SILVER SPRING, Md., February 4, 2021 / PRNewswire / – As a public health agency responsible for regulating medical products, we need to ensure that healthcare providers have the most up-to-date diagnoses, treatments, and vaccines in their toolbox to combat this pandemic. We understand the need to adapt and pivot to support the modification or development of these rescue tools as new variants of the coronavirus are identified.
Since the beginning of the pandemic, the U.S. Food and Drug Administration has anticipated the possible appearance of coronavirus variants. The FDA continues to monitor identified and emerging variants circulating worldwide, as well as their detection in the US
We have been actively evaluating the impact of new strains on authorized products and continue to work with medical product sponsors and our international partners to evaluate the impact each variant may have on the efficacy or usefulness of authorized medical products.
Our agency has experience in the evolution of infectious diseases. Influenza vaccines and diagnoses are often modified each year to address the predicted predominant strains circulating worldwide. The agency has created and used regulatory processes to facilitate these updates. We will use our experience with the flu to help inform the way forward if SARS-CoV-2 variants appear against which currently authorized vaccines are not effective enough. Similarly, the FDA also has extensive experience in the development of HIV resistance to antiviral drugs and will follow regulatory pathways to rapidly enable the development of new antiviral drugs for resistant viruses.
We have already contacted individual medical product sponsors to provide information as they evaluate the impact of COVID-19 variants on their products. And as part of our commitment to a public and transparent process, the FDA is developing guidelines for diagnostic, therapeutic, and vaccine developers to help guide the continued development of medical products.
In terms of therapeutics, particularly virus-targeted monoclonal antibodies, we are considering methods to help accelerate drug development in this key area, including the discussion of appropriate regulatory flexibilities. We are aware that some of the authorized or developing neutralizing monoclonal antibodies are less effective against some of the COVID-19 variants that have emerged and we are working with drug developers to accelerate the evaluation of new antibodies that could be effective against mutations. . Based on our growing experience with this class of drugs, our teams are discussing approaches for the generation and evaluation of preclinical, clinical and chemical, manufacturing and control data.
For diagnosis, we have been monitoring for new mutations, identifying and working with test developers whose performance may be negative, and communicating with the public when there is useful information. At this time, we believe that the risk of these mutations affecting the overall accuracy of molecular testing is low. To move forward, we are considering expanding the role of in silico control by sponsors before and after authorization to assess whether there are mutations that affect test performance, test designs to minimize the impact of new mutations, and forms. to label products authorized to be transparent. about what we know the test can detect.
In the case of authorized vaccines, our teams are currently deliberating and debating on the types of data needed to support changes in vaccine composition, either by altering the existing vaccine or by adding components. of the new vaccine, including how sponsors could prove to be immune. response to new variants through simplified clinical programs that still collect the crucial data the FDA needs to demonstrate efficacy, but that can be run quickly to collect that data. To be clear, as we continue to develop an understanding and resolution of any impact of variants on FDA-regulated products, at this time, the available information suggests that licensed vaccines remain effective in protecting the U.S. public from COVID-19 strains currently circulating. .
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 remains a practical effort to enable the agency to simultaneously address multiple public health needs. With the advent of multiple variants and their potential impact on vaccine performance and effectiveness, therapeutics and diagnosis, 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 other people information about the agency’s decision-making process.
In addition to these guidelines, the FDA is conducting scenario planning to prepare us to anticipate and address impacts on products and supply chains as soon as possible, regardless of the path the pandemic takes in the next few months. As we continue this process, we are committed to sharing this information with the public when it is ready.
We are committed to identifying efficient processes for authorized products that need to be modified, based on information on emerging variants. We don’t think we need to start with any of these products – we recognize that we are in a pandemic, and we need to arm health care providers with the most appropriate tools to combat 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 continue to monitor the situation and update our plans as more information becomes available. We are committed to communicating with you as we continue to determine the best paths to follow. We urge Americans to keep getting tested, get their vaccines, and follow important health measures: wash their hands, wear a mask, and keep their social distance.
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The FDA, an agency of the U.S. Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and security of human and veterinary drugs, vaccines, and other biological products for human use and medical devices. The agency is also responsible for the security of our nation’s food supply, cosmetics, dietary supplements, products that emit electronic radiation, and the regulation of tobacco products.
SOURCES US Food and Drug Administration
