AstraZeneca may have submitted outdated data for vaccination study in the US
The AstraZeneca vaccine is not yet approved in the United States. According to a new study, it is one hundred percent effective against severe disease. But “out of date information” could have been used for this.
BAstraZeneca’s results of a large-scale US study of the corona vaccine may have used “out of date information,” according to US federal health experts. There are concerns that AstraZeneca may have provided an incomplete overview of effectiveness data, the Data and Safety Monitoring Board (DSMB) said on Tuesday.
The DSMB is a group of independent experts who are not part of the study and who review their data.
In response, AstraZeneca said it was working on more updated information and that the latest findings were consistent with the original statement that the vaccine offered strong protection. The group announced an update within 48 hours.
AstraZeneca said on Monday that the company’s coronavirus vaccine was 79 percent effective against symptoms of Covid-19 disease, according to the US study, even in older adults. In addition, it is 100 percent effective in preventing serious illness and hospitalization.
AstraZeneca announced on Monday that no safety concerns were identified with the vaccine developed together with Oxford University, not even with regard to the risk of rare thromboses identified in Europe.
The vaccine is approved in more than 50 countries, but its use was temporarily suspended in some countries due to safety concerns. It is not yet approved in the USA.
AstraZeneca must file results from the study with the US Food and Drug Administration and the Centers for Disease Control and Prevention. An independent committee must review the data before the authorities decide on an emergency approval for the vaccine in the United States.
Trust in security heavily burdened
The AstraZeneca drug is a so-called vector vaccine based on monkey cold viruses. It can be stored and transported at normal refrigerator temperatures, while the mRNA vaccines from Biontech and Pfizer as well as Moderna must be stored frozen.
Reports of thrombosis in connection with the AstraZeneca vaccination have recently weighed heavily on confidence in safety. Almost 55 percent of Germans consider the vaccine to be unsafe and less than a third to be safe, according to the survey by the polling institute YouGov.