Johnson & Johnson COVID-19 Vaccine Booster Shot Authorized for Emergency Use by U.S. FDA

NEW BRUNSWICK, N.J., Oct. 20, 2021 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) (the Company) today announced the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for a booster dose of the Johnson & Johnson COVID-19 vaccine for adults aged 18 and older at least two months following primary vaccination with single-shot Johnson & Johnson COVID-19 vaccine; and for eligible individuals who received a different authorized or approved COVID-19 vaccine. The Johnson & Johnson booster shot will be the same formulation and dosage as the primary shot.

The EUA follows a unanimous recommendation from the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) based on data provided by the Company, including efficacy, safety and immunogenicity data from its clinical trials and real-world evidence data. When administered as a primary or booster dose, following initial vaccination with the Company's COVID-19 single-shot vaccine, it provided protection against symptomatic disease and was generally well-tolerated, highlighting the favorable benefit-risk profile of a booster dose in light of the ongoing pandemic.

"We welcome the FDA's decision to authorize emergency use of our COVID-19 vaccine as a booster," said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson. "Our data support a schedule that provides benefit to individuals based on their risks associated with COVID-19, whether administered as a single dose for an efficient response to the pandemic, or as a booster dose after at least two months – to protect against symptomatic COVID-19. We also welcome the FDA's decision to include a heterologous boosting option as part of this authorization. The ability to boost immune responses regardless of the primary vaccine regimen an individual has received provides more flexibility in protecting those already immunized, and is very beneficial to global public health as we look to curb this pandemic."

"Today's authorization by the FDA is yet another positive step toward the goal of curbing the COVID-19 pandemic," said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson. "It is now even clearer that Johnson & Johnson's vaccine booster can play an important role in maintaining protection against COVID-19. We look forward to sharing our robust safety, efficacy and immunogenicity data in support of a booster dose with other regulatory bodies and advisory groups around the world to address the continued threat of COVID-19."

A single booster dose of the Johnson & Johnson COVID-19 vaccine may also be administered as a heterologous booster dose following completion of primary vaccination with another authorized or approved COVID-19 vaccine. The eligible population(s) and dosing interval for the heterologous booster dose are the same as those authorized for a booster dose of the vaccine used for primary vaccination.

The Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) will provide a potential recommendation on October 21.

In the U.S., there is sufficient supply to support boosting to those who have received the Johnson & Johnson COVID-19 vaccine. More than 15.2 million doses of the Company's COVID-19 vaccine have been administered as primary vaccinations in the U.S.

For more information on the Company's multi-pronged approach to helping combat the pandemic, visit: www.jnj.com/covid-19.

Authorized Use

The Janssen COVID-19 Vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent Coronavirus Disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) to provide:

• Primary vaccination regimen for the Janssen COVID-19 Vaccine is a single-dose (0.5 mL) administered to individuals 18 years of age and older.
• A single Janssen COVID-19 Vaccine booster dose (0.5 mL) may be administered at least 2 months after the primary vaccination to individuals 18 years of age and older.
• A single booster dose of the Janssen COVID-19 Vaccine (0.5 mL) may be administered as a heterologous booster dose following completion of primary vaccination with another authorized or approved COVID-19 vaccine. The eligible population(s) and dosing interval for the heterologous booster dose are the same as those authorized for a booster dose of the vaccine used for primary vaccination.

IMPORTANT SAFETY INFORMATION

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
• 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 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.

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 to eligible individuals who have completed primary vaccination with a different authorized or approved COVID-19 vaccine. Please check with your health care provider regarding eligibility for and timing of the booster dose.

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, 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. Reporting of these blood clots and low levels of platelets has been highest in females ages 18 through 49 years. The chance of having this occur is remote. You should seek medical attention right away if you have any of the following symptoms after receiving 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.

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.

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.

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 1-800-565-4008.

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.

Please read Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) including full EUA Prescribing Information available at: www.JanssenCOVID19Vaccine.com/EUA-factsheet.

About Johnson & Johnson
At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That's why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world's largest and most broadly-based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. We are blending our heart, science and ingenuity to profoundly change the trajectory of health for humanity. Learn more at www.jnj.com. Follow us at @JNJNews.

About the Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension. Learn more at www.janssen.com. Follow us at @JanssenGlobal.

Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding development of a potential preventive vaccine for COVID-19. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Janssen Pharmaceutical Companies, and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 3, 2021, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in the company's most recently filed Quarterly Report on Form 10-Q, and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

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SOURCE Johnson & Johnson