CDC signs off on Johnson & Johnson's single-dose COVID-19 vaccine

The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) has voted to recommend Johnson & Johnson's COVID-19 vaccine for emergency use for individuals ages 18 and older in the United States.

The 12-0 vote, with one recusal for a potential conflict of interest, comes following an official emergency use authorization by the Food and Drug Administration on Saturday. The ACIP, a group of independent health experts that advises the CDC on the types of populations and circumstances for which vaccines should be used, made the recommendation after an emergency session was called to review the vaccine's data.

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CDC Director Dr. Rochelle Walensky signed off on the recommendation on Sunday, calling the decision "another milestone toward an end to the pandemic."

"The Janssen vaccine has been shown to be safe and effective in preventing severe COVID-19 illness, hospitalization and death," Walensky said in a statement. "This vaccine is also another important tool in our toolbox to equitably vaccinate as many people as possible, as quickly as possible."

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"As a one-dose vaccine, people do not have to return for a second dose to be protected," she continued. "In addition, this vaccine does not need to be kept in a freezer and can be stored at refrigerated temperatures – so it is easy to transport and store and allows for expanded availability in most community settings and mobile sites, as supply scales up."

Shipment of Johnson & Johnson's initial supply of 3.9 million vaccine doses to state health departments, pharmacies, federally qualified health centers and community vaccination centers across the country will begin immediately, with deliveries expected as early as Tuesday.

Johnson & Johnson expects to deliver enough single-shot vaccines by the end of March to vaccinate more than 20 million Americans, and 100 million single-shot vaccines during the first half of 2021.

Johnson & Johnson's vaccine is the third for the United States, following previous emergency use approvals for vaccines manufactured by Pfizer and BioNTech and Moderna. Unlike the other two available vaccines, Johnson & Johnson's requires a single dose.

"For more than 130 years, Johnson & Johnson has come to the aid of people during times of crisis," Johnson & Johnson chief scientific officer Paul Stoffels said in a statement. "We believe today’s recommendation from the CDC to begin use of our vaccine as part of the U.S. national immunization program will add a critical tool in the fight against COVID-19."

According to an analysis by the FDA, Johnson & Johnson's vaccine was about 67% effective in preventing moderate to severe cases within 14 days after dosing and 66% effective against severe to critical cases after 28 days. In addition, the vaccine was approximately 77% effective in preventing severe or critical COVID-19 occurring at least 14 days after vaccination and 85% effective in preventing severe or critical COVID-19 occurring at least 28 days after vaccination.

Meanwhile, the Pfizer and Moderna vaccines were 95% and 94.1% effective, respectively.

Walensky noted the latest vaccine comes at a "potentially pivotal time," citing the agency's latest data, which suggests recent declines in COVID-19 cases may be stalling and potentially leveling off at very high numbers.

"That is why it is so critical that we remain vigilant and consistently take all of the mitigation steps we know work to stop the spread of COVID-19 while we work our way toward mass vaccination," Walensky said. "I know that many Americans look forward to rolling up their sleeves with confidence as soon as a COVID-19 vaccine is available to them. Having different types of vaccines available for use, especially ones with different dosing recommendations and storage and handling requirements, can offer more options and flexibility for the public, jurisdictions and vaccine providers. Getting vaccinated with the first vaccine available to you will help protect all of us from COVID-19."

The United States has surpassed more than 28.5 million COVID-19 cases and 513,000 related deaths as of Sunday, according to the latest data from Johns Hopkins University. As of Sunday, the CDC reported over 75.2 million COVID-19 vaccine doses have been administered.

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