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The Food and Drug Administration (FDA) today issued an emergency use authorization (EUA) for the Johnson & Johnson COVID-19 vaccine, giving the United States a third vaccine to fight the pandemic—one that offers an easier, one-dose option.
The formal announcement follows yesterday’s unanimous recommendation from the FDA’s outside advisory panel, the Vaccines and Related Biological Products Advisory Committee (VRBPAC).
In a statement, acting FDA Commissioner Janet Woodcock, MD, said vaccines are the best prevention in the fight against COVID-19.
And Peter Marks, MD, PhD, who directs the FDA’s Center for Biologics and Research, said, “With today’s authorization, we are adding another vaccine in our medical toolbox to fight this virus. At the same time, the American people can be assured of the FDA’s unwavering commitment to public health through our comprehensive and rigorous evaluation of the data submitted for vaccines to prevent COVID-19.”
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Supply will build gradually in first month
The vaccine is the first adenovirus-based COVID-19 vaccine to be approved for emergency use in the United States and the first to be given as a single dose. It can also be stored at normal refrigeration temperatures, which eases shipping and storage.
Johnson & Johnson has said it expects to produce 100 million doses for the US market in the first half of the year, starting with about 2 million doses allocated to states next week and increasing to 20 million doses by the end of March.
In a large international trial spanning three continents, the vaccine showed an overall 66.1% effectiveness after about 1 month, but it was higher, at 72%, in the United States. Protection was a bit lower in South Africa against the B1351 variant strain.
Next step: CDC panel deliberations
The vaccine needs to clear two more hurdles before Johnson & Johnson can begin shipping doses. A vaccine advisory group for the Centers for Disease Control and Prevention (CDC) will discuss the vaccine tomorrow and decide whether to recommend it.
If the CDC accepts the expected recommendation from the Advisory Committee on Immunization Practices (ACIP), as it typically does, distribution can start.
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