• by DanBC on 12/2/2020, 9:55:51 PM

    Some cultural notes: UK Conservative politicians have started claiming that our rapid approval was because of Brexit.

    UK med regulators have said that's bollocks. They say the med was approved under existing EU regs.

    MHRA say that no corners were cut. They claim the rapidity of the decision was because all parties were in alignment: they want a safe vaccine, so all funding was available when it needed to be and all evidence was rapidly assessed.

    https://twitter.com/ShaunLintern/status/1334078198318059520?...

  • by The_Amp_Walrus on 12/3/2020, 12:24:34 AM

    What are the object-level facts here? This article is very abstract and is mostly concerned with what various parties are saying.

    "They are rushing!"

    "No we are not rushing, we are going a good job"

    "No! Too fast! We are being more thorough than you because we are waiting for more data."

    "We are being rigorous"

    The closest we get to any kinds of concrete statements about the review process is:

    "The EMA started a rolling review of preliminary data from Pfizer trials on Oct. 6, an emergency procedure aimed at speeding up possible approval, which usually takes at least seven months from reception of full data. The UK regulator launched its own rolling review on Oct. 30, and analysed less data than made available to the EMA."

    It's still not clear what "the data" is, what a "rolling review" is and what any of this means from a practical decision-making standpoint. Should UK citizens take the vaccine? What issues could be missed given the UK regulator "analysed less data"?

  • by _Microft on 12/2/2020, 9:36:59 PM

    And there goes the hope that they were just more efficient in working through the available data...

  • by Hickfang on 12/2/2020, 11:47:27 PM

    Dear EU, you don't get to tell us what to do anymore!