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 toolkit to combat this pandemic. We understand the need to adapt and turn to support the modification or development of these life-saving tools as new variants of coronavirus are identified.
Since the start of the pandemic, the U.S. Food and Drug Administration has been anticipating the potential emergence of coronavirus variants. The FDA continues to monitor the identified and new variants in circulation worldwide, as well as their detection in the US.
We have actively assessed the impact of new strains on authorized products and continue to work with sponsors of medical products and our international partners to evaluate the impact each variant can have on the effectiveness or usability of authorized medical products.
Our agency has experience with evolving infectious diseases. Influenza vaccines and diagnostics are often updated every year to address the predicted predominant strains circulating worldwide. The agency has developed and used regulatory processes that enable these updates. We will use our experience with influenza to determine a path forward if SARS-CoV-2 variants emerge against which currently approved vaccines are not sufficiently effective. Likewise, the FDA also has extensive experience in developing HIV antiviral drug resistance and will follow regulatory routes to rapidly develop new antiviral drugs for resistant virus.
We have already communicated with individual sponsors of medical products to provide information in evaluating 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 guide the continued development of medical products.
For therapeutics, in particular virus-targeted monoclonal antibodies, we are considering approaches to accelerate drug development in this key area, including discussing appropriate regulatory flexibility. We are aware that some of the neutralizing monoclonal antibodies that are authorized or under development are less effective against some of the COVID-19 variants that have entered the market, and we are working with drug developers to evaluate new antibodies that could be effective against mutations. Relying on our growing experience with this class of drugs, our teams discuss approaches to generating and evaluating preclinical, clinical and chemical, manufacturing and control data.
For diagnostics, we checked for new mutations, identified and collaborated with test developers whose performance could be adversely affected by them, and communicated with the public when useful information becomes available. At present, we believe that the risk of these mutations affecting the overall test accuracy of molecular tests is low. In the future, we consider expanding the role of in silico monitoring by sponsors before and after authorization to assess for mutations affecting assay performance, assay designs to minimize the impact of new mutations, and ways to transparently label authorized products about what we know the test can detect.
For authorized vaccines, our teams are currently deliberating and discussing the types of data required to support changes in vaccine composition, either by modifying the existing vaccine or adding new vaccine components, including how sponsors are immune. can demonstrate. response to new variants through streamlined clinical programs that still collect the critical data the FDA needs to demonstrate effectiveness, but can be implemented quickly to collect this data. To be clear, while we continue to develop an understanding of and address the impact of variants on FDA-regulated products, the information available at this point suggests that the authorized vaccines remain effective in protecting the U.S. public from the currently circulating strains of COVID-19. .
We believe these guidelines demonstrate our flexibility to work with individual sponsors to support their adaptation or development of products to combat COVID-19. The FDA’s response to the COVID-19 pandemic remains an effort of all hands to enable the agency to meet multiple public health needs simultaneously. With the emergence of multiple variants and their potential impact on the performance and efficacy of vaccines, therapies and diagnostics, it is critical that the FDA is transparent about its thinking in this area so that all parties know they are receiving consistent advice and that other individuals understand the decision-making process of the agency.
In addition to these guidelines, the FDA is conducting scenario planning to prepare us to anticipate and address the impact on products and supply chains as soon 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 it is ready.
We are committed to identifying efficient processes for authorized products that may need to be modified, based on information about new variants. We do not believe it will be necessary to start from scratch 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 fight this pandemic on the front line. We don’t want to create obstacles to get these tools to the front line.
As with any changing situation, we will continuously 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 forward. We urge Americans to keep getting tested, get their vaccines, and follow important health measures – wash your hands, wear a mask, and keep a social distance.
Media contact: FDA Office for Media Affairs301-796-4540
Questions from consumers: 888-INFO-FDA
The FDA, an agency within the United States Department of Health and Human Services, protects public health by ensuring the safety, effectiveness, 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 safety and security of our country’s food supply, cosmetics, food supplements, products that emit electronic radiation, and for regulating tobacco products.
SOURCE US Food and Drug Administration
