(WPRI) — On Thursday an advisory panel to the CDC is holding an all-day meeting, following roughly 100 reports of a rare neurological disorder in people who received the Johnson & Johnson COVID-19 vaccine.
The Advisory Committee on Immunization Practices (ACIP) plans to make recommendations on how to address those new safety concerns, and if the benefits of the J&J vaccine outweigh its potential risks.
The panel will look at the 100 preliminary reports of cases of Guillain-Barré Syndrome (GBS) following vaccination. Of these reports, the U.S. Food & Drug Administration (FDA) says 95 were serious and required hospitalization, and there was one reported death.
The disorder causes the body’s immune system to damage nerve cells and can cause muscle weakness or in the most severe cases, paralysis.
According to the FDA, an estimated 3,000 to 6,000 people develop GBS each year in the United States. The FDA says most people fully recover from the disorder, which is also a possible side effect of certain seasonal flu or shingles shots.
“Although the available evidence suggests an association between the Janssen vaccine and increased risk of GBS, it is insufficient to establish a causal relationship,” the FDA wrote in a statement on July 13.
Ahead of the ACIP meeting, the FDA has already updated the label and fact sheet for J&J’s vaccine, which notes “reports of adverse events suggest an increased risk of GBS.”
Additionally, a new paper from researchers at New York University Grossman School of Medicine, suggests an even lower efficacy of the single-dose shot when facing the highly contagious Delta variant.
The paper, published on Tuesday in bioRxiv, is based on lab experiments and has not been peer-reviewed yet.
Scientific and medical articles are traditionally “peer-reviewed” before a formal publication in a scholarly journal, and will typically only be published in a journal once editors, who take advice from various experts, are satisfied the authors have addressed any concerns.
The conclusions from NYU researchers are at odds with those from smaller studies published by Johnson & Johnson earlier this month, suggesting a single dose of the vaccine is effective, even eight months after inoculation.
“Additional Company data also demonstrated the Johnson & Johnson single-shot COVID-19 vaccine generated strong, persistent activity against the rapidly spreading Delta variant and other highly prevalent SARS-CoV-2 viral variants,” a company spokesperson told 12 News.
The NYU paper also suggests if so-called breakthrough infections result in an increase in severe COVID-19 cases, that booster shots for all three vaccines should be strongly considered.
Right now, Johnson & Johnson, Pfizer, and Moderna are all looking at booster shots, even though federal regulators do not currently recommend they are needed.
The CDC panel on Thursday will also discuss data and clinical considerations for boosters in immunocompromised people, though there are no votes scheduled.