A new antiviral pill that could provide relief and protection for those in the early stages of COVID-19 symptoms is under consideration for emergency use authorization. Public health response agencies believe the drug to be another powerful tool to fight the disease. (Screen capture by Kansas Reflector of University of Kansas Health System live video on Facebook)
TOPEKA — Public health and emergency response leaders say a new antiviral COVID-19 pill awaiting approval would be a welcome addition to the toolbox for fighting the disease.
Pfizer announced Tuesday it had filed for emergency use authorization from the U.S. Food and Drug Administration for the experimental pill known as Paxlovid. The pill is meant to work in tandem with another antiviral drug, ritonavir, to treat mild to moderate cases in patients at the first sign of symptoms.
The pill is not meant to replace the vaccine but work in tandem with it to combat the pandemic.
As opposed to monoclonal antibody treatments used to treat COVID-19, these pills would be much easier to administer, said Dana Hawkinson, medical director of infection prevention for the University of Kansas Health System.
“It will be even better than Tamiflu as far as protecting against progression of disease, but the key there is getting it early on,” Hawkinson said. “I think the other key is making sure you have a definitive diagnosis” of COVID-19.
Hawkinson was joined by members of the U.S. Department of Health and Human Services focused on the region, including Kansas, to discuss the new antiviral and the response to the COVID-19 pandemic. They also addressed COVID-19 shifting from a pandemic to an endemic — always present — disease.
At the current pace of treatment, health experts have argued COVID-19 will soon be an endemic disease. As such, the federal public health response team overseeing Kansas, Missouri, Iowa and Nebraska is hoping to add new measures, like the antiviral pill, to reduce the potential ramifications of a continually prevalent virus.
“We’re going to have to live with it for a while,” said Catherine Satterwhite, the regional administrator for HHS. “The question is at what level? We know that there’s still a lot we can do to get our burden down from case counts to deaths because we’re not fully utilizing those tools.”
Satterwhite said she was unsure when the FDA may grant emergency use authorization for the pill.
Earlier this month, Pfizer announced results from an analysis of the antiviral trial, which showed an 89% reduction in the risk of hospitalization or death from COVID-19 among those given the drug within the first three days of symptoms.
“The overwhelming efficacy achieved in our recent clinical study of PAXLOVID, and its potential to help save lives and keep people out of the hospital if authorized, underscores the critical role that oral antiviral therapies could play in the battle against COVID-19,” said Albert Bourla, chairman and CEO of Pfizer, in a statement.
Another antiviral pill known as molnupiravir is set for review by an FDA advisory committee Nov. 30. The oral antiviral became the first of its kind to be authorized for treatment of COVID-19 when it received approval earlier this month from the UK Medicines and Healthcare Products Regulatory Agency.
With the fluctuation and uncertainty COVID-19 has brought, Dawn O’Connell, with the HHS Office of the Assistant Secretary for Preparedness and Response, said new treatments are an encouraging sign. Her office has worked to provide well over three million pieces of PPE to the region and made a considerable number of ventilators available across those states.
She said so far, Kansas and the surrounding states have needed limited emergency assistance beyond this.
Steven Stites, chief medical officer at the University of Kansas Health System, said Kansas is in position to continue managing the virus without much assistance from the emergency response office if it continues to follow the pillars of infection control.
“Remember the rules of infection prevention and control, travel with you wherever you go. They keep you safe, even into this moment and every day going forward,” Stites said. “Whether you’re vaccinated or unvaccinated, masking still works.”
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