The company only announced on Tuesday how up to date the data was. This information is important because a more topical examination of clinical trial results may provide a different efficacy and safety.
If the analysis was done on data from a month or two ago, it is possible that a more current appearance will give a different picture of the efficacy and safety of the vaccine. The company said it would provide a more comprehensive, recent set of data to the FDA than it announced Monday. Although no clinical trial is large enough to rule out extremely rare side effects, AstraZeneca reported that the study did not raise any serious safety issues.
The new data may have come too late to make a big difference in the United States, where the vaccine has not yet been approved and is unlikely to be available before May. By that time, federal officials predict, there will be enough vaccine doses for all of the country’s adults from the three authorized vaccines: Pfizer-BioNTech, Moderna and Johnson & Johnson.
Nevertheless, the better-than-expected results are seen as an encouraging turnaround for AstraZeneca’s shot, whose low cost and simple storage requirements have made it an important part of the world’s vaccination effort.
The results were also thought to alleviate concerns about the AstraZeneca vaccine in Europe. Regulators there said last week that the shot was ‘safe and effective’, after conducting an investigation after a small number of people who were recently vaccinated got blood clots and abnormal bleeding. The US trial showed no sign of such problems, although some safety issues can only be detected in the real world if a drug or vaccine has been widely used.
Many millions of people have received the AstraZeneca survey worldwide, including more than 17 million in Britain and the European Union, almost all without serious side effects. In an effort to increase public confidence, many European political leaders have received the injections in recent days. The AstraZeneca vaccine was also administered to leaders in South Korea, Taiwan and Thailand last week.
AstraZeneca said Monday that it will continue to analyze the new data and prepare to apply for emergency clearance in the United States in the coming weeks. The vaccine has already been approved in more than 70 countries, but the approval of US regulators would strengthen its global reputation.