World Health Organization Strategic Advisory Group of Experts (SAGE) Interim Recommendation Supports Use of Johnson & Johnson COVID-19 Vaccine as a Booster

NEW BRUNSWICK, N.J., Dec. 9, 2021 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) (the Company) today announced the interim recommendation by the Strategic Advisory Group of Experts on Immunization (SAGE) for the World Health Organization (WHO) supporting the use of the Johnson & Johnson COVID-19 vaccine as a booster shot in persons aged 18 years and above. The WHO recommend the booster shot should be administered two to six months after the primary vaccination. SAGE advises WHO on global vaccine and immunization policies, and its recommendations provide guidance on the use of vaccines supplied through the COVAX Facility, a global risk-sharing mechanism for pooled procurement and equitable distribution of COVID-19 vaccines to all participating countries.

SAGE recommended that the Johnson & Johnson COVID-19 vaccine can be used for homologous (same vaccine) boosting, using the Company's vaccine for both primary vaccination and the booster shot. The WHO supports a flexible approach to heterologous (mix-and-match) boosting, using the Johnson & Johnson COVID-19 vaccine as a booster for eligible individuals aged 18 years and older who received an authorized COVID-19 vaccine primary regimen.

"Today's recommendation from the Strategic Advisory Group of Experts on Immunization for the World Health Organization is further affirmation that the Johnson & Johnson COVID-19 vaccine can help reduce the burden of the pandemic," said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson. "Our COVID-19 vaccine continues to play a critical role in the world's fight to end this pandemic, and we welcome this recommendation as we work with the global community to protect as many people as possible from COVID-19."

The interim SAGE recommendation was based on efficacy, safety and immunogenicity data from the Company's clinical trials and the South African Health Products Regulatory Authority-sponsored Sisonke Phase 3b study in South Africa. When administered as a booster dose, following primary vaccination with the Johnson & Johnson COVID-19 vaccine, it provided increased protection against symptomatic infection and severe disease, and was generally well-tolerated.

Earlier this year SAGE recommended the use of the single-shot Johnson & Johnson COVID-19 vaccine based on evidence from the Company's Phase 3 ENSEMBLE study, which demonstrated efficacy against severe disease, and showed strong protection against COVID-19 related hospitalization and death, beginning 28 days after vaccination. These data were consistent with a large real-world evidence study conducted in the U.S., which showed stable vaccine effectiveness against COVID-19-related infections and hospitalizations, with no evidence of reduced effectiveness over the study duration of six months – including when the Delta variant became dominant in the U.S. (sequencing data were not available for analysis). 

Johnson & Johnson is delivering on its commitment to make available up to 900 million doses of its COVID-19 vaccine to the African Union (via the African Vaccine Acquisition Trust) and COVAX, combined, through 2022.

The Johnson & Johnson COVID-19 vaccine is compatible with standard vaccine storage and distribution channels with ease of delivery to remote areas. The vaccine is estimated to remain stable for two years at -4°F (-20°C), and a maximum of six months at routine refrigeration temperatures of 36° to 46°F (2° to 8°C). The COVID-19 vaccine should not be re-frozen if distributed at temperatures of 36°F to 46°F (2°-8°C).

The Johnson & Johnson COVID-19 vaccine, also referred to as the Janssen COVID-19 Vaccine, received initial Emergency Use Authorization (EUA) in the United States on February 27, 2021, and an EUA as a booster shot on October 20. It also received Conditional Marketing Authorisation by the European Commission on March 11. The WHO issued Emergency Use Listing on March 12, and the Company received an interim recommendation on primary vaccination by SAGE on March 17. On November 24, Health Canada approved the Company's single-shot COVID-19 vaccine. Many more authorizations and approvals have been granted in countries worldwide, including 50 countries in Africa, with further regulatory submissions ongoing.

Johnson & Johnson continues to submit relevant data to other regulators, the WHO and National Immunization Technical Advisory Groups (NITAGs) worldwide to inform decision-making on local vaccine administration strategies, as needed.

In collaboration with academic groups in South Africa and around the world, the Company is also evaluating the effectiveness of its COVID-19 vaccine across variants, now including the new and rapidly spreading Omicron variant. In addition, the Company is pursuing an Omicron-specific variant vaccine and will progress it as needed.

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).

• 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 to individuals 18 years of age and older as a heterologous booster dose following completion of primary vaccination with another authorized or approved COVID-19 vaccine. The dosing interval for the heterologous booster dose is the same as that 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 individuals 18 years of age and older who have completed primary vaccination with a different authorized or approved COVID-19 vaccine. Please check with your health care provider regarding 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, manufacture and distribution of the Johnson & Johnson COVID-19 vaccine. 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.

SOURCE Johnson & Johnson