The US Food and Drug Administration (FDA) has announced that a future vaccine against the coronavirus pandemic might be given emergency approval before the end of trials which are designed to ensure its safety and effectiveness.
The disclosure was made by the head of the US Food and Drug Administration, Stephen Hahn, during an interview with the Financial Times. He said that a request for such extraordinary approval would have to come from the vaccine developer.
He also promised that any review of a potential COVID-19 vaccine in the United State will be transparent to the public and with any clearance or approval is driven by data alone.
During the interview, Stephen Hahn said, ‘’If they do that before the end of Phase Three, which involves large-scale human testing, we may find that appropriate. We may find that inappropriate, we will make a determination.’’
He, however, insisted he was not acting under pressure from President Donald Trump, who has been pushing hard for a vaccine, saying one might be ready before US elections November 3.
The FDA head said, “This is going to be a science, medicine, data decision. This is not going to be a political decision.”
Three Western drugmakers are in the third phase of their clinical trials involving tens of thousands of participants. These 3 drugmakers are AstraZeneca, which is in partnership with Oxford University in UK, Moderna, which is collaborating with the US National Institutes of Health and the Pfizer/BioNTech alliance.
The experimental vaccine was given to half of the participants in such trials, whereas the other half are given a placebo. Under normal procedures, test administrators must wait probably for months to see whether there is a statistically significant difference in the infection rate of the 2 groups.
Hahn revealed that an emergency authorization would not necessarily cover everyone but might be granted for specific, high-risk groups.
He said, ‘’Our emergency use authorization is not the same as a full approval.’’
Hahn apologized last week for overstating the benefits of blood plasma-based therapy during a press conference with President Donald Trump.
He has faced mounting criticism from the medical community for giving in to political pressure from the Trump administration, especially with 2 incidents.
Apart from the one stated above, in March, the FDA gave emergency authorization for the use of hydroxychloroquine to treat COVID-19 after Trump on several occasions praised its use. The authorization was later withdrawn in June after serious side effects emerged.