A great article! Thanks. I wish the FDA was more cognizant of the potential benefits of drugs when weighing them against the harms (and measuring the harms more precisely than they seem to do.) One thing I wish you, as well as other commentators/experts on Covid, is to include the elderly in the group that should be considered eligible and in need of more potentially efficacious treatments. The elderly - defined as those over 65 - constitute a 30+ million member constituency, much great than the "immunocompromised" and actually could be described as "immunocompromised" because of the waning strength of the protective systems as we age. It is no surprise that figures of about 85% of deaths from COVID are the elderly. And yet this grouping is so often disregarded in setting policy - like recommended vaccine frequency. I sometimes wonder how long it took for the manufacturers and the FDA to approve a stronger flu vaccine for seniors. It wasn't always the fact
I am one of the people who received Evusheld. Since I’ve had severe (negative!) reactions to the first 2 COVID vaccines (March 2021) and the first booster (Nov. 2021), my doctor has advised my not taking any further COVID boosters or vaccines.
I’m immunocompromised due to rheumatoid arthritis medications, and saw Evusheld as my backup.
I received Evusheld in June 2022. I caught COVID in September 2022, and had no respiratory issues, but felt like I had been run over by a train. I was bedridden for 4 days. I told my doctor, and she pointed out that I’d had a mild case—I wasn’t in the hospital! To this day I thank Evusheld for that.
When it was pulled, I felt more vulnerable than before. “Hey, CDC, what about me?” I hope the decision will be to bring it back. For people like me, even a little protection is better than what we have now—nothing.
VYD222 from Invivyd has applied for EUA and the early data shared from their trials shows great promise. As a spouse of someone who is immunocompromised my hope it that the FDA will review VYD222 quickly, especially because it has been shown to neutralize current variants.
I would also add that I would prefer not to have false hope with an mAb that may not neutralize current strains. When you can’t rely on vaccines due to immunosuppression, having concrete data in a timely manner is key in understanding if one is actually protected or not.
The FDA: the oral version of remdesivir, made in Japan, has been "fast tracked" for a year now, with nothing to show. With Woodcock leaving, will there be more action? Our tool box is pretty slim.
A great article! Thanks. I wish the FDA was more cognizant of the potential benefits of drugs when weighing them against the harms (and measuring the harms more precisely than they seem to do.) One thing I wish you, as well as other commentators/experts on Covid, is to include the elderly in the group that should be considered eligible and in need of more potentially efficacious treatments. The elderly - defined as those over 65 - constitute a 30+ million member constituency, much great than the "immunocompromised" and actually could be described as "immunocompromised" because of the waning strength of the protective systems as we age. It is no surprise that figures of about 85% of deaths from COVID are the elderly. And yet this grouping is so often disregarded in setting policy - like recommended vaccine frequency. I sometimes wonder how long it took for the manufacturers and the FDA to approve a stronger flu vaccine for seniors. It wasn't always the fact
I am one of the people who received Evusheld. Since I’ve had severe (negative!) reactions to the first 2 COVID vaccines (March 2021) and the first booster (Nov. 2021), my doctor has advised my not taking any further COVID boosters or vaccines.
I’m immunocompromised due to rheumatoid arthritis medications, and saw Evusheld as my backup.
I received Evusheld in June 2022. I caught COVID in September 2022, and had no respiratory issues, but felt like I had been run over by a train. I was bedridden for 4 days. I told my doctor, and she pointed out that I’d had a mild case—I wasn’t in the hospital! To this day I thank Evusheld for that.
When it was pulled, I felt more vulnerable than before. “Hey, CDC, what about me?” I hope the decision will be to bring it back. For people like me, even a little protection is better than what we have now—nothing.
VYD222 from Invivyd has applied for EUA and the early data shared from their trials shows great promise. As a spouse of someone who is immunocompromised my hope it that the FDA will review VYD222 quickly, especially because it has been shown to neutralize current variants.
I would also add that I would prefer not to have false hope with an mAb that may not neutralize current strains. When you can’t rely on vaccines due to immunosuppression, having concrete data in a timely manner is key in understanding if one is actually protected or not.
The FDA: the oral version of remdesivir, made in Japan, has been "fast tracked" for a year now, with nothing to show. With Woodcock leaving, will there be more action? Our tool box is pretty slim.
https://www.shionogi.com/global/en/news/2023/04/20230404.html