Johnson & Johnson vaccine remains on hold

BUT I DO THINK IT’S GONNA UNDERMINE CONFIDENCE IN A MULTITUDE OF OF WAYS ADMINISTRATION OF THE JOHNSON. & JOSEPHINE HALTED TUESDAY ON THE RECOMMENDATION OF THE CDC AND THE FDA AFTER SIX WOMEN WHO RECEIVED THE SHOT DEVELOPED AN EXTREMELY RARE TYPE OF BLOOD CLOT ANYTHING THAT HAS HAPPENED TO YOU AFTER A VACCINE COULD BE AN ADVERSE EVENT. AND SO THE FDA IN THE CDC DOES TAKE THAT VERY SERIOUSLY AND MAKES SURE THAT THEY DO. DUE DILIGENCE MEETING. THEY’LL INVESTIGATE THIS TO SEE IF THERE IS ANY CORRELATION BETWEEN THE VACCINE AND THESE EVENTS WITH SEVEN MILLION SHOTS ADMINISTERED DR. LEMAY SAYS EVEN SIX CASES NEED TO BE INVESTIGATED IN THE SPIRIT OF SAFETY AND TRANSPARENCY TO ME. IT’S THE RIGHT THING TO DO TO ME. I’M ALSO POSITIVE ABOUT IT AND OPTIMISTIC BECAUSE THAT MEANS THAT OUR SAFETY MONITORING SYSTEMS ARE ALSO WORKING RIGHT THE FACT THAT WE WERE ABLE TO DETECT SIX OUT OF SEVEN MILLION IS PRETTY AMAZING WHEN YOU THINK ABOUT THAT BUT AS THERE ARE BIG CONCERNS IN THE MEDICAL COMMUNITY THAT THIS WILL INCREASE VACCINE HESITANCY, WHICH IS ALREADY BEEN A PROBLEM WITH THE JOHNSON & JOHNSON VACCINE BECAUSE OF THE LOWER EFFICACY RATING NOW THAT IT HAS BEEN PAUSED. I THINK THERE WILL BE ISSUES OF EVEN IF THERE IS NO ISSUE WITH THERE’S NO LINK BETWEEN THE VACCINE AND BLOOD CLOTTING. I THINK PEOPLE ARE NOW GOING TO BE SCARED TO TAKE IT. SO YOU’RE ESSENTIALLY REMOVING A PRODUCT FROM THE MARKET WHICH THEN AGAIN LEADS TO A DEMAND ISSUE, DR. LEMAY SAYS SOME OF THAT HESITANCY COULD EVEN SPILL OVER TO THE OTHER VACCINES, BUT SHE HAS SOME WORDS OF WISDOM FOR ANYONE OUT THERE WITH CONCERNS. I THINK THE DECISION HAS TO BE MADE ARE THE BENEFITS OUTWEIGHING THE RISKS. I THINK CURRENTLY WHEN YOU THINK ABOUT THE TWO MRNA PRODUCTS THE PFIZER AND MODERNA PRODUCTS, I DO THINK FOR THE VAST VAST MAJORITY OF THE PEOPLE THE BENEFITS ARE GONNA OUTWEIGH THE RISKS. DR. LAMAY SAYS THE CDC WILL START MEETING ABOUT THIS TOMORROW AND SHE IS HOPEFUL THEY WILL HAVE RESULTS AND UPDATED. GUIDANCE WITHIN THE NEXT FEW WEEKS REPORTING LIVE AT

Above video: What to know if you got the J&J COVID-19 vaccineJohnson & Johnson's COVID-19 vaccine will remain in limbo a while longer after U.S. health advisers told the government Wednesday that they need more evidence to decide if a handful of unusual blood clots were linked to the shot — and if so, how big the potential risk really is.The reports are exceedingly rare — six cases out of more than 7 million U.S. inoculations with the one-dose vaccine. But the government recommended a pause in J&J vaccinations this week, not long after European regulators declared that such clots are a rare but possible risk with the AstraZeneca vaccine, a shot made in a similar way but not yet approved for use in the U.S.At an emergency meeting, advisers to the Centers for Disease Control and Prevention wrestled with the fact that the U.S. has enough vaccine alternatives to do without the J&J vaccine for a time, but other countries anxiously awaiting the one-and-done shot may not.Members of the Advisory Committee on Immunization Practices committee said they did not have enough information to make changes in their recommendations, or even to suggest extending a pause in administering the vaccine.One committee member, Dr. Grace Lee, was among those who advocated tabling a vote. She echoed concerns about getting more data to better understand the size of the risk and whether it was greater for any particular group of people."I continue to feel like we're in a race against time and the variants, but we need to (move forward) in the safest possible way," said Lee, of Stanford University.The clots under investigation are highly unusual. They occurred in strange places, in veins that drain blood from the brain, and in people with abnormally low levels of clot-forming platelets. The six cases raised an alarm bell because that number is at least three times more than experts would have expected to see even of more typical brain-drainage clots, said CDC's Dr. Tom Shimabukuro.File video: Infectious disease doctor says 'don't panic' about J&J vaccine pause"What we have here is a picture of clots forming in large vessels where we have low platelets," Shimabukuro explained. "This usually doesn't happen," but it's similar to European reports with the AstraZeneca vaccine.The clot concerns could undermine public confidence in a vaccine many hoped would help some of the hardest-to-reach populations — in poor countries or in places like homeless shelters in the U.S.Health officials recommended the J&J timeout in part to make sure doctors know how to recognize and treat the unusual condition. On Wednesday, the CDC said four of the six women with the unusual clots were treated with a blood thinner named heparin — a treatment the government is warning doctors to avoid.The U.S. set up intensive systems to track the safety of COVID-19 vaccines, knowing that side effects too rare to have occurred in studies of thousands of people could pop up once millions rolled up their sleeves. Shimabukuro said spotting such a rare potential risk amid the nation's huge vaccine rollout "is an example of a success story for vaccine safety."The six cases were among more than 6.8 million Americans who have received a dose of that vaccine.Video: Fauci reminds of small risk for J&J vaccine"Less than 1 in a million," Dr. Anthony Fauci noted Tuesday during a White House briefing.All six cases were among women between the ages of 18 and 48, the agencies said in a statement, and symptoms occurred six to 13 days after vaccination. The recommendation to pause comes out of "an abundance of caution," they added, and these cases "appear to be extremely rare.""It makes sense now to pause, get a sense for whether this is a real phenomenon, whether it really is associated with the vaccine and who in particular might be at highest risk," Dr. Jonathan Reiner, a professor of medicine and surgery at George Washington University, told CNN on Tuesday.Reiner added he worries the pause may contribute to further hesitancy about the vaccines being administered in the U.S."The way I want people to look at it is this: These vaccines are incredibly effective. You're much more likely to die of the coronavirus than you are to have a significant complication from these vaccines," he said.So far, the J&J vaccine has been a minor player in U.S. vaccinations. More than 122 million Americans have received at least one vaccine dose, the vast majority with shots made by Moderna or Pfizer, and nearly 23% are fully vaccinated.CNN contributed to this report.

Above video: What to know if you got the J&J COVID-19 vaccine

Johnson & Johnson's COVID-19 vaccine will remain in limbo a while longer after U.S. health advisers told the government Wednesday that they need more evidence to decide if a handful of unusual blood clots were linked to the shot — and if so, how big the potential risk really is.

The reports are exceedingly rare — six cases out of more than 7 million U.S. inoculations with the one-dose vaccine. But the government recommended a pause in J&J vaccinations this week, not long after European regulators declared that such clots are a rare but possible risk with the AstraZeneca vaccine, a shot made in a similar way but not yet approved for use in the U.S.

At an emergency meeting, advisers to the Centers for Disease Control and Prevention wrestled with the fact that the U.S. has enough vaccine alternatives to do without the J&J vaccine for a time, but other countries anxiously awaiting the one-and-done shot may not.

Members of the Advisory Committee on Immunization Practices committee said they did not have enough information to make changes in their recommendations, or even to suggest extending a pause in administering the vaccine.

One committee member, Dr. Grace Lee, was among those who advocated tabling a vote. She echoed concerns about getting more data to better understand the size of the risk and whether it was greater for any particular group of people.

"I continue to feel like we're in a race against time and the variants, but we need to (move forward) in the safest possible way," said Lee, of Stanford University.

The clots under investigation are highly unusual. They occurred in strange places, in veins that drain blood from the brain, and in people with abnormally low levels of clot-forming platelets. The six cases raised an alarm bell because that number is at least three times more than experts would have expected to see even of more typical brain-drainage clots, said CDC's Dr. Tom Shimabukuro.

File video: Infectious disease doctor says 'don't panic' about J&J vaccine pause

"What we have here is a picture of clots forming in large vessels where we have low platelets," Shimabukuro explained. "This usually doesn't happen," but it's similar to European reports with the AstraZeneca vaccine.

The clot concerns could undermine public confidence in a vaccine many hoped would help some of the hardest-to-reach populations — in poor countries or in places like homeless shelters in the U.S.

Health officials recommended the J&J timeout in part to make sure doctors know how to recognize and treat the unusual condition. On Wednesday, the CDC said four of the six women with the unusual clots were treated with a blood thinner named heparin — a treatment the government is warning doctors to avoid.

The U.S. set up intensive systems to track the safety of COVID-19 vaccines, knowing that side effects too rare to have occurred in studies of thousands of people could pop up once millions rolled up their sleeves. Shimabukuro said spotting such a rare potential risk amid the nation's huge vaccine rollout "is an example of a success story for vaccine safety."

The six cases were among more than 6.8 million Americans who have received a dose of that vaccine.

Video: Fauci reminds of small risk for J&J vaccine

"Less than 1 in a million," Dr. Anthony Fauci noted Tuesday during a White House briefing.

All six cases were among women between the ages of 18 and 48, the agencies said in a statement, and symptoms occurred six to 13 days after vaccination. The recommendation to pause comes out of "an abundance of caution," they added, and these cases "appear to be extremely rare."

"It makes sense now to pause, get a sense for whether this is a real phenomenon, whether it really is associated with the vaccine and who in particular might be at highest risk," Dr. Jonathan Reiner, a professor of medicine and surgery at George Washington University, told CNN on Tuesday.

Reiner added he worries the pause may contribute to further hesitancy about the vaccines being administered in the U.S.

"The way I want people to look at it is this: These vaccines are incredibly effective. You're much more likely to die of the coronavirus than you are to have a significant complication from these vaccines," he said.

So far, the J&J vaccine has been a minor player in U.S. vaccinations. More than 122 million Americans have received at least one vaccine dose, the vast majority with shots made by Moderna or Pfizer, and nearly 23% are fully vaccinated.

CNN contributed to this report.

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