Promising Covid vaccine may be delayed
The coronavirus vaccine being developed by AstraZeneca may be facing delays. Clinical trials were paused after a participant got a rare spinal cord infection. The British health authority MHRA already gave permission for trials to restart, but the American FDA - where the majority of testing is done - is still dithering, AD reports.
The American shutdown could have consequences for when European member states, including the Netherlands who already bought 300 million doses, will get the vaccine. Roughly 50 thousand people are participating in clinical trials for this vaccine worldwide, 30 thousand of them are in the United States. AstraZeneca can only submit a market application once enough test subjects have contracted the virus and a reliable judgement can be made on how effective the vaccine is.
The European Medicines Agency did not want to comment on the situation with AstraZeneca to AD. But according to the newspaper, the EMA is now less optimistic about a working coronavirus vaccine being fully developed this year. Earlier this month the EMA called that a realistic possibility. Now the agency expects no more than "a symbolic dose of corona vaccines" in 2020.
The EMA also said that it will monitor all potential coronavirus vaccines extra closely for safety, "given the fast pace at which they are being developed". The Dutch Medicines Evaluation Board said much the same.
Clinical trials on the AstraZeneca vaccine were paused when one of the test subjects were diagnosed with transverse myelitis, a rare spinal cord infection, according to AD. As to why the U.S. is taking so long to restart trials, some experts told AD that the FDA may not yet be convinced that the transverse myelitis and the vaccine have nothing to do with one another. Others argued that the U.S. is stalling so that an American vaccine can hit the market first, instead of this British-Swedish one.