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Johnson & Johnson said Wednesday that it reduced enrollment for its vaccine trial against the coronavirus disease (COVID-19) to 40,000 volunteers from its original plan to 60,000, as higher rates of COVID-19 infections amid from a worsening pandemic should generate the data you need. with fewer study subjects.
The move could speed up the timeline for US regulatory approval, because they will need two months of tracking safety data from 10,000 fewer people to meet US Food and Drug Administration guidelines.
A senior US official said in a press call on Wednesday that the lower target means the trial could be fully enrolled this week. J&J said that it is still waiting for an interim data reading in late January and that it could apply for the US emergency use authorization in February.
“Given the high incidence of COVID-19 among the general population, we expect approximately 40,000 participants to generate the data necessary 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 of 205,661 new COVID-19 cases each day for the past week.
Meanwhile, Pfizer Inc could receive an EUA from the US Food and Drug Administration in a few days for its vaccine, developed with Germany’s BioNTech SE, US Health Secretary Alex Azar said on the call. , adding that vaccines could start next week.
A panel of outside FDA expert advisors will meet Thursday to review the Pfizer vaccine and decide whether to recommend that the agency grant the EUA. A decision from the FDA is expected shortly thereafter.
Authorities said they are preparing to distribute 2.9 million doses to more than 600 locations across the country once the vaccine is licensed. They are reserving the remainder of their first allocation of 6.4 million doses to guarantee a second dose in the two-dose regimen for those who received a first injection, and to have a precautionary reserve.
Although the federal government is coordinating distribution efforts, the states, territories, and five federal agencies will decide who should get a vaccine first.
On Wednesday, the Defense Department said it would receive about 44,000 doses of the initial national supply and will prioritize vaccinating healthcare workers at military medical centers.
Moncef Slaoui, the chief adviser to the U.S. efforts on coronavirus vaccines, said Wednesday that Americans with a history of severe allergic reactions may not be candidates for Pfizer’s vaccine, after two people with allergies serious had serious adverse reactions to injection on the first day of vaccinations in the UK British health officials said both are recovering well.
Britain’s drug regulator said it was changing its guidance to warn people with a history of significant allergies to vaccines, drugs and food not to get vaccinated.
Canadian health officials are making a similar recommendation after Canada approved the Pfizer / BioNTech vaccine on Wednesday. – Reuters
