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J&J's COVID-19 shot gets CDC panel backing; vaccine near shipping

FILE PHOTO: Vials labelled "COVID-19 Coronavirus Vaccine" and syringe are seen in front of displayed J&J logo in this illustration

By Carl O'Donnell

(Reuters) - A U.S. Centers for Disease Control and Prevention advisory panel voted unanimously on Sunday to recommend Johnson & Johnson's COVID-19 shot for widespread use, and U.S. officials said initial shipments would start on Sunday.

Providing a final clearance for the vaccine a day after it was authorized by U.S. regulators, the Advisory Committee on Immunization Practices (ACIP) voted 12-0 to recommend the vaccine from J&J as appropriate for Americans 18 and older. There was one abstention due to prior conflicts of interest.

"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," Paul Stoffels, J&J's chief scientific officer, said in a statement. [nPn6GNp0Sa]

"We're getting these doses out the door as soon as they're available to ensure vaccines get into arms as quickly as possible," one senior U.S. official told reporters late on Sunday, adding that initial deliveries were expected by Tuesday. [nL2N2KY0OJ]

State and local public health authorities will use Food and Drug Administration (FDA) and CDC guidance as they administer the first 3.9 million doses, which will be shipped through distribution partner McKesson Corp .

Senior administration officials acknowledged that vaccination rates among minorities were "not where we ultimately want them to be", but measures had been put into place to boost those numbers. Federal officials were closely monitoring distribution by states to ensure it was equitable, they said.

The officials urged everyone in the United States to get a shot as soon as it was their turn, and said Black and brown Americans should understand that safeguards had been put in place after past cases of discrimination in the medical field.

"Time is certainly of the essence. Getting vaccinated saves lives," said one of the officials.

ACIP has played a major role in guiding states on how to allocate scarce doses, though states themselves have the final say in how they allocate shots. [nL2N2KX06G]

CDC epidemiologist Dr. Sara Oliver said during a Sunday presentation that there are not yet any studies comparing J&J's vaccine directly to the other approved vaccines from Pfizer-BioNTech and Moderna Inc , but that all vaccines were highly effective at reducing hospitalizations and deaths.

Both the Pfizer and Moderna vaccines, which are based on new messenger RNA technology, showed higher efficacy rates in trials that used two doses versus J&J's single-shot vaccine. Direct comparison, however, is difficult because the trials had different goals and J&J's was conducted while more contagious new variants of the virus were circulating.

Oliver also said there was insufficient data to know whether the vaccines' safety or efficacy could be compromised by pre-existing conditions that compromise a person's immune systems.

CDC Director Rochelle Walensky has approved the panel's recommendations.

Oliver and senior U.S. officials said that deploying J&J's vaccine could help ensure equitable distribution of shots to underserved communities.

J&J's shot will be the only one-dose COVID vaccine available in the United States. It is also the easiest to ship and store, as it can be kept in a refrigerator rather than a freezer. [nL1N2KV3RB] [nL4N2KF48Y]

J&J expects to ship more than 20 million doses by the end of March and 100 million by midyear, enough to vaccinate nearly a third of Americans.

(Reporting by Carl O'Donnell; Editing by Lisa Shumaker)