The US drug regulatory agency FDA has dampened hopes for rapid approval of a corona vaccine. The agency released its guidelines for accelerated approval of a corona vaccine on Tuesday. According to this, manufacturers testing a vaccine in the third and final phase of testing on thousands of people should schedule a follow-up period of at least two months after the second vaccine dose to collect sufficient data “to assess the risk-benefit profile of a vaccine.”
This makes it extremely unlikely that a vaccine will be available before the November 3 US presidential election. President Donald Trump had recently promised this time and again.
The two companies Moderna and Pfizer, the furthest in clinical trials to date, began the third phase of testing in late July. Since the second dose of vaccine is administered 28 days after the first dose, the follow-up period required by the FDA for the very first subjects would end in late October. The companies would then likely not have enough data to apply for approval in the accelerated procedure.
Meanwhile, US media reported that the White House was trying to influence the new FDA guidelines. Accordingly, the White House did not consider the follow-up time necessary and wanted to remove it from the guidelines.
Trump is under great pressure due to the widespread spread of the corona virus in the United States. In the polls he is behind his challenger Joe Biden. Opposition Democrats have long expressed fear that Trump is exerting enormous pressure on researchers and health authorities to get a vaccine approved as soon as possible. (AFP)