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% effective in a global trial, per documents posted ahead of a meeting of a panel of independent experts.
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.
This is a developing story, please check back for updates.
Fox News’ Alexandria Hein contributed to this report.
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