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The United States Resumes Use of the J&J/Janssen COVID-19 Vaccine

Posted: May 06, 2021
The United States Resumes Use of the J&J/Janssen COVID-19 Vaccine image

Martin S. Tallman, MD, AML expert and President of the American Hematology Society (ASH) released a statement on April 23rd, 2021 in conjunction with the CDC and FDA’s decision to lift the pause on the Johnson & Johnson’s Janssen (J&J/Janssen) COVID-19 vaccine. 

Tallman states, “Highly effective vaccines are the most powerful tool in our arsenal to end the COVID-19 pandemic. Based on existing evidence, the benefits of vaccination against COVID-19 significantly outweigh the extremely low risk of blood clots or other hematologic complications reported after vaccination. In fact, COVID-19 infection carries a much higher risk of blood clots —147,000 in 1 million hospitalized COVID-19 patients experience clots, compared to roughly 2 in 1 million individuals who received the J&J/Janssen vaccine. Getting vaccinated against COVID-19 is the greatest protective measure one can take to avoid COVID-19-associated blood clots.

This statement comes after a 10-day pause on the J&J/Janssen vaccine after several cases of blood clots were reported. These blood clots are now termed thrombocytopenia with thrombosis syndrome (TTS). Thrombocytopenia describes a condition where there aren’t enough platelets in the blood. Platelets help the blood to clot (clump), which stops you from bleeding excessively (for example, if you cut yourself). Thrombosis occurs when a blood clot forms in a vein or artery. TTS is a very rare, new and specific syndrome. It occurs when a person has blood clots (thrombosis) as well as low platelet counts (thrombocytopenia). It’s also referred to as "vaccine-induced prothrombotic immune thrombocytopenia" (VIPIT).

During the J&J/Janssen pause, the FDA and CDC reviewed all sources of vaccine event reporting in the United States following J&J/Janssen vaccine administration and conducted a detailed risk/benefit analysis. The CDC Advisory Committee on Immunization Practices met on April 23, 2021, and voted to recommend that the J&J/Janssen vaccine again be available for adults aged 18 years and older under the FDA’s Emergency Use Authorization. They concluded that the benefits of the vaccine far outweigh the very low risk of TTS.

What Does This Mean for Patients with AML?

ASH specifically reports that there is no information to date on any increased risk for TTS in patients with blood diseases. They recommend patients with blood cancer continue to get vaccinated and even report that the single-dose J&J/Janssen vaccine may be particularly attractive for patients who are about to start chemotherapy or other immunosuppressive therapies.

In addition to receiving a COVID-19 vaccine, patients with AML can further reduce their risk of COVID-19 infection by wearing masks when around others, keeping hands clean and sanitized, continuing to practice social distancing recommendations and participating in follow-up telehealth visits when appropriate. 


 

Martin S. Tallman, MD, AML expert and President of the American Hematology Society (ASH) released a statement on April 23rd, 2021 in conjunction with the CDC and FDA’s decision to lift the pause on the Johnson & Johnson’s Janssen (J&J/Janssen) COVID-19 vaccine. 

Tallman states, “Highly effective vaccines are the most powerful tool in our arsenal to end the COVID-19 pandemic. Based on existing evidence, the benefits of vaccination against COVID-19 significantly outweigh the extremely low risk of blood clots or other hematologic complications reported after vaccination. In fact, COVID-19 infection carries a much higher risk of blood clots —147,000 in 1 million hospitalized COVID-19 patients experience clots, compared to roughly 2 in 1 million individuals who received the J&J/Janssen vaccine. Getting vaccinated against COVID-19 is the greatest protective measure one can take to avoid COVID-19-associated blood clots.

This statement comes after a 10-day pause on the J&J/Janssen vaccine after several cases of blood clots were reported. These blood clots are now termed thrombocytopenia with thrombosis syndrome (TTS). Thrombocytopenia describes a condition where there aren’t enough platelets in the blood. Platelets help the blood to clot (clump), which stops you from bleeding excessively (for example, if you cut yourself). Thrombosis occurs when a blood clot forms in a vein or artery. TTS is a very rare, new and specific syndrome. It occurs when a person has blood clots (thrombosis) as well as low platelet counts (thrombocytopenia). It’s also referred to as "vaccine-induced prothrombotic immune thrombocytopenia" (VIPIT).

During the J&J/Janssen pause, the FDA and CDC reviewed all sources of vaccine event reporting in the United States following J&J/Janssen vaccine administration and conducted a detailed risk/benefit analysis. The CDC Advisory Committee on Immunization Practices met on April 23, 2021, and voted to recommend that the J&J/Janssen vaccine again be available for adults aged 18 years and older under the FDA’s Emergency Use Authorization. They concluded that the benefits of the vaccine far outweigh the very low risk of TTS.

What Does This Mean for Patients with AML?

ASH specifically reports that there is no information to date on any increased risk for TTS in patients with blood diseases. They recommend patients with blood cancer continue to get vaccinated and even report that the single-dose J&J/Janssen vaccine may be particularly attractive for patients who are about to start chemotherapy or other immunosuppressive therapies.

In addition to receiving a COVID-19 vaccine, patients with AML can further reduce their risk of COVID-19 infection by wearing masks when around others, keeping hands clean and sanitized, continuing to practice social distancing recommendations and participating in follow-up telehealth visits when appropriate. 


 

The author Katie Braswell

about the author
Katie Braswell

Katie joined HealthTree as the Community Director for AML in 2021 and became HealthTree's Director of Education in 2023. Katie is a registered dietitian who is passionate about health literacy and patient empowerment. She loves to cook, travel and spend time with her newborn son, husband and dog.

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