Use of the Johnson and Johnson COVID-19 vaccine remains suspended in the United States as officials gather more information about the rare clots reported in the six people who received the shot. An independent advisory committee to the Centers for Disease Control and Prevention said it does not have enough information yet to say which groups may be at risk of clots or recommend who should receive this vaccine.
"I don't think we have enough information today," Grace Lee, deputy chief medical officer for the practice of innovation at Lucille Packard Children's Hospital in California, said during a committee meeting on Wednesday. The Group will reconvene as soon as possible-probably next week after collecting additional data and evaluating this information.
The Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) recommended Tuesday morning that the U.S. pause use of the Johnson and Johnson vaccine in light of six reports of unusual blood clots in people who received the shot. Although there is no proven link between clots and vaccines, and events are likely rare, institutions wanted time to investigate the reports and give doctors information on how to treat the condition. The institutions said Tuesday that they hope to resolve the pause as quickly as possible.
Underserved communities in the US are most affected by Johnson's and Johnson's pause. The easy-to-store single-family vaccine is used for the elderly from home, in pop-up clinics in rural areas, and for people experiencing homelessness. The impact of this pause on these groups has become a serious topic of today's meeting. "This one-and-done vaccine that doesn't require a cold chain is a significant loss," said Camille Cotton, clinical director of transplant and immunocompromising infectious disease recipients at Massachusetts General Hospital. This group, however, may have the most trouble getting treatment for a blood clot if they develop one, noted Helen Talbot, an associate professor of medicine at Vanderbilt University.
The CDC received six reports between March 19 and April 12 through the Vaccine Adverse Events Reporting System (VAERS). Unusually, all six patients had venous sinus thrombosis (a type of blood clot in the brain) combined with low platelet counts, a type of blood cell involved in blood clotting.
The CDC has kept a special eye out for reports of these clots due to issues seen with the AstraZeneca vaccine in Europe and the United Kingdom, Tom Shimabukuro, a member of the CDC COVID-19 Vaccine Task Force, said during a committee meeting. "This is a really good example of how robust the U.S. vaccine safety monitoring system is and how in this case, during a massive national mass vaccination program, the system worked in various functions exactly as planned," he said.
The COVID-19 working group on the CDC's Advisory Committee on Immunization Practices (ACIP) met earlier this week to hear the reports. The six people who had blood clots were young women. Although they were rare, they occurred at a higher-than-expected rate in this group.
Sarah Oliver, an epidemic intelligence officer at the CDC, said during today's meeting that the working group noted how much we still don't know about these clots. It is unclear how often a combination of blood clots and low platelets tend to appear in the general population, making it difficult to say how much above normal these reports are. We also don't have a good sense of the risk factors for developing this condition. There may also still be more reports - almost 4 million people have received doses in the last two weeks, and these people are still in the window where a clot can occur.
The group also noted that the Johnson & Johnson vaccine is not the only vaccine available in the United States. Officials do not see the same problems in people who have received Pfizer / BioNTech or Moderna vaccines. Only about 5 percent of the vaccines given in the U.S. so far have been Johnson and Johnson shot.
"We are very lucky because we have several other alternatives in the U.S. to end the health care pandemic," Talbot said. "We are in a different position and can be more cautious."