CDC Panel Recommends Restarting Johnson & Johnson COVID-19 Vaccinations

April 23, 2021
Aislinn Antrim, Associate Editor

A CDC panel voted to add a warning label to the vaccine regarding rare cases of cerebral venous sinus thrombosis.

A panel of advisers with the CDC has voted to recommend lifting the pause on Johnson & Johnson’s COVID-19 vaccine for all adults, although they voted to add a label about the rare blood clotting disorder that has created recent concerns.1

According to a report from The New York Times, a CDC scientist presented 9 new confirmed cases of cerebral venous sinus thrombosis (CVST), the rare condition that has been potentially linked to the vaccine.1 Those 9 cases bring the total number to 15, all of which have been in women, with 13 cases in women between 18 and 49 years of age.1

Officials with the FDA and CDC halted use of the vaccine on April 13, citing concerns about these CVST cases. As of April 12, more than 6.8 million doses of the vaccine have been administered in the United States, with an additional 9 million shipped to the states.2

“Right now, these adverse events appear to be extremely rare,” said Anne Schuchat, MD, principal deputy director of the CDC, and Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in a joint statement announcing the pause. “COVID-19 vaccine safety is top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously.”2

The statement said patients who receive the Johnson & Johnson vaccine should monitor for severe headache, abdominal pain, leg pain, or shortness of breath for 3 weeks following vaccination, and should contact their health care provider if they experience any of these symptoms.2 According to The New York Times, women between 30 and 39 years of age appear to be at the greatest risk for developing the condition, with 7 cases per million doses in this patient population.1

“This pause was essential to our ability to inform the public,” said Jose R. Romero, MD, FAAP, FIDSA, FPIDS, FAAAS, the chair of the CDC advisory panel, according to The New York Times.1

Officials from Johnson & Johnson have agreed to add the warning label to the vaccine and have worked with the FDA to develop language for the label. Additional potential cases of the clotting disorder, including some in men, are currently being investigated.1

REFERENCES

  1. Zimmer C. and Anthes E. A CDC panel recommends J&J shots restart with a label noting the risk of very rare blood clots. New York Times; April 23, 2021. https://www.nytimes.com/live/2021/04/23/world/covid-vaccine-coronavirus-cases. Accessed April 23, 2021.
  2. CDC, FDA Announce Pause in Use of Johnson & Johnson COVID-19 Vaccine Over Concerns of Rare Blood Clot. Pharmacy Times; April 13, 2021. https://www.pharmacytimes.com/view/cdc-fda-announce-pause-in-use-of-johnson-johnson-covid-19-vaccine-after-concerns-of-rare-blood-clot. Accessed April 23, 2021.