An independent advisory panel for the Centers for Disease Control and Prevention (CDC) voted Friday 10 – 4 to recommend the continued use of the Johnson & Johnson (J&J) vaccine after the single-dose shot was paused over blood clotting concerns. The panel did not recommend adding any extra warning about the risk of rare blood clotting disorders.
The recommendation by the CDC’s Advisory Committee on Immunization Practices (ACIP) has to be approved by the CDC and the U.S. Food and Drug Administration (FDA) before becoming official government policy.
The ACIP said the link between blood clots and J&J’s COVID vaccine was “plausible,” but concluded the vaccine’s benefits still outweigh the risks and recommended the vaccine for persons 18 years of age and older in the U.S. under the FDA’s Emergency Use Authorization (EUA).
“This is a serious adverse event,” said Dr. Grace Lee, a pediatrician at the Lucile Packard Children’s Hospital and Stanford University School of Medicine in Stanford, California. “We need to continue to ensure that awareness is raised. But I also think that we have to come out with a clear recommendation,” she said.
Dr. Pablo Sanchez, a pediatrician at The Ohio State University’s Nationwide Children’s Hospital in Columbus and one of the four “no” votes, said he supported returning the vaccine to the market, but felt it was important to add a warning. “We have to have stronger language to ensure people are (fully informed),” he said.
According to The Wall Street Journal, J&J was willing to add language to the vaccine’s label warning about the blood clot risk at the FDA’s request, J&J Chief Medical Officer Dr. Joanne Waldstreicher told members of the vaccine committee.
Waldstreicher said resumption of vaccinations with J&J’s shot would likely prevent many more deaths and hospitalizations from COVID than the number of rare blood clot cases that may occur in people receiving the vaccine.