J&J vaccine suspended in Nevada underneath new federal guideline
Nevada health officials have temporarily stopped using Johnson & Johnson’s COVID-19 vaccine, following the recommendation of federal regulators investigating six reports nationwide of potentially rare but serious side effects.
The Centers for Disease Control and Prevention and the Food and Drug Administration recommended a “break” in single-dose vaccine use Tuesday to investigate reports of potentially dangerous blood clots, a development that could jeopardize vaccine adoption.
Authorities said they were investigating any unusual blood clots that appeared six to 13 days after the vaccination. The FDA commissioner said she expected the break to be a few days.
Nevada quickly joined the new leadership.
“The state of Nevada is committed to protecting the health and safety of all Nevadans and will suspend Janssen’s use of the one-shot vaccine until the review is complete,” said a press release referring to the subsidiary who manufactures the product J&J vaccine.
The clots appeared in veins that drain blood from the brain and occurred along with low platelets, the fragments in the blood that normally form clots. All six cases involved women between the ages of 18 and 48 years. One person died and all cases are still being investigated.
In the United States, more than 6.8 million doses of the J&J vaccine have been administered, the vast majority with no or minor side effects.
In Nevada, more than 65,000 doses of the Janssen vaccine had been administered and recorded in Nevada WebIZ as of April 12, according to Shannon Litz, a representative with the Nevada Department of Health and Human Services. More than 1.55 million doses of all vaccine types, including Pfizer BioNTech and Moderna vaccines, have been administered, according to the state’s COVID-19 data portal.
The department said it is working with local partners to contact those who are due to receive the J&J vaccine.
Like the state, the Southern Nevada Health District said it is suspending administration of the vaccine and has advised its community partners to do the same.
To date, Clark County has administered more than 1.1 million doses of vaccine, including nearly 49,000 doses of the J&J vaccine, according to Jennifer Sizemore, health district representative.
During a health district briefing, Chief Health Officer Dr. Fermin Leguen that so far only about 50 “minor adverse events” of the J&J vaccine, such as pain at the injection site, have been reported in the district.
Leguen did not expect that the suspension of vaccine use would have a major impact on the availability of the vaccine locally, as the J&J vaccine is only a relatively small percentage of the supply here.
However, he found that the vaccine, which requires only one dose and is easier to store and handle, was a useful tool for inoculating hard-to-reach populations.
When asked if developments on Tuesday could increase vaccination hesitation, Leguen admitted it was a problem.
Arthur Caplan, a nationally recognized vaccination agency, has made the potential impact even clearer.
“I really think it’s a potential disaster for the fight against COVID,” Caplan, a medical ethicist at the NYU School of Medicine, told the review journal. “This will fuel a lot of vaccine hesitation, skepticism and doubt.”
He believes the public may not differentiate that the regulatory concerns concern a specific COVID-19 vaccine rather than the Moderna or Pfizer vaccines. He found that even if the blood clots are clearly related to the J&J vaccine, the evidence suggests that the risk is low.
“My message is to take the vaccine,” said Caplan. “Don’t worry about the potential tiny risks.”
He said that for some people, such as younger women, it might make sense to choose a different type of vaccine if they have that option.
“But let’s not be paralyzed by a risk that is almost difficult to measure against the certainty that many people are dying of the disease today,” he said.
Side effects taken seriously
Another top vaccine agency, Dr. Paul Offit, also hopes for a measured public reaction.
“People should be reassured that even very, very rare side effects are taken seriously by regulators,” Offit said in a telephone interview. Offit, director of the Vaccine Education Center at Philadelphia Children’s Hospital, was a member of an independent committee advising the FDA on COVID-19 vaccines.
He believes the identified blot clots are related to the vaccine’s technology, which uses a virus known as adenovirus as a platform. This is the same platform used by the vaccine developed by AstraZeneca and Oxford University, which has also been linked to rare blood clots in countries where it is given. AstraZeneca has not filed for approval for its vaccine in the US
The FDA said the cases studied resembled the clots that may be related to the AstraZeneca vaccine.
“I think this type of vaccine causes these types of very rare but serious side effects,” Offit said. “I think it was wise for the FDA and CDC to take a breath.”
Moderna and Pfizer’s vaccines use a different technology known as mRNA to deliver instructions into the human body to make proteins that prepare it to attack a specific virus, in this case the new coronavirus.
The CDC’s Advisory Committee on Immunization Practices (ACIP) is expected to meet on Wednesday to review the six cases and make a recommendation.
One possible course of action would be to recommend, for example, restricting the vaccine to people over 55, as the blood clots have been linked to younger women, Offit said. However, he urged that risk be put into perspective.
“A question of relative risks”
“It’s always about relative risks. Here you have a virus that killed 570,000 people, ”he said. “There are benefits to just having to give one dose, and some people might say, ‘You know, it’s one in a million chances of getting this.'”
A Las Vegas resident who received the vaccine on Monday was unaffected by the development on Tuesday.
Darlene Blose, 77, of Las Vegas said she drove more than 30 miles on Monday to be the first in line at a fire station in east Las Vegas to hand out J&J vaccines.
“I feel safer with one shot,” said Blose, adding that it would have been more difficult for her to make two appointments because she doesn’t have a computer.
Blose heard of the vaccine being discontinued Tuesday morning but was not concerned.
Blose said she still had the vaccine despite the possibility of complications. Now she’s looking forward to having lunch with her friends for the first time in a year.
“We have to deal with this and try to get back to normal life,” she said.
Contact Mary Hynes at [email protected] Follow @ MaryHynes1 on Twitter.
The Review Journal’s authors, Katelyn Newberg and Michael Scott Davidson, and the Associated Press contributed to this report.