CDC, FDA recommendations lead to pause of Johnson & Johnson COVID-19 vaccine

In a joint statement released today, the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) recommended a pause in the distribution of the Johnson & Johnson (Janssen) COVID-19 vaccine over rare health concerns.

Much as has beleaguered the AstraZeneca vaccine elsewhere, the CDC and FDA are reviewing data involving six reported U.S. cases of a rare, severe type of blood clot in people given the Janssen vaccine. Each case occurred among women between the ages of 18 and 48, who developed symptoms six to 13 days after vaccination.

However, there have been a reported six cases of this potential side effect out of more than 6.8 million doses distributed as of April 12, 2021.

“CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance. FDA will review that analysis as it also investigates these cases,” Dr. Anne Schuchat, principal deputy director of the CDC, and Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a joint statement. “Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution. This is important, in part, to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot. Right now, these adverse events appear to be extremely rare.”

Pauses like this are commonplace for vaccine rollout, usually out of an abundance of caution. In this case, the agencies have asked any recipients of the Janssen vaccine who develop severe headaches, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination to contact their health care provider.

Given that the vaccine plays a part in a national campaign, however, the White House also addressed concerns. Earlier today, Jeff Zients, White House COVID-19 response coordinator on the Johnson & Johnson vaccine, noted that even in the event of a pause, the larger U.S. vaccination plan should not be greatly affected. At present, the Johnson and Johnson vaccine accounts for less than 5 percent of the total vaccinated populace to date.

“Based on actions taken by the President earlier this year, the United States has secured enough Pfizer and Moderna doses for 300 million Americans,” Zients said. “Over the last few weeks, we have made available more than 25 million doses of Pfizer and Moderna each week, and in fact, this week, we will make available 28 million doses of these vaccines. This is more than enough supply to continue the current pace of vaccinations of 3 million shots per day, and meet the President’s goal of 200 million shots by his 100th day in office—and continue on to reach every adult who wants to be vaccinated. We are working now with our state and federal partners to get anyone scheduled for a J&J vaccine quickly rescheduled for a Pfizer or Moderna vaccine.”