This week at HLTH, FDA Commissioner Robert Califf discussed the current state of healthcare AI. He talked about some of the qualms he has, such as his worry that AI is worsening health inequities and his concern that providers aren’t capable of validating AI tools’ effectiveness.
The company's vaccine is the second approved for emergency use by the FDA. It is expected to pose fewer logistical challenges than the first, which was developed by Pfizer and BioNTech.
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The news sent the stock market soaring as it represents a key milestone in developing and distributing a vaccine for the virus. Still public confidence in vaccines need to be boosted, an expert noted.
The guidance calls for a median two months' worth of follow-up safety data from well-designed Phase III studies as a precondition for a vaccine receiving an EUA. The Wall Street Journal reported that the White House had backed down in its opposition to the guidance, which pushes the date of an EUA past Election Day.
Reuters reported Wednesday that U.S. regulators would look at data from previous clinical trials that came from the same scientists who created the vaccine, AZD1222, which originated at the University of Oxford and is also known as ChAdOx1 nCoV-19.
The company emphasized that the partial hold was due to "additional questions" about the study, including the delivery device being used, and was not related to any adverse events. As such, the Phase I study of the vaccine, INO-4800, is proceeding.
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The New York Times reported that in a memo, Alex Azar stated that the power to sign new rules is "reserved" for him, a move that one expert called a "power grab." It is unclear how it will affect authorizations of vaccines against the coronavirus.
The agency's Covid-19 Treatment Guidelines Panel stated there was insufficient evidence for or against the treatment and pointed out that in certain groups, such as intubated patients, no benefit in seven-day overall survival was observed.
In an interview with The Financial Times Sunday, the embattled FDA commissioner said he would be open to the agency green-lighting a vaccine against the SARS-CoV-2 virus before Phase III trials are complete. The agency also ousted its spokesperson, Emily Miller, after only 11 days on the job Saturday.
The FDA commissioner took to Twitter Monday night to defend his performance at the agency, which came under sharp criticism amid accusations that the authorization of a plasma treatment for Covid-19 was politically motivated and that he stood by while President Trump unfairly maligned FDA staffers, prompting calls for his resignation.
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While the emergency use authorization granted Sunday was not seen as scientifically unwarranted, it drew concerns from some experts that it could hinder enrollment in clinical trials, while the timing and circumstances of the FDA's move fueled suspicions that political pressure - rather than science and data alone - may have played a role.
Over the weekend, Trump called the agency, without evidence, part of a "deep state" that was slow-walking vaccines and drugs for Covid-19. The next day, the agency authorized convalescent plasma despite having turned it down shortly before due to insufficient evidence.
The New York Times reported that the FDA was prepared to issue an emergency use authorization for the treatment last week, but NIH Director Francis Collins and NIAID Director Anthony Fauci intervened, arguing that data were too weak.
In a CRL issued for valoctocogene roxaparvovec, the FDA told BioMarin that differences between its Phase I/II and Phase III studies limited the ability to rely on the earlier trial to support durability of effect, which an analyst said likely referred to a product comparability issue.
While there had been some risks to filgotinib's approval cited before, analysts expressed surprise at the decision, with one writing it would likely delay approval by at least a year. Shares of both companies fell sharply on the news.