After a thorough safety review, including two meetings of the CDC’s Advisory Committee on Immunization Practices, the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention determined that the recommended discontinuation was part of use of the Janssen (Johnson & Johnson) COVID-19 vaccine in the US should be increased and use of the vaccines should be continued.
Discontinuation is recommended after reports of six cases of a rare and severe blood type in individuals following administration of the Janssen COVID-19 Vaccine. During the cessation, medical and scientific teams at the FDA and CDC examined available data to assess the risks of thrombosis involving the cerebral vein sinuses, or CVST (large blood vessels in the brain), and other areas of the brain. body (including, but not limited to numerous abdominal blood vessels and veins in the legs) with thrombocytopenia, or low blood platelet count. FDA and CDC teams also conduct extensive outreach to providers and clinicians to ensure they are aware of the potential for these adverse events and can properly manage and identify these. events due to the unique treatment required for these blood clots and low platelets, known as thrombosis-thrombocytopenia syndrome (TTS).
The two agencies determined the following:
- Use of the Janssen COVID-19 Vaccine should be continued in the United States.
- The FDA and CDC have confidence that this vaccine is safe and effective in preventing COVID-19.
- The FDA determined that the available data showed that the known and potential benefits of the vaccine outweigh the known and potential risks to individuals 18 years and older.
- At this time, available data suggest that the chance of TTS occurring is very low, but the FDA and CDC will remain vigilant in continuing to investigate this risk.
- Health care providers administering vaccines and vaccine recipients or caregivers should review Janssen COVID-19 Vaccine Authentic Sheet for Healthcare Vaccine Administration Providers (Vaccination Providers)external icon and Fact Sheet for Recipients and Caregiversexternal icon, Modified to include information about the risk of this syndrome, which occurs in a very small number of people who receive the Janssen COVID-19 Vaccine.
CDC’s independent Advisory Committee on Immunization Practices met today to discuss the latest TTS data, on hearing from vaccine manufacturer Janssen and the COVID-19 Vaccine Safety Technical (extensive) group members, as well as a risk benefit analysis. ACIP has become more vigilant and responsive to further information impacting the risk benefit analysis of any of these vaccines. Vaccine safety monitoring will continue and any new information about TTS will be brought to ACIP as needed.
“Safety is our top priority. This stop is an example of our many safety monitors working as they are designed to operate – recognizing even small cases. we upheld the suspension based on FDA and review of all available data and in consultation with CDC medical experts and based on recommendation from the CDC’s Advisory Committee on Immunization Practices. We conclude that the known and potential benefits of the Janssen COVID-19 Vaccine outweigh the known and potential risks to individuals 18 years of age and older. We are confident these vaccines continue to meet our standards for safety, efficacy and quality. We recommend people with vaccine questions are right for them discussions with their health care provider, ”said Janet Woodcock, MD, Acting FDA Commissioner.
“Above all, health and safety are at the forefront of our decisions,” said CDC Director Dr. Rochelle P. Walensky. “Our vaccine safety system will work. we recognized exceptionally unique events-from the millions of doses of Janssen COVID-19 administered-and we stopped to examine them carefully. As we always do, we will continue to watch for all the signals that more and more Americans are being vaccinated. I continue to be encouraged by the growing body of real-world evidence that the authorized COVID-19 vaccine is safe and effective, and they protect people from illness, hospitalization, and death. I would like anyone with questions about the COVID-19 vaccine to speak to their healthcare provider or local public health department. “
Analysis of Available Data
Medical and scientific teams at the FDA and CDC reviewed several sources of information and data related to the Janssen COVID-19 Vaccine to reach a decision today.
Specifically, the agencies compiled the report submitted to Vaccine Sensitive Event Reporting System (VAERS),external icon reviewed the medical literature and considered information from global management partners about thrombosis with thrombocytopenia reported after the use of an identical, but not identical, COVID-19 vaccine using a virus from the family adenovirus modified to contain a gene for the production of a protein from SARS-CoV-2.
Bad Events Update
On April 13, the FDA and CDC Office has partneredexternal icon that, out of more than 6.8 million doses administered, six reports of a rare and severe type of blood clot accompanied by low blood platelet levels occurring in people after receiving Janssen COVID -19 Vaccine report by VAERS. In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) is found to be associated with low levels of blood platelets (thrombocytopenia).
Today, agencies can confirm that a total of 15 TTS cases have been reported by VAERS, including the original six reported cases. All of these cases occurred in women aged 18 and 59, aged 37 years. Reports of manifested symptoms begin between 6 and 15 days after vaccination.
Perseverance for Salvation Perseverance
Surveillance systems in place to monitor the safety of the COVID-19 vaccine authorized for emergency use are working, as demonstrated by the two agencies ’rapid work in identifying and evaluating these unique features. , but serious bad events. The FDA and CDC will continue these efforts to closely monitor the safety of these vaccines.
Reports of adverse events following vaccination may be made to those Vaccine Sensitive Event Reporting Systemexternal icon.