The Trump administration anticipates two more vaccine developers could seek FDA authorization for their shots by the end of February.
That would mean the U.S. would have four Covid-19 vaccines available — including the first vaccine to only require one shot — to meet its goal of immunizing 100 million people by the end of March.
The timeline: The first results from Johnson & Johnson's late-stage U.S. trial could come in the beginning of January, said Moncef Slaoui, the chief adviser to Operation Warp Speed, at a Monday press conference. By late January, the company could have enough safety data to submit an application to FDA for emergency use.
Johnson & Johnson cut its enrollment in its last-stage clinical trial from 60,000 to 40,000 because the virus is so widespread that data on efficacy is coming in faster than the company expected. J&J has so far enrolled more than 42,000 people and will stop recruiting participants later this week, Slaoui said.
The vaccine is the only one among the frontrunners that is given as a single dose. “Because it’s a one dose vaccine, they can really scale up very quickly,” Slaoui said.
The first efficacy readout of AstraZeneca’s vaccine could come in the second half of January, Slaoui estimated, and the company could potentially file for emergency use later in February.
AstraZeneca has already released data from a mix of late-stage clinical trials, showing that the standard two-dose vaccine was 62 percent effective. A lower dose paired with a standard-strength second-dose was 90 percent effective. That finding was the result of an error impacting a small group of trial participants.
On Friday night, the FDA authorized the first vaccine for emergency use from Pfizer. Federal health officials expect the second, for Moderna’s shot, could come later this week.
Why it matters: Coronavirus vaccines are the key to ending the pandemic, and authorizing more for emergency use could help ramp up availability. The first shots went into arms Monday, as the U.S. gears up for its most complex vaccination quest in history.
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December 15, 2020 at 02:12AM
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2 more vaccine developers could seek FDA's green light by February - POLITICO
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