NYS J&J Vaccine Pause; FDA Recommends Moving Away from Crisis Capacity Conservation Strategies for Respirators

April 13, 2021

The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) issued a joint statement to recommend a pause in the use of Johnson & Johnson COVID-19 vaccine. The recommendation is out of an abundance of caution due to six reported US cases of a rare and severe type of blood clot in individuals after they received the Johnson & Johnson vaccine. Following the announcement, New York State Department of Health (DOH) Commissioner Dr. Howard Zucker issued a statement announcing that New York State will follow the CDC and FDA recommendation and pause use of the Johnson & Johnson vaccine statewide immediately today while these health and safety agencies evaluate next steps.

The CDC’s Advisory Committee on Immunization Practices will meet tomorrow to review the six cases of adverse events to determine recommendations for next steps for use of the Johnson & Johnson vaccine. To date, more than 6 million doses have been administered across the United States. The CDC recommends that individuals who received the vaccine in the past three weeks and who are experiencing symptoms of severe headache, abdominal pain, leg pain, or shortness of breath should seek medical attention. CDC further recommends that providers evaluate vaccine status for patients with such symptoms. GNYHA anticipates additional guidance from the CDC, FDA, and DOH.

FDA Recommends Moving Away from Crisis Capacity Conservation Strategies for Respirators

The FDA issued a letter to health care personnel and facilities recommending that they transition away from crisis capacity conservation strategies for respirators such as decontaminating or bioburden reducing disposable respirators for reuse. Based on the increased domestic supply of new respirators approved by the CDC National Institute for Occupational Safety and Health currently available to facilitate this transition, the FDA and CDC believe there is an adequate supply of respirators to transition away from use of decontamination and bioburden reduction systems.

For a compilation of recent COVID-19 guidance, including guidance related to vaccine distribution, please visit GNYHA’s COVID-19 webpage.