On Tuesday, the office published its guidelines for an accelerated process of approval for the vaccine. According to these guidelines, the vaccine has to be tested on thousands of participants who have to be monitored for a period of at least two months after the second dose to be sure there is enough data on risk and benefits. Meanwhile, American media sources report that the White House had deemed this monitoring period as unnecessary and was working to influence these guidelines. The President had made promises to have a vaccine approved before the election in November, which is now looking rather improbable.
The companies currently furthest ahead in their trials have started their third round of test at the end of July, which would mean the FDA-prescribed observation period would be over for the first participants in October. The collected data will most likely not suffice for an early approval, though.
The accelerated spread of the corona virus in the US puts President Trump under pressure, as he trails behind his opponent Biden in polls, and Democrats are suspecting him of pressuring the FDA for a fast approval of a vaccine.
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