The Centers for Disease Control and Prevention (CDC) and U.S. Food and Drug Administration (FDA) on Tuesday recommended vaccine providers pause giving the single-dose Johnson & Johnson COVID-19 vaccine. The recommendation came after six people, out of 6.8 million who have received the Johnson & Johnson (J&J) vaccine, had a rare and severe type of blood clot after receiving the vaccine, according to the federal agencies.
The announcement left people with appointments to get the J&J COVID-19 vaccine trying to figure out what to do next.
Should I cancel my appointment to get the J&J COVID-19 vaccine?
You shouldn’t cancel your appointment without first checking with your provider. Some providers are offering the Moderna or Pfizer vaccines instead of the J&J vaccine for people who already have appointments, while others are rescheduling appointments.
WHAT WE FOUND
Peter Marks, director of the FDA Center for Biologics Evaluation and Research, said the recommendation by the FDA and CDC is not a mandate. Therefore, it’s up to health care providers and people scheduled to get the J&J COVID-19 vaccine to come to their own decisions.
“We’re recommending the vaccine be paused in terms of its administration,” Marks said during a media call Tuesday. “However, if an individual health care provider has a conversation with an individual patient and they determine the benefits-risk for that individual patient is appropriate, we’re not going to stop that provider from administering the vaccine because in many cases that benefit-risk will be beneficial overall to that individual in a large majority of cases.”
Marks said the recommendation was made out of an abundance of caution as the CDC and FDA further evaluate the six reported cases of concern, one of which resulted in death. In a joint statement Tuesday, the CDC and FDA said the cases, all among women between 18 and 48, involved a type of blood clot called cerebral venous sinus thrombosis (CVST) in combination with low levels of blood platelets.
Marks said standard treatment of blood clots involves an anticoagulant drug called heparin. But when patients have CVST and low platelet levels, heparin could be dangerous, Marks said. Therefore, health care professionals need to be made aware of the cases, consider vaccine history and specific treatment for patients on an individual level.
Anne Schuchat, principal deputy director of the CDC, said there is not enough evidence to say whether some subpopulations are predisposed to the rare adverse effects seen in these six cases. She said the number of cases is small enough that it’s hard to generalize trends but large enough for the CDC and FDA to issue the pause.
Janet Woodcock, acting FDA commissioner, said she expects the pause to last “a matter of days.”
In the meantime, Schuchat said partners providing the J&J COVID-19 vaccine will be working to reschedule appointments.
“This may be a bit bumpy,” she said. “We want to make sure we’re getting the word out to the public and our providers. We want to make sure people who are scheduled to have vaccinations will be able to get that when the vaccine is available.”
Many states, counties and cities are taking matters into their own hands. In New York, state health commissioner Howard Zucker said New York would pause the administration of the J&J vaccine immediately. He said everyone who scheduled a J&J vaccine appointment Tuesday at the state’s mass vaccination sites would receive the first dose of the Pfizer vaccine. In Detroit, Michigan, the city has halted the administration of the J&J COVID-19 vaccine until further notice but advised people to keep their appointments and they would be given the Moderna or Pfizer vaccine. In Harris County, Texas, people with J&J COVID-19 vaccine appointments are being told not to cancel, and that they will receive one of the other coronavirus vaccines instead.
Some private providers are taking similar approaches. Walgreens and Publix said they are immediately suspending the administration of the J&J COVID-19 vaccine and are working with patients to reschedule appointments for the Moderna or Pfizer vaccines.
The 6.8 million people who have received the J&J vaccine represent a small portion of the 121 million people in the U.S. who have received at least one COVID-19 vaccine shot so far. A spokesman for the White House said the U.S. has enough Pfizer and Moderna doses for 300 million Americans, and that Tuesday’s pause recommendation will not have a significant impact on the vaccine rollout.
“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,” Jeff Zients, White House COVID-19 response coordinator, said in a statement.
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