Administration of Johnson & Johnson COVID-19 vaccine allowed to resume as FDA and CDC lift pause
Administration of the Johnson & Johnson COVID-19 vaccine may be resumed after a 10-day pause, the US Food and Drug Administration (FDA) and US Centers for Disease Control and Prevention (CDC) say. The initial pause went into effect April 13, 2021, due to multiple cases of a rare and potentially fatal blood clotting disorder.
The FDA and CDC announced April 23, that administration of the vaccine could be resumed after a review of the cases that triggered the pause. The FDA and CDC issued a joint statement highlighting their belief that the vaccine is safe and effective for preventing COVID-19 and outlining how the benefits of the vaccine outweigh the risks for the populations that the vaccine is authorized to be used for.
“This pause was an example of our extensive safety monitoring working as they were designed to work—identifying even these small number of cases. We’ve lifted the pause based on the FDA and CDC’s review of all available data and in consultation with medical experts,” said Janet Woodcock, MD, Acting FDA Commissioner. “We are confident that this vaccine continues to meet our standards for safety, effectiveness and quality.”
As the vaccine rollout in the United States continues, it remains unclear if this pause will have an effect on people’s perception of the safety of the vaccine and if it will impact vaccination rates.
FDA and CDC: FDA and CDC Lift Recommended Pause on Johnson & Johnson (Janssen) COVID-19 Vaccine Use Following Thorough Safety Review