FDA committed to prioritizing ‘safe and effective’ COVID-19 vaccine, therapy candidates
The FDA has taken unprecedented steps to ensure that safe and effective therapies and vaccine candidates for COVID-19 are moving rapidly through the development process, according to a presenter.
Raj Nair, MD, an acting team leader in the division of rheumatology and transplant medicine at the FDA, informed attendees at the 2020 Association of Women in Rheumatology National Conference that he would be speaking as an individual, and that his comments do not represent or endorse official agency policy.
At the moment, Nair has been working at the Center for Drug Evaluation and Research at the administration, which has had a number of key priorities during the pandemic. “These include making safe and effective drugs to treat COVID-19 as soon as possible,” he said. “We are also monitoring the nation’s supply of medicines and taking action to prevent drug shortages.”
The Coronavirus Treatment Acceleration Program (CTAP) is part and parcel of these activities and demonstrates how the FDA “quickly transitioned and adapted” to the pandemic, according to Nair. He added that CTAP helped to create a “regulatory framework” to move treatments into studies and find out if they are helpful or harmful.
There are currently more than 20 antiviral medications, more than 20 cell gene therapies, more than 30 neutralizing antibodies and more than 90 immunomodulators in various stages of investigation. To manage this unprecedented number of treatments moving in a similar direction, the FDA created a triage team to review proposals for clinical trials and approvals and provide feedback to developers to ensure that they are following appropriate protocols.
This team acknowledges receipt of proposals within 24 hours and can highlight missing or incomplete information. “They will provide feedback to the developers,” Nair said. “Proposals with enough information are sent to the organizational unit thought best to handle the request.”
Nair was clear why the FDA is taking such steps to facilitate the development process. “While we are committed to moving products into clinical trials efficiently, we still must work to ensure patients are not exposed to unreasonable risk of illness or injury,” he said.
Emergency-use authorizations are another strategy used by the FDA to combat the pandemic. “This is not a usual step in drug or biologic development but can be a key step in facilitating patient access,” Nair said.
There have been more than 100 emergency-use authorizations issued over the last several months, from different types of tests for COVID-19 to those for personal protective equipment.
For clinicians who are unable to keep up with the breakneck pace of emerging therapies, the FDA has issued 60 draft guidance statements since the pandemic started. These documents, which are written by multidisciplinary teams, are intended to provide direction for groups hoping to provide treatments for the virus.
Another program initiated by the FDA is the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership, which is coordinated by the NIH. “ACTIV involves a collaboration among government and industry partners, including FDA, to prioritize vaccine and therapeutic candidates, streamline clinical trials and rapidly expand the clinical researcher resources focused on developing therapies for the COVID-19 pandemic,” Nair said.
This “comprehensive and cooperative” approach will ensure that safe and effective therapies reach the patients who need them, Nair said.
The final program Nair mentioned was Operation Warp Speed, which aims to deliver 300 million doses of a vaccine by January. The departments HHS, Energy and Defense are involved, along with the CDC and NIH.
“The federal government is making investments in the necessary manufacturing capacity at its own risk, giving firms confidence that they can invest aggressively in development and allowing faster distribution of an eventual vaccine,” Nair said.
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Nair R. Spotlight Session on COVID-19 and Rheumatic Diseases. Presented at: AWIR National Conference; August 13-16, 2020; (virtual meeting).
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