FDA Limits Who Can Receive Johnson & Johnson COVID-19 Vaccine Over Rare Blood Clots
BALTIMORE (WJZ) -- There's been another blow to the Johnson and Johnson COVID-19 vaccine after the FDA announced it's putting severe limitations on the use of the single-shot vaccine.
The agency is reinforcing its message that Americans choose Moderna or Pfizer because of rare but potentially deadly blood clots that have emerged with the Johnson and Johnson shot.
Of the 17 million Americans who got the vaccine, researchers said they found 60 people who got blood clots and as of mid-March of this year, 9 people died.
Because of this slight risk, on Thursday the FDA started to put restrictions on who can get J&J.
Only folks who may be allergic to Moderna or Pfizer or people who specifically ask for Johnson and Johnson will be able to get it.
"And if you aren't going to get Moderna or Pfizer, the FDA is very clear, if you're not going to get otherwise vaccinated, J&J remains a very good option is a highly effective vaccine," says Dr. Ashish Jha, the White House COVID-19 Response Coordinator. "And these are very rare side effects. The guidance is really because we have alternatives that don't have this rare side effect that FDA is, is saying people should get the others instead."
At the height of the COVID-19 pandemic, the single-shot COVID-19 vaccine was seen as a game-changer.
But researchers started to notice extremely rare cases of potentially deadly blood clots. Medical experts say the blood clots emerged in about 1 in every 3 million doses.
Emergent Bio Solutions Bayview facility was contracted to ramp up production of the Johnson and Johnson vaccine, but just about a year ago, there was a scandal at the East Baltimore plant where about 15 million doses of the vaccine were ruined because they got contaminated.
After the FDA announced the new limitations on the J&J vaccine Thursday, a spokesperson for the company said in an emailed statement to CBS News: "Data continues to support a favorable benefit-risk profile for the Johnson & Johnson COVID-19 vaccine in adults, when compared with no vaccine."
Of the more than four million Marylanders who've been vaccinated, about 342,000 got J&J.
The vaccine's label will have a more urgent warning about potential long-term risks.
