And those U.S. clinical trials were far behind schedule due to another problem that stemmed from AstraZeneca’s seeming tendency to be less than fully open in its initial communication. In early September, the company paused its clinical trials around the world due to a possible safety concern: one volunteer in its U.K. study had developed a serious neurological condition. But the company did not initially disclose the pause publicly, acknowledging it only after a reporter from the medical news site STAT News broke the story. Worse, the company had not yet informed the FDA about the safety pause, meaning the regulator was blindsided by the STAT News report. Such pauses to investigate possible safety issues are routine in clinical trials, and they are not usually announced publicly. The FDA also gives those conducting trials seven days to inform it of possible serious safety incidents. But the company should have realized that a “business as usual” communications strategy was not going to cut it. Given the pandemic, the entire world was fixated on the race to bring COVID-19 vaccines to market, and AstraZeneca had seemed like an early front-runner. What’s more, the world was particularly dependent on the company’s vaccine: because it can be stored at normal refrigerator temperatures and because it is inexpensive, the AstraZeneca vaccine is expected to play a key role in vaccinating people in low- and middle-income countries. At the time, it was also thought the vaccine would be used to inoculate about 60% of the U.S. population. The company further compounded the uproar over whether it was being fully forthcoming, when AstraZeneca CEO Soriot later revealed to financial analysts that the trial had also been paused a few months earlier for another safety concern around similar neurological symptoms. In this case, the FDA had been informed. But the public had not. Nor had the company mentioned the previous pause in its initial public statements about the September safety stop. While the independent review board looking into the neurological symptoms quickly concluded that there was no clear evidence linking the vaccine to the neurological symptoms the volunteer experienced and trials resumed in much of the world after just seven days, in the U.S. the pause stretched out to seven weeks. The regulator had requested additional data about previous vaccine trials Oxford had conducted using the same underlying technology. CNN reported that it took AstraZeneca an unusually long amount of time to give the FDA this additional information: more than a month. AstraZeneca says it struggled to get this data from Oxford in a format that was acceptable to the FDA. Whatever the reason, the long delay in restarting the U.S. trial did not help to boost confidence in the company’s vaccine. Trouble in Europe In fact, all of these problems have helped to undermine confidence in AstraZeneca’s vaccine. So much so that in many parts of Europe, a lot of people have been unwilling to take the vaccine, even when it is the only one on offer and large numbers of doses have gone unused. It hasn’t helped that European politicians and the German medical regulator openly questioned whether enough older adults had been included in the non-U.S. clinical trials to have confidence in the vaccine’s efficacy for those over the age of 65. More recently, the company has had to defend the vaccine to medical authorities in a number of European countries who paused its rollout after a small number of cases in which people developed unusual blood clotting problems. The European Medical Authority has reiterated that the vaccine is safe: even if the clotting issue is linked to the vaccine—and so far there is no clear evidence that it is—it is an extremely rare side effect. The risk of severe COVID-19 is far worse. The European regulators who decided to pause the rollout were almost certainly getting the balance-of-risks here wrong: the problem is, because of the previous stumbles in how AstraZeneca presented its results, confidence in the vaccine had already been severely undermined and fed suspicions about whether the company was being entirely truthful about the clotting issue too. The company’s tendency to be economical with the truth has also plagued the commercial aspects of its vaccine rollout. The company has played up the fact that it is supplying the vaccine at cost “for the duration of the pandemic.” But The Financial Times reported that the company’s supply with various governments gave it the right to unilaterally declare the pandemic over as early as July 2021, a fact it had never mentioned publicly. Similarly, the company drew the ire of European Union politicians after the company encountered manufacturing issues at the plant of a contractor in Belgium that was producing the vaccine. The problem meant AstraZeneca would be able to supply the EU with only a fraction of the vaccine doses it had promised. The problems were twofold: first, it took the company weeks to notify the EU. It has said it needed time to ascertain the nature of the problem in order to get an estimate for how big the impact would be. Secondly, Soriot infuriated EU officials by pointing out that its supply contract only said the company would make its “best effort” meet its delivery schedule. |