This email is to inform you of:
- An update to the Janssen COVID-19 Vaccine EAU Fact Sheets.
- Information about Guillain-Barré syndrome.
Revised EUA Fact Sheets
FDA has approved the update to the Janssen COVID-19 EUA Fact Sheets to include the following new information, changes, and clarifications.
FACT SHEET FOR HEALTHCARE PROVIDERS ADMINISTERING VACCINE (VACCINATION PROVIDERS)
WARNINGS AND PRECAUTIONS
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In Section 5.2 Thrombosis with Thrombocytopenia: The sentence, “Most cases of thrombosis with thrombocytopenia reported following the Janssen COVID-19 Vaccine have occurred in females ages 18 through 49 years; some have been fatal.” was deleted and replaced with, “The reporting rate of thrombosis with thrombocytopenia following administration of the Janssen COVID-19 Vaccine has been highest in females ages 18 through 49 years; some have been fatal.”
- Subsection ‘5.3 Guillain-Barré Syndrome’ including the following information was added: Reports of adverse events following use of the Janssen COVID-19 Vaccine under emergency use authorization suggest an increased risk of Guillain-Barré syndrome during the 42 days following vaccination.
OVERALL SAFETY SUMMARY
- The sentence, “Thrombosis involving large blood vessels, including the cerebral venous sinuses, portal vein, lower extremity veins, and pulmonary artery, with thrombocytopenia have been reported following the Janssen COVID-19 vaccine.” was deleted.
- The following was added to this section: “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.”
Post Authorization Experience
- The sentence, “Thrombosis involving large blood vessels, including the cerebral venous sinuses, portal vein, lower extremity veins, and pulmonary artery, combined with thrombocytopenia" was deleted
- The following was added to this section: Because these reactions are reported voluntarily, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure.
- Blood and Lymphatic System Disorders: Thrombosis with thrombocytopenia
- Immune System Disorders: Allergic reactions, including anaphylaxis
- Nervous System Disorders: Guillain-Barré syndrome
- Vascular Disorders: Capillary leak syndrome, Thrombosis with thrombocytopenia
HOW SUPLLIED/STORAGE AND HANDLING
This section was updated to state that at room temperature (maximally 25°C/77°F), a carton of 10 vials will take approximately 4 hours to thaw.
FACT SHEET FOR RECIPIENTS AND CAREGIVERS
This fact sheet has been updated to include the following new information and changes in the section “WHAT ARE THE RISKS OF THE JANSSEN COVID-19 VACCINE?”:
- The sentence, “Blood clots involving blood vessels in the brain, 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” was revised to “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.”
- The following sentence was deleted: “Most people who developed these blood clots and low levels of platelets were females ages 18 through 49 years.” and replaced with: “Reporting of these blood clots and low levels of platelets has been highest in females ages 18 through 49 years.”
- The following information was added under a new subsection entitled “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"
CDC Statement on Guillain-Barré Syndrome
COVID-19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously. CDC and FDA are monitoring reports of Guillain-Barré Syndrome (GBS) after receiving Johnson & Johnson’s Janssen (J&J/Janssen) COVID-19 Vaccine. GBS is a neurological disorder in which the body’s immune system damages nerve cells, causing muscle weakness or in the most severe cases paralysis. Each year in the United States, an estimated 3,000 to 6,000 people develop GBS; it is typically triggered by a respiratory or gastrointestinal infection. Most people fully recover from GBS.
Reports of GBS after receipt of the J&J/Janssen COVID-19 Vaccine in the Vaccine Adverse Event Reporting System (VAERS) are rare, but do likely indicate a small possible risk of this side effect following this vaccine. Around 100 preliminary reports of GBS have been detected in VAERS after 12.8 million doses of J&J/Janssen COVID-19 Vaccine administered. These cases have largely been reported about two weeks after vaccination and mostly in males, many aged 50 years and older. Available data do not show a similar pattern with mRNA vaccines (Pfizer-BioNTech and Moderna), after over 321 million doses administered in the United States. This issue will be discussed as part of an upcoming ACIP meeting.
In the United States, nearly all COVID-19 hospitalizations and deaths are now occurring in unvaccinated people. The risk of severe adverse events after COVID-19 vaccination remains rare. Everyone age 12 years and older is recommended to receive a COVID-19 vaccine.
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