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by The_Amp_Walrus
2027 days ago
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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"? |
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> This was done using a regulatory process known as a ‘rolling review’. A ‘rolling review’ can be used to complete the assessment of a promising medicine or vaccine during a public health emergency in the shortest time possible. This is done as the packages of data become available from ongoing studies on a staggered basis.
> The MHRA expert scientists and clinicians reviewed data from the laboratory pre-clinical studies, clinical trials, manufacturing and quality controls, product sampling and testing of the final vaccine and also considered the conditions for its safe supply and distribution.
> The National Institute for Biological Standards and Control, part of the agency, has been and will continue doing, independent laboratory testing so that every batch of the vaccine meets the expected standards of safety and quality.
The information sheet for doctors gives a long list of "we don't know yet" about safety and efficacy for certain populations[2].
[1] https://www.gov.uk/government/news/uk-medicines-regulator-gi...
[2] https://assets.publishing.service.gov.uk/government/uploads/...