FDA, CDC lift Johnson & Johnson COVID-19 vaccine pause

Posted at 11:42 PM, Apr 23, 2021

TAMPA BAY, Fla- — The FDA and CDC are lifting a recommended pause on Johnson & Johnson’s COVID-19 vaccine.

Earlier this month, federal health officials recommended a pause of the one-dose vaccine for a safety review.

During a CDC advisory panel Friday, it was revealed there were 15 reported cases of a rare blood clot with low platelets. They occurred in women 18-59 years old, with the onset of symptoms 6-15 days after vaccination. Three died, seven remain hospitalized and five were discharged to home.

The company said about 8-million doses of the vaccine were given.

The advisory panel voted 10 to 4 to recommend its use, including a fact sheet warning providers and recipients of the risk. Hours later, FDA and CDC officials said the vaccine could resume immediately, determining potential benefits outweigh potential risks.

The agencies said they have confidence the vaccine is “safe and effective in preventing COVID-19.” “Based on the in-depth analysis there is likely an association but the risk is very low. What we are seeing is the overall rate of events was 1.9 cases per million people.

In women 18-49 years there was an approximate 7 cases per million. And the risk is even lower in women over the age of 50 at .9 cases per million,” said the CDC’s director, Rochelle Walensky.

Walensky said a risk-benefit analysis determine for every 1-million doses of the vaccine, it could prevent over 650 hospitalizations and 12 deaths in women 18 to 49 and over 4,700 hospitalizations and nearly 600 deaths among women over 50.

“I think we have to do extraordinary outreach to clinicians as we have been doing this past week we already have plans to start doing that Monday, to public health officials. And then we have to do extraordinary outreach to patients to meet people where they’re at,” Walensky said.

Some medical experts said the pause underscores the system is working.

“Our detection systems are very sensitive to detect this rare side effect so this is a good thing that we have found that there are monitoring systems work so that’s an important lesson to learn,” said Dr. Manuel Gordillo, an infectious disease specialist at Sarasota Memorial Health Care System.

He noted, as did the advisory panel, the access the one-dose vaccine can provide.

“There are certain groups where this is a very important vaccine so for the majority of people there will be other options but there are certain selected populations this was very important to keep,” he said. Florida initially used the Johnson & Johnson vaccine in mobile clinics and homebound programs in efforts to reach underserved communities. During the pause, it switched to two-dose vaccines.

Maribell Miriam Caban said she received the Johnson & Johnson vaccine through a homebound program before the pause, as she’s bed-bound fighting significant health challenges. “It made a huge difference,” Caban said.

The pause didn’t phase her.

“I’m not worried about it whatsoever. I think everybody should take it. It’s common sense it’s basic common sense. You need this vaccine you have to have this vaccine it’s vital this is no joke,” she said.

The Florida Division of Emergency Management said it plans to resume use of the Johnson & Johnson vaccine as soon as possible. It’s reviewing the CDC and FDA guidance right now, and determining which day to start.