID-19 Vaccine is only authorized if other COVID-19 vaccines are not accessible or clinically appropriate, and for individuals who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine.

CAN I RECEIVE THE JANSSEN COVID-19 VACCINE AT THE SAME TIME AS OTHER VACCINES?

Data have not yet been submitted to FDA on administration of the Janssen COVID-19 Vaccine at the same time as other vaccines. If you are considering receiving the Janssen COVID-19 Vaccine with other vaccines, discuss your options with your healthcare provider.

WHAT IF I AM PREGNANT OR BREASTFEEDING?

If you are pregnant or breastfeeding, discuss your options with your healthcare provider.

WILL THE JANSSEN COVID-19 VACCINE GIVE ME COVID-19?

No. The Janssen COVID-19 Vaccine does not contain SARS-CoV-2 and cannot give you COVID-19.

KEEP YOUR VACCINATION CARD

When you receive the Janssen COVID-19 Vaccine, you will get a vaccination card to document the name of the vaccine and date of when you received the vaccine.

ADDITIONAL INFORMATION

If you have questions or to access the most recent Janssen COVID-19 Vaccine Fact Sheets, scan the QR code using your device, visit the website or call the telephone numbers provided below.

QR CodeFact Sheets WebsiteTelephone numbers

Image

www.janssencovid19vaccine.com.US Toll Free: 1-800-565-4008 US Toll: (908) 455-9922

HOW CAN I LEARN MORE?

  • Ask the vaccination provider.
  • Visit CDC at https://www.cdc.gov/coronavirus/2019-ncov/index.html.
  • Visit FDA at https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.

Contact your local or state public health department.

WHERE WILL MY VACCINATION INFORMATION BE RECORDED?

The vaccination provider may include your vaccination information in your state/local jurisdiction’s Immunization Information System (IIS) or other designated system. For more information about IISs visit: https://www.cdc.gov/vaccines/programs/iis/about.html.

CAN I BE CHARGED AN ADMINISTRATION FEE FOR RECEIPT OF THE COVID-19 VACCINE?

No. At this time, the provider cannot charge you for a vaccine dose and you cannot be charged an out-of-pocket vaccine administration fee or any other fee if only receiving a COVID-19 vaccination. However, vaccination providers may seek appropriate reimbursement from a program or plan that covers COVID-19 vaccine administration fees for the vaccine recipient (private insurance, Medicare, Medicaid, HRSA COVID-19 Uninsured Program for non-insured recipients).

WHERE CAN I REPORT CASES OF SUSPECTED FRAUD?

Individuals becoming aware of any potential violations of the CDC COVID-19 Vaccination Program requirements are encouraged to report them to the Office of the Inspector General, U.S. Department of Health and Human Services, at 1-800-HHS-TIPS or TIPS.HHS.GOV.

WHAT IS THE COUNTERMEASURE INJURY COMPENSATION PROGRAM?

The Countermeasures Injury Compensation Program (CICP) is a federal program that may help pay for costs of medical care and other specific expenses for certain people who have been seriously injured by certain medicines or vaccines, including this vaccine. Generally, a claim must be submitted to the CICP within one (1) year from the date of receiving the vaccine. To learn more about this program, visit www.hrsa.gov/cicp or call 1-855-266-2427.

WHAT IS AN EMERGENCY USE AUTHORIZATION (EUA)?

The United States FDA has made the Janssen COVID-19 Vaccine available under an emergency access mechanism called an EUA. The EUA is supported by a Secretary of Health and Human Services (HHS) declaration that circumstances exist to justify the emergency use of drugs and biological products during the COVID-19 pandemic.

The Janssen COVID-19 Vaccine has not undergone the same type of review as an FDA-approved or cleared product. FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, and available alternatives. In addition, the FDA decision is based on the totality of scientific evidence available showing that the product may be effective to prevent COVID-19 during the COVID-19 pandemic and that the known and potential benefits of the product outweigh the known and potential risks of the product. All of these criteria must be met to allow for the product to be used during the COVID-19 pandemic.

The EUA for the Janssen COVID-19 Vaccine is in effect for the duration of the COVID-19 declaration justifying emergency use of these products, unless terminated or revoked (after which the products may no longer be used).

Manufactured by:
Janssen Biotech, Inc.
a Janssen Pharmaceutical Company of Johnson & JohnsonHorsham, PA 19044, USA

© 2021 Janssen Pharmaceutical Companies

For more information, call US Toll Free: 1-800-565-4008, US Toll: (908) 455-9922 or go to www.janssencovid19vaccine.com

Revised: May/05/2022

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