U.S. health officials lifted the pause on the Johnson & Johnson vaccine after a Centers for Disease Control and Prevention advisory board met last Friday and recommended lifting the pause.
The decision came 10 days after the agency along with the Federal Drug Administration recommended that the vaccine be paused to investigate its possible link to rare blood clots. According to the CDC, there have been 15 cases of blood clots out of the 7.9 million doses administered, which is more than double the six cases initially reported.
Now, providers will have to give people a warning about the risk of the blood clots associated with the Johnson & Johnson shot before they administer it.
Health officials said all of the 15 cases were women -- most of them in their 30s. Three of the women have died, but it’s still unknown if the Johnson & Johnson vaccine contributed to the clots.
The Advisory Committee on Immunization Practices -- the Centers for Disease Control and Prevention’s independent vaccine advisory panel -- decided that the benefits of the Johnson & Johnson’s COVID-19 vaccine outweighed the potential risk and recommended that the pause should be lifted. The motion carried by a 10-4 vote, with one abstention.
“We really rely on surveillance and the reporting system to pick up these more rare things once the vaccines are being rolled out. That’s what happened in this case. I think we should all feel really reassured that something that’s as rare as a few cases in a million has been picked up and looked at really closely,” said Dr. Thomas Holland at Duke University.
The agency said mild side effects with COVID vaccines are not uncommon, especially after the second doses of Pfizer and Moderna because the immune response to the second shot is stronger.
According to the CDC, within a day or two, people may notice the following symptoms:
- muscle pain
The CDC found that out of 13.7 million Americans vaccinated during December and January, side effects were higher among women. Nearly 79% of women reported adverse reactions -- the most common were headache, fatigue and dizziness.
62 people also reported having a severe allergic reaction. Of them, 46 got the Pfizer vaccine and 16 got Moderna.
Health officials across the globe have said the benefits of the vaccine outweigh the risks. Still, fewer Americans are now rushing to get vaccinated.
The daily average of shots is now below 3 million a day for the first time in weeks.
(The map below shows estimated vaccine hesitancy. The areas in darker blue show where Americans are resisting the vaccine the most.)
Novant Health officials talked about the impact the decision could have on the race to get people vaccinated.
Dr. Ashley Perrott is a family medicine physician and senior physician executive with Novant Health Medical Group. She said although the panel’s decision could impact some people’s desire to get the Johnson & Johnson product, there are still some people who would want it.
“There is a small group of people who still have a preference for J&J even with this pause that has occurred. So, we will likely along with HD and other organizations continue to give J&J though we expect fewer people will be interested in that vaccine since there has been a pause,” Perrott said.
Resident Keith Goodman got the Moderna vaccine last Friday, but that wasn’t his first choice.
“I like a one shot deal. These are two shots, that was one shot. I could have got one. I wouldn’t have had to wait,” he said.
When Goodman heard that federal officials paused the J&J product, he told Channel 9 he decided to go with another product, but said some of his friends decided not to get vaccinated at all.
“I do know a lot of people, they have decided they don’t want to get a vaccine on account of this Johnson & Johnson. They want to see what happens on account of it before they were getting a vaccine.”
Kelci Trhams manages Moose Pharmacy in Concord.
“I have noticed a decrease in vaccination recently. I’m not sure if it is due to the J&J vaccine or due to our ability to get more vaccine,” Trhams said.
Both Moose Pharmacy and Novant Health told Channel 9 that they’ll continue to provide the information that people need to help them make an informed choice about vaccination.
North Carolina resumes use of Johnson & Johnson vaccine
North Carolina health officials are recommending that healthcare providers in the state resume use of the Johnson & Johnson COVID-19 vaccine following a safety review by federal agencies.
Earlier this month, a pause was placed on the vaccine after reports of six cases of a rare type of blood clot in people who received the one-dose vaccine. During the pause, nine additional cases were identified, resulting in 15 total cases among more than eight million doses given in the U.S All of the cases occurred in women between the ages of 18 and 59.
During the pause, medical and scientific teams at the Centers for Disease Control and Prevention and the Food and Drug Administration examined available data to assess the risk of that type of reaction. The FDA said it determined that the data show that the vaccine’s known and potential benefits outweigh its known and potential risks in adults.
The North Carolina Department of Health and Human Services said in a news release that it is recommending that providers resume administration of the vaccine. More than 250,000 people had received the Johnson & Johnson vaccine in North Carolina as of April 13.
The Associated Press contributed to this report.
Local vaccine providers prepared to explain J&J warning to patients before giving shot
Some vaccine providers told Channel 9 they’ll start scheduling appointments for the product as early as Tuesday after the CDC paused its use to study rare blood clotting issues in a small number of women.
The FDA and CDC said that they have confidence in the J&J vaccine and it’s ability to safely and effectively prevent COVID-19.
Novant health officials have said there could be some vaccine hesitancy as a result of the pause, but that they are prepared to help answer questions.
“There will always be a group of people concerned about things or need an extra nudge or some extra information to make them feel comfortable. I encourage people to ask questions, or call someone to tell them to ask questions,” Dr. Ashley Perrott with Novant Health said.
Novant said it is in the process of carefully reviewing the FDA and CDC report. It does not have an update on whether it will continue to administer the J&J product at this point.
Moose Pharmacy owner Joe Moose said his first clinic using J&J since the pause was last Friday in Mount Pleasant. Other stores will wait until later this week.
“I had a half dozen calls today wanting J&J specific,” said Moose. “They want to know when are we restarting.”
People who want to get the J&J shot will now see a new warning inside the product fact sheet. It reads: Blood clots involving blood vessels in the brain, abdomen and legs along with low levels of platelets have occurred in some people who’ve taken the product.
“We want to get all our staff trained up on the new information,” Moose said. “We’ll have a conversation with you about what we’ve learned since the pause.”
Rowan County’s health department told Channel 9 it planned to do the same when officials give the vaccine to Catawba College students.
“We will verbally explain to them here is the safety info why we’re moving forward we’ll get consent from them before we actually move forward to give them the shot,” Interim Health Director Alyssa Harris said.
Mecklenburg County health officials said they’ll offer the J&J vaccine Tuesday to at least one clinic and also to patients who are homebound.
As of April 27, there was roughly 132,000 doses of the Johnson & Johnson vaccine available across North Carolina.
That includes hundreds of doses at Walker’s Drug Store in Charlotte’s Cotswold neighborhood. Pharmacist Taylor Fortson said she’s seeing a delay in vaccinations.
“We had a lot of people looking forward to getting the one-dose vaccine,” she explained.
Once the CDC paused the J&J vaccine, Fortson said vaccine hesitancy, overall, increased. Health officials now agree that the benefits of the vaccine outweigh the risks.
That’s why Fortson and her team are working to give out the shots, starting Tuesday.
“I’m hoping to get those vaccine appointments booked up so we can get more of the population vaccinated,” she said.
Providers like Walker’s will review the warning about the risks associated with the shot before they administer it.
Some people, including Rebecca Taylor, who’s fully vaccinated with Pfizer, said people should listen to the experts.
“Follow your doctor’s orders and if they say get it, then that’s what we need to do,” she said.
Others, like Pam McClung, said she’d prefer Pfizer but will take what’s available.
“It doesn’t really matter to me one way or the other, to be honest with you,” McClung Said. “I’ll take what I can get.”
Fortson said if people are reluctant, especially women, the pharmacy is also offering Moderna.
North Carolina officials are expecting to order new shipments of the J&J brand in the coming days.