FDA says trials are not needed for vaccines modified for variants

The agency says the company would need to submit new data that shows the modified vaccine is safe and produces a similar immune response to the original formula.
The U.S. Food and Drug Administration issued guidances for medical product developers,...
The U.S. Food and Drug Administration issued guidances for medical product developers, specifically covering vaccines, diagnostics, and therapeutics products, to address the emergence and potential future emergence of variants of SARS-CoV-2, the virus that causes COVID-19.(WBAY)
Published: Feb. 23, 2021 at 7:56 AM EST
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LANSING, Mich. (WILX) - New guidance from the Food and Drug Administration says COVID-19 vaccines that have been modified for new variants do not need to undergo lengthy clinical trials.

The agency says the company would need to submit new data that shows the modified vaccine is safe and produces a similar immune response to the original formula. The FDA would then clear the new vaccines as an amendment to the originally approved emergency use authorization application.

“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,” said Acting FDA Commissioner Janet Woodcock, M.D. “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.”

The FDA anticipated the possibility of an emergence of SARS-CoV-2 variants and has been prepared to address changes in the virus, informed by the agency’s experience with evolving infectious diseases, such as influenza and HIV. While the FDA has already been in communication with individual medical product sponsors to deliver information and scientific advice as they evaluate the impact of the variants on their products, in the spirit of transparency and to continue to encourage public input on this important topic, the agency published the new guidance:


  • 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 an 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.

COVDID-19 Testing

  • The FDA issued new guidance for test developers, Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests. The guidance provides information on evaluating the potential impact of emerging and future viral genetic mutations, which may be the basis of viral variants, on COVID-19 tests, including design considerations and ongoing monitoring. The FDA has already issued a safety alert to caution that the presence of viral genetic mutations in a patient sample can potentially change the performance of a diagnostic test. The FDA identified a few tests that are known to be impacted by emerging viral mutations, though at this time the impact does not appear to be significant.
  • The clinical impact of viral genetic mutations on a test’s performance is influenced by various factors, such as the sequence of the variant, the design of the test (for example, molecular tests designed to detect multiple SARS-CoV-2 genetic targets are less susceptible to the effects of genetic variation than tests designed to detect a single genetic target), and the prevalence of the variant in the patient population. The guidance describes the FDA’s activities to better understand the public health impact of new virus variants and the impact on test performance, such as monitoring publicly available genomic databases for emerging SARS-CoV-2 genetic mutations and monitoring the potential effects of genetic variation on molecular tests that have been issued an EUA. The guidance also provides recommendations to test developers, such as considering the potential for future viral genetic mutations when designing their test and conducting their own routine monitoring to evaluate the potential impact of new and emerging viral genetic mutations, which may be the basis of viral variants, on the performance for molecular, antigen and serology SARS-CoV-2 tests.

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

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