CDC Advisory Committee discuss rare side effect possibly linked to Johnson & Johnson COVID-19 vaccine

Posted at 6:31 AM, Jul 22, 2021
and last updated 2021-07-22 17:08:35-04

TAMPA, Fla. — The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, or ACIP, met on Thursday to review data on the need for COVID-19 booster shots, and also discuss newly discovered safety concerns about Johnson & Johnson’s COVID-19 vaccine.

Researchers have recently identified some cases of a rare disease known as Guillain-Barré syndrome, or GBS, that could be connected to Johnson & Johnson’s COVID-19 vaccine.

“This is a disease in which the body’s own immune system goes haywire and attacks the nerves in the arms and legs and chest and face. For the patient, this results in progressive paralysis, can result in complete paralysis, and ventilator dependence for a time although usually with supportive care 90% of patients will ultimately return to normal. It may take several months to recover,” said Dr. Clifton Gooch, Chair of Neurology at the University of South Florida Morsani College of Medicine and VP of Research for Tampa General Hospital.

Federal health officials say there have been about 100 preliminary reports of the neurological disorder, among the nearly 13 million people who have received the J&J vaccine.

“With the data, we already have on 13 million people, I would suspect if there is an association, it’s a small association because in 13 million if there was a strong association we would be seeing really, really high numbers of cases and we’re not seeing that,” said Gooch.

Doctors say GBS has also been seen in other vaccines in the past like the swine flu vaccine and the flu vaccine at very low levels.

Experts stress the data shows this potential reaction to the J&J vaccine is rare.

“It appears that the excess is so small at this point that we’re not 100% sure that we can draw a clear connection between the two. That’s why this meeting is happening with the CDC to try to determine whether this exists and what the strength of the advisory should be,” said Gooch.

Last week, Food and Drug Administration updated the label on the J&J vaccine to include GBS as a rare risk, with an increased chance of getting the syndrome during the 42 days following vaccination.

“What makes us concerned is the fact that the time course of the administration of the vaccine and the onset of the symptoms, which in Guillain-Barré if there’s an infection or a vaccine which precipitates it, it’s usually a two to four-week time frame and a lot of these patients fell into that two to four-week time frame. So that makes us concerned that there may be a connection and that’s part of what the committee is going to be looking into,” said Gooch.

The general consensus from the ACIP was that the benefits far outweigh the risks when it comes to the Johnson and Johnson vaccine.

“I expect they’re going to say that it’s possible this could be associated based upon the timing primarily and the slightly excess number of cases for the number of people vaccinated that we’re seeing, but I don’t think they’re going to come out with a definitive statement saying we’re absolutely certain this is causing Guillain-Barré. I think they’re going to say it could be and we’re going to monitor it, we’re advising caution and careful monitoring but people should still get vaccinated,” said Gooch.

During the last half of the meeting, they also discussed the potential need for COVID-19 booster shots in immunocompromised people. This group of people makes up about 2.7% of the U.S. population.

Thoughts among medical professionals were pretty split when it came to whether or not a recommendation should be made for a booster shot to the COVID-19 vaccine, specifically for people who are immunocompromised.

Studies show immunocompromised people have less of an antibody response to COVID-19 vaccines, specifically if those people have received an organ transplant.

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The same group of people is also more likely to develop a severe case of COVID-19.

During the meeting, Dr. Sara Oliver with the ACIP mentioned that both France and Israel have already moved to recommend a 3rd dose for certain immunocompromised people, and the United Kingdom is currently considering it.

During the public comment portion, several doctors chimed in to say that they already knew of patients who had gone and gotten a booster shot on their own free will, in hopes of boosting their antibody response.

“Emerging data suggest that an additional COVID-19 vaccine dose in immunocompromised people may enhance antibody response in some, and increases the proportion who respond,” said Dr. Oliver.

No decisions or votes were made on either matter, but the committee did say they have plans to hold additional meetings in August.