J&J's COVID-19 shot scores safety backing from CDC experts, but booster need left for FDA

COVID-19 vaccine
The CDC said despite the higher rate of a rare nerve disorder among J&J COVID-19 vaccine recipients, the jab's benefits still far outweigh its risks. (Kunal Mahto/iStock/Getty Images Plus/Getty Images)

Johnson & Johnson’s COVID-19 vaccine presents greater benefits than it does safety risks, especially amid the quickly spreading Delta variant, a key CDC expert panel decided. However, the panel said that a ruling over the need for a booster added to all COVID shots will have to start with the FDA. 

The CDC’s Advisory Committee on Immunization Practices (ACIP) decision on Thursday came after an hours-long discussion over a handful of Guillain-Barré syndrome (GBS) cases reported after J&J’s jab. The independent group of experts were also tasked with reviewing the need for booster shots, specifically for people with compromised immune systems. 

Just last week, the CDC updated J&J’s label again to warn of “an increased risk” for GBS, although the agency has maintained that a definitive link hasn’t been established. Europe’s medicines regulator added its own warning on Thursday just ahead of ACIP’s meeting. 

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As of June’s end, there have been 100 reported GBS cases among J&J recipients, most of whom were hospitalized and one person has died, CDC officials reported. Most cases were seen in older men within 13 days following the single-dose vaccine. 

GBS is a rare but potentially life-threatening disorder in which the body’s immune system attacks nerve cells. The condition has been associated with the use of other widely used vaccines, such as GlaxoSmithKline’s Shingrix. 

J&J’s shot generates roughly 8 GBS cases per million vaccinated people, far higher than just a single case reported per million among mRNA recipients, CDC reported. 

The vaccine has been through the ringer over safety worries before. In April, U.S. authorities halted its use and later tagged it with a warning over reports of rare blood clots occurring alongside bleeding in some recipients. 

But one clear concern among the CDC’s expert group this time around was the rapidly spreading Delta variant, first found in India. That mutated strain now accounts for over 80% of new U.S. infections that are sequenced, CDC data shows. 

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J&J’s top brass told the group that its shot holds up against the Delta variant compared with older versions of the virus. After 8 months, the vaccine presents a similar antibody and T-cell response to Delta as it does with other concerning variants, J&J reported.

“The Delta variant is clearly circulating, and it’s more contagious, and it seems to be causing more disease,” said ACIP member Katherine Poehling, M.D., an epidemiologist at Wake Forest School of Medicine. 

But when it came to deciding on whether Americans with compromised immune systems should get an extra dose of any COVID-19 vaccine, the CDC said it would need to wait for the FDA to give its regulatory thumbs up first. That could come either through amending its emergency use nods or awarding full approvals.

The FDA has already clashed with COVID vaccine heavyweights Pfizer and BioNTech over the immediate need for boosters for the broader population. While the drugmakers argue a third shot would offer the highest level of protection, both the CDC and FDA immediately came out against that assertion.

The CDC's delay likely came as a disappointment to representatives for the immunocompromised community, who pleaded with the CDC's expert group to give the go-ahead for booster use in these people, who do not mount a strong enough defense against the virus.

Officials did, however, acknowledge that there's growing evidence an extra jab may enhance the antibody response in immunocompromised people. Some small studies suggest up to 50% of people with no antibody response after the authorized regimen of two mRNA jabs developed a response after an additional dose, said CDC's Sara Oliver, M.D.

Immunocompromised people account for roughly 2.7% of U.S. adults including patients who've received an organ transplant, living with HIV or have received active or recent treatment for cancer, Oliver said.

For its part, the FDA’s representative at the meeting, Doran Fink, M.D., said the drug regulator is “working as rapidly as possible to conduct a thorough and comprehensive” review of all the COVID-19 vaccines that have applied for full approval. Pfizer and Moderna recently submitted their applications for a full nod.

“It’s truly an important scientific issue and important public health issue and FDA is actively exploring all regulatory options for providing access to additional doses of authorized vaccines in situations where data suggests the benefits would outweigh the risks,” Fink said.