Most Crossroads vaccine providers will pause distribution of Johnson & Johnson’s COVID-19 vaccine while regulators review six reports of blood clot disorders in women who had received the vaccine in the U.S.
So far, the six blood clots are the only adverse events identified in the 6.8 million people in the U.S. who have received the Johnson & Johnson vaccine.
“This is six cases out of a total of almost 7 million doses,” said Dr. Prathit Kulkarni, an infectious disease expert and assistant professor at the Baylor College of Medicine. “Right now based on the current information that we have, that’s theoretically less than a one in a million chance of having this very rare potential side effect from the vaccine.
This week, federal regulators and advisors will review the six cases reported to determine whether there is a link between the vaccine and the clotting, Kulkarni said. He said he expected the pause to be brief, and that updated guidance would likely be released within the next two weeks.
A vaccine clinic scheduled for Thursday in Cuero has been canceled, and local Walgreens pharmacies have said they will pause distribution of the Johnson & Johnson vaccine. Overall, the impact in the Crossroads will be relatively small, as the majority of local vaccine providers are providing Pfizer’s and Moderna’s COVID-19 vaccines.
Both the U.S. Centers for Disease Control and Prevention and the Food and Drug Administration recommended Tuesday that vaccine providers voluntarily pause distribution of the vaccine. The recommendation does not affect the distribution of Moderna and Pfizer’s COVID-19 vaccines, which rely on a different technology than Johnson & Johnson’s Janssen vaccine. There have been no blood clots reported in people who received the Moderna or Pfizer vaccines.
Although very rare, the six blood clots identified were serious, according to the CDC and the FDA. All six were identified in women between the ages of 18 and 48, and developed the illness between six and 13 days after receiving the vaccine. One woman has died, according to the agencies’ joint statement. None of these six blood clots were identified in women in Texas, according to a news release from Gov. Greg Abbott’s office.
Dr. Scott Gottlieb, the former head of the FDA under the Trump administration, said during an interview on CNBC that the pause was really “an alert to doctors.”
“For most consumers, I wouldn’t be concerned about this,” Gottlieb said Tuesday. “It’s advice to doctors to be monitoring more closely.”
Kulkarni and coronavirus expert Dr. Ben Neuman, a coronavirus expert at Texas A&M University-Texarkana, both said the pause was evidence that the country’s system for monitoring vaccines can respond quickly and safely.
“When we do studies on vaccines, a lot of what we learn is about how people are different, and this appears to be one of those cases,” Neuman said.
Neuman said the agencies’ response gave him “increased confidence that we’re doing the right thing in terms of watching what’s going on and responding.”
Experts encouraged people who had planned to get the Johnson & Johnson vaccine to consult with their physician and to make plans to receive the Pfizer or Moderna vaccine if recommended by their physician or if they can get the Pfizer or Moderna vaccine sooner.
Kulkarni noted that the occurrence of the blood clots is, so far, so infrequent that the risk to any individual who has already received the vaccine “very, very low.”
COVID-19 cases are continuing to increase in certain parts of the country but haven’t yet reached the sky-high levels seen locally or nationally earlier in the pandemic. On Tuesday, the state health department reported 4,370 new cases of the disease and 54 new deaths from COVID-19.