The FDA today issued guidance for medical product developers to address the emergence of variants of SARS-CoV-2, which causes COVID-19.
Variants of the virus have been detected in multiple countries across the globe, including the U.S., and they pose a major threat to potentially ending the COVID-19 pandemic as protocols such as mask-wearing and hand-washing remain in place and vaccines are being distributed.
“The FDA is committed to identifying efficient ways to modify medical products that either are in the pipeline or have been authorized for emergency use to address emerging variants,” acting FDA Commissioner Dr. Janet Woodcock said in a news release. “We know the country is eager to return to a new normal and the emergence of the virus variants raises new concerns about the performance of these products. By issuing these guidances, we want the American public to know that we are using every tool in our toolbox to fight this pandemic, including pivoting as the virus adapts.
“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.”
Having already updated guidance in October to offer insights on variants to vaccine developers, the FDA said that, currently, available information suggests that authorized vaccines developed by Pfizer (NYSE:PFE)/BioNTech (NSDQ:BNTX) and Moderna (NSDQ:MRNA) remain effective in protecting the American public against circulating strains of COVID-19.
However, the FDA stressed that an emergence of SARS-CoV-2 variant(s) in the U.S. that are moderately or fully resistant to the current vaccines may require developers to tailor the vaccines to defend against those variants.
The FDA’s updated guidance recommends modifications to authorized vaccines and expects that manufacturing information will remain generally the same for such vaccines from the same manufacturers. Effectiveness must be supported by data from clinical immunogenicity studies which would compare the recipient’s immune response to virus variants induced by the modified version against the immune response to the authorized vaccine.
Further discussion will be held on the matter to decide if modified COVID-19 vaccines may be authorized without the need for clinical studies in the future, the FDA said.
For COVID-19 diagnostics, the FDA already issued a safety alert to warn that the presence of variants in a sample could potentially change the performance of a test, having already identified a few that are impacted by mutations, although the impact does not appear to be significant at present.
The guidance recommends that test developers consider the potential for future viral genetic mutations when designing their test while conducting their own routine monitoring to evaluate the potential impact of new mutations on the diagnostics.
Finally, the FDA issued new guidance and revised a second guidance all centering around COVID-19 monoclonal antibody therapeutics.
The new guidance recommends efficient approaches to the generation of non-clinical, clinical and chemistry, manufacturing and controls data that support emergency use authorization for a developer of such therapeutics, as the administration has been made aware that some antibodies currently authorized are less active against some of the variants.
Additionally, the second guidance, which covers drugs and biological products more broadly, was updated to address the variants and the availability of authorized vaccines as the FDA outlined clinical trials for therapeutics, including patient populations, efficacy endpoints, safety considerations and statistical considerations.
“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 wrote in the release.
