Thread by @rvenkayya

@bnallamo Fair question. Here are a few thoughts from a non-regulator. First, @US_FDA, led by Peter Marks and Operations Warp Speed, led by Moncef Slaoui, recognize that every day matters for HCWs and high-risk groups and are moving with extraordinary speed. 1/

https://twitter.com/CNNSotu/status/1330521936221392902?s=20

@bnallamo @US_FDA An EUA (Emergency Use Authorization) for a vaccine is not the same as a therapeutic, given that the vaccine is being given to subgroups of people who are “healthy” and may or may not be exposed to the virus. The bar for safety & efficacy data is therefore higher than for Rx. 2/

@bnallamo @US_FDA The dataset is very large (44K participants), and thorough analyses of safety & efficacy take time. Moreover, the studies aren’t powered to conclude efficacy in the subgroups being considered for EUA, yet convincing benefit-risk assessments for those groups need to be shown. 3/

@bnallamo @US_FDA The review will also cover the manufacturing process. Companies must be able to show they can reproducibly manufacture large volumes of vaccine at high standards of quality. It’s hard to overstate the complexity and difficulty of achieving this, esp in these timeframes. 4/

@bnallamo @US_FDA Independent external review is important in this process. VRBPAC (Vaccines and Related Biological Products Advisory Committee) is meeting on Dec 10 and @US_FDA staff need to prepare materials. Note: ACIP is having a special session this week to discuss prioritization. 5/

@bnallamo @US_FDA There is a lot at stake here: making vaccine available for high-risk groups as soon as possible while maintaining high standards for scientific rigor, objectivity and transparency. And everything is happening under extraordinary scrutiny. 6/

@bnallamo @US_FDA I believe the professional staff at @US_FDA, Operation Warp Speed, and the biopharmaceutical companies are doing everything they can to make vaccine available to the public without compromising the standards we all expect. 7/

@bnallamo @US_FDA This just out from @jonathanvswan @axios, addressing the question that started this thread: why not faster? FDA reinforces the points made above, on the extensive database to review, manufacturing validation, and importance of subset analyses. 8/

https://twitter.com/axios/status/1333626796944723969?s=20

@bnallamo @US_FDA @jonathanvswan @axios We should always ask "can we go faster?", esp when lives are on the line. We then need to ask "what are the risks and can we manage them without compromising our goals?" The dual goals here are protecting health and maintaining public confidence in vaccines & the process. 9/

@bnallamo @US_FDA @jonathanvswan @axios

https://twitter.com/ZacharyBrennan/status/1334315047091392518?s=20