Quote:A secondary endpoint analyzed severe cases of COVID-19 and included 11 severe cases (as defined in the study protocol) in this first interim analysis. All 11 cases occurred in the placebo group and none in the mRNA-1273 vaccinated group.
Quote:The 95 COVID-19 cases included 15 older adults (ages 65+) and 20 participants identifying as being from diverse communities (including 12 Hispanic or LatinX, 4 Black or African Americans, 3 Asian Americans and 1 multiracial).
Quote:A secondary endpoint analyzed severe cases of COVID-19 and included 11 severe cases (as defined in the study protocol) in this first interim analysis. All 11 cases occurred in the placebo group and none in the mRNA-1273 vaccinated group.
Quote:The 95 COVID-19 cases included 15 older adults (ages 65+) and 20 participants identifying as being from diverse communities (including 12 Hispanic or LatinX, 4 Black or African Americans, 3 Asian Americans and 1 multiracial).
(11-16-2020, 10:47 AM)magnus Wrote: Russia's offering hit 92% last week in their interim analysis
https://www.reuters.com/article/idUSKBN27W1F9
They only had 20 confirmed cases before taking a snapshot.
AstraZeneca comes out in a couple weeks. At this rate (90, 92, 94), we should expect 96% effective right? =)
(11-16-2020, 10:47 AM)magnus Wrote: Russia's offering hit 92% last week in their interim analysis
https://www.reuters.com/article/idUSKBN27W1F9
They only had 20 confirmed cases before taking a snapshot.
AstraZeneca comes out in a couple weeks. At this rate (90, 92, 94), we should expect 96% effective right? =)
(11-16-2020, 11:49 AM)oregontim Wrote: A question for those of you who have this expertise, on this board (and thanks to you too; I find real information here extremely valuable)...
Six months ago I saw a talking head on cable news saying that the fastest vaccine in history took four years ... but here we have several getting through testing in roughly a year. I'm not surprised, if both are true, because of the level of urgency ... but are both true? Does this timespan compare to a previous best of four years?
(11-16-2020, 11:49 AM)oregontim Wrote: A question for those of you who have this expertise, on this board (and thanks to you too; I find real information here extremely valuable)...
Six months ago I saw a talking head on cable news saying that the fastest vaccine in history took four years ... but here we have several getting through testing in roughly a year. I'm not surprised, if both are true, because of the level of urgency ... but are both true? Does this timespan compare to a previous best of four years?
Quote:Out of 170 adult volunteers in the nearly 44,000-subject trial who developed Covid-19 with at least one symptom, 162 received a placebo, while eight got the vaccine, Pfizer and BioNTech said.
Quote:Out of 170 adult volunteers in the nearly 44,000-subject trial who developed Covid-19 with at least one symptom, 162 received a placebo, while eight got the vaccine, Pfizer and BioNTech said.
(11-16-2020, 06:03 PM)BostonCard Wrote:(11-16-2020, 11:49 AM)oregontim Wrote: A question for those of you who have this expertise, on this board (and thanks to you too; I find real information here extremely valuable)...
Six months ago I saw a talking head on cable news saying that the fastest vaccine in history took four years ... but here we have several getting through testing in roughly a year. I'm not surprised, if both are true, because of the level of urgency ... but are both true? Does this timespan compare to a previous best of four years?
Yes, not only is the timespan substantially faster than the fastest previous vaccine effort, it is faster than what most experts predicted at the onset. I think most of what I had heard was that it would be 18 months until a vaccine, if we are lucky.
Turns out we are both lucky and good. Here are some of the factors that have helped.
- The new technology (mRNA) works. This was a technology that certainly is much faster to create and scale vaccines up with, but it had never successfully brought a vaccine to market. So, this was a higher risk but faster approach, and we caught a b
- Operation Warp Speed helped (yes, credit Trump here), especially for smaller companies like Moderna and Novavax, which didn't have the capability to run a large scale trial of a vaccine. It's not just about cost sharing, but about knowledge sharing.
- The Chinese were quick to release the virus' genetic sequence. There's a lot to criticize the Chinese for, but the viral sequence was needed to develop the mRNA vaccines, and having the sequence turned around in record time meant the vaccine work could get started in record time.
- We were lucky. A lot of the things that sink vaccines are unpredictable; there was no way of knowing that the vaccines would be so efficacious; we were lucky there wasn't an unpredictable safety risk (we're not totally out of the woods there, but with 90+% efficacy, that opens things up), and we were lucky that targeting the spike protein produces immunity and that the immunity protects against disease
- The vaccine companies trimmed a lot of fat in the timeline. As a rough guideline, it takes about 6 months to go from when you first write a protocol to when the first patient enrolls in a clinical trial. But a lot of that is making sure that everyone who needs to sign off on it has reviewed the protocol and approved it. In the midst of a pandemic, you can trim a week of review time and say "Authoring will be done tomorrow; please review and approve by the next day". Ethics review boards that maybe meet once a month could empanel a special meeting just to approve the vaccine trial. The FDA has 30 days to open an IND; it probably did that in a couple days. Also, a lot of activities can take place "at risk". Normally, you might wait until your phase I data is back before you start working on activities on your phase II study. For this, they probably had everything written in advance and just filled the blanks. It means you've wasted a lot of time and effort if things don't work out in the early phase study, but it cuts time if your early phase study works.
- I'm sure there was a lot of interest from people in participating in clinical trials of the vaccines, both for selfless and selfish reasons. Although there were good reasons not to run them, I am sure we could have recruited volunteers for a challenge study, which goes to show what people would have been willing to risk to help us get a vaccine.
- In a bit of irony, the fact that the pandemic is raging out of control also helped, since it meant that the companies were able to accrue cases quickly (after only a couple of months), and thus do the analysis pretty quickly. Had the pandemic been well-contained, it would have taken longer to see enough cases to determine whether the virus was efficacious, which would have meant that we wouldn't have been able to have these "early looks" to determine efficacy. Hey, maybe it was all part of the Trump strategy.
BC
(11-16-2020, 06:03 PM)BostonCard Wrote:(11-16-2020, 11:49 AM)oregontim Wrote: A question for those of you who have this expertise, on this board (and thanks to you too; I find real information here extremely valuable)...
Six months ago I saw a talking head on cable news saying that the fastest vaccine in history took four years ... but here we have several getting through testing in roughly a year. I'm not surprised, if both are true, because of the level of urgency ... but are both true? Does this timespan compare to a previous best of four years?
Yes, not only is the timespan substantially faster than the fastest previous vaccine effort, it is faster than what most experts predicted at the onset. I think most of what I had heard was that it would be 18 months until a vaccine, if we are lucky.
Turns out we are both lucky and good. Here are some of the factors that have helped.
- The new technology (mRNA) works. This was a technology that certainly is much faster to create and scale vaccines up with, but it had never successfully brought a vaccine to market. So, this was a higher risk but faster approach, and we caught a b
- Operation Warp Speed helped (yes, credit Trump here), especially for smaller companies like Moderna and Novavax, which didn't have the capability to run a large scale trial of a vaccine. It's not just about cost sharing, but about knowledge sharing.
- The Chinese were quick to release the virus' genetic sequence. There's a lot to criticize the Chinese for, but the viral sequence was needed to develop the mRNA vaccines, and having the sequence turned around in record time meant the vaccine work could get started in record time.
- We were lucky. A lot of the things that sink vaccines are unpredictable; there was no way of knowing that the vaccines would be so efficacious; we were lucky there wasn't an unpredictable safety risk (we're not totally out of the woods there, but with 90+% efficacy, that opens things up), and we were lucky that targeting the spike protein produces immunity and that the immunity protects against disease
- The vaccine companies trimmed a lot of fat in the timeline. As a rough guideline, it takes about 6 months to go from when you first write a protocol to when the first patient enrolls in a clinical trial. But a lot of that is making sure that everyone who needs to sign off on it has reviewed the protocol and approved it. In the midst of a pandemic, you can trim a week of review time and say "Authoring will be done tomorrow; please review and approve by the next day". Ethics review boards that maybe meet once a month could empanel a special meeting just to approve the vaccine trial. The FDA has 30 days to open an IND; it probably did that in a couple days. Also, a lot of activities can take place "at risk". Normally, you might wait until your phase I data is back before you start working on activities on your phase II study. For this, they probably had everything written in advance and just filled the blanks. It means you've wasted a lot of time and effort if things don't work out in the early phase study, but it cuts time if your early phase study works.
- I'm sure there was a lot of interest from people in participating in clinical trials of the vaccines, both for selfless and selfish reasons. Although there were good reasons not to run them, I am sure we could have recruited volunteers for a challenge study, which goes to show what people would have been willing to risk to help us get a vaccine.
- In a bit of irony, the fact that the pandemic is raging out of control also helped, since it meant that the companies were able to accrue cases quickly (after only a couple of months), and thus do the analysis pretty quickly. Had the pandemic been well-contained, it would have taken longer to see enough cases to determine whether the virus was efficacious, which would have meant that we wouldn't have been able to have these "early looks" to determine efficacy. Hey, maybe it was all part of the Trump strategy.
BC
