The Centers for Disease Control, the Food and Drug Administration, and the NYS COVID-19 Clinical Advisory Task Force have given the green light to resume the administration of the J&J/Janssen COVID-19 vaccine, which had been paused on April 13. After reports of rare blood clot events following receipt of the J&J vaccine, vaccine surveillance protocols were set in motion, demonstrating the speed of efforts and dedication to safety exhibited by members of the Advisory Committee on Vaccine Practices (ACIP).
ACIP met on Friday, April 23, to review clinical data about the adverse events and discuss the benefit-risk profile of the J&J vaccine. After several hours of presentations, analysis, and public comments, ACIP members voted 10-4 in favor of resuming the US roll-out of the J&J COVID-19 vaccine to all those aged 16+ in the setting of a pandemic.
The Fact Sheet for health care providers and the EUA Fact Sheet for vaccine recipients have been updated to include the information regarding the risk of a rare but serious blood clot that may be linked to the vaccine, especially in women under 50 years of age. The ACIP decision stresses that the benefits of the vaccine to public health outweigh the possible individual risks. They noted that blood clots and fatalities are far more frequent in severe COVID than in vaccinated individuals. Details about the findings as well as the updated Fact Sheets can be found in the FDA news release.
Weighing heavily in the experts' decision was the need for vaccine access during the public health emergency. The J&J vaccine is the only FDA authorized single-dose vaccine and its availability has greatly improved immunization efforts in vulnerable populations including homebound individuals and those experiencing homelessness.
Full coverage of the ACIP decision will be available to members in Friday's issue of the HCP Insider. Direct questions and comments to the Public Policy team via email: email@example.com or firstname.lastname@example.org.
In an effort to simplify the COVID-19 immunization process and expand access, New York City Mayor Bill de Blasio announced Friday that all eligible New Yorkers can walk-in without an appointment and be vaccinated at all city-run sites. Appointment requirements were recently eliminated for those aged 60+, and due to the success of that protocol change, the decision was made to expand the walk-in option to all those aged 16+.
Locate a city-run site by visiting: nyc.gov/vaccinefinder.
State-run sites will continue to allow walk-in vaccines for those aged 60+. Some may allow a companion to be vaccinated as well. All other vaccinators such as pharmacies and primary care providers still require appointments in order to maintain social distancing and other safety measures.
Count on HCP's Public Policy team to keep you informed about any developments regarding easing appointment restrictions.