Last Monday, AstraZeneca published a press release announcing that the results of an interim analysis of their large phase III clinical trials conducted in the United States had proven the vaccine was statistically significant at preventing 79% of symptomatic COVID-19 cases and was 100% effective at preventing severe illness caused by COVID-19, and announced that the company would be filing for Emergency Authorization Use at the Federal Drugs Administration (FDA).
Although this announcement was received as good news for the vaccination process in both the United States and the world, the optimism quickly morphed into confusion as the National Institution of Health (NIH) said they had some significant concerns that the company had used “outdated and potentially misleading data” that could embellish the effectiveness of the jab, according to a memo obtained by the Washington Post.
The memo further argued that the decision of AstraZeneca to publish only the information that was “most favorable for the study as opposed as the most recent and most complete” AstraZeneca has responded by issuing a press release where they clarified that the data released monday was based on an interim analysis with data up to February 17th and that the data provided by such analysis was being shown as consistent with the preliminary primary analysis.
The British-Swedish company also commented they would immediately engage with medical authorities and keep them up to date with the latest vaccine data. The company ended up publishing their primary research analysis from their tests last night, announcing their vaccine showed 76% efficacy on preventing symptomatic COVID-19.
Despite the debacle announcement by AstraZeneca, U.S. medical expert Anthony Faucci says that the jab is “likely a good vaccine” and that the initial data that was available was promising, although not completely accurate.
AstraZeneca data mishap further damages its public image
AstraZeneca unforced error would definitely erode public trust in a jab that can be very significant to the global vaccination campaign. It comes after the European Union had temporarily suspended its use due to concerns about the jab creating blood clots, a decision the bloc rescinded after finding no evidence for concern and after leaders like Emmanuel Macron have publicly called (and then retracted) the jab as “quasi-ineffective”.
Although vaccination in Europe has resumed, the saga did appear to diminish public trust on the vaccine. With 53% of germans, 61% of french, 54% of italians, and 59% of spanish saying that the AstraZeneca dose was “unsafe”, according to a poll made by YouGov, presenting significant increases from the last time the poll was conducted. This increasing level of mistrust could present some challenges to the already slow european vaccination rollout
The latest data mishap would certainly do no help at AstraZeneca’s attempts to regain the trust on their product, which is regrettable as large tracts of the british population (including its Prime Minister) have been vaccinated with the AstraZeneca jab and there has been no reason to doubt its safety.
AstraZeneca has ben in the myriad of many COVID-19 vaccination controversies, including a possible trade war between the EU and the UK, since it began to being massively administered. Such fights have done no help at the company’s public image, which is vital for developing an appropriate level of public trust towards the vaccination process.
The FDA would still need to review the data provided by the company and reach an independent analysis of it, in order to reach a conclusion about its authorization in the United States, according to Dr. Fauci.