AstraZeneca, a British-Swedish multinational pharmaceutical and biotechnology company, must think we Americans are a bunch of ignorant rubes. After the company finally released results from its vaccine’s Stage 3 Trials, U.S. regulators were shocked to discover that the information was “outdated and potentially misleading.”
The rosy picture the company painted of its vaccine on Monday — that it had a 79 percent efficacy against COVID-19 and substantially reduced serious illness — turns out to have been more PR than real.
In a statement issued soon after midnight Tuesday morning, the National Institute of Allergy and Infectious Diseases said it had been informed about the data questions by the data and safety monitoring board auditing the trial. DSMBs consist of independent medical experts who review data produced from clinical trials.
“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,” NIAID said.
The head of the NIAID, Dr. Anthony Fauci, was at a loss to explain it. “I was sort of stunned,” Fauci said. “The data and safety monitoring board were concerned that the data that went into the press release by AZ was not the most accurate and up-to-date data. That is what the DSMB communicated to AZ in a rather harsh note. Having seen that letter we could not just let it go unanswered.”
AstraZeneca is under enormous pressure following its rollout in Europe, where several EU countries have paused distribution because of some highly publicized illnesses after patients received the vaccine. There is almost certainly no causal connection between the symptoms — which include blood clots — and the vaccine, but in this hypersensitive environment where people are refusing to get vaccinated, it may be the death knell for the vaccine in the U.S.
The DSMB’s letter, however, said more recent data indicated the vaccine was 69 to 74% effective at preventing symptomatic Covid-19, according to the Washington Post, which obtained a copy of the letter.
“The DSMB is concerned that AstraZeneca chose to use data that was already outdated and potentially misleading in their press release,” the letter says. “The point that is clear to the board is that the [vaccine efficacy number] . . . they chose to release was the most favorable for the study as opposed to the most recent and most complete. Decisions like this are what erode public trust in the scientific process.”
There’s plenty of that erosion of “public trust in the scientific process” going around.
The mystery is why AstraZeneca thought U.S. regulators wouldn’t say anything about the discrepancy between their press release (79 percent efficacy) and the actual latest data (69 percent). Did they believe the press release didn’t count? Now they have a real clusterfark on their hands despite the latest data being favorable to their vaccine.
Based on the trial data released Monday, AstraZeneca said the study identified no new safety concerns. A specific review found no risk of blood clots. The study also did not see a specific type of clot in blood vessels near the brain that the EMA said might be associated with the vaccine. However, this type of clot, called a cerebral venous sinus thrombosis, is so rare it might not be expected to occur in even a large clinical trial.
The advantages of the AstraZeneca vaccine are that it’s cheaper and easier to manufacture and distribute than either the Moderna or Pfizer vaccines. That was good news, especially for the poorer countries of Asia and Africa where road networks and infrastructure aren’t as modern as Europe and the U.S.
The AstraZeneca vaccine may still get U.S. approval but given its history, it’s not likely to be anyone’s first choice.