You know the big mistake was? It was not that Astra Zeneca put out a press release with 79% efficacy instead of 76% — probably in their excitement to get good news out early.
It's that we didn't approve a highly effective vaccine in December. We lost 180,000 lives since Jan 1
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For the public to know about Data Safety Monitoring Boards (DSMBs).
Ive been on DSMBs for trials led by colleagues. Those colleagues have been on DSMBs for trials led by me. People in DSMBs don't necessarily have some special superior skills to the study team. And vice versa.
DSMBs in randomized trials get to see data ahead of the study team investigators and decide if any safety concerns and to decide when to stop the trial/release results either because the endpoint was met or there was futility or a safety issue.
The DSMB is independent of the study team and does what is in the best interest of the trial participants and the public.
Their advantage comes from access to data early and without the bias that a study team may have.
Updated progress towards herd immunity in USA:
~30 million have had COVID
~85 million have received at least 1 dose of vaccine
(~70 million are children)
~100 million to go to get 80% of eligible population immune —an overestimate coz it excludes people who had undiagnosed COVID
I'm excluding people who have had COVID by seroprevalence because 1) it's hard to get a good idea of the % for the whole country; 2) the immunity from mild COVID may not be as robust; 3) Im excluding children so it compensates on the other end; 4) meant to be worst case scenario
At the rate we are vaccinating we are within 1-2 months of where we need to be. Which is good news.
I've said for months that we are closer to herd immunity than we think we are. Because of other factors. But that was a soft call. This time with vaccines I'm more confident.
I would take a deep breath and wait for AZ to release primary efficacy results to see if there is any meaningful difference from the prespecified interim analysis reported yesterday. Usually there will be some differences. It happened with the other vaccines also.
It is quite extraordinary for a DSMB to express concern over release. Not sure if there was a misunderstanding when the DSMB asked AZ to release results, if it specifically told them to wait and release Primary Analysis or not.
Again unless the difference is meaningful not sure what to make of this other than it's pretty strange. Never happened to me in any of the trials that I have been involved with.
I called it a blunder then.
Why because it didn't make sense as the right judgment call.
We were essentially saying no to a vaccine when we we had 200,000 new daily cases a day and 3000 new deaths a day.
Too many pundits criticized the initial Astra Zeneca trials. Overstating procedural problems double blind placebo controlled trials. Most of these pundits were purists who had never led a randomized trial themselves. Let alone in lightning speed.
5/ The rate of DIC and cerebral venous thrombosis appear higher than expected baseline.
6/ Since these adverse events are very rare, the risks of COVID high, & the high efficacy of the vaccine, the @EMA_News recommended that the benefits of the vaccine outweighed the risks.