What you need to know about the pause.
Why did the FDA pause the Johnson & Johnson COVID-19 vaccine?:
After receiving reports that six people developed a rare kind of blood clot after receiving the Johnson & Johnson COVID-19 vaccine, federal medical officials recommended that the program for the single-dose vaccination be paused.
What happened to the people affected?:
The CDC and FDA said they received reports of six women ages 18 and 48 who developed clots from 6 to 13 days after receiving the Johnson & Johnson vaccine. The clots, known as cerebral venous sinus thrombosis (CVST), develop in the sinuses of the brain, where blood is drained. This is dangerous, but what concerns doctors is that the CVST is seen in combination with low levels of blood platelets, known as thrombocytopenia, a condition where blood will be harder to clot. This combination means that the usual treatment for blood clots, the blood thinner heparin, is potentially “dangerous.” One of the six patients has died and another is hospitalized in critical condition.
Officials said the reports of the clots are “extremely rare” — six of the 6.8 million doses of J&J that have been given.
So a pause? Does that mean the vaccine might still be offered?:
Yes and no. The government is recommending — not mandating — that the vaccine distribution stop while it investigates further and says some people may decide to proceed after weighing the benefits versus the adverse reactions. That said, Gov. Ron DeSantis already has halted J&J in the state.
I got the Johnson & Johnson vaccine, should I be worried?:
Officials said if you received your shot more than two weeks ago, it is unlikely you need to worry. If you notice any of the following CVST symptoms after receiving a J&J vaccine, you should consult your doctor immediately:
■ Severe headaches.
■ Abdominal pain.
■ Leg pain or shortness of breath within three weeks after vaccination.
I had a headache and body aches after getting J&J? Should I be worried?:
Doctors said it is common to have a headache for a day or two after the shot but if a person has a severe headache, pain in limbs, stomach pain a week or two later, then it could be cause for concern and a call to your doctor or visit to ER. Doctors, they said, should then check for low platelet count, which is a sign of the rare clot.
Are these clots seen after getting the Pfizer or Moderna vaccine?:
Doctors said no.
Then why do they happen after Johnson & Johnson?:
Officials said it is only speculation at this point, but they said the autoimmune response for J&J appears to be the issue.
Is there a link to use of birth control?:Because
the reported cases involve women of child-bearing age, officials were asked whether there is a link between the clots and the use of oral contraceptives, which can also cause clots.
Didn’t this happen in Europe?:
There were reports of rare blood clots with the AstraZeneca vaccine, which is approved for use in the European Union but not yet in the United States. Countries paused their programs, and some are restarting them but only for older people. For example, Italy is recommending it only for people over 60 while Britain will offer it only to those over 30.
So what’s next in the U.S.?:
Florida has already paused its J&J program. Right now, Johnson & Johnson made up about 5 percent of all shots given, but some sites, such as the FEMA sites in Florida, were switching to the one-dose vaccine and have now stopped their programs. Officials said overall supplies of Pfizer and Moderna are good, so they expect to switch to those.
Will the J&J vaccine be available again?:
The CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to review the known blood clot cases and assess their potential significance. The FDA will then review that group’s findings. It is unclear how long that review will take.