FDA Issues New Guidance for COVID-19 Vaccine Developers

March 02, 2021 - FDA recently issued three guidance documents for COVID-19 vaccine developers and other medical product creators covering to address the current and potential future emergence of variants of SARS-CoV-2. 

Throughout the pandemic, the agency has prepared to address changes in COVID-19, informed by its past experiences with evolving infectious diseases, including influenza and HIV.

Although FDA has been in communication with individual medical product sponsors to provide information and scientific advice regarding SARS-CoV-2 variants on their products, the agency published a suite of guidelines to encourage public input and support on the topic. 

“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 Janet Woodcock, MD, said in the announcement.  

“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,” Woodcock continued. 

In the first guidance, FDA updated its October 2020 guidance titled Emergency Use Authorization for Vaccines to Prevent COVID-19. 

The updated recommendations are intended for vaccine developers, including those who have already received emergency use authorization (EUA) for their COVID-19 vaccines and are looking to revise their EUA to address new variants. 

The updated guidance highlights FDA’s scientific recommendations for modifications to authorized vaccines. Overall, FDA expects that manufacturing information will remain the same for an authorized vaccine and a modified vaccine candidate from the same manufacturer.

But for clinical data, FDA recommends that effectiveness of a vaccine should be supported by data from clinical immunogenicity studies. The studies should compare an individual’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 non-vaccinated individuals and those previously vaccinated with the authorized vaccine.  

The agency noted that further discussions may be necessary to determine if modified COVID-19 vaccines can be authorized without clinical studies. 

FDA’s second guidance focuses on COVID-19 tests. The guidance, Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests, is intended for test developers.

The guidance provides information on evaluating the potential impact of emerging and future viral genetic mutations. These genetic mutations could be the basis of viral variants on COVID-19 tests. 

The guidance also describes FDA’s goal to better understand the public health impact of new virus variants and the impact on test performance, including monitoring genomic databases for emerging SARS-CoV-2 genetic mutations and monitoring the potential effects of genetic variation on FDA authorized molecular tests. 

Lastly, FDA provided new recommendations for test developers regarding the potential of future viral genetic mutations when designing their test. 

The last FDA guidance released as part of the Feb. 22 announcement is called Development of Monoclonal Antibody Products Targeting SARS-CoV-2, Including Addressing the Impact of Emerging Variants, During the COVID-19 Public Health Emergency. The guidance document addresses the impact of emerging variants of SARS-CoV-2 on the development of monoclonal antibody products targeting the virus. 

The agency also revised a second guidance covering drugs and biological products more broadly for COVID-19. 

The first guidance provides recommendations on non-clinical, clinical, chemistry, manufacturing, and controls data to support an EUA for monoclonal antibody products that may be effective against emerging variants.

And the revised guidance addresses the evolving landscape for COVID-19 drug development, including the emergence of SARS-CoV-2 variants and authorized COVID-19 vaccines. 

FDA stated that it encourages developers of drugs or biological products targeting SARS-CoV-2 to continuously monitor genomic databases for emerging SARS-CoV-2 variants. Additionally, developers should evaluate any specific variants in the product target that could impact general activity.