J&J Seeks FDA Authorization for One-Shot Vaccine

Johnson & Johnson JNJ 0.93% requested U.S. regulators on Thursday to authorize the emergency use of its Covid-19 vaccine, setting the stage for a possible third vaccine to turn out to be accessible within the U.S. inside weeks.

J&J’s transfer follows final week’s launch of outcomes from a world scientific trial exhibiting {that a} single shot of the vaccine was 66% efficient at stopping average and extreme Covid-19 illness. Within the U.S. portion of the trial, the vaccine was 72% efficient at stopping illness.

The addition of J&J’s vaccine might jump-start a U.S. mass-vaccination marketing campaign that has been uneven because it started in December. There was a restricted provide of the primary two vaccines, from Moderna Inc. and Pfizer, with its associate BioNTech SE, and distribution roadblocks have brought on a slower-than-expected tempo of vaccinations.

J&J’s shot wouldn’t solely increase the general provide of Covid-19 vaccine doses, but additionally might simplify vaccinations for a lot of as a result of it’s given in a single dose. The vaccines from Pfizer and Moderna are administered as two doses, three or 4 weeks aside. J&J’s vaccine additionally could be saved at increased refrigerated temperatures for an extended interval than the primary two vaccines.

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The New Brunswick, N.J., firm expects to have thousands and thousands of doses accessible instantly upon authorization, federal officers have stated. The corporate expects to make a couple of billion doses in complete this yr globally. The U.S. authorities has bought 100 million doses from J&J, which expects to provide that quantity by midyear, a J&J spokesman stated. The federal government has choices to buy extra.

“Upon authorization of our investigational Covid-19 vaccine for emergency use, we’re prepared to start transport,” J&J Chief Scientific Officer Paul Stoffels stated. “We’re working with nice urgency to make our investigational vaccine accessible to the general public as shortly as potential.”

J&J filed its request to the U.S. Meals and Drug Administration, which has scheduled a Feb. 26 assembly of a committee of out of doors advisers to evaluation the proof for the vaccine’s security and effectiveness, because it did in December for the primary two vaccines. If the FDA follows the identical timeline as for the primary two vaccines, it might attain a choice on J&J’s vaccine by the tip of the month. The FDA stated Thursday it is going to evaluation J&J’s request as shortly as potential.

J&J stated it additionally began utility processes with a number of well being businesses exterior the U.S., and expects to file for European Union regulatory clearance for the vaccine within the coming weeks.

The vaccine works by deploying the virus behind the frequent chilly—modified in order that it doesn’t replicate—to ship a gene from the coronavirus. As soon as injected, the gene instructs human cells to make a protein resembling the spike protein discovered on the floor of the coronavirus. This, in flip, mobilizes an individual’s immune system to battle off the precise virus if uncovered to it.

The primary two vaccines from Pfizer and Moderna use a unique know-how.

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Within the massive examine, when trying solely at extreme instances, J&J stated its vaccine was 85% efficient throughout all areas studied, as of 28 days after vaccination.

However J&J’s vaccine had a 57% efficacy charge towards average to extreme illness within the South Africa portion of the trial. A brand new coronavirus variant has circulated in that nation that’s believed to be extra immune to Covid-19 vaccines. J&J and different corporations have begun work on potential new vaccines that may higher goal the brand new pressure.

Individually, Novavax Inc. stated Thursday it has initiated the appliance course of for authorization of its Covid-19 vaccine within the U.S. and a number of other different nations. Within the U.S., the regulatory evaluation is anticipated to proceed whereas Novavax completes a big scientific trial. The corporate has stated a choice might come within the spring if examine outcomes are constructive. Final week, Novavax stated its vaccine was 89% efficient in a U.Ok. trial and 49% efficient in a South Africa trial.

The corporate additionally stated it is able to start transport upon authorization and expects to provide 100 million doses to the U.S. within the first half of 2021.

Covid-19 Vaccines

Write to Peter Loftus at peter.loftus@wsj.com

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Appeared within the February 5, 2021, print version as ‘J&J Seeks FDA Approval for Vaccine.’

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