'Mother! Good luck not passing otherwise, we'll have to poke again later.'
Pharmaceutical company Veru Inc's plan to produce a vaccine for high-risk Covid-19 patients has failed to get approval from the United States (US) health regulator.
It is understood that 8 members of the panel opposed the use of the oral drug sabizabolin produced by Veru due to concerns about its efficacy and safety based on the company's small-scale clinical trials.
According to a panelist, Susanne May, the data presented by Veru showed amazing results but there was no strong evidence of its effectiveness to support antiviral activity and advised the company to do more research.
The rejection is seen to put pressure on Veru in its efforts to create a vaccine using sabizabulin, a drug often used to inhibit tumor growth in the treatment of colon cancer.
Returning to the original title, the US Food and Drug Administration (FDA) once heralded the effectiveness of sabizabulin in producing antiviral and anti-inflammatory responses but did not explain its effect on Covid-19.
In the meantime, Veru is understood to be conducting their vaccine trials on 210 patients while regulators set the minimum sample size for any drug to be 500 people.
In addition to the issue of sabizabulin and the lack of a sample population, the panelists also cited the issue of high death rates in the placebo group with Jennifer Schwartzott highlighting concerns about future side effects.
