CDC director signs off on J&J’s single-shot Covid vaccine, clearing way for distribution to begin

Johnson & Johnson Coronavirus vaccine illustration

Dado Ruvic | Reuters

An advisory panel to the Centers for Disease Control and Prevention voted unanimously Sunday to recommend the use of Johnson & Johnson‘s one-shot Covid-19 vaccine as the federal government prepares to ship out millions of doses this week.

Once CDC Director Dr. Rochelle Walensky accepts the Advisory Committee on Immunization Practices’ recommendation, the federal government will be able to begin shipping doses out to sites across the country. The ACIP met in an emergency session to review data on the vaccine, which on Saturday became the third shot to receive an emergency use authorization from the Food and Drug Administration.

Walensky said Friday that she would “stand by to review” the ACIP’s recommendation and be “ready to sign.”

“We are at the precipice of having another vaccine in our toolboxes, the Johnson & Johnson Covid-19 vaccine. Like many of you, I’m excited about the news that another safe and effective vaccine option could be coming as quickly as next week,” she said Friday. “Having an additional safe and effective vaccine will help protect more people faster.”

J&J Vice President of Medical Affairs Dr. Richard Nettles told lawmakers on Tuesday that the company is prepared to ship nearly 4 million doses as soon as it receives emergency use authorization. He added that the company expects to be able to provide 20 million doses by the end of March.

The introduction of the J&J shot could be a boon to the U.S. supply of vaccine. While the new vaccine showed signs of being less effective at preventing Covid-19 in clinical trials when compared with that of the PfizerBioNTech and Moderna vaccines, the J&J shot was 100% effective at preventing death and hospitalizations caused by Covid-19 in clinical trials.

The J&J vaccine’s level of protection against Covid-19 in trials varied by region, according to FDA documents released on Wednesday. About a month after the inoculation, the shot demonstrated 72% efficacy in the U.S., 61% in Latin America and 64% in South Africa, where the B.1.351 variant is rapidly spreading.

Notably, the FDA review showed the vaccine was significantly less effective in people 60 and older who also have comorbidities such as diabetes or heart disease. The agency noted, though, that the data was too sparse to draw conclusions from that.

In contrast, Pfizer’s vaccine was found in clinical trials to be 95% effective against preventing Covid-19, while Moderna’s was found to be about 94% effective. Infectious disease experts pointed out that J&J’s numbers can’t be used as a direct comparison to the other two vaccines because it’s a single dose and the company’s trial was conducted when there were more infections as well as new, more contagious variants.

But federal health officials have pointed out the one-shot J&J regimen comes with unique logistical advantages that could make it ideal for hard-to-reach populations.

J&J’s vaccine “makes it operationally easier in lots of contexts,” Dr. Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Diseases, told the Journal of the American Medical Association during a Q&A event on Friday. “I expect lots of considerations state health departments are having around these vaccines is more about the ease of use of the J&J vaccine and how it might be better suited for some populations.”

J&J has said it plans to ship the vaccine, which contains five doses per vial, at 36 to 46 degrees Fahrenheit. By comparison, Pfizer’s vaccine typically needs to be stored in ultra-cold freezers that keep it between minus 112 and minus 76 degrees Fahrenheit, though the FDA said recently that it can be stored at standard pharmacy freezer temperatures for up to two weeks. Moderna’s vaccine needs to be shipped at 13 below to 5 degrees above zero Fahrenheit.

— CNBC’s Berkeley Lovelace contributed to this report.

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