As the Food and Drug Administration and Centers for Disease Control and Prevention announced today, out of an abundance of caution, they have recommended a pause in the use of the Johnson & Johnson vaccine while they review data involving six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the Johnson & Johnson vaccine.
Tuesday, the California Department of Public Health (CDPH) issued a statement from Dr. Erica Pan, state epidemiologist, regarding the Johnson & Johnson/Janssen COVID-19 vaccine.
“Today, the CDC and FDA have recommended a temporary pause in the use of the Johnson & Johnson COVID-19 vaccine out of an abundance of caution. Of over 6.8 million doses administered nationally, there have been six reported cases of a rare and severe type of blood clot with symptoms occurring 6 to 13 days after vaccination.
“California is following the FDA and CDC’s recommendation and has directed health care providers to pause the use of the Johnson & Johnson vaccine until we receive further direction from health and safety experts. Additionally, the state will convene the Western States Scientific Safety Review Workgroup to review the information provided by the federal government on this issue. As the federal government has said, we do not expect a significant impact to our vaccination allocations. In California, less than 4% of our vaccine allocation this week is the Johnson & Johnson vaccine.”
According to a report in The New York Times, officials from the Food and Drug Administration and the U.S. Centers for Disease Control are recommending an immediate pause in the use of the Johnson & Johnson vaccine after the six U.S. recipients -- all women between the ages of 18 and 48 -- developed serious blood clots within two weeks of getting vaccinated.
One woman died and a second woman in Nebraska was hospitalized in critical condition, the report said.
The City of Los Angeles is following the CDC and FDA guidance and cancelling all J&J vaccines scheduled for today.
Mid-morning Tuesday, Governor Gavin Newsom tweeted: "Out of an abundance of caution CA will follow the CDC & FDA & temporarily pause use of J&J. J&J is just 4% of CA’s supply from the feds right now.
Vaccines are still overwhelmingly safe. We’re vaccinating 3+ million people a week and are still on track to fully reopen 6/15."
L.A. County this week received an allocation of 323,470 doses of vaccine -- including Johnson & Johnson, Pfizer and Moderna. That represents an overall drop of roughly 80,000 from last week, due to a major reduction in supply of the Johnson & Johnson vaccine.
"Following guidance from public health officials, City-run vaccination sites have paused use of the Johnson & Johnson COVID-19 vaccine. This impacts about 3,000 scheduled vaccinations today. All appointments at our permanent sites will happen as planned, and the City’s MOVE clinics will honor the appointments for anyone scheduled to receive the Johnson & Johnson vaccine with a first dose of Pfizer, as we await further information from health officials," Los Angeles Mayor Eric Garcetti said in a statement.
"All COVID-19 vaccines are helping to stop the spread of the virus. We continue to encourage eligible Angelenos to get vaccinated so we can end the pandemic as soon as possible," Garcetti added.
County health officials were anticipating supplies of the Johnson & Johnson vaccine to being increasing again in the coming weeks -- but now new questions could change plans.
The FDA and CDC provided details in a morning briefing Tuesday.
“I’d like to stress these events appear to be extremely rare. However COVID-19 vaccine safety is a top priority,” FDA Acting Commissioner Janet Woodcock said at a news conference.
A CDC committee will meet Wednesday to discuss the cases and the FDA has also launched an investigation into the cause of the clots and low platelet counts.
“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 joint statement.
They are recommending that people who were given the J&J vaccine who are experiencing severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after receiving the shot contact their health care provider.
Johnson & Johnson vaccine makes up less than 5 percent of the recorded shots in arms in the United States to date.
Based on actions taken by President Joe Biden earlier this year, the U.S. has secured enough Pfizer and Moderna doses for 300 million Americans. Over the last few weeks, more than 25 million doses of Pfizer and Moderna each week have been made available and this week there’ll be 28 million doses available.
“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,” Jeff Zients, White House COVID-19 Response Coordinator on Johnson & Johnson vaccine said in a statement.
The administration is working now with state and federal partners to get anyone scheduled for a J&J vaccine quickly rescheduled for a Pfizer or Moderna vaccine.