COVID-19 Vaccine: US FDA Says Early Approval For COVID-19 Vaccine Possible Even Before End Of Trials!
: The chief of the US Food and Drug Administration, Dr Stephen Hahn raised the possibility that a vaccine against the SARS-CoV-2 coronavirus might be given emergency approval even before the end of trials designed to ensure its safety and effectiveness.
However such a request for extraordinary approval would have to come from the vaccine developer, Dr Stephen Hahn told the Financial Times on Sunday.
He said, "If they do that before the end of Phase Three which involves large-scale human testing we may find that appropriate."
However Dr Hahn 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.
Dr Hahn insisted "This is going to be a science, medicine. This is not going to be a political decision."
However critics were quick to comment that science does not permit early approval of vaccines till there is proper scientific data collated through proper scientific studies.
To date, three Western drugs makers are well along with their Phase 3 clinical trials, involving tens of thousands of participants.
These are AstraZeneca, which is partnering with Oxford University in England; Moderna, collaborating with the US National Institutes of Health, and the Pfizer/BioNTech alliance.
It should be noted that by the nature of the trials it is difficult to predict when reliable results will emerge.
Typically, half of the research participants in such trials receive an experimental vaccine, while the other half are given a placebo.
In proper vaccine research protocols, test administrators must wait probably for months to see whether there is a statistically significant difference in the infection rate of the two groups.
While the world desperately awaits an effective vaccine against the deadly virus, China and Russia have already approved vaccines without waiting for the conclusion of trials drawing criticism from public health officials in other countries, including the US. It must be also noted that both countries are famous for botched vaccines in the past that resulted in many deaths and also people getting chronically sick.
Dr Hahn also said that an emergency authorization would not necessarily cover everyone it might be granted for specific, high-risk groups.
He added, "Our emergency use authorization is not the same as a full approval.”
Dr Hahn has faced mounting criticism from the medical community that he has given in to political pressure from the Trump administration, largely involving two incidents. In early part of the year, the US FDA gave emergency authorization for the use of hydroxychloroquine to treat COVID-19 after Trump repeatedly praised its use; the authorization had to be withdrawn in June after serious side effects emerged.
Recently, Hahn delivered a far too optimistic appraisal, during a news conference with Trump, of the effectiveness of convalescent plasma against the virus. He said it could save 35 o
ut of 100 patients; the more likely number, experts said, is five in 100.
Dr Eric Topol, director of the Scripps Research Translational Institute, commented on Twitter,"It is f-ing outrageous to expedite *any* approval of a #SARSCoV2 vaccine, irrespective of @SteveFDA's subservience to Trump," "We will not know about safety for many months."
Many are expecting that the Trump administration will grant approvals for a COVID-19 vaccine sometime in October despite all the odds and lack of proper scientific data.
The actions are most like to convert many who have been supporting vaccinations to become anti-vaxxers in this particular scenario due to fear of a product that has not been scientifically tested product in a proper manner.
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