NPF COVID-19 Task Force Reinstates Guidance for Johnson & Johnson Vaccine

Once again, the National Psoriasis Foundation recommends that that individuals with psoriatic disease receive the first COVID-19 vaccine offered to them.

Portland, Oregon – April 30, 2021

On April 23, the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control (CDC) lifted the recommended pause the COVID-19 vaccine manufactured by Johnson & Johnson. The pause was recommended after reports of 6 cases of a rare and severe blood clot in individuals who had received the Johnson & Johnson vaccine.

“We applaud the caution exercised by the FDA and CDC,” said Stacie Bell, Ph.D., Chief Scientific and Medical Officer for the National Psoriasis Foundation (NPF). “The safety of those who receive any COVID-19 vaccine must be the priority. The pause gave these regulatory agencies the time they needed to thoroughly examine the available data to assess the risk of thrombosis that involves the cerebral venous sinuses.”

The two agencies have determined the following [1]:

  • Use of the Johnson & Johnson 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 thrombosis-thrombocytopenia syndrome 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) and Fact Sheet for Recipients and Caregivers, 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 Johnson & Johnson COVID-19 Vaccine

In light of the findings of the FDA and CDC, the NPF COVID-19 Task Force once again recommends that individuals with psoriatic disease receive the first COVID-19 vaccine offered to them with the administration guidelines in mind, as all three of the currently available vaccines are extremely effective at preventing serious COVID-19 outcomes like hospitalization and/or death.

“We recognize that these delays and deliberations over vaccine safety will not help vaccine hesitancy, and it was our groups’ strong feeling that benefits outweigh risks and that expediency of getting the immune mediated inflammatory disease population vaccinated outweighs and potential risks,” said Cassandra Calabrese, DO, associate staff in the Departments of Rheumatology and Infectious Disease at Cleveland Clinic, board-certified in both rheumatology and infectious disease.

“Our multi-disciplinary group of dermatologists, rheumatologists, and specialists in infectious diseases and pulmonary critical care medicine are unanimous in our recommendation that patients with psoriatic disease get the first COVID19 vaccine available to them. The benefits of these vaccines far outweigh their risks and COVID19 remains a major public health threat in the United States,” said Joel M. Gelfand, M.D., MSCE, Professor of Dermatology and Epidemiology at the University of Pennsylvania Perelman School of Medicine and Co-Chair of the NPF COVID-19 Task Force.

The updated NPF Task Force COVID-19 Guidance Statements contain two considerations, 4.8 and 4.9, addressing the use of the Johnson & Johnson (Ad26.COV2.S) vaccine for those with psoriatic disease. These statements were withheld during the FDA and CDC recommended pause in the use of this vaccine. They are now reimplemented.   

The National Psoriasis Foundation launched its COVID-19 Task Force in May 2020, charged to identify critical needs for the psoriatic disease community and to serve as an expert resource to the organization in an advisory capacity. The Task Force is comprised of physicians with expertise in dermatology, rheumatology, infectious disease, and critical care, in addition to fellows and NPF staff.

The Foundation continues to closely monitor the evolving situation. The Task Force encourages the psoriatic disease community to receive the first vaccine offered to them, adhere to public health guidelines, and consult with a health care provider if infected with SARS-CoV-2. For more information, visit the NPF COVID-19 Resource Center.

 

About the National Psoriasis Foundation

Serving its community through more than 50 years of patient support, advocacy, research, education and funding, the National Psoriasis Foundation, NPF, is the world’s leading nonprofit fighting for individuals with psoriasis and psoriatic arthritis. The NPF mission is to drive efforts to cure psoriatic disease and dramatically improve the lives of more than 8 million individuals in the United States affected by this chronic immune-mediated disease. As part of that effort, NPF created its Patient Navigation Center to offer personalized assistance to everyone with psoriasis or psoriatic arthritis. To date, NPF has funded more than $24 million in research grants and fellowships that help drive discoveries that may lead to more and better treatments and ultimately a cure. Learn more at psoriasis.org

 

 

Reference

FDA CDC Reference

[1] FDA and CDC Lift Recommended Pause on Johnson & Johnson (Janssen) COVID-19 Vaccine Use Following Thorough Safety Review. April 23, 2021. FDA News Release. fda.gov/news-events/press-announcements/fda-and-cdc-lift-recommended-pause-johnson-johnson-janssen-covid-19-vaccine-use-following-thorough

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