The benefits of the Johnson & Johnson Janssen coronavirus vaccine still outweigh potential risks, according to data from the US Centers for Disease Control and Prevention.
“Many hospitalizations, ICU admissions and deaths can be prevented through Janssen and mRNA Covid-19 vaccines, far outweighing the risks,” CDC researcher Dr. Hannah Rosenblum told the agency’s Advisory Committee on Immunization Practices in a meeting on Thursday. The Pfizer/BioNTech and Moderna vaccines are messenger RNA or mRNA vaccines.
Earlier this month, the US Food and Drug Administration updated the label on Johnson & Johnson’s coronavirus vaccine to warn of the possible increased risk of a rare neurological complication known as Guillain-Barré syndrome (GBS).
The FDA said 100 preliminary reports of Guillain-Barré syndrome had been filed with the US government’s Vaccine Adverse Event Reporting System, out of 12.8 million Janssen vaccines given. While the FDA said it had not established the vaccine could cause the syndrome, it noted an increase in reports of the sometimes paralyzing condition.
In Thursday’s meeting, Rosenblum presented data illustrating how many Covid-19 cases could be prevented by every million doses of Johnson & Johnson’s vaccine administered, compared with how many complications of Guillain-Barré syndrome might emerge.
The CDC data show that for women ages 18 to 29, the vaccine would prevent 8,900 cases of Covid-19 and five Covid-19 deaths and only one GBS case might occur. For men in that age group, 6,600 Covid-19 cases and three Covid-19 deaths would be prevented and only two GBS cases might occur.
For every million doses administered among women ages 30 to 49, the data suggest 10,100 Covid-19 cases and 20 Covid-19 deaths could be prevented compared with the risk of about six to seven GBS cases. For men in that age group, 7,600 Covid-19 cases and 25 Covid-19 deaths could be prevented compared with the risk of about seven to eight GBS cases, according to the CDC data.
For every million doses administered among women ages 50 to 64, the data suggest 12,100 Covid-19 cases and 120 Covid-19 deaths could be prevented compared with the risk of seven to eight GBS cases. Among men, the vaccine would prevent about 10,100 Covid-19 cases and 140 Covid-19 deaths and come with the risk of between 14 to 17 GBS cases, according to the CDC data.
“In 65 and older, benefits are even greater,” Rosenblum said.
Among women ages 65 and older, for every million doses administered, some 29,000 Covid-19 cases and 840 Covid-19 deaths would be prevented compared with the risk of about eight to 10 GBS cases. For men in that age group, about 36,600 Covid-19 cases and 2,300 Covid-19 deaths would be prevented and seven to eight GBS cases might occur.
“The risk of developing Guillain-Barre after Covid is much higher than the risk of any of the risks presented here,” Dr. Joanne Waldstreicher, Johnson & Johnson’s chief medical officer, said in the meeting.
With about 100 cases of GBS out of more than 12 million people in the US who received the Johnson & Johnson vaccine as of June 30, that gives “an overall reporting rate of 8 cases per million people vaccinated,” Waldstreicher said. “This is in the context of the different published rates of GBS in the US, which have ranged from 1 to 5 cases per million people.”
‘Those risks have got to be stated’
Some ACIP members said on Thursday they are still concerned about the potential risk of GBS, a neurological disorder in which the body’s immune system may damage nerve cells, causing muscle weakness and sometimes paralysis.
“I definitely agree that the overall benefits of Covid-19 vaccines far outweigh the risks,” ACIP member Dr. Pablo Sanchez, a pediatrician at Ohio State University — Nationwide Children’s Hospital, said. “However, I am concerned about the Janssen product,” Sanchez said, calling the risks not benign and, although rare, are “quite significant.”
“I have no problem continuing to have the Janssen product available, but I think that those risks have got to be stated upfront to the person who’s receiving that vaccine,” Sanchez said. “And personally, if it were my choice, at this time from what I know, I would recommend the messenger RNA vaccines over the Janssen product.”
ACIP member Dr. Sarah Long, a pediatrician at Drexel University, said that risks tied to Pfizer and Moderna vaccines should also be part of conversations.
Pfizer/BioNTech and Moderna’s vaccines use messenger RNA or mRNA to deliver the vaccine, while J&J’s uses an inactivated common cold virus called an adenovirus.
In June, the US Food and Drug Administration added a warning about the risk of myocarditis and pericarditis to fact sheets for Moderna and Pfizer-BioNTech Covid-19 vaccines.
The warning notes that reports of adverse events following vaccination — particularly after the second dose — suggest increased risks of both types of heart inflammation.
The one and done
Johnson & Johnson’s coronavirus vaccine is administered as a one-dose shot, whereas the Pfizer and Moderna vaccines are administered as two doses, given 21 and 28 days apart, respectively.
“Having a single-dose product available is important,” said ACIP member Dr. Henry Bernstein, a pediatrician at Zucker School of Medicine at Hofstra/Northell.
Bernstein also agreed that the benefits outweigh the risks.
“There are a lot of people who really just want the one — the single-dose vaccine,” said ACIP member Dr. Sharon Frey, who is a vaccine specialist at St Louis University Medical School.
“The risk-benefit leans towards benefit of receiving these vaccines in so many ways,” Frey added. “If I was going to be the recipient of these vaccines, knowing what data that is out there, that I would like to have that data provided to me as a receiver of vaccine, and I think that’s what we need to be able to accomplish, is making that data available to people so they can choose what’s best for them.”
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