How badly has the FDA been lagging?

How badly has the FDA been lagging?

How badly has the FDA been lagging?

By Tyler Cowen at Marginal Revolution
The FDA also reviews manufacturing data from Pfizer on how they made the drug. But not only can that data be reviewed in a few hours, it should have been done months ago when it was available. While the FDA was waiting for Pfizer’s long-term vaccine results to come in, the agency should have anticipated this step and done it early. The final step of the FDA review is to look at the outcomes of the study volunteers, including rates and severity of infection and side effects in the vaccine and placebo groups. Again, there is no plausible reason why this basic analysis cannot be done in 24 hours. The FDA and external scientists have a simple task: confirm or reject  the review already conducted by the trial’s independent data safety monitoring board before FDA submission.
FDA insiders say the agency and its approximately 17,000 employees were dark for the four-day Thanksgiving holiday, including those working on the vaccine approval. For those of us who lived through the 2008 financial crisis (agencies other than the Fed were not on the ball in response), or who have studied (and indeed practiced) the economics of bureaucracy for forty years, or who know the extensive literature on how the FDA operates, will not be surprised by a lack of urgency.  Or from the NYT: Dr. Fauci said the politicization of the pandemic in his own country had led regulators to move a little more cautiously than the British, to avoid losing public support.
article date: 2020 12 04
posted: 2020-12-06 19:31:06
Tags:

Read the original post >

Related News

County now under regional stay-at-home order

County now under regional stay-at-home order

As COVID-19 cases and hospitalizations surge and ICU capacity declines, San Mateo and 10 other Bay Area counties are under a mandatory Regional Stay Home Order that takes effect Thursday, Dec. 17, at 11:59 p.m., county officials announced.
Herd Immunity is Herd Immunity

Herd Immunity is Herd Immunity

Some assorted thoughts: In the big picture, the efficacious of a vaccine doesn’t matter per se what matters is getting to herd immunity. If you have a less efficacious vaccine you need to vaccinate more people but herd immunity is herd immunity, i.e. vaccines mostly protect people not because they are efficacious but because we […] The post Herd Immunity is Herd Immunity appeared first on Marginal REVOLUTION.
Youyang Gu will estimate vaccination numbers and herd immunity

Youyang Gu will estimate vaccination numbers and herd immunity

60% of population immune) will be reached in the US by late summer/early fall 2021 (Sep-Nov 2021). At the time herd immunity is reached, roughly half of the immunity will be achieved via natural infection, and the other half will be achieved via vaccination. New COVID-19 infections may become negligible […] The post Youyang Gu will estimate vaccination numbers and herd immunity appeared first on Marginal REVOLUTION.