August 3, 2020, 2:53 PM
It escaped no one that the proposed deadline also intersected nicely with President Donald Trump’s need to curb the virus before the election in November. Despite concerted efforts by the Trump administration and a bevy of pharmaceutical companies it is working with, the original October target has slipped, with the administration now pushing to have hundreds of millions of doses available by the end of the year or early 2021.
“We expect to have a vaccine available very, very early before the end of the year, far ahead of schedule,” he said. “We’re very close to having that finalized.” An independent advisory panel of outside experts also weighs in, and while the agency has the power to make its own decision, it typically follows the advice of its outside panels. The FDA’s senior regulator has the power to approve or deny vaccines for emergency use, but that decision could be overridden by the agency’s top leaders, or by the secretary of Health and Human Services.
At the same time, a senior administration official refused to promise that any emergency approval of a vaccine would be vetted through the Food and Drug Administration’s outside advisory panel of experts, scheduled to meet on Oct. 22. Kushner, Dr. Deborah L. Birx, the White House coronavirus coordinator, and others interviewed Dr. Moncef Slaoui, a pharmaceutical industry veteran, and orchestrated his appointment as chief scientific adviser despite concerns within the FDA about conflicts of interest because of his financial ties to two companies that are developing a vaccine. Rather than being bothered by the conflict, Kushner and others reasoned that it took someone with such industry experience to oversee the effort.
The pharmaceutical companies are reporting the results of their trials at regular intervals, accelerating the review process. With the government paying much of the cost, the companies are beginning the process of manufacturing millions of doses of vaccine essentially on spec so that they can be distributed quickly if they secure approval.
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