The Centers for Disease Control and Prevention (CDC) in conjunction with the Food and Drug Administration (FDA) is working through “a handful” of reports regarding possible adverse events related to the Johnson & Johnson COVID-19 vaccine that have been flagged since the rollout was paused last week.
In the White House COVID-19 briefing on Monday, Dr. Rochelle Walensky said that the agency is working to determine whether the incidents do qualify as a case, and will present the new information to the Advisory Committee on Immunization Practices in a meeting on Friday. She said the reports were made through the Vaccine Adverse Event Reporting System (VAERS), and that she was encouraged by the low numbers.
“These have been a handful of cases, not an overwhelming number of cases we are working through and adjudicating them and verifying whether they do in fact reflect a true case and that will be the work of the CDC this week as well as the FDA and then we will present that to the ACIP on Friday,” Walensky said. “We are doing that work right now – we are encouraged that it hasn’t been an overwhelming number of cases, but we are looking at seeing what’s come in.”
The pause came after six incidents involving a rare, severe type of blood clot that occurred alongside low platelet counts were flagged in the nearly 7 million recipients who received the Johnson & Johnson one-shot COVID-19 vaccine.
In a meeting held the next day, the ACIP was notified about a seventh case involving a woman who formed a clot but it did not occur in the brain, and another instance involving a male during clinical trials but it could not be tied to the shot at that time.
Rather than issue updated guidance or recommendations regarding the vaccine, the ACIP decided to extend the pause in the rollout to allow for more time for people to report possible instances and collect more data. Critics said the extended pause would add to vaccine hesitancy and that the low number of instances suggested minimal risk to the greater population.
However, officials said the pause would allow for more time to reach health care providers to inform them how to treat the CVST clot, which calls for a different regimen than standard clots. Federal officials said they were working with states to facilitate rescheduling appointments for people who were due to receive the Johnson & Johnson vaccine.