“Today’s recommendation supports the use of the Johnson & Johnson COVID-19 vaccine as a booster for eligible individuals in the U.S. regardless of which vaccine they initially receive,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson. “The Johnson & Johnson vaccine provided 94 percent protection in the U.S. against COVID-19 when given as a booster following the single-shot Johnson & Johnson vaccine, and due to its unique mechanism of action, offers long-lasting, durable protection. We remain confident in the benefit it will provide to millions around the world.”
The Johnson & Johnson COVID-19 vaccine was recommended as a booster for adults aged 18 and older who received the Johnson & Johnson single-shot vaccine at least two months earlier. A booster dose of the Johnson & Johnson COVID-19 vaccine was also recommended for eligible adults at least six months following the second dose of an authorized mRNA vaccine.
The ACIP recommendation has been forwarded to the Director of the CDC and the U.S. Department of Health and Human Services (HHS) for review and adoption.
The Company’s single-dose COVID-19 vaccine received FDA Emergency Use Authorization for adults aged 18 and older on February 27, 2021. On October 20, 2021, the FDA authorized for emergency use a booster shot of the Johnson & Johnson COVID-19 vaccine for adults aged 18 and older at least two months following primary vaccination with the Company’s single-dose vaccine.
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.
• 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 vaers.hhs.gov. 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.