Is the Johnson & Johnson COVID-19 vaccine safe?

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Johnson & Johnson vaccine on track for final approval in coming days

The single-dose vaccine is a 'big addition' the COVID-19 vaccine arsenal, Fox News medical contributor Dr. Marc Siegel says.

A third COVID-19 vaccine could enter the fight against the novel virus in the coming days. But what does its safety profile look like?

While a panel of independent experts are deliberating endorsement for the vaccine Friday, staff at the Food and Drug Administration released documents earlier this week, finding the jab had a "favorable safety profile with no specific concerns identified that would preclude issuance of an EUA."

The briefing documents noted no COVID-19-related deaths in the vaccinated trial group as of Feb. 5, suggesting the vaccine reduces COVID-19-related mortality. There were seven coronavirus-related deaths in the placebo group.

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The most common reactions associated with the vaccine included pain at the injection site, headache, fatigue and myalgia, which were mostly "mild and moderate," resolving within two days post-vaccination. Participants ages 18-59 experienced reactions occurring soon after vaccination more often than those aged over 60.

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"There were no specific safety concerns identified in subgroup analyses by age, race, ethnicity, medical comorbidities, or prior SARS-CoV-2 infection," per the documents. The committee noted five cases of urticaria, or red swelling, among vaccinated participants, compared to one in the placebo group. The committee said this non-serious event was "possibly related to the vaccine." Further, insufficient data behind blood clots and tinnitus couldn’t pin a "causal relationship between these events and the vaccine."