The current federal regulatory process to develop monoclonal antibodies to treat mutating strains of COVID-19 imposes unnecessary hurdles that hinder the creation and approval of effective treatments for the immunocompromised, finds a new brief released today by the Center for Medical Economics and Innovation at the nonpartisan Pacific Research Institute.
“Monoclonal antibodies provided benefits to vulnerable populations and six different ones were authorized to treat COVID-19,” said Dr. Wayne Winegarden, director of PRI’s Center for Medical Economics and Innovation. “That’s why it is so important that only scientific constraints limit patient access to mAb treatments, not misguided government policy or regulatory inefficiencies.”
Monoclonal antibodies, or mAbs, work by mimicking the body’s natural antibodies, which is why they are so valuable to treating the immunocompromised. Six different mAbs were authorized by the federal Food and Drug Administration (FDA) early on during the COVID-19 pandemic. However, the predominant COVID-19 strain – the JN.1 variant – shows numerous mutations all at once. As a result, the FDA has pulled authorization for current treatments as the current virus continues to mutate.
Winegarden argues that the federal regulatory environment should promote a wider array of treatment options, including the continued development of potentially efficacious mAbs.
The brief documents the similarities between the pathways to develop updated influenza and COVID-19 vaccines for patient use. The government and manufacturers work together to monitor virus mutations and devise updated vaccines that best reflect the available data with the goal of ensuring a safe and effective treatment against the expected virus mutation. The FDA does not require vaccine makers to conduct new vaccine trials that duplicate the information already gained from past trials.
The government entity that regulates mAbs, the Center for Drug Evaluation and Research, or CDER, has not developed a similar process for seasonal mAb treatments geared toward the expected mutated COVID-19 virus strains. Winegarden argues the current regulatory pathway ensures that any mAb enhancement for virus mutations are not expeditiously approved, denying patients access to medications that could effectively treat the latest mutations of the virus. He says the FDA should adopt a consistent regulatory structure for developing updated mAbs to benefit patients.
“Immunocompromised patients would benefit greatly if effective mAbs can be developed and approved,” said Winegarden. “Unfortunately, the current regulatory structure erects barriers that reduce the potential to develop timely mAb therapies. Mirroring the process for updating flu vaccines for developing mAbs to treat new mutations of the COVID-19 virus would improve health outcomes for vulnerable patients and help us stay one step ahead of the constituently mutating virus.”
