MatterVille
We spoke generally about the adenovirus-based J&J vaccine yesterday.
Today, Derek Lowe, who is veteran drug development guy has demonstrated his bona fides around here many times, weighs in on three important aspects of the vaccine's efficacy, in its single shot form, based on an analysis of the briefing documents for the company's hearing before the US Food and Drug Administration that will be held on Friday.
First, Lowe notes that the J&J vaccine does well preventing severe disease onset and death:
...Like every other vaccine that we’ve seen the clinical data on, this one also seems to completely prevent deaths from the coronavirus. I might be mistaken, but so far I don’t think we’ve seen a single SARS-Cov-2 fatality in the treatment group of any of the Phase III trials. As for severe disease, this one had a strong effect as well, but it might take a bit to kick in completely. 14 days after the single dose, there were 29 people hospitalized with coronavirus in the placebo group and only 2 in the treatment group, but if you look at the 28-day mark there were zero hospitalizations at all...
Second, the J&J vaccine did reasonably well in locations where viral variants were emerging at the time of the trials:
...The coronavirus landscape has changed since the earlier (clinical trials with the mRNA) vaccines, and you can see some of that in the way that the J&J data break out their South African trial. Overall vaccine efficacy was 72% in the US versus 58% in South Africa, where there’s been a lot more B.1.351 variant circulating. But they also have data from Brazil, where the P.2 variant there doesn’t seem to have made much of a difference, and the B.1.1.7 variant first noted in the UK doesn’t seem to be a problem, either...
Third, there is some evidence (but it is still not yet a for sure, settled thing as we also noted previously) that the J&J vaccine provides some protection against viral transmission:
...Of the roughly 10,000 people in the treatment arm of the trial, 2892 of them were tested with or without symptoms for signs of coronavirus infection. The FDA’s take on the data (see numbered page 35 of this document) is that there is weak-to-no evidence of such protection out to day 29, and around 60 to 70% efficacy in the post day-29 data. Like the other trials, it seems very likely that all of this will also reduce transmission of the virus, although the study isn’t designed to track that specifically...
So, like many other knowledgable commentators, Dr. Lowe concludes that it is likely that the J&J vaccine will receive emergency use authorization in the U.S. soon after hearing on Friday. If this occurs it is likely Canada will soon follow suit. A note of caution, here, however, is that the company has been slow to ramp up production, although Lowe notes that it is now starting catching up.
...Like every other vaccine that we’ve seen the clinical data on, this one also seems to completely prevent deaths from the coronavirus. I might be mistaken, but so far I don’t think we’ve seen a single SARS-Cov-2 fatality in the treatment group of any of the Phase III trials. As for severe disease, this one had a strong effect as well, but it might take a bit to kick in completely. 14 days after the single dose, there were 29 people hospitalized with coronavirus in the placebo group and only 2 in the treatment group, but if you look at the 28-day mark there were zero hospitalizations at all...
Second, the J&J vaccine did reasonably well in locations where viral variants were emerging at the time of the trials:
...The coronavirus landscape has changed since the earlier (clinical trials with the mRNA) vaccines, and you can see some of that in the way that the J&J data break out their South African trial. Overall vaccine efficacy was 72% in the US versus 58% in South Africa, where there’s been a lot more B.1.351 variant circulating. But they also have data from Brazil, where the P.2 variant there doesn’t seem to have made much of a difference, and the B.1.1.7 variant first noted in the UK doesn’t seem to be a problem, either...
Third, there is some evidence (but it is still not yet a for sure, settled thing as we also noted previously) that the J&J vaccine provides some protection against viral transmission:
...Of the roughly 10,000 people in the treatment arm of the trial, 2892 of them were tested with or without symptoms for signs of coronavirus infection. The FDA’s take on the data (see numbered page 35 of this document) is that there is weak-to-no evidence of such protection out to day 29, and around 60 to 70% efficacy in the post day-29 data. Like the other trials, it seems very likely that all of this will also reduce transmission of the virus, although the study isn’t designed to track that specifically...
So, like many other knowledgable commentators, Dr. Lowe concludes that it is likely that the J&J vaccine will receive emergency use authorization in the U.S. soon after hearing on Friday. If this occurs it is likely Canada will soon follow suit. A note of caution, here, however, is that the company has been slow to ramp up production, although Lowe notes that it is now starting catching up.
Thus, it looks like good news, overall, that we in Canada will soon have a third vaccine, likely starting in April, with a solid efficacy profile is coming.
Until then, mask up and socially distance at all times!
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J&J also has a 2 dose clinical trial going that should produce data by May of this year.
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1 comment:
Good information here.
I look forward to the J&J data in May. These variants are really the thing to look out for but I see it as an ongoing forever problem as this kind of virus likes to mutate continuously. Although I think companies can readjust as time goes by but it's the 'keeping up' that may be at issue. I think getting boosters every year may be a thing in the future.
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