AstraZeneca Admits Vaccine Efficacy Based On "Interim" Data, Vows To Release Update Within 48 Hours
by Tyler Durden
Tuesday, Mar 23, 2021
Update (0800ET): As the media (and the rest of the world) tries to figure out what exactly is going on with the AstraZeneca trial data, and whether the vaccine's ability to protect the population from COVID truly does outweigh the risks, the company has just released a statement promising to release up-to-date results from the final phase of the trial within 48 hours.
AZ said yesterday's trial conclusions were based on an "interim analysis" with all data received by the cutoff date of Feb. 17. Then, it promised to "immediately engage with the independent data safety monitoring board to share our primary analysis with the most up to date efficacy data." Results of this primary analysis will be available within 2 days.
The numbers published yesterday were based on a pre-specified interim analysis with a data cut-off of 17 February.
We have reviewed the preliminary assessment of the primary analysis and the results were consistent with the interim analysis. We are now completing the validation of the statistical analysis.
We will immediately engage with the independent data safety monitoring board (DSMB) to share our primary analysis with the most up to date efficacy data.
We intend to issue results of the primary analysis within 48 hours.
More academics complained about the optics of the situation.
"The last thing this vaccine needs is more concern when we kind of thought we were at that point now where we would put to bed all the other concerns," said Paul Griffin, an associate professor of medicine at the University of Queensland in Brisbane, who is conducting clinical studies in Australia on four Covid-19 vaccine candidates.
And reporters complained that AstraZeneca's explanation, and the whole back-and-forth between Astra and the NIH, seemed bizarre.
This is a truly bizarre situation. NIAID says the data safety monitoring board for AZ’s #covid19 vaccine trial notified it that it was concerned AZ included outdated efficacy information in its release yesterday. No further details. (1) pic.twitter.com/Q8X66wdzuK
— Meg Tirrell (@megtirrell) March 23, 2021
In statement just out, AstraZeneca says yesterday’s update was based on interim analysis with cutoff Feb 17, and it will provide primary analysis without 48 hours: https://t.co/0NEz10EbeJ pic.twitter.com/K32F9mphnW
— Meg Tirrell (@megtirrell) March 23, 2021
The efficacy rate in the US trial was stronger than the 70% figure AstraZeneca reported from an earlier study. But those data were an average of different readings (62% and 90%) from two separate arms of the study. Bottom line: Whatever the 'final' efficacy number is, it should probably be taken with a grain of salt.
To that point, Dr. Anthony Fauci, the nominal head of the NIAID, insisted that, in all likelihood, the AstraZeneca jab is "very likely a very good" vaccine. This is presumably just another in a seemingly endless stream of hiccups.
*FAUCI ON ASTRAZENECA: THIS IS VERY LIKELY A VERY GOOD VACCINE
Translation: stick a fork in it
— zerohedge (@zerohedge) March 23, 2021
Translation: the US will follow through with plans to approve the AstraZeneca jab (after a notably lengthy delay) - but turn around and give all the AZ jabs it has on hand to Mexico and other governments.
Pretty soon, maybe AstraZeneca can stop blaming European governments for stoking skepticism about the company's COVID jab, and start blaming the US (or maybe the drugmaking giant might consider accepting some responsibility, considering the reaction to rare blood clots isn't the first safety issue to mar the jabs reputation).
One day after proclaiming to the world that an extremely thorough and credible study based in the US (but carried out both in the US and across South America) had shown its jab to be 79% effective at preventing COVID (and 100% effective at preventing serious cases of the virus-caused disease) US officials are slamming the drug company and the data for possibly misrepresenting the vaccine's efficacy.
Earlier Tuesday morning, US officials issued an unusual statement expressing concerns the company had included "outdated information" from its study and that it may have provided "an incomplete view of the efficacy data." The concern, according to the Data and Safety Monitoring Board (the group responsible for overseeing trials of new medication and vaccines), is that the report included "outdated information" which may have provided "an incomplete view" of the efficacy data.
More:
https://www.zerohedge.com/markets/american-health-regulators-slam-astrazeneca-releasing-incomplete-trial-data