I should have waited another day before commenting on the AstraZeneca COVID-19 vaccine U.S. trial. By now, everyone knows this is not my favorite vaccine, and I have been critical of the company’s handling of its testing. But even I could not have expected this turn of events!
The results on their U.S. trial that AstraZeneca announced in a press release yesterday looked acceptable if not spectacular, with their two-dose vaccine essentially matching the results of Johnson and Johnson single dose vaccine. However, the biggest accomplishment was that AstraZeneca had not screwed up the trial as they had with all their prior studies!
Yet last night, literally in the middle of the night, the NIH took the extraordinary step of putting out a public statement questioning the AstraZeneca results! This is a bit of a complicated story but important for everyone to understand.
Every clinical trial has an independent review board that continually evaluates the safety and efficacy of the vaccine or drug being tested. For studies supported by the United States Government, such as the Operation Warp Speed COVID-19 vaccine trials, this independent review board is housed at NIH. It is specifically managed at the National Institute of Allergy and Infectious Diseases (NIAID), which is directed by Dr. Anthony Fauci.
The Data and Safety Monitoring Board (DSMB), as it is called, involves scientific experts that understand the benefits and risks of the vaccine testing and can stop the trial if they feel it is either futile or dangerous. This board specifically protects the participants from dangers that are identified during the trial and assures the government that the results are valid. For disclosure purposes, I am a member of another, unrelated NIAID DSMB, so I understand this process well.
In a statement Monday night, the DSMB overseeing AstraZeneca’s trial notified the National Institute of Allergy and Infectious Diseases (NIAID), the Biomedical Advanced Research and Development Authority (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 The DSMB expressed concern that “AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data.”
Evidently, by reporting data from only the first half of the clinical trial AstraZeneca may have made their vaccine look better than it actually is. The reason for that is infections in the subjects will continue over the entire time of the clinical trial, and as a result there would be fewer infections at earlier time points. AstraZeneca should have taken the same duration of time as the trials for the other vaccines so they could be comparable. This was the way the study was designed.
By reporting out of date data it appears that AstraZeneca may have tried to game the system to make their vaccine look more effective. This ploy also might have reduced the adverse events since those would continue during the entire study.
These self inflicted wounds again damage the confidence in a vaccine that was going to help immunize the world against COVID-19! Vaccine hesitancy against this vaccine is already running very high, according to the Economist. Canadians are reportedly refusing appointments to be vaccinated with the AZ vaccine.
NIH added, “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.”
It also may be time for BARDA to ask for their money back.