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ACOG Statement on the Johnson & Johnson COVID-19 Vaccine


On April 23, 2021, the Centers for Disease Control and Prevention and the U.S. Food and Drug Administration (FDA) recommended use of Johnson & Johnson’s Janssen (J&J/Janssen) COVID-19 Vaccine resume in the United States after the temporary pause. A review of available data showed that the J&J/Janssen COVID-19 Vaccine’s known and potential benefits outweigh its known and potential risks. Currently, obstetric-gynecologic patients can receive any FDA-authorized COVID-19 vaccine available to them. For more information see ACOG’s Practice Advisory: COVID-19 Vaccination Considerations for Obstetric–Gynecologic Care.

Washington, DC – The following is a statement from Christopher M. Zahn, MD, Vice President, Practice Activities for the American College of Obstetricians and Gynecologists (ACOG), developed in partnership with Laura E. Riley, MD; Richard Beigi, MD; Denise J. Jamieson, MD, MPH; Brenna L. Hughes, MD, MSc; Geeta Swamy, MD; Linda O’Neal Eckert, MD; Mark Turrentine, MD, the authors of ACOG’s Practice Advisory on Vaccinating Pregnant and Lactating Patients Against COVID-19.

“ACOG is aware that the U.S. Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) have put the Johnson & Johnson COVID-19 vaccination program on hold out of an abundance of caution based on a possible safety signal that requires further investigation. To date, six cases of cerebral venous sinus thrombosis (CVST) have been reported among recipients of the Jonson & Johnson vaccine, out of a reported total of 6.8 million doses administered in the United States. The available data on these cases shows that all occurred in women ages 18–48 years. The clinical syndrome includes cerebral venous thrombosis associated with thrombocytopenia occurring 6–13 days post vaccination.

“This syndrome is similar to the cases reported in Europe associated with AstraZeneca COVID-19 vaccine, which is another adenovirus vector vaccine.

“Because the CDC and the FDA have placed the Johnson & Johnson vaccine program on hold out of an abundance of caution, it is not currently available for anyone, including women of reproductive age. Those who wish to be vaccinated in the interim should be aware that the Pfizer and Moderna COVID-19 vaccines remain available.”

What Obstetrician–Gynecologists Should Know

“At this time, there is no clear phenotype of women who are more or less likely to experience this rare complication. However, until there is a better understanding of the frequency and impact of this finding, it will be important to encourage pregnant and postpartum women who wish to be vaccinated to receive the mRNA vaccines: Pfizer or Moderna.

“Individuals who have been vaccinated with the Johnson & Johnson vaccine within the last 21 days who experience severe headache, abdominal pain, leg pain, or shortness of breath should seek immediate evaluation. They should be certain to communicate that they have received the Johnson & Johnson vaccine to prompt appropriate evaluation. Given the elevated risk for thrombosis experienced by women during pregnancy or the postpartum period and while using birth control pills, evaluation of acute thrombosis is commonly performed in our specialty. Rapid treatment with anticoagulation is the standard; however, this is not the same event and anticoagulation for treatment of CVST is dangerous.”

“If venous thrombosis is noted in the setting of thrombocytopenia, treatment includes intravenous immunoglobulin and other supportive care.  Importantly, treatment with heparin is contraindicated in these cases.”

For more information