SILVERLENTE, Md., February 4, 2021 / PRNewswire / – As the public health agency responsible for regulating medical products, we need to ensure that healthcare providers have the latest diagnoses, treatments and vaccines in their toolbox to combat this pandemic. We understand the need to adapt and turn around to support the modification or development of these life-saving tools as new variants of coronavirus are identified.
Since the onset of the pandemic, the U.S. Food and Drug Administration has been expecting the possible emergence of coronavirus variants. The FDA continues to monitor the identified and emerging variants circulating 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 medical products and our international partners to evaluate the impact that each variant may have on the effectiveness or usefulness of authorized medical products.
Our agency has experience with developing infectious diseases. Influenza vaccines and diagnostics are regularly adjusted every year to address the predicted predominant strains circulating worldwide. The agency has created and used regulatory processes that facilitate these updates. We will leverage our flu experience to help pave the way if SARS-CoV-2 variants emerge against which currently authorized vaccines are not sufficiently effective. Similarly, the FDA also has extensive experience in developing HIV-resistant antiviral drugs, and will follow regulatory pathways to enable the rapid development of antiviral drugs for resistant viruses.
We have already communicated with 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 the ongoing development of medical products.
For therapeutic agents, especially monoclonal antibodies that focus on viruses, we are considering approaches to accelerate drug development in this key area, including the discussion of appropriate flexible regulations. We are aware that some of the neutralizing or developing neutralizing monoclonal antibodies are less effective than some of the COVID-19 variants that have emerged, and we are working with drug developers to evaluate new ones. to accelerate antibodies. effective against mutations. Based on our growing experience with this class of medicine, our teams discuss approaches to the generation and evaluation of pre-clinical, clinical and chemical, manufacturing and control data.
For diagnosis, we checked for new mutations and identified the developers of tests whose performance could be adversely affected, and worked with developers and communicated with the public when useful information was available. At present, we believe that the risk that these mutations will affect the overall test accuracy of molecular tests is low. Going forward, we are considering extending the role of sponsors before and after the authorization of silico monitoring to determine whether mutations affecting test performance test designs to minimize the impact of new mutations, and ways to label authorized products as transparent. about what we know can detect the test.
For authorized vaccines, our teams are currently discussing and discussing the types of data needed to support changes in the composition of the vaccine, either by modifying the existing vaccine or by adding new vaccine component (s). including how sponsors can show immunity. response to new variants through streamlined clinical programs that still collect the important data the FDA needs to show efficacy, but can be executed quickly to collect this data. To be clear, as we continue to develop an understanding of and address the impact of variants on FDA-regulated products, the information available at this time indicates that the authorized vaccines remain effective for the U.S. public. to protect against the current circles of COVID-19. .
We believe these guidelines will show us the flexibility to work with individual sponsors to support their modification or development of products to combat COVID-19. The FDA’s response to the COVID-19 pandemic is still an attempt to enable the agency to meet multiple public health needs simultaneously. With the emergence of several variants and their potential impact on the performance and efficacy of vaccines, therapy 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 insight into the decision-making process of the agency.
In addition to these guidelines, the FDA is undertaking scenario planning to prepare us to anticipate and address the effects of products and supply chains as quickly as possible, no matter which 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 change, based on information about emerging variants. We do not believe it is necessary to start with one of these products in the first place; we realize that we are in a pandemic and we need to arm healthcare providers with the most appropriate tools to fight this pandemic at the forefront. We do not want to create barriers to bringing these tools to the front line.
As in all evolving situations, we will constantly 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 call on Americans to continue to be tested, take their vaccines and take important health measures: wash your hands, wear a mask and keep social distance.
Media contact: FDA Office of Media Affairs, 301-796-4540
Consumer inquiries: 888-INFO-FDA
The FDA, an agency within 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 food supply, cosmetics, nutritional supplements, products that emit electronic radiation and for the regulation of tobacco products in our country.
SOURCE US Food and Drug Administration
