Media learned about AstraZeneca’s obstacles with US vaccine approval data
Vaccine developer AstraZeneca has encountered problems gathering the necessary data to apply for approval in the United States, the Wall Street Journal reported, citing sources familiar with the situation.
The British-Swedish company said last month that it intends to apply for an emergency use of the vaccine in the States in the first half of April.
However, according to one source, the company recently told US officials that it will take more time – probably until mid-May – to complete the data collection for filing an application with the US FDA regulator.
It is noted that when considering other vaccines, the FDA studied data from controlled clinical trials. AstraZeneca, however, has been used to vaccinate the population in the UK for four months now, and the company is forced to collect a huge amount of data on the vaccines made: information on the effectiveness, transmission of the virus in the population and the safety of the drug. This made the task more difficult, and is likely to lengthen the process of consideration of the application by the regulator.
Pfizer / BioNTech, Moderna and Johnson & Johnson vaccines are approved for use in the United States.
Media learned about AstraZeneca’s obstacles with US vaccine approval data