SILVER SPRING, Md., February 4, 2021 / PRNewswire / – As a public health agency responsible for regulating medical products, we must ensure that healthcare providers have the most up-to-date diagnostics, treatments and vaccines in their toolbox to combat this pandemic. We understand the need for adaptation and pivot to support the modification or development of these life-saving tools as new variants of the coronavirus are identified.
Since the beginning of the pandemic, the US Food and Drug Administration has anticipated the possible emergence of coronavirus variants. The FDA continues to monitor identified and emerging variants that circulate globally, as well as their detection in the U.S.
We have actively assessed the impact of new strains on authorized products and continue to work with medical product sponsors and our international partners to assess the impact that each variant may have on the effectiveness or usefulness of authorized medical products.
Our agency has experience with evolving infectious diseases. Vaccines and flu diagnoses are often modified each year to deal with predicted predominant strains that circulate globally. The agency created and used regulatory processes that facilitate these updates. We will use our experience with the flu to help inform a way forward if variants of SARS-CoV-2 arise against which the currently authorized vaccines are not effective enough. Likewise, the FDA also has extensive experience with developing HIV resistance to antiviral drugs and will follow regulatory paths to enable the development of new antiviral drugs for resistant viruses.
We are already communicating with individual medical product sponsors to provide information as they assess the impact of COVID-19 variants on their products. And as part of our commitment to a transparent and public process, the FDA is developing guidelines for diagnostic, therapeutic and vaccine developers to help guide the continued development of medical products.
For therapy, particularly monoclonal antibodies to the virus, we are considering approaches to help accelerate drug development in this key area, including the discussion of appropriate regulatory flexibilities. We are aware that some of the neutralizing monoclonal antibodies that have been authorized or are under development are less effective against some of the variants of COVID-19 that have emerged, and we are working with drug developers to speed up the evaluation of new antibodies that could be effective against mutations. . Counting on our growing experience with this class of drugs, our teams are discussing approaches for the generation and evaluation of pre-clinical, clinical and chemical, manufacturing and control data.
For diagnosis, we have monitored new mutations, identifying and working with test developers whose performance may be adversely affected by them and communicating with the public when useful information becomes available. At the moment, we believe that the risk that these mutations will affect the overall accuracy of molecular tests is low. Moving forward, we are considering expanding the in silico monitoring function by sponsors before and after authorization to assess mutations that affect test performance, test projects to minimize the impact of new mutations, and ways to label authorized products to be transparent about the that we know the test can detect.
For authorized vaccines, our teams are currently deliberating and discussing the types of data needed to support changes in vaccine composition, either by modifying the existing vaccine or adding new vaccine component (s), including how sponsors can demonstrate immunity in response to new variants through streamlined clinical programs that still gather the crucial data that the FDA needs to demonstrate effectiveness, but can be run quickly to collect that data. To be clear, while we continue to develop an understanding and address any impact of variants on FDA-regulated products, at this point in time, available information suggests that authorized vaccines remain effective in protecting the American public against the strains of COVID-19 currently in circulation .
We believe that these guidelines will demonstrate our flexibility to work with individual sponsors to support their modification or product development to combat COVID-19. The FDA’s response to the COVID-19 pandemic continues to be a joint effort to enable the agency to simultaneously address various public health needs. With the emergence of multiple variants and their potential impact on the performance and effectiveness of vaccines, therapies and diagnostics, it is critical that the FDA be transparent about its thinking in this space so that all parties know that they are receiving consistent advice and that other individuals have a vision. the agency’s decision-making process.
In addition to these guidelines, the FDA is carrying out scenario planning to prepare us to anticipate and address impacts on products and supply chains as quickly as possible, regardless of the path the pandemic takes in the coming months. As we continue this process, we are committed to sharing this information with the public when they are ready.
We are committed to identifying efficient processes for authorized products that may need to be modified, based on information about emerging variants. We do not believe that there will be a need to start from scratch with any of these products – we recognize that we are in a pandemic and we need to equip health professionals with the most appropriate tools to fight this pandemic on the front lines. We do not want to create obstacles to bring these tools to the forefront.
As with any evolving situation, we will be continuously monitoring the situation and updating our plans as more information becomes available. We are committed to communicating with you as we continue to determine the best ways forward. We ask Americans to continue doing tests, vaccinations and follow important health measures – wash your hands, wear a mask and keep your social distance.
Media contact: FDA Media Affairs Office, 301-796-4540
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The FDA, an agency of the United States Department of Health and Human Services, protects public health by ensuring the safety, efficacy and safety of human and veterinary drugs, vaccines and other biological products for human use and medical devices. The agency is also responsible for the security and protection of the supply of food, cosmetics, dietary supplements, products that emit electronic radiation and for the regulation of tobacco products.
SOURCE US Food and Drug Administration
