The Food and Drug Administration (FDA) and the Centers for Disease Control (CDC) on Tuesday called for an immediate pause in the usage of Johnson & Johnson’s COVID-19 vaccine after six people in the U.S. developed a rare blood clot disorder called thrombocytopenia within two weeks of receiving the shot.
All six recipients were women between the ages of 18 and 48. One of them has died and just one is currently in critical care in Nebraska.
Administration of J&J’s vaccine is expected to be halted at all federally-run vaccination sites pending investigation. States don’t have to follow the recommendation, though many of them already have. Within hours of Tuesday’s announcement, health departments in Ohio, New York State, Connecticut, Maryland, Virginia and Washington D.C. said they’re no longer giving J&J shots.
About seven million people in the U.S. have received J&J’s single-dose vaccine. The FDA and CDC said in a joint statement that they are recommending the pause “out of an abundance of caution,” noting that the observed blood clot cases appear to be an extremely rare adverse effect.
A CDC advisory committee will meet Wednesday to examine possible links between the disorder and J&J’s vaccine. The agency said at a press briefing Tuesday that they hope to have preliminary findings “in a matter of days.”
Still, the FDA and CDC decision was met with criticism from vaccine advocates and local officials tasked to vaccinate everyone over the age of 16 by the end of May.
Mark D. Levine, a New York City councilman, said the pause is “a huge blow to vaccination in New York City” and that he’s worried the federal agencies’ guidance would undermine the public’s confidence in all coronavirus vaccines.
“I know this was done to maintain confidence in the vaccines. Worried it will have the opposite effect,” Levine tweeted.
The J&J news is a huge blow to vaccination in NYC.
No official word yet on on cancellation of existing J&J appts but I am assuming that will happen effective immediately.
I know this was done to maintain confidence in the vaccines. Worried it will have the opposite effect.
— Mark D. Levine (@MarkLevineNYC) April 13, 2021
“This is an extremely rare (less than one in a million) ‘safety signal,'” tweeted Angela Rasmussen, a virologist at the Center of Infection and Immunity at the Columbia University School of Public Health. While acknowledging that it’s normal for the FDA to investigate out of caution, she said, “I got the J&J vaccine 8 days ago. I’m not losing sleep over this.”
6 cases out of 7 million doses.
This is an extremely rare (less than 1 in a million) “safety signal.” Its normal for FDA to investigate, and to pause while it does out of caution.
I got the J&J vaccine 8 days ago. I’m not losing sleep over this. https://t.co/J56BtGSCG3
— Dr. Angela Rasmussen (@angie_rasmussen) April 13, 2021
“I would not say do not get vaccinated just because this very rare side effect,” Dr. Carlos del Rio, a infectious disease expert at Emory University School of Medicine said on CNN Tuesday.
New York Governor Andrew Cuomo urge people not to cancel their vaccination appointments. “If you have an appointment today at a state-run mass vaccination site for the Johnson & Johnson vaccine, you will be offered the Pfizer vaccine instead,” he tweeted Tuesday morning.
The good news is that at least J&J’s emergency use authorization is still in effect. “[The FDA] didn’t revoke the EUA, they didn’t order this off the market. This was a requested pause which is an awkward regulatory step but it reflects a level of caution not to appear too forcefully here,” former FDA commissioner Scott Gottlieb said on CNBC Tuesday.
The six blood clot cases were all observed 6 to 13 days after vaccination. The CDC said people who received the J&J shots over a month ago don’t have to worry too much; those vaccinated more recently should watch out for abnormal symptoms such as sudden pain in arms and legs.