On Monday of this week everything looked pretty good at first. But only for a brief moment. The company AstraZeneca, which is developing a vaccine against Covid-19 with Oxford University, reported that their vaccine was 90 percent effective in a study group.
Less than four days later, the chaos is perfect. AstraZeneca has now admitted errors – among other things, that the wrong dosage was used in said study group, which was found to be highly effective. Due to a mistake, 2,900 study participants in the UK were given half the dose and then a full dose.
When the bug was discovered, all other 8,900 study participants were given the full dose twice. In this larger group, the vaccine only worked a disappointing 62 percent. Overall, AstraZeneca published an overall value of 70 percent effectiveness in the press release, without indicating that the study deviated from the originally planned protocol due to an error.
Now AstraZeneca operates damage control
Germany, Italy, France and the Netherlands ordered 400 million doses of vaccine from AstraZeneca in June. AstraZeneca is now facing a number of difficult questions and is doing damage control. Experts around the world have now criticized both the dosage error and a number of other irregularities in the evaluation and communication of the study data.
Government officials in the US said the data is not clear. The British vaccination initiative would have communicated the dosage error, not the company. “I think they damaged confidence in the whole development program,” Geoffrey Porges, an analyst for investment bank SVB Leerik, told the New York Times. Michael Meixell, a spokesman for AstraZeneca, said the studies “were conducted to the highest standards.”
In an interview on Wednesday, Menelas Pangalos, an AstraZeneca officer who leads much of the research, defended how the company had dealt with error communication. The authorities were informed as soon as the error was noticed. When asked why the company only informed certain investors and experts, but not the public, Pangalos replied: “I think the best way to publish the results is in a specialist journal, not in newspapers.” An article has not yet appeared , but should follow in the specialist magazine “Lancet”.
“The press release raised more questions than it gave answers”
The most important question is now: Why do the results differ so widely in both groups? AstraZeneca and Oxford researchers say they don’t know.
And one more piece of information was missing from the press release: AstraZeneca said that the studies showed 131 cases of Covid-19, but did not specify in which group. Is it in the placebo group where you suspect the infections? Is it in the low dose group or in the subjects who received the two full doses? “The press release raised more questions than it answered,” said John Moore, a professor of microbiology and immunology at Weill Cornell College of Medicine, told the New York Times.
But that’s not all. AstraZeneca mixed up data from various studies in the press release. Biontech and Moderna have evaluated data from a single phase 3 study, as required and customary in vaccine development. This is the standard that the regulatory authorities require. At this point it is clear that AstraZeneca has violated this gold standard.
Data does not meet the usual conditions for an emergency approval
In addition to this, there is another serious problem. The study group in the UK only vaccinated people aged 55 and under. So there are no results whatsoever on middle-aged and elderly people. Together with the medical staff, however, the very old should be vaccinated first, i.e. people who are over 75 or over 80 years old. It is known that older people have a poorer immune system.
It therefore remains to be seen whether the previously published effectiveness of the vaccine would be confirmed in a large study that included people aged 55 to 85, such as those at Biontech and Moderna.
At this point in time, the data therefore does not meet the usual conditions for an emergency approval. How the US authorities, the European or British approval authorities will deal with this data in the face of these errors remains open. Stephanie Caccomo, a spokeswoman for the US Medicines Agency, did not want to comment on the situation.
In view of the fact that two companies, Moderna and Biontech, have presented good results for their vaccine candidates with an effectiveness of 95 percent, it remains more than questionable whether the AstraZeneca vaccine with its shaky data can receive an emergency approval for the EU.