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FDA considers regulatory flexibility to allow the agency and sponsors to adapt and pivot to changes in coronavirus.
FDA has outlined action plans to address the potential impact emerging SARS-CoV-2 coronavirus variants may have on the effectiveness of vaccines and therapies in development or approved under Emergency Use Authorization. The agency promised transparency and an all-hands-on-deck effort to address multiple public health needs in a Feb. 4, 2021 statement.
The statement from Acting Commissioner Janet Woodcock noted the agency’s “need to adapt and pivot to support modification or development of these lifesaving tools as new variants of coronavirus are identified.”
The statement also noted that FDA has been assessing the impact of new strains on medical products and diagnostic tools and is working with sponsors and international partners to assess the implications. In addition, FDA is developing guidance documents for diagnostic, therapeutic, and vaccine developers to help guide ongoing medical product development.
The agency will turn to its experience and regulatory processes employed with evolving infectious diseases, citing the modifications to influenza vaccines and diagnostics, which often change annually to address the predicted predominant strains, Woodcock noted in the statement.
“We will utilize our experience with influenza to help inform a path forward if SARS-CoV-2 variants emerge against which currently authorized vaccines are not sufficiently effective,” the statement noted. “Similarly, the FDA also has vast experience with HIV developing resistance to antiviral drugs and will follow regulatory pathways to quickly enable new antiviral drug development for resistant virus.”
Recognizing that some of the authorized neutralizing monoclonal antibody therapies are less effective against the new virus strains, FDA is considering “appropriate regulatory flexibilities” to help expedite drug development, including approaches to the generation and evaluation of preclinical, clinical, and chemistry, manufacturing and controls data.
For authorized vaccines, FDA teams are discussing what data are needed to support changes in the composition of the vaccine, including ways sponsors could demonstrate immune response to new variants through streamlined clinical programs.
“To be clear, while we continue to develop an understanding of and address any impact of variants on FDA-regulated products, at this time, available information suggests that the authorized vaccines remain effective in protecting the American public against currently circulating strains of COVID-19,” the statement clarified.
The agency also is conducting scenario planning to anticipate impacts to products and supply chains as quickly as possible and will share this information with the public when it is available.
“We are committed to identifying efficient processes for authorized products that may need to be modified, based on information on emerging variants. We do not believe there will be the need to start at square one with any of these products—we recognize we are in a pandemic and we need to arm health care providers with the most appropriate tools to fight this pandemic on the frontlines,” the statement noted. “We do not want to create obstacles to getting these tools to the frontlines.”