When Vladimir Putin said this month that Russia had become the first country to grant regulatory approval for a vaccine to prevent coronavirus, the announcement was met with caution from scientists and officials. Now Donald Trump is attempting to put America, if not first, at least a close second in fast-tracking a vaccine for widespread public use.
His administration is mooting whether normal standards should be bypassed with a suggestion that US regulator, the Food and Drug Administration, could rubber stamp a candidate being developed in the UK ahead of presidential elections in early November. If other candidates now in extensive trials, such as those from Moderna and Pfizer, produce results during October, they might also be candidates for so-called “emergency use authorisation”. The FDA has already authorised the use of convalescent plasma, a treatment that involves injecting patients with blood containing antibodies, which — while successful in combating other illnesses — has not been trialled in line with the usual rules.
There are grounds to distinguish Washington’s efforts from those of Moscow. AstraZeneca and Oxford university, the partnership behind the potential vaccine in question, will make the outcomes of each stage of its trials public and approval would be based on a study of 10,000 volunteers. While that sample size is far smaller than the 30,000 that US government scientists might like to see, the prevalence of coronavirus could enable a smaller-than-usual sample size to produce strong results.