U.S. FDA Issues New Guidance to Medical Product Developers Addressing Virus Variants

The U.S. Food and Drug Administration (FDA) announced guidances for medical product developers, specifically covering vaccines, diagnostics, and therapeutics products, to address the emergence and potential future emergence of variants of the SARS-CoV-2 coronavirus.

‘While the FDA has already been communicating with individual medical product sponsors to provide information and scientific advice as they evaluate the impact of SARS-CoV-2 variants on their products, in the spirit of transparency and to continue to encourage public input on this important topic, the agency published this suite of guidances, stated the FDA press statement issued on February 22, 2021.

“The FDA is committed to identifying efficient ways to modify medical products that are either in the pipeline or have been authorized for emergency use to address emerging variants,” commented Acting FDA Commissioner Janet Woodcock, M.D.

“We need to arm health care providers with the best available diagnostics, therapeutics, and vaccines to fight this virus. We remain committed to getting these life-saving products to the frontlines.”

As with any evolving situation, the FDA will be continuously monitoring the situation and updating its plans as more information becomes available. The agency is committed to communicating with the public as the FDA determines the best paths forward. 

The FDA updated its October 2020 guidance, Emergency Use Authorization for Vaccines to Prevent COVID-19, to provide recommendations to vaccine developers, including those who have already received emergency use authorization (EUA) for their COVID-19 vaccines and are seeking to amend their EUA to address new variants. 

At this time, available information suggests that the FDA-authorized vaccines remain effective in protecting the American public against currently circulating strains of SARS-CoV-2. 

However, if there is an emergence of SARS-CoV-2 variant(s) in the U.S. that are moderately or fully resistant to the antibody response elicited by the current generation of COVID-19 vaccines, it may be necessary to tailor the vaccines to the variant(s).

The updated guidance outlines the FDA’s scientific recommendations for modifications to authorized vaccines. 

For example, the FDA expects that manufacturing information will remain generally the same for an authorized vaccine and a modified vaccine candidate from the same manufacturer. 

For clinical data, the guidance recommends that a determination of effectiveness be supported by data from clinical immunogenicity studies, which would compare a recipient’s immune response to virus variants induced by the modified vaccine against the immune response to the authorized vaccine. 

Manufacturers are also encouraged to study the modified vaccine in both naïve (non-vaccinated) individuals and in individuals previously vaccinated with the authorized vaccine. 

Additionally, the guidance outlines the FDA’s recommendations for assessments of safety to support a EUA for a modified vaccine. 

Finally, the guidance states that further discussions will be necessary to decide whether in the future, modified COVID-19 vaccines may be authorized without the need for clinical studies. 

With these guidances, the FDA is encouraging developers of drugs or biological products targeting SARS-CoV-2 to continuously monitor genomic databases for emerging SARS-CoV-2 variants and evaluate phenotypically any specific variants in the product target that are becoming prevalent or could potentially impact its activity. 

The FDA, an agency within the U.S. Department of Health and Human Services, protects 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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