Benefits of Johnson & Johnson’s coronavirus vaccine still outweigh risks, CDC data shows

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“Many hospitalizations, intensive care admissions and deaths can be avoided with the Janssen and Covid-19 mRNA vaccines, far exceeding the risks,” CDC researcher Dr Hannah Rosenblum told the agency’s advisory committee on vaccination practices at a meeting Thursday. The Pfizer / BioNTech and Moderna vaccines are messenger RNA or mRNA vaccines.

Earlier this month, the United States Food and Drug Administration updated the label of the Johnson & Johnson coronavirus vaccine to warn of the possible increased risk of a rare neurological complication known as syndrome by Guillain-Barré (SGB).

The FDA said 100 preliminary reports on Guillain-Barré syndrome had been filed with the US government’s Vaccine Adverse Event Reporting System, out of 12.8 million Janssen vaccines administered. While the FDA said it has not established that the vaccine can cause the syndrome, it has noted an increase in reports of the sometimes crippling condition.

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CDC data shows that for women aged 18 to 29, the vaccine would prevent 8,900 cases of Covid-19 and five deaths from Covid-19 and that only one case of GBS could occur. For men in this age group, 6,600 cases of Covid-19 and three deaths from Covid-19 would be prevented and only two cases of GBS could occur.

For every million doses given to women aged 30 to 49, data suggests that 10,100 cases of Covid-19 and 20 deaths from Covid-19 could be prevented compared to the risk of about six to seven cases of GBS . For men in this age group, 7,600 cases of Covid-19 and 25 deaths from Covid-19 could be avoided compared to the risk of around seven to eight cases of GBS, according to CDC data.

For every million doses given to women aged 50 to 64, data suggests that 12,100 cases of Covid-19 and 120 deaths from Covid-19 could be prevented compared to the risk of seven to eight cases of GBS. In men, the vaccine is believed to prevent around 10,100 cases of Covid-19 and 140 deaths from Covid-19 and carries a risk of 14 to 17 cases of GBS, according to CDC data.

“At 65 and over, the benefits are even greater,” Rosenblum said.

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In women aged 65 and over, for every million doses administered, some 29,000 cases of Covid-19 and 840 deaths from Covid-19 would be avoided against a risk of about eight to 10 cases of GBS. For men in this age group, around 36,600 cases of Covid-19 and 2,300 deaths from Covid-19 would be prevented and seven to eight cases of GBS could occur.

“The risk of developing Guillain-Barre after Covid is much higher than the risk of any of the risks presented here,” Johnson & Johnson chief medical officer Dr Joanne Waldstreicher said at the meeting.

With around 100 cases of GBS out of the more than 12 million people in the United States who have received the Johnson & Johnson vaccine as of June 30, this gives “an overall notification rate of 8 cases per million people vaccinated,” said Waldstreicher . “This is against the background of the different published rates of GBS in the United States, which range from 1 to 5 cases per million people.”

“These risks must be declared”

Some ACIP members said on Thursday they were still concerned about the potential risk of GBS, a neurological disorder in which the body’s immune system can damage nerve cells, causing muscle weakness and sometimes paralysis.

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“I totally agree that the overall benefits of Covid-19 vaccines far outweigh the risks,” said ACIP member Dr. Pablo Sanchez, pediatrician at Ohio State University – Nationwide Children’s Hospital. “However, I am concerned about the Janssen product,” Sanchez said, calling the risks not benign and, although rare, “quite significant”.

“I have no problem continuing to have the Janssen product available, but I think these risks should be declared up front to the person receiving this vaccine,” Sanchez said. “And personally, if that was my choice, at the moment, 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 the risks of Pfizer and Moderna vaccines should also be part of the conversations.

Vaccines from Pfizer / BioNTech and Moderna use messenger RNA or mRNA to deliver the vaccine, while J & J’s uses an inactivated cold virus called adenovirus.

In June, the U.S. Food and Drug Administration added a warning about the risk of myocarditis and pericarditis to the Moderna and Pfizer-BioNTech Covid-19 vaccine fact sheets.

The warning notes that reports of adverse events after vaccination – particularly after the second dose – suggest increased risks of both types of heart inflammation.

The one and done

The Johnson & Johnson coronavirus vaccine is given in a single dose, while the Pfizer and Moderna vaccines are given in two doses, 21 and 28 days apart, respectively.

“It’s important to have a single dose product,” said Dr. Henry Bernstein, ACIP member, pediatrician at the Zucker School of Medicine in Hofstra / Northell.

Bernstein also agreed that the benefits outweigh the risks.

“There are a lot of people out there who really just want one – the single dose vaccine,” said Dr Sharon Frey, ACIP member, vaccine specialist at St. Louis University School of Medicine.

“The risk-benefit ratio looks at the benefit of receiving these vaccines in so many ways,” added Frey. “If I was going to receive these vaccines, knowing what data is available, I would like that data to be provided to me as a vaccine recipient, and I think that’s what we need to be able to accomplish, puts this data to the fore. available to people so they can choose what works best for them. “

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