(WPRI) — An advisory committee to the U.S Centers for Disease Control and Prevention (CDC) held a virtual emergency meeting Wednesday to discuss the safety of Johnson & Johnson’s single-dose vaccine.
The vaccine, which received Emergency Use Authorization by the U.S. Food and Drug Administration (FDA) on Feb. 27, was recommended by the CDC and FDA to be put on pause as they investigate six cases of a rare, but severe blood clot.
The FDA says the cases were reported in women between the ages of 18 to 48 and symptoms occurred 6 to 13 days after receiving the vaccine. One woman died, while another is hospitalized in critical condition, according to health officials.
Health officials in both Massachusetts and Rhode Island say no cases were reported, but they would follow the recommended pause while federal agencies investigate.
Anyone who has received the J&J vaccine and develops a severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider. The FDA says anyone that has received the vaccine more than a month ago is at extremely low risk.
R.I. Department of Health Director Dr. Nicole Alexander-Scott said the statistical chance of these side effects is roughly one in a million. She says what’s unique about the kind of blood clots reported is the kind of medication used to treat it.
“Being able to get that message to providers has been a critical element of this and warranted the pause so that we could make that clear, because that is a definitive shift from how we would usually treat such a condition identified,” she explained.
Rhode Islanders scheduled to receive the Johnson & Johnson vaccine at regional or state-run mass vaccination sites will keep their slots, but be offered Pfizer or Moderna instead. However, about 300 who signed up at Green Line Apothecary, White Cross Pharmacy and the Rhode Island Free Clinic are being contacted to reschedule.
Tom McCarthy, executive director of the state’s COVID-19 Response Team, says retail pharmacies like CVS, Walgreens, Walmart and Stop & Shop will also contact people who had J&J appointments.
McCarthy says the state does not anticipate the J&J pause will delay expanding eligibility next Monday, nor will it affect the anticipated milestones of 70% of Rhode Islanders 16 and up receiving one dose by May 15 and two doses by June 5. He says due to a previously expected decreased in J&J doses, the state had planned to rely heavily on Pfizer and Moderna vaccines to meet those goals.
“The good news is is we have a very robust distribution system in place, so when the pause is lifted, you know, just about any amount of Johnson & Johnson that we have in the state we could, we could administer that week,” McCarthy said.
The Advisory Committee on Immunization Practices held a three-hour meeting on the adverse events reported in connection with the J&J vaccine Wednesday afternoon.
Before voting on updated recommendations for use, committee members reviewed the safety with the vaccine, discussed the thromboembolic events and safety surveillance, and heard an assessment from the committee’s Vaccine Safety Technical Subgroup.
The committee’s recommendations won’t bring an immediate end to the pause, however. The FDA will also review the committee’s findings and recommendations before making the final call.
The FDA commissioner said Tuesday the pause was expected to last “a matter of days.”
At this time, the FDA says these adverse events appear to be extremely rare.
Health care providers are asked to report any adverse events to the Vaccine Adverse Event Reporting System at https://vaers.hhs.gov/reportevent.htmlexternal icon.