SACRAMENTO – The California Department of Public Health (CDPH) issued a statement from Dr. Erica Pan, state epidemiologist, regarding the Western States Scientific Safety Review Workgroup’s recommendation to support the lift of a temporary pause on administration of the Johnson & Johnson(Janssen) COVID-19 vaccine.
“After a thorough review of very rare adverse events following the Johnson & Johnson vaccine, the Western States Scientific Safety Review Workgroup supports the recommendation of the FDA and CDC to lift the pause on the vaccine. Clinics in California may begin administering the Johnson & Johnson vaccine immediately as long as they provide appropriate educational materials to inform patients of the vaccine’s low risk of associated health effects and other available vaccine options.
More than half of Californians 16 and older have received one of the three vaccines available, and the one-shot Johnson & Johnson vaccine is also an important tool in our fight to stop the spread of COVID-19, especially as more aggressive variants of the virus spread throughout the country. We hope we continue to make progress in getting more Californians vaccinated so we can move beyond this pandemic,” Dr. Pan said.
Pan’s statement came after a thorough safety review, including two meetings of the CDC’s Advisory Committee on Immunization Practices, the U.S. Food and Drug Administration (FDA), and the U.S. Centers for Disease Control and Prevention (CDC) determined that the recommended pause regarding the use of the Johnson & Johnson COVID-19 Vaccine in the U.S. should be lifted and use of the vaccine should resume.
The pause was recommended after reports of six cases of a rare and severe type of blood clot in individuals following administration of the Johnson & Johnson (Janssen) COVID-19 Vaccine. During the pause, medical and scientific teams at the FDA and CDC examined available data to assess the risk of thrombosis involving the cerebral venous sinuses, or CVST (large blood vessels in the brain), and other sites in the body (including but not limited to the large blood vessels of the abdomen and the veins of the legs) along with thrombocytopenia, or low blood platelet counts.
The teams at FDA and CDC also conducted extensive outreach to providers and clinicians to ensure they were made aware of the potential for these adverse events and could properly manage and recognize these events due to the unique treatment required for these blood clots and low platelets, also known as thrombosis-thrombocytopenia syndrome (TTS).
The two agencies have determined the following:
- Use of the Janssen COVID-19 Vaccine should be resumed in the United States.
- The FDA and CDC have confidence that this vaccine is safe and effective in preventing COVID-19.
- The FDA has determined that the available data show that the vaccine’s known and potential benefits outweigh its known and potential risks in individuals 18 years of age and older.
- At this time, the 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 the vaccine and vaccine recipients or caregivers should review the Janssen COVID-19 Vaccine Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers)external icon and Fact Sheet for Recipients and Caregiversexternal icon, which have been revised to include information about the risk of this syndrome, which has occurred in a very small number of people who have received the Janssen COVID-19 Vaccine.
San Luis Obispo County Health Office has not released a statement whether or not the county will resume administration of the vaccine as of today.