Now it’s time for On Point, where we speak to experts to delve deeper into the biggest stories in the news right now.
Pharmaceutical giant Merck and its partner Ridgeback Biotherapeutics have requested the FDA grant emergency approval for their anti-viral COVID-19 pill.
They say the experimental drug showed “compelling results” in a phase three clinical trial.
Merck says the pill, called molnupiravir, cut the risk of hospitalization or death in patients with mild to moderate COVID-19 by about 50 percent.
In fact, the Merck was so impressed that it decided to wrap the trial ahead of time and seek the emergency use authorization or EUA.
Right. And this could be a game changer because, if the FDA gives Merck the green light, the pill will be the world's first oral antiviral for COVID-19.
Another antiviral, remdesivir, can only be administered through an IV drip.
For more, we are joined on Skype by Professor Michael Toole, Associate Principal Research Fellow, at the Burnet Institute in Melbourne, Australia.
Professor, having an oral option will be a big change and a huge step forward helping us get back to normal life.
Judging by the data you’ve seen, do you think the FDA will grant EUA to Merck for (mol-new-peerah-veer) molnupiravir? And do we know how it works in the body to combat COVID-19?
Let’s hope the FDA gets through this process as quickly as possible. If approval is granted, how quickly can this oral treatment be in the hands of doctors in the U.S. and distributed to those who have the virus?
We’re told that, while fully vaccinated people can still contract COVID-19, they have a high degree of protection against severe illness and death. As a result, do you foresee this oral treatment being reserved exclusively - at least at the outset - for those who A. Haven’t been able to get vaccinated for whatever reason … and B. those who’ve opted against getting the jab?
And before we let you go, South Korea, Australia, Singapore and other nations have made advance purchase agreements with Merck for this treatment. Will the FDA’s decision on whether to approve or not in the U.S. have any sway in the decision making process of drug regulatory bodies in other countries?
Will appreciate your insights and let’s hope for the best.
Professor Michael Toole, Associate Principal Research Fellow, at the Burnet Institute. Thank you for joining us.