The Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) issued a joint statement on Tuesday recommending that states pause using Johnson & Johnson's COVID-19 vaccine "out of an abundance of caution" after 6 recipients in the U.S. developed a rare disorder involving blood clots.
"Right now, these adverse events appear to be extremely rare," the agencies said. "Treatment of this specific type of blood clot is different from the treatment that might typically be administered."
All of the cases were in women between the ages of 18 and 48, and occured with low platlets in veins which drain blood from the brain. A CDC official said at a press conference Tuesday that they are not seeing clotting events from low platelet counts with the vaccines from Pfizer or Moderna.
One blood clot case was fatal, and another is in critical condition, officials said.
Federal health regulators recommend that people who experience severe headaches, abdominal pain, leg pain, or shortness of breath within three weeks of getting the shot contact their health care provider.
"For people who got the vaccine more than a month ago, the risk to them is very low at this time," Dr. Anne Schuchat, Principal Deputy Director of the CDC, said. "To people who recently got the vaccine within the last couple weeks, they should look for anysymptoms."
Dr. Schuchat noted that the blood clot symptoms are different from the ones "that many people experience in the couple days after receiving the vaccine," which can include fever and mild, flu-like conditions.
The CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to review these cases, but until that happens, the agencies are recommending the pause.
"Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution," 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 statement.
"This is important to ensure that the health care provider community is aware of the potential for these adverse events and can plan due to the unique treatment required with this type of blood clot," they said.
At a press conference held by the CDC and FDA, officials said they expect the pause to last "a matter of days."
"Right now I’d like to stress these events appear to be extremely rare," Dr. Janet Woodcook, Acting FDA Commissioner, said. "However, COVID-19 vaccine safety is a top priority for the federal government and we take all reports of adverse events following vaccination very seriously."
"This is a recommendation, not a mandate," Dr. Peter Marks, the Director of the FDA Center for Biologics Evaluation and Research, said. "It’s out of an abundance of caution we're recommending that the vaccine be paused in terms of its administration. However, if an individual healthcare provider has a conversation with an individual patent and they determine that the benefit-risk for that individual patient is appropriate, we’re not going to stop the provider from administering the vaccine."
Dr. Schuchat said that the pause is necessary "so that there was time for the healthcare community to learn what they needed to learn about how to diagnose, treat, and report," and in response to those saying it was an overreaction – namely, six cases out of nearly 7 million administered – she said " it was of the utmost importance for us to get the word out" as part of the government's commitment to "safety and transparency."
Dr. Anthony Fauci, the nation’s leading infectious disease expert, joined the White House press briefing on Tuesday to stress that there have been “no red flags” severe enough to warrant a similar pause on either the Pfizer or Moderna vaccines. The FDA is “internationally known for their capability of making sure that we have the safest products” available to Americans, he added.
Fauci continued to say that it is “premature” to comment on when the ACIP review of the vaccine would be completed, and couldn’t say what he thought the outcome would be.
Without making any predictions, Fauci said it would be “entirely conceivable” that upon review of those who experienced the severe thromboembolic side effects, the FDA and CDC may provide updated guidance on which demographics of people should — or should not — receive a Johnson & Johnson vaccine.
White House COVID-19 response coordinator Jeff Zients also added that “Pfizer and Moderna are clearly safe, and are saving lives, and every American should get vaccinated once it's their turn.”
Zeints said that the Johnson & Johnson pause "will not have a significant impact" on the Biden administration's vaccination plans, noting that Johnson & Johnson's shot "makes up less than 5 percent of the recorded shots in arms in the United States 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. 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," Zeints added. "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."
Zeints said that the White House is currently working with state and federal partners to ensure that anyone who is scheduled to receive the Johnson & Johnson vaccine can be "quickly rescheduled" to get a dose of Pfizer or Moderna instead.
Johnson & Johnson said in a statement that the company was aware of the reports about blood clots, but maintained that there is no link to its vaccine that has yet been established.
"We are aware that thromboembolic events including those with thrombocytopenia have been reported with Covid-19 vaccines," the company said in a statement. "At present, no clear causal relationship has been established between these rare events and the Janssen Covid-19 vaccine."
Nearly 7 million people have received a dose of the single-shot Johnson & Johnson vaccine, according to data from the CDC.
New York is halting use of the Johnson & Johnson shot immediately, according to the state's health commissioner.
Sources at the Jacob Javits Center in New York, one of the largest vaccine distrubtion centers in the world, told Spectrum News that they are pausing use of Johnson & Johnson's vaccine, and people with appointments will be given the vaccine from Pfizer instead.
Ohio is also pausing use of the vaccine, according to Gov. Mike DeWine.
Kentucky's Gov. Andy Beshear is also suspending the state's use of the vaccine.
The state of Florida is pausing use of the vaccine, according to Gov. Ron DeSantis.
The news was first reported by the New York Times.
This is a developing story. Check back later for further updates.