4 ms·

I wonder why not cover younger people with the GSK version and older people with some other vaccine?

Throwawayaerlei 6y ago
Excellent question. Probably the biggest factor is that Phase III trials are insanely expensive, like a billion dollars plus or minus. High touch, 30,000 people minimum for the US, lasts two years, etc. Sanofi/GSK is hazarding some of their own money in this, and has to look at the market for COVID-19 vaccines, which is obviously weighted towards the elderly. Might also be risk management in wondering if the final results for the younger would be disappointing or worse, this problem with the elderly was learned through surrogate endpoints from serological as in blood testing of immune system responses. See Oxford for how they were led astray from their first big 500 Phase I/II people test of their vaccine platform, and achieved much worse results than they anticipated when put in the crucible of multiple Phase III trials and the real endpoints of getting COVID-19, or serious cases of it.
- sampo 6y ago
  > Phase III trials are insanely expensive, like a billion dollars plus or minus Do you have a source for that? JAMA Internal Medicine says a median of 19 million, but that's for all drugs, not specifically vaccines. https://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2702287 https://jamanetwork.com/journals/jamainternalmedicine/articl...
  - Throwawayaerlei 6y ago
    Not a good or recent one, but reading the linked article indicates the sort of trials being done for vaccines will have a median much greater than the $19 million you cite. These trials enroll 30,000 subjects at minimum, and take 2 years, both of which substantially exceed the maximums cited in the paper that they or anyone else they knew of had tried. In the case of length, by 4 times. Thinking further, a billion is too high an estimate today, because these trials or one I looked closely at use smartphone "ediaries" to reduce the number of direct person to person contacts. But they're still high touch affairs, nothing substitutes for phone calls and direct examinations, although the latter are limited in number, but start with a general medical exam. Thanks for bringing that paper to my attention, I'll look more closely at it later.
- pja 6y ago
  That figure doesn’t pass the smell test. I think you’re confusing the cost of a phase III trial with the total end-to-end cost of developing new drugs. Injecting 30,000 people twice with a vaccine & tracking their post injection experience does not cost $1billion. (Googles) The FDA thinks a phase III trial costs about $20million. So there you go.

Excellent question. Probably the biggest factor is that Phase III trials are insanely expensive, like a billion dollars plus or minus. High touch, 30,000 people minimum for the US, lasts two years, etc. Sanofi/GSK is hazarding some of their own money in this, and has to look at the market for COVID-19 vaccines, which is obviously weighted towards the elderly. Might also be risk management in wondering if the final results for the younger would be disappointing or worse, this problem with the elderly was learned through surrogate endpoints from serological as in blood testing of immune system responses. See Oxford for how they were led astray from their first big 500 Phase I/II people test of their vaccine platform, and achieved much worse results than they anticipated when put in the crucible of multiple Phase III trials and the real endpoints of getting COVID-19, or serious cases of it.

sampo 6y ago
> Phase III trials are insanely expensive, like a billion dollars plus or minus Do you have a source for that? JAMA Internal Medicine says a median of 19 million, but that's for all drugs, not specifically vaccines. https://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2702287 https://jamanetwork.com/journals/jamainternalmedicine/articl...
- Throwawayaerlei 6y ago
  Not a good or recent one, but reading the linked article indicates the sort of trials being done for vaccines will have a median much greater than the $19 million you cite. These trials enroll 30,000 subjects at minimum, and take 2 years, both of which substantially exceed the maximums cited in the paper that they or anyone else they knew of had tried. In the case of length, by 4 times. Thinking further, a billion is too high an estimate today, because these trials or one I looked closely at use smartphone "ediaries" to reduce the number of direct person to person contacts. But they're still high touch affairs, nothing substitutes for phone calls and direct examinations, although the latter are limited in number, but start with a general medical exam. Thanks for bringing that paper to my attention, I'll look more closely at it later.
pja 6y ago
That figure doesn’t pass the smell test. I think you’re confusing the cost of a phase III trial with the total end-to-end cost of developing new drugs. Injecting 30,000 people twice with a vaccine & tracking their post injection experience does not cost $1billion. (Googles) The FDA thinks a phase III trial costs about $20million. So there you go.