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Single-shot coronavirus vaccine approved in US



WASHINGTON — The U.S. Food and Drug Administration authorized emergency use of Johnson & Johnson’s coronavirus vaccine, adding a third option to the United States’ arsenal as President Joe Biden aims for broad protection by this summer.

The J&J shot is the first one-dose vaccine to hit the U.S. market and is easily shipped and stored, presenting what could be a critical alternative for vaccinating hard-to-reach or skeptical Americans. FDA on Saturday cleared the vaccine for use in people 18 and older.

J&J has 4 million shots on hand, half of which will be shipped to state health officials in the upcoming week, according to Biden officials; the rest go to pharmacies and community health centers. The pharmaceutical company has said it can provide 20 million shots by the end of March and 100 million total by the end of June.

President Joe Biden in a statement called the authorization “exciting news for all Americans” but cautioned that the country most continue to follow basic public health measures, such as masking and keeping distance — especially as new, more contagious virus variants spread.

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

The vaccine is 66 percent effective against broad coronavirus infection but particularly good at curbing severe illness, hospitalization and death, which J&J executives say is most important for consumers.

An expert panel advising the FDA agreed, voting unanimously late Friday to recommend the vaccine for people 18 years and older.

“We need vaccines that are effective and well-tolerated. And importantly, ones that are simple to deploy,” Gregory Poland, director of the Mayo Clinic’s vaccine research group, said during a J&J presentation before the Vaccines and Related Biological Products Advisory Committee on Friday.

State and local health officials have also expressed optimism about the incoming vaccine.

“I’m already looking forward to the Johnson & Johnson vaccine and I would love to have information — what temperature does it need to be stored at … how many doses of each vaccine is going to be contained in these vials — so I could already start planning for it,” Rais Vohra, interim health officer for Fresno County, Calif., told POLITICO earlier this month.

An advisory panel to the U.S. Centers for Disease Control and Prevention will meet Sunday to consider and vote on recommendations on who should receive the J&J shot. That’s the final step before the vaccine can be used for the general public.

The panel may address some remaining questions about how well the vaccine works in older people with some common health problems. Limited J&J data from this group indicates the shot is just 42 percent effective among people 60 and older with common risk factors, like diabetes, heart problems and obesity.

However, FDA and the company on Friday said additional data may ultimately prove the shot is more effective in this group.



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