Veklury gets full approval for use in children and the Biden Administration commits to expanding the Test-to Treat initiative and getting COVID-19 anti-virals to those who need them.
The White House announced that President Joseph R. Biden’s Administration is nearly doubling the number of places oral antivirals to treat COVID-19 are available in the coming weeks.
Simultaneously, the FDA expanded the approval of Gilead’s COVID-19 treatment Veklury (remdesivir) to include pediatric patients 28 days of age and older weighing at least 3 kilograms (around 7 pounds), FDA said in a news release.
Currently, oral antivirals are available in about 20,000 locations across the country—including pharmacies, community health centers, hospitals, urgent care centers, and Veterans Affairs clinics, and Department of Defense Medical Treatment Facilities, the White House said in a fact sheet.
The United States has also committed to purchasing 20 million treatment courses of Pfizer’s Paxlovid (nirmatrelvir/ritonavir tablets), which has an emergency use authorization to treat mild-to-moderate COVID-19 The President’s National COVID-19 Preparedness Plan lays out a roadmap for ensuring that these pills, along with other treatments, are available for any American who needs one.
“Now that the United States has ample supply of these treatments, the Administration is making it easier for pharmacies to order antivirals from the federal government. Starting this week, the Administration will allow all pharmacy partners in the federal antiviral pharmacy program—tens of thousands of pharmacy locations nationwide—to order free oral antiviral treatments directly from the federal government,” the White House said.
Pharmacies will also continue to be able to receive treatments from state and territorial health departments and through the Test-to-Treat initiative.
“For many Americans, pharmacies are the most common and convenient place to pick up their prescriptions and receive other forms of healthcare. Opening ordering to all of these pharmacies will dramatically expand the number of local pharmacies with oral antivirals in stock for patients in their community,” The White House said.
The Administration expects that oral antivirals will soon be available in more than 30,000 locations. Additionally, the Department of Health and Human Services (HHS) will work with pharmacy partners to increase availability even further to up to 40,000 sites over the coming weeks.
The White House is also launching a new effort to create federally-supported Test-to-Treat sites. Building on the current 2,200 Test-to-Treat sites in pharmacies and other clinical settings, the federal government will work with states and jurisdictions to establish additional Test-to-Treat locations with federal support.
“These sites will co-locate testing, an assessment from a medical provider, and oral antiviral treatments in one convenient stop—launching in partnership with state, Tribal, and territorial governments, and with support and coordination from HHS and the Federal Emergency Management Agency,” the White House said.
The sites will launch in select communities in the coming weeks and, as more data comes in, the Administration will determine how federally-supported sites can best be expanded and scaled if needed during any potential future surge in cases.
“These sites will be targeted to meet demand and increase equitable access to lifesaving COVID-19 treatments and will function in direct collaboration with state and local health agencies. The Administration will also continue working with existing Test-to-Treat pharmacy partners to improve the patient experience, including through telehealth options,” the White House said.
Meanwhile, the FDA said its expanded access to Veklury is for children with positive results of direct SARS-CoV-2 viral testing, who are either hospitalized or not hospitalized and have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death.
“This action makes Veklury the first approved COVID-19 treatment for children younger than 12 years of age,” the FDA said. As a result, the agency also revoked the emergency use authorization for Veklury that previously covered this pediatric population.
“As COVID-19 can cause severe illness in children, some of whom do not currently have a vaccination option, there continues to be a need for safe and effective COVID-19 treatment options for this population,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research. “This approval of the first COVID-19 therapeutic for this population demonstrates the agency’s commitment to that need.”