Johnson & Johnson COVID-19 vaccine has ‘favorable safety profile,’ FDA staff finds

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The Food and Drug Administration posted documents Wednesday finding a single-dose COVID-19 vaccine developed by Johnson & Johnson had a “favorable safety profile with no specific concerns identified that would preclude issuance of an EUA.”

The endorsement, which is not the same as the committee’s vote or FDA approval process, is a promising sign for the vaccine. It would mark the third COVID-19 vaccine to receive EUA in the U.S.

The vaccine candidate showed to be 66.9% effective against moderate-to-severe disease in a global trial two weeks post-vaccination, per documents posted ahead of a meeting of a panel of independent experts. The company is seeking authorization for use in individuals ages 18 and older.

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The committee noted no COVID-19-related deaths in vaccinated individuals as of Feb. 5, though seven COVID-19-related deaths occurred in the placebo group. All seven deaths involved individuals at study sites in South Africa with at least one underlying health condition.

“These results suggest that the vaccine is efficacious against mortality associated with COVID-19,” the documents read.

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However, the committee noted that vaccine efficacy results had “limited interpretability” for those aged over 75 and “certain racial groups.” There was not enough data to assess vaccine efficacy in those previously infected.

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.”

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The shot differs from Pfizer and BioNTech’s and Moderna’s, which were developed using mRNA technology, as this was derived from an adenovirus vector formula. It also requires one dose as opposed to two spaced out over several weeks.

Fox News’ Alexandria Hein contributed to this report.

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