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says the data safety monitoring board for AZ’s #covid19 vaccine trial notified it that it was concerned AZ included outdated efficacy information in its release yesterday.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— zerohedge (@zerohedge) March 23, 2021
Translation: stick a fork in it
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.
Late Monday, the Data and Safety Monitoring Board (DSMB) notified NIAID, BARDA, and AstraZeneca that it was concerned by information released by AstraZeneca on initial data from its COVID-19 vaccine clinical trial. The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data. We urge the company to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible. Authorization and guidelines for use of the vaccine in the United States will be determined by the Food and Drug Administration and Centers for Disease Control and Prevention after thorough review of the data by independent advisory committees.
And once again, the AZ shot - which is a linchpin of the WHO's effort to vaccinate poorer countries via its Bill Gates-approved COVAX initiative - has been mired in controversy. Notably, AstraZeneca neglected to include key numbers like the number of trial participants who developed 'severe COVID'. The company's president told CNBC the number was '5' during an interview on CNBC's Squawk Box shortly after the data were released.
"The way they handled their data early on, AstraZeneca basically shot themselves in the foot," Julian Tang, a virologist at the University of Leicester, said even before the latest issue arose. "Even though the new study confirms what we previously thought about the vaccine’s efficacy, people may have lingering doubts," he said. "Unfortunately, that might mean more people will die of COVID."
Criticisms of AstraZeneca studies stem back to the first data released in the UK, which purported to show that the jab was 70% effective. However, the trial data didn't account for a manufacturing mistake, and also didn't include enough participants over the age of 65 to deduce efficacy among older patients. European governments like Germany and France responded by initially limiting the jab to patients under the age of 65. US authorities suspended the US trial for 6 weeks last fall for mysterious reasons that were never fully explained. Following the latest release, Astrazeneca head of research and development Mene Pangalos called the data "much cleaner" than prior releases, expressing hope it "puts to bed any doubts."
In a report on the DSMB's complaints, the Associated Press warned that this latest 'speed bump' could have a lasting impact, even if the company clears up the issue, before citing the decades-long lingering doubts about the measles vaccine that have supercharged the anti-vaxxer movement in the US.
As analysts scrambled to interpret the statement, one scientist on twitter claimed the US government has stopped just short of accusing AstraZeneca of manipulating its trial data.
This is a highly unusual statement by the US National Institute of Allergy and Infectious Diseases (NIAID). It comes close to accusing Oxford/AZ of having wilfully misrepresented some results from their recent US vaccine trial. https://t.co/cj86TYdY7e— Prof Francois Balloux (@BallouxFrancois) March 23, 2021
To clarify, there is no obvious conflict of interest between NIAID and Oxford/AZ. the AZ US Phase III trial was funded by BARDA, which is part of the US Department of Health and Human Services (HHS), and NIAID was involved.https://t.co/Vr7xm7ocoP— Prof Francois Balloux (@BallouxFrancois) March 23, 2021
After all the criticism levied at European leaders for taking extreme precaution and halting the shots over reports of a handful of cases of deadly blood clots developing in certain patients post-vaccination, is it now Dr. Anthony Fauci's fault that trust in the world's most important COVID vaccine has tumbled to an all-time low?