A US FDA analysis of data submitted by Johnson & Johnson determined that the one-shot Jansen COVID-19 Vaccine was effective at preventing severe disease and is safe to administer. The analysis comes before a Feb 26 meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC), which will review data and make a recommendation for (or against) emergency use authorization.
According to the FDA document, “The analysis supported a favorable safety profile with no specific safety concerns identified that would preclude issuance of an EUA.”
If approved, the Jansen Ad26.COV2.S vaccine would be the third candidate authorized in the United States, after Pfizer/BioNTech and Moderna in late 2020.
On Monday, J&J said it was prepared to distribute 20 million vaccine doses by end of March 2021, with 100 million by end of June 2021.
The White House coronavirus task force added Wednesday, “If authorized, we are ready to roll out this vaccine without delay,” according to Jeffrey Zients, White House coronavirus czar. “If an EUA is issued, we anticipate allocating 3 to 4 million doses of Johnson & Johnson vaccine next week. Johnson & Johnson has announced it aims to deliver a total of 20 million doses by the end of March. We’re working with the company to accelerate the pace and timeframe by which they deliver the full 100 million doses, which is required by contract by the end of June.”