April 29, 2021, 12:19 p.m. Michael Devitt — The CDC’s Advisory Committee on Immunization Practices has published updated recommendations on the use of the Janssen/Johnson & Johnson COVID-19 vaccine. The recommendations, published in a Morbidity and Mortality Weekly Report Early Release on April 27, include a new warning on the risk of thrombosis with thrombocytopenia syndrome in women ages 18 to 49, and follow the committee’s April 23 vote to reaffirm its interim recommendation for use of the vaccine in individuals 18 and older under the FDA’s emergency use authorization.
“Resumption of administering the Johnson & Johnson vaccine is a positive step for family physicians and our patients since we know the vaccine is extremely effective at preventing morbidity and mortality due to COVID-19,” said Julie Wood, M.D., M.P.H., the Academy’s senior vice president for research, science and health of the public.
“TTS is a rare event and now family physicians are prepared to recognize and treat the condition,” Wood continued. “Family physicians also have an important opportunity to remind patients there is a higher risk of blood clots from COVID-19 than from the vaccine. The Johnson & Johnson vaccine remains an effective and safe option. Given the misinformation circulating around all the vaccines, family physicians continue to play a crucial role in answering questions and providing accurate information to our patients and communities.”
The FDA and CDC initially recommended a short pause for the use of the Janssen/Johnson & Johnson vaccine on April 13, based on reports from the Vaccine Adverse Event Reporting System that linked the vaccine with six cases of cerebral venous sinus thrombosis seen in combination with thrombocytopenia. All six cases occurred among white women between the ages of 18 and 48. Four patients developed focal neurological symptoms, and one patient died from intraparenchymal brain hemorrhage.
The updated recommendations provided additional data. As of April 21, nearly 8 million doses of the Janssen/Johnson & Johnson vaccine had been administered in the United States. Between March 2 and April 21, VAERS had received 15 reports of TTS occurring after vaccination, with 13 cases occurring in women aged 18-49 and two cases in women 50 and older. All 15 patients were hospitalized; as of the most recent followup, three patients had died, seven remained hospitalized and five had been discharged home.
The ACIP’s vote to reaffirm the recommendation for use was based on a risk-benefit analysis that showed the benefits of vaccination, such as prevention of COVID-19-related hospitalizations and ICU admissions, outweighed the risks (expected cases of TTS) in all populations. The summary of evidence also found the Janssen/Johnson & Johnson vaccine to be “a highly effective and flexible prevention tool that can be useful in communities with increasing COVID-19 incidence and emerging variants of SARS-CoV-2.”
The FDA has added a warning about the risk of TTS to the Janssen/Johnson & Johnson EUA. The agency has also published updated fact sheets for clinicians, as well as for patients and caregivers, and has updated its Janssen COVID-19 Vaccine FAQ webpage to provide additional details on adverse events.
The updated recommendations also say treatment for TTS that occurs after a patient receives the Janssen/Johnson & Johnson vaccine should be approached differently than the treatment typically administered for blood clots; in particular, heparin should not be administered, and consultation with a hematology specialist is strongly recommended.
Clinicians are encouraged to consult a recent CDC Health Alert Network notification along with guidance from the American Society of Hematology for more information on the diagnosis and treatment of patients suspected to have TTS.
Additional clinical considerations for the use of COVID-19 vaccines are available from the CDC.
The AAFP also has updated its COVID-19 Vaccine webpage to provide members with the latest information on the Janssen/Johnson & Johnson vaccine.