FDA Media Call: COVID-19 Variant Guidances – 2/22/2021
The FDA had a media call today which is on youtube. I listened because I thought they might give reasoning for the new guidances. It is 32 minutes long, starts with Dr. Woodcock giving remarks, and then a short Q&A with journalists. The Q&A was not relevant - questions were about vaccines and tests. The main discussion topic seemed to be what the FDA was doing about variants. Most of Woodcock's talk is pasted below. There is no video - it is a conference call. If a therapeutic were available whose efficacy against variants was outstanding, one would think it would get a lot of attention at the FDA (and it probably is, but she did not give any hints).
https://www.youtube.com/watch?v=Y1mmHYrIM8o
Today the FDA issued guidances for medical product developers who are developing covid-19 products including vaccines, diagnostics, and therapeutics. The purpose of these guidances is to address the emergence and the potential future emergence of variants of SARS Cov-2, the virus that causes covid-19. The reason for these guidances is any of these products might be impacted by changes to the virus, particularly their efficacy or their performance. Therefore we need to identify special ways to modify the products that are either in the pipeline or our EUA products to address these variants. We also need to make sure that the products that are marketed under EUA or actually marketed are monitored to make sure that if their performance is altered, we know about it and the manufacturers know about it right away. The FDA has anticipated the possible emergence of variants. We have been prepared to address this issue because we have experience with other evolving infectious diseases such as influenza and of course the chronic viral infection HIV.
We recognize we are in a pandemic situation and we need to make sure that healthcare providers have the best available diagnostics, therapeutics, and vaccines to fight the virus and that these may need to be modified over time to remain maximally effective. We also know that to contain the virus, we’re going to have to contain it around the world. The virus, wherever it is replicating, it is mutating. And so as long as there’s a large amount of infection going on around the world, probably additional virus variants will emerge. We need a global approach to this global pandemic and we’d just like the public to know we’re going to use every tool in our toolbox to fight the pandemic including modifications and pivoting as the virus adapts. We want to get ahead of it and we remain committed to getting the products out there even in the face of virus changes.
I'm sure you have more specific questions about each of the guidances, but I'll take a moment to touch on them at a high level. The FDA’s already been communicating with the individual medical products sponsors to provide information and scientific advice as they evaluate the impact of these variants on their products but we want to publish draft guidances both for transparency and to enable scientific input from various parties so that we have the best possible advice on how to deal with this.
Vaccines………
Tests………….
Finally, the FDA is issuing two guidances today regarding variants and development of therapeutics and monoclonal antibody treatment in particular. As you know monoclonal antibodies are laboratory made proteins that mimic the immune system in fighting off harmful pathogens such as viruses. We know that some of the monoclonal antibodies that are currently authorized are less active against some of the SARS Cov-2 variants that having emerged and are prevalent in some parts of the world. So today we're outlining recommendations on efficient approaches to the generation of non-clinical, clinical, and chemistry manufacturing controls data to support an emergency use authorization for monoclonal antibody products that neutralize specific variants. And fortunately there a lot of monoclonals in the pipeline. We have a lot of ways to we can fairly easily understand their performance against different variants so we have a lot of prior knowledge about this to work on. The second therapeutics guidance is a revision to a guidance issued last May for drugs and biological products under development to treat or prevent covid-19 and it provides recommendations regarding Phase 2 and 3 clinical trials including patient population, trial design, efficacy, endpoints, safety considerations, and the statistical analysis for such trials and more. We have updated this guidance since a lot has happened over the last months to address the evolving landscapes of covid-19 drug development including the emergence of variants and the availability of authorized covid-19 vaccines.
So with these guidances the FDA is encouraging developers of drugs and biological products to continuously monitor genomic databases for the emerging variants and evaluate potentially prevalent variants circulating in the United States for impact on product performance and ones outside the United States to be aware of as they may end up here and circulate. We will do this as well - we will continuously monitor the situation and update our plans as more information becomes available. We are developing scenario planning so that we can respond to whatever contingency arises and we're committed to communicating with the public as we determine the best path forward. We urge all Americans to follow important health measures ……….
The FDA had a media call today which is on youtube. I listened because I thought they might give reasoning for the new guidances. It is 32 minutes long, starts with Dr. Woodcock giving remarks, and then a short Q&A with journalists. The Q&A was not relevant - questions were about vaccines and tests. The main discussion topic seemed to be what the FDA was doing about variants. Most of Woodcock's talk is pasted below. There is no video - it is a conference call. If a therapeutic were available whose efficacy against variants was outstanding, one would think it would get a lot of attention at the FDA (and it probably is, but she did not give any hints).
https://www.youtube.com/watch?v=Y1mmHYrIM8o
Today the FDA issued guidances for medical product developers who are developing covid-19 products including vaccines, diagnostics, and therapeutics. The purpose of these guidances is to address the emergence and the potential future emergence of variants of SARS Cov-2, the virus that causes covid-19. The reason for these guidances is any of these products might be impacted by changes to the virus, particularly their efficacy or their performance. Therefore we need to identify special ways to modify the products that are either in the pipeline or our EUA products to address these variants. We also need to make sure that the products that are marketed under EUA or actually marketed are monitored to make sure that if their performance is altered, we know about it and the manufacturers know about it right away. The FDA has anticipated the possible emergence of variants. We have been prepared to address this issue because we have experience with other evolving infectious diseases such as influenza and of course the chronic viral infection HIV.
We recognize we are in a pandemic situation and we need to make sure that healthcare providers have the best available diagnostics, therapeutics, and vaccines to fight the virus and that these may need to be modified over time to remain maximally effective. We also know that to contain the virus, we’re going to have to contain it around the world. The virus, wherever it is replicating, it is mutating. And so as long as there’s a large amount of infection going on around the world, probably additional virus variants will emerge. We need a global approach to this global pandemic and we’d just like the public to know we’re going to use every tool in our toolbox to fight the pandemic including modifications and pivoting as the virus adapts. We want to get ahead of it and we remain committed to getting the products out there even in the face of virus changes.
I'm sure you have more specific questions about each of the guidances, but I'll take a moment to touch on them at a high level. The FDA’s already been communicating with the individual medical products sponsors to provide information and scientific advice as they evaluate the impact of these variants on their products but we want to publish draft guidances both for transparency and to enable scientific input from various parties so that we have the best possible advice on how to deal with this.
Vaccines………
Tests………….
Finally, the FDA is issuing two guidances today regarding variants and development of therapeutics and monoclonal antibody treatment in particular. As you know monoclonal antibodies are laboratory made proteins that mimic the immune system in fighting off harmful pathogens such as viruses. We know that some of the monoclonal antibodies that are currently authorized are less active against some of the SARS Cov-2 variants that having emerged and are prevalent in some parts of the world. So today we're outlining recommendations on efficient approaches to the generation of non-clinical, clinical, and chemistry manufacturing controls data to support an emergency use authorization for monoclonal antibody products that neutralize specific variants. And fortunately there a lot of monoclonals in the pipeline. We have a lot of ways to we can fairly easily understand their performance against different variants so we have a lot of prior knowledge about this to work on. The second therapeutics guidance is a revision to a guidance issued last May for drugs and biological products under development to treat or prevent covid-19 and it provides recommendations regarding Phase 2 and 3 clinical trials including patient population, trial design, efficacy, endpoints, safety considerations, and the statistical analysis for such trials and more. We have updated this guidance since a lot has happened over the last months to address the evolving landscapes of covid-19 drug development including the emergence of variants and the availability of authorized covid-19 vaccines.
So with these guidances the FDA is encouraging developers of drugs and biological products to continuously monitor genomic databases for the emerging variants and evaluate potentially prevalent variants circulating in the United States for impact on product performance and ones outside the United States to be aware of as they may end up here and circulate. We will do this as well - we will continuously monitor the situation and update our plans as more information becomes available. We are developing scenario planning so that we can respond to whatever contingency arises and we're committed to communicating with the public as we determine the best path forward. We urge all Americans to follow important health measures ……….
3
