The US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) have lifted a pause on the rollout of Johnson & Johnson’s (J&J) COVID-19 vaccine in the US and recommended that the rollout of the vaccine should resume.

The pause had been recommended after reports by the agencies of six cases of a rare and severe type of blood clot in individuals receiving the vaccine out of approximately more than 6.8 million doses of the vaccine administered. The agencies later confirmed a total of 15 cases, including the original six reported cases. All of these cases occurred in women between the ages of 18 and 59, with a median age of 37 years.

The decision to resume the vaccine’s use was based on a recommendation from the CDC’s Advisory Committee on Immunization Practices, which followed an evaluation of data relating to a very rare adverse event involving blood clots in combination with low platelet counts, also known as thrombosis-thrombocytopenia syndrome (TTS), observed within approximately one to two weeks following vaccination.

The agencies 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 (as reported on April 23, 2021), the available data suggest that the chance of TTS occurring is very low, but the FDA and CDC say they will continue to investigate this risk.

J&J has updated the Emergency Use Authorization Fact Sheets for Healthcare Providers Administering Vaccine (Vaccination Providers), and Recipients and Caregivers for its COVID-19 vaccine to include information about the diagnosis and treatment of thrombosis with thrombocytopenia.

J&J says it continues to work with other healthcare authorities and regulators globally to ensure this information is included in product labels for its COVID-19 vaccine. Last week (April 20, 2021), the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee also issued a recommendation, confirming the overall benefit-risk profile of  J&J’s COVID-19 vaccine remains positive.

Source: US Food and Drug Administration, Centers for Disease Control and Prevention, and Johnson & Johnson (vaccinations to resume) and Johnson & Johnson (CDC Advisory Committee Decision)