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J&J Covid-19 Vaccine Authorized for Use in U.S.


The first single-dose Covid-19 vaccine, a shot from

Johnson & Johnson,


JNJ -2.64%

was authorized for use, a big boost for a mass-vaccination campaign rushing to end the deadliest pandemic in more than a century.

The vaccine’s authorization on Saturday, the third issued by the U.S. Food and Drug Administration, will give health authorities a desperately needed new source of doses as they scramble to ramp up inoculations ahead of elusive emerging strains.

J&J said it has begun shipping the vaccine to the U.S. government, which is managing allocation and distribution. That indicates first doses could be administered during the coming week.

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“There is light at the end of the tunnel, but we cannot let our guard down now or assume that victory is inevitable. We must continue to remain vigilant, act fast and aggressively, and look out for one another,” President Biden said.

The shot’s addition to the country’s vaccination drive comes at a precarious moment in the pandemic in the U.S. Newly reported cases, hospitalizations and deaths have been dropping in recent weeks, but remain higher than peaks seen last summer and spring.

Also, new variants are spreading. More than 2,100 cases linked to variants first identified in the U.K., South Africa and Brazil have now been detected in the U.S., according to the Centers for Disease Control and Prevention.

J&J’s shot wasn’t as effective in studies as two Covid-19 vaccines, from

Pfizer Inc.


PFE -0.98%

and

Moderna Inc.,


MRNA 4.33%

that have been previously authorized. It also didn’t work as well against at least one new strain of the virus—the one first identified in South Africa—as against the original strain of the virus.

Vaccines’ Effectiveness

Efficacy against

severe disease

Efficacy in people

65 and older

Health authorities say J&J’s vaccine still works well, and are encouraging eligible people to get whatever shot they can.

Also, the vaccine showed preliminary signs, according to J&J, of curbing spread of the virus among people who don’t show symptoms. They have been a significant source of transmission.

J&J’s single-dose shot could greatly simplify the vaccination drive, which has been complicated by the need to give two doses, three or four weeks apart, as required by the two vaccines cleared earlier.

The J&J vaccine also has more favorable temperature requirements for distribution and storage, making it easier for sites, including many in rural areas, that lack expensive freezers to give the shots.

J&J has said it would deliver 20 million doses by the end of March.



Photo:

/Associated Press

Some studies have shown that the Pfizer and Moderna vaccines provide good protection after just one shot, but the research is ongoing and regulators haven’t signed off on any change.

Likewise, the Pfizer and Moderna vaccines can be stored for longer at higher temperatures than was initially thought, but storage and handling of J&J’s shot will still be easier. Pfizer’s vaccine can be stored in a regular refrigerator for five days, while J&J’s can stay there for at least three months.

Limited initial supplies, however, will probably blunt any early impact from the addition of the newly authorized shot. J&J expects to have just 4 million doses ready to ship right away. The company has said it would deliver 20 million doses by the end of March.

J&J expects output will quickly increase, so that the company can deliver a total of 100 million doses for use in the U.S. by the end of June.

“This milestone follows a…



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