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J&J says cutting enrollment for COVID-19 vaccine trial by 20,000 as cases rise

(Reuters) - Johnson & Johnson said on Wednesday it has cut enrollment for its pivotal COVID-19 vaccine trial to 40,000 volunteers from its original plan for 60,000, as higher rates of COVID-19 infections amid a worsening pandemic should generate the data it needs with fewer study subjects.

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The move could speed up the time frame for U.S. regulatory clearance, because they will need two months of follow-up safety data from 10,000 fewer people in order to meet U.S. Food and Drug Administration guidelines.

A top U.S. official said on a Wednesday press call that the lower target means the trial could be fully enrolled this week. J&J said it continues to expect an interim data readout in late January and could apply for U.S. emergency use authorization (EUA) in February.

“Given the high incidence of COVID-19 among the general population, we expect that approximately 40,000 participants will generate the data needed to determine the safety and efficacy of our investigational COVID-19 vaccine candidate,” J&J said in a statement.

The United States has reported an average and 205,661 new COVID-19 cases each day over the past week.

Meanwhile, Pfizer Inc could within days receive an EUA from the U.S. Food and Drug Administration for its vaccine, developed with Germany’s BioNTech SE, U.S. Health Secretary Alex Azar said on the call, adding that vaccinations could begin as soon as next week.

A panel of outside expert advisers to the FDA will meet on Thursday to review the Pfizer vaccine and decide whether to recommend that the agency grant the EUA. An FDA decision is expected soon after that.

Officials said they are preparing to distribute 2.9 million doses to more than 600 locations across the country once the vaccine is authorized. They are setting aside the remainder of their first 6.4 million-dose allotment to guarantee a second dose in the two-dose regimen for those who received a first shot, and to have a precautionary reserve.

Although the federal government is coordinating distribution efforts, states, territories, and five federal agencies will decide who should receive a vaccine first.

On Wednesday, the Department of Defense said it would receive about 44,000 doses of the initial nationwide supply and will prioritize vaccinating healthcare workers at military medical centers.

Moncef Slaoui, the chief adviser for U.S. efforts on coronavirus vaccines, said on Wednesday Americans with a history of severe allergic reactions may not be candidates for Pfizer’s vaccine, after two people with severe allergies had serious adverse reactions to the shot on the first day of vaccinations in the U.K. British health officials said both are recovering well.

Britain’s medicine regulator said it was changing its guidance to warn people with a history of significant allergies to vaccines, medicine and food to not get the vaccine.

Canadian health officials are making a similar recommendation after Canada approved the Pfizer/BioNTech vaccine on Wednesday.

Reporting by Carl O’Donnell and Rebecca Spalding in New York; Additional reporting by Michael Erman in New York, Manojna Maddipatla in Bangaluru and Julie Steenhuysen in Chicago; Editing by Bill Berkrot

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