1580: A new report has been released by the American Heart Association/American Stroke Association Stroke Council Leadership in response to the decision by the Centers for Disease Control and Prevention (CDC) and the US Food and Drug Administration (FDA) to lift the pause on the use of Johnson & Johnson (Janssen) COVID-19 vaccine.

The pause was imposed after there were reports of a possible link between the J&J vaccine and cerebral venous sinus thrombosis (CVST) and thrombosis-thrombocytopenia syndrome (TTS, blood clots and low platelets). CVST and TTS were also associated with patients in Europe and Canada who were administered the AstraZeneca COVID-19 vaccine.

The new report states that these conditions are very rare.

Lead author Karen L. Furie stated that the risk of CVST due to infection with COVID-19 is 8 to 10-fold higher than after receiving a COVID-10 vaccine. Furie added that people can be reassured by the CDC and FDA investigation and these data that the chances of developing CVST after a COVID-19 vaccine is extremely low. The authors urged all adults to receive any of the approved vaccines.

The new guidance was published online  in Stroke, and enumerates the signs and symptoms of CVST and TTS, and of vaccine-induced immune thrombotic thrombocytopenia (VITT). It also recommends the best options for the treatment of these conditions.

In the analysis, investigators evaluated a database of 59 healthcare organizations and 81 million patients (98% of these were in the United States). Out of nearly 514,000 patients diagnosed with COVID-19 from January 2020 through March 2021, 20 had a diagnosis of CVST.

Among close to 490,000 people who were administered either the Pfizer or Moderna vaccine, there were no cases of thrombocytopenia.

Furie stated that CVST blood clots were very rare adverse events, while also recommending that any patient in the emergency department with a suspected clot must undergo screening to ascertain if they received a COVID-19 vaccine during the previous few weeks.

For those who recently received a COVID-19 vaccine, a suspected clot should be treated with non-heparin anticoagulants. No heparin products should be given for suspected CVST, TTS, or VITT. With the right treatment, most patients can recover completely.

Cases of TTS/VITT were noted up to 2 1/2 weeks following receipt of the J&J vaccine in the United States and up to 3 1/2 weeks following the AstraZeneca vaccine in Europe.

An April 23 report from the CDC and FDA stated that among nearly 7 million adults administered the J&J vaccine, the agencies investigated only 15 reported cases of TTS. An April 7 report from the European Medicines Agency stated that among over 25 million individuals administered the AstraZeneca vaccine in the European Union, 62 cases of CVST were noted.

[Source: Medscape]

Dr KK Aggarwal

President CMAAO, HCFI and Past National President IMA