All-Hands-On-Deck as the U.S. FDA Confronts New Coronavirus Variants

As the public health agency responsible for regulating medical products, we must ensure that health care providers have the most up-to-date diagnostics, treatments, and vaccines in their toolbox to fight this pandemic, stated the Acting Commissioner of the Food and Drug Administration (FDA) Janet Woodcock M.D.

We understand the need to adapt and pivot to support modification or development of these lifesaving tools as new coronavirus variants are identified, continued Dr. Woodcock’s excerpted statement issued on February 4, 2021.

Since the beginning of the pandemic, the FDA has anticipated the possible emergence of coronavirus variants. The FDA continues to monitor the identified and emerging variants circulating globally and their detection in the USA.

We have been actively assessing the impact of new strains on authorized products and continue to work with medical product sponsors and our international partners to evaluate the effect that each variant may have on the effectiveness or utility of authorized medical products.

Our agency has had experience with evolving infectious diseases. Influenza vaccines and diagnostics are often modified each year to address the predicted predominant strains circulating globally. 

The agency has created and used regulatory processes that facilitate these updates. 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. 

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 the resistant virus.

And as part of our commitment to a public and transparent process, the FDA is developing guidance for diagnostic, therapeutic, and vaccine developers to help guide ongoing medical product development. 

For therapeutics, particularly virus-targeting monoclonal antibodies, we are considering approaches to help expedite drug development in this key area, including discussing appropriate regulatory flexibilities. 

We are aware that some of the neutralizing monoclonal antibodies that have been authorized or are under development are less effective against some of the COVID-19 variants that have emerged. We are working with drug developers to accelerate the evaluation of new antibodies that could be effective against mutations. Relying on our growing experience with this class of drugs, our teams discuss approaches to the generation and evaluation of pre-clinical, clinical and chemistry, manufacturing, and controls data. 

For diagnostics, we have been monitoring new mutations, identifying and working with developers of tests whose performance may be adversely impacted by them, and communicating with the public when helpful information becomes available. At this time, we believe the risk that the currently known mutations will impact the overall testing accuracy of molecular tests is low. 

Moving forward, we are considering expanding the role of in silico monitoring by sponsors before and following authorization to assess for mutations that impact the performance of the test, test designs to minimize the impact of new mutations, and ways to label authorized products to be transparent about what we know the test can detect.

For authorized vaccines, our teams are currently deliberating and discussing the types of data needed to support changes in the composition of the vaccine, either through altering the existing vaccine or through the addition of new vaccine component(s), including how sponsors could demonstrate an immune response to new variants through streamlined clinical programs that still gather the crucial data the FDA needs to demonstrate effectiveness but can be executed quickly to gather this data. 

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 FDA’s response to the COVID-19 pandemic continues to be an all-hands-on-deck effort to enable the agency to address multiple public health needs simultaneously.

As with any evolving situation, we will be continuously monitoring the status and updating our plans as more information becomes available. We are committed to communicating with you as we continue to determine the best paths forward. 

We urge Americans to continue to get tested, get their vaccines and follow necessary health measures—wash your hands, wear a mask and maintain social distance, concluded Dr. Woodcock’s edited, reduced comments.

The FDA is an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines, and other biological products for human use and medical devices.

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