AstraZeneca’s vaccine has not yet been approved in the United States. On Monday, the pharmaceutical company therefore presented a large study according to which the active ingredient protects against Covid-19 very reliably.
Yet again, there appear to be doubts about the company’s vaccine data: The American Data Safety Monitoring Board (DSMB), an independent committee overseeing the study, »has expressed concerns that AstraZeneca may have included outdated information that could provide an incomplete picture of the Could have conveyed efficacy data, “said the US National Institute of Allergy and Infectious Diseases (NIAID) in a statement. The NIAID is led by Anthony Fauci, an infectious disease expert. It is part of the National Institutes of Health.
In the study, which included 30,000 people, the vaccine was 79 percent effective in preventing symptomatic cases of Covid-19 – even in the elderly. The vaccinated subjects did not experience serious illness or hospitalization, while the subjects who received a placebo experienced five such cases. The low number is consistent with evidence from the UK and other countries that the vaccine protects against the worst forms of the disease.
AstraZeneca stated that independent inspectors of the study did not find any serious side effects, including an increased risk of rare blood clots such as those found in Europe. The company plans to file an emergency US approval application in the coming weeks.
“We urge the company to work with the DSMB to review the efficacy data and ensure the most accurate and up-to-date data is released as soon as possible,” it said. According to their own information, the Data Safety Monitoring Board has informed AstraZeneca of their concerns. The company has not yet responded to a request from the Reuters news agency asking for a statement. More details on what data may be missing or what consequences this could have are not yet known.
The approval and guidelines for use of the vaccine in the United States will be determined by the Food and Drug Administration and the Centers for Disease Control and Prevention after thorough review of the data by independent advisory bodies.