ARGINT PRIMARIE, Md., February 4, 2021 / PRNewswire / – As the public health agency responsible for regulating medical products, we need to make sure that healthcare providers have the most up-to-date diagnoses, treatments and vaccines in the toolbox to combat this pandemic. We understand the need for adaptation and pivoting to support the modification or development of these life-saving tools as new coronavirus variants are identified.
Since the beginning of the pandemic, the US Food and Drug Administration has anticipated the possible appearance of coronavirus variants. FDA continues to monitor identified and emerging variants circulating globally, as well as their detection in the US
We have actively evaluated the impact of the new strains on authorized products and have continued to work with medical product sponsors and our international partners to assess the impact that 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 changed each year to address the predominant predicted strains circulating globally. The Agency has created and used regulatory processes that facilitate these updates. We will use our experience with influenza to help inform a way forward if SARS-CoV-2 variants against which currently authorized vaccines are not effective are available. Similarly, the FDA also has extensive experience in developing HIV resistance to antiviral drugs and will follow regulatory avenues to allow the rapid development of new antiviral drugs for the resistant virus.
We have already communicated with individual sponsors of medical products 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.
For therapy, especially virus-targeting monoclonal antibodies, we are considering approaches to help accelerate the development of drugs in this key area, including discussing appropriate regulatory flexibilities. We are aware that some of the neutralizing monoclonal antibodies that have been authorized or are being developed are less effective against some of the COVID-19 variants that have emerged and we are working with drug developers to expedite the evaluation of new antibodies that may be effective against mutations. Based 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 diagnosis, we monitored new mutations, identified and worked with test developers whose performance may be adversely affected by them, and communicated with the public when useful information was available. At this time, we believe that the risk of these mutations having an impact on the overall accuracy of molecular tests is low. Going further, we plan to expand the role of in silico monitoring by sponsors before and after authorization to evaluate mutations that affect test performance, test design to minimize the impact of new mutations, and how to label authorized products to be transparent about what 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 components to the vaccine, including how sponsors could demonstrate immunity to new vaccines. variants through simplified clinical programs that still gather the essential data that the FDA needs to demonstrate efficacy, but that can be quickly executed to collect this data. To be clear, as we continue to develop an understanding and address any impact of the variants on FDA-regulated products, at this time, the available information suggests that licensed vaccines remain effective in protecting the U.S. public against current COVID-19 strains.
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 practical effort to enable the agency to respond to multiple public health needs simultaneously. With the emergence of several variants and their potential impact on vaccine performance and efficacy, therapy and diagnosis, it is essential that the FDA be transparent in its thinking in this area so that all parties know that they are receiving consistent advice and other people have a perspective on the agency’s decision-making process.
In addition to these guidelines, the FDA is committed to planning scenarios 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 it is ready.
We are committed to identifying efficient processes for authorized products that may require modifications, based on information about emerging variants. We do not believe that we will need to start from the first square with any of these products – we recognize that we are in a pandemic and we must arm our healthcare providers with the most appropriate tools to combat this pandemic on the front line. We do not want to create obstacles in the way of getting these tools in the forefront.
As in any evolving 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 establish the best ways forward. We urge Americans to continue to be tested, get vaccinated, and follow important health measures – wash your hands, wear a mask, and keep your social distance.
Media contact: FDA Office of Media Affairs, 301-796-4540
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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 safety 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
