It should have been a simple misunderstanding that can be cleared up quickly. But one thing that could still be fatal for trust: AstraZeneca wants to bring order to the data mess about its clinical study in the USA within 48 hours. The Swiss regulatory authority Swissmedic has not yet received any new data from the current AstraZeneca study. In any case, the test is carried out exactly, as Swissmedic spokesman Lukas Jaggi says. Whether this delays approval in Switzerland depends on whether the company now needs longer to enter the data at Swissmedic.
The US health authority NIH had an extraordinary night on Tuesday opinion on AstraZeneca’s new vaccine study published. The Data and Safety Supervisory Board (DSMB) is concerned that AstraZeneca may have included outdated information that may have provided an incomplete picture of the efficacy data.
The data was based on the interim analysis of the study with data up to February 17, AstraZeneca said. The preliminary final analysis that has now been carried out agrees with the results at that time, the British-Swedish group continues. He will immediately provide the DSMB with the latest data. The results of the final analysis of the study are to be published in 48 hours.
The monitoring body asked AstraZeneca to review the numbers and ensure that the most accurate and up-to-date information is released as soon as possible. According to an informant, the committee is said to have postponed the publication of the study several times in order to request data, as reported by the New York Times. A spokeswoman for AstraZeneca confirms this, but points out that the processes in such a process are normal.
Expert: “Never seen it before”
A US expert holds the process at the request of the “New York Times” but for extraordinary and worrying. For example, Eric Topol, a clinical trial expert in San Diego, says it is “highly unusual” to see such a public confrontation. Normally the monitoring committee and the company conducting the study worked closely together. “I’ve never seen anything like it,” Topol said in reply, “that’s very worrying.”
For the USA, AstraZeneca is no longer an important vaccine, they rely on the drug from Johnson & Johnson, which is already being distributed in the country. A possible delivery from AstraZeneca would not arrive until May as the US ordered later. Until then, there should be enough vaccines from Moderna, Biontech and Johnson & Johnson.
Admission delayed in Switzerland?
In Switzerland, AstraZeneca could be used as the third vaccine after Biontech and Moderna, after Johnson & Johnson approved but not ordered has been. The new study results of the British-Swedish group from Monday raised hopes for the longed-for vaccination boostif Swissmedic approves the vaccine quickly. The BAG has ordered 5.3 million cans which, according to AstraZeneca, could arrive in Switzerland “very soon after approval”.
The fuss about the study data could delay the hoped-for early approval again. The debacle is unlikely to improve the situation for AstraZeneca in Switzerland, although it is not certain whether the BAG will still rely on the British-Swedish method. A month ago, Nora Kronig from the BAG said that Switzerland AstraZeneca I no longer need it and am considering passing on the vaccine. Instead, they are still waiting for the approval of the protein vaccine Novavax (6 million doses ordered) and the mRNA vaccine Curevac (5 million), for which the BAG is planning deliveries from May. In addition, another 3 million doses of the Biontech vaccine were reordered.
Controversy over the first study
AstraZeneca’s vaccine has been controversial for months. After the EU-wide approval of the AstraZeneca vaccine at the end of December, Germany and other member states initially restricted its use to people up to 64 years of age because insufficient data was available for older people. The study on which the approval was based also caused a stir because of several errors. In some cases, only half the dose was administered, which even led to better results. AstraZeneca called the mistake a “godsend”. At the same time, however, there was also uncertainty about the time interval between the first and second vaccination. It was not until the beginning of March that Germany and other EU countries also released the drug for older people on the basis of new research data.
After reports of blood clots in connection with the AstraZeneca vaccinations, Germany and numerous other countries stopped vaccinations altogether in mid-March. The EU Medicines Agency (EMA) reiterated its assessment that the vaccine was “safe and effective” after a renewed review. Most countries then resumed vaccinations.
Confidence in AstraZeneca decreased
Even before the new turmoil, confidence in AstraZeneca had sunk significantly in several European countries. According to a survey by the British institute Yougov, a majority of people in Germany, France, Spain and Italy consider the vaccine to be unsafe. Accordingly, the proportion of Germans who distrust the AstraZeneca preparation increased by 15 percentage points to 55 percent within one month. Only 32 percent of German citizens rated the vaccine as safe. The recent confusion in the US study could increase skepticism.
The picture is very different in the UK, where the survey shows that more than three-quarters of citizens say they think the AstraZeneca vaccine is safe. Various studies there showed that the vaccine is highly effective and prevents severe courses. The British are also investigating whether the AstraZeneca drug works even better if the second vaccination is given after three months.
Asia also relies on the British-Swedish vaccine. South Korea has been vaccinating with it for a long time, and Taiwan also started its corona vaccination campaign with it on Monday. Prime Minister Su Tseng-chang and Health Minister Chen Shih-chung had themselves vaccinated in order to gain acceptance among the population. So far, AstraZeneca has been the only manufacturer to deliver vaccination doses to Taiwan.