High-Volume PCR and Rapid Antigen Tests Unlikely to Be Impacted by New Omicron Variant, Says US FDA

S. Food and Drug Administration (FDA; Silver Spring, MD, USA).

The FDA has been actively monitoring for the possible emergence of SARS-CoV-2 variants since early in the pandemic and has worked with medical product developers when a new variant (or mutation) emerges that could impact product performance. The agency had laid out an industry guidance February and is working with companies to evaluate and address the potential impact of emerging and future viral mutations on COVID-19 tests, therapeutics and vaccines. It has taken a number of steps to adapt to emerging variants thus far in the pandemic, such as requiring companies to actively monitor for and evaluate the impact of variants on their products as a condition of authorization, and quickly taking appropriate action. The agency has previously limited the scope of use of certain monoclonal antibodies depending on variants circulating in certain areas, updated fact sheets for health care providers with information about how known variants impact certain therapeutics, and communicated with the public about tests affected by viral mutations.

At this time, the current vaccines remain highly effective at preventing COVID-19 and serious clinical outcomes associated with a COVID-19 infection, including hospitalization and death. Additionally, currently available data from its international partners and vaccine manufacturers that has been evaluated by the FDA, suggests that an additional booster shot following the completion of a primary vaccination provides further protection against a COVID-19 infection. Based on its preliminary review, the FDA believes that high-volume PCR and rapid tests show low likelihood of being impacted and continue to work.

However, the FDA will continue to closely review and adjust course as needed. The FDA is now actively working with its federal partners, international regulators and medical product companies to address any potential impacts of the new omicron variant on the tools to fight the pandemic. The agency is working to evaluate the potential impact of this variant on the currently available diagnostics, therapeutics and vaccines. Historically, the work to obtain the genetic information and patient samples for variants and then perform the testing needed to evaluate their impact takes time. However, the agency expects the vast majority of this work to be completed in the coming weeks. The FDA anticipates having more information from the ongoing evaluation regarding if and how well the current vaccines work against this variant in the next few weeks. If a modification to the current vaccines is needed, the FDA and companies will work together to develop and test such a modification quickly.

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