baQtotheraQ just won’t let it go. Lol.
OT: COVID Science - Pfizer/Moderna vaccines >90% effective; Regeneron antibody cocktail looks very promising in phase II/III trial and more
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baQtotheraQ just won’t let it go. Lol.
I disagree somewhat. As per my post below from about a week ago, I and others have been posting how expectations were for efficacy in the 75-80% range based on the healthy volunteer immune response data (Slauoi guessed 80%) - that also was not "interim" data on the actual phase III trial Pretty much all of the vaccines have shown a pretty robust immune response, but that doesn't always translate to efficacy, plus in the J&J case many of us have been thinking that since it's an adenovirus vector vaccine delivery, it might be more similar to the "mediocre" (relative to Pfizer/Moderna) efficacy of the Astra-Zeneca adenovirus vector vaccine. I do think many have been hoping it would be highly effective, as that would make it a gamechanger given it's a single shot and refrigerator-stable. It still prevented all deaths, which is fantastic, so it'll get used and will help. I'd still pick the mRNA vaccines if given a choice though, although I'd still like to know how effective the mRNA vaccines would be against the South African variant (we just don't know, although they look good in vitro).
Forget about given a choice. If it's the first available to you would you eagerly get it ASAP?
Ok since the posts above are directly related to both Novavax's protein/adjuvant vaccine results and J&J's adenovirus vector vaccine results, figured I'd quote them for reference and then post the entire fantastic discussion below from Derek Lowe today on both of these. And remember, he gets paid nothing for this blog (other than kudos from most scientists). He's simply the best science blogger in the blogosphere, IMO.
Anyway, the one thing he touches on (2nd bold part below; my bolding) is the same thing I was wondering and which @Upstream and @ArminRU and I and others were discussing earlier, with regard to what, exactly do the J&J data say about "severe" and "hospitalizations." As per his commentary, it sounds like he was on the conference call and also thinks J&J meant that there were no deaths but that the 85% prevention of "severe" infections meant that the others were hospitalized, but he also acknowledges that no deaths is more important. He did say he expectes to hear clarification on this next week.
He also mentioned the same thing I did, which is that we don't truly know the efficacy of the Moderna/Pfizer mRNA vaccines against the South African variant. We have in vitro data showing that the immune response would be expected to "neutralize" the SA variant in a pseudovirus, but that's not exactly the same thing as real world data in the field (1st bold part; my bolding) and that it's possible the mRNA vaccines would also have reduced efficacy against the SA variant, like we've seen for Novavax and J&J. I asked my Pfizer buddy about this and he said Pfizer (and Moderna) is gathering that data in the field, post-vaccination, but has nothing to share yet. That will be critical data and could be a major differentiator between the vaccine types.
https://blogs.sciencemag.org/pipeline/archives/2021/01/29/jj-and-novavax-data
J&J and Novavax Data
By Derek Lowe 29 January, 2021
Suddenly we have a lot more vaccine efficacy data to discuss! Yesterday came an announcement from Novavax about trials they’ve been conducting in the UK and in South Africa with their recombinant protein vaccine, and today comes equally anticipated data from J&J (Janssen) on their adenovirus vector candidate. We’ll have a look at the numbers in that order.
The full Novavax package should be coming out in a few days. But what we know now is that in the UK trial (roughly 15,000 people), the vaccine showed 89% efficacy. And the company says that around half of these participants were infected with the B.1.1.7 variant, so these are excellent results against that one and against “coronavirus classic”. The South African trial was smaller (around 4,000 patients), and the data have correspondingly more scatter in them. But the readout is clear: the vaccine is less effective against the B.1.351 variant, perhaps around 50%. Almost all the cases in this trial were from that one. Novavax says that they have already begun working on another protein vaccine to be used as a booster for those who’ve received another one, and that’s good news. Not least because Novavax also noted that they were seeing people infected with B.1.351 who had already been infected with the earlier strains. There appear to have been no significant safety signals during the trials (an initial report of volunteers being hospitalized appears to have been mistaken). Keep in mind that there’s another trial of the Novavax candidate still underway here in the US as well – the question is now how many countries will authorize the vaccine based on the data we have in hand and when this vaccine can be rolled out.
Now to J&J – then we’ll discuss some implications. Their data for the one-shot dosing protocol show 72% efficacy in the North American volunteers, 66% in Latin America, and 57% in South Africa. That last one has to be another B.1.351 effect. There were also no safety signals – adverse events were actually more frequent in the placebo group. There were also no real differences across different age groups, which is very good to see.
Now, these numbers from J&J are definitely lower than the Moderna and Pfizer/BioNTech vaccines. I wish that they were higher. But this is the landscape we have, and given the development timelines, I think we’d better get used to this it, because now the biggest and most advanced players have reported in. Broadly speaking, it looks like the mRNA vaccines have definitively higher efficacy, but we have to remember that their trials were run before the new variants got much of a foothold. We have in vitro data about how they might respond to B.1.1.7 and B.1.351, but so far we have no real-world efficacy reads. For all we know, the Moderna and Pfizer/BioNTech vaccines also come down to 50-60% efficacy against B.1.351.
But at any rate, with a 95% value (or the 96% seen with Novavax against “coronavirus classic”), you can have a good deal of confidence that you’re going to have solid real-world effects. When we see numbers like J&J’s, or (especially) AstraZeneca’s (the EMA says this morning that overall efficacy for that one is 60%), or probably everyone’s against B.1.351, we have to look more closely at the clinical outcomes. You may not be able to prevent so many people from going PCR-positive, but can you keep them out of the hospital? Out of the morgue?
J&J is saying that overall, their vaccine was overall at 66% efficacy at preventing all coronavirus infection, but 85% effective at preventing “severe disease” requiring hospitalization. They had a conference call this morning, and my impression is that this statement wasn’t clarified very much (we’ll hear more next week, I believe). But they also say that there were no coronavirus deaths at all in the vaccinated group. So the real-world effects are nothing to turn up one’s nose at – if this had been the first vaccine to report, we’d have been setting off fireworks. Similarly, it looks like the AstraZeneca/Oxford vaccine, for all the problems in figuring out its dosing and its efficacy numbers, also does a good job of preventing severe disease. We don’t have data on severity of disease from the Novavax team yet; I hope that we see it very soon.
Given the advent of the new variants – and the threat of seeing more of the same – all of these vaccines are going to have a part in beating back the pandemic. The AZ/Oxford, J&J, and Novavax vaccines do not have the ultra-cold-chain distribution problems that the mRNA vaccines have, and thus can have greater penetration into areas with less infrastructure. We also have to remember that these vaccines all have different manufacturing processes at many of their stages, which means that ramping them up doesn’t turn into a zero-sum cage match.
There are two more factors to consider. I keep coming back to the idea of antibody maturation via clonal selection of B cells, and I note that J&J says that the protection afforded by their vaccine did increase over time. That’s working in our favor with all the vaccines, but we have no idea (yet) if one of these might do a better job with this process than others. As far as I know, the only way to know is to keep collecting data to see if such differences emerge. The other thing to keep in mind is (as mentioned above) the possibility of retooling these agents to better deal with the new variants. My impression is that this would be easiest for the mRNA and recombinant protein vaccines (that is, for Moderna, Pfizer/BioNTech, and Pfizer) and harder for the viral-vector ones (J&J and AZ/Oxford). But we’ll need to clear up the regulatory framework on this – you’d think it should be much more like the clearance of (say) the yearly flu vaccine and not like coming in with a completely new vaccine.
It looks like we’re going to need these updates. The B.1.351 variant is clearly pushing the efficacy numbers down for the first crop of vaccines, and there is no reason whatsoever to think that the process will end there. We’ve got to stay ahead of the damn viruses however we can.
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Yes, in a heartbeat. Preventing death is #1, #2, and #3 for me. Everything else is gravy.
I honestly only figured this would be the case (or something similar) due to this thread. Maybe it was just the crowd I talk to but saw a lot of misunderstandings about the data.
New study shows hydroxychloroquine ‘may be a benefit’ in treating the coronavirus after all - Washington Examiner
A medical study out of New Jersey shows the drug hydroxychloroquine may help people with mild symptoms of COVID-19. "We make it clear we can't recommend it to be given," said Andrew Ip, a lymphoma physician and director of the Division of Outcomes and Value Research at the John Theurer Cancer...www.washingtonexaminer.com
A medical study out of New Jersey shows the drug hydroxychloroquine may help people with mild symptoms of COVID-19.
"We make it clear we can't recommend it to be given," said Andrew Ip, a lymphoma physician and director of the Division of Outcomes and Value Research at the John Theurer Cancer Center. "This is only an observational study. We can only recommend it in the context of a clinical trial. There may be a benefit for using this drug in an outpatient setting."
In other ground breaking world news, the sun rose in the east again, we saw an awesome full moon last night, and I put milk/extra raisins/some sugar on my Raisin Bran yesterday.
RU #'s - any idea if the comparison may not represent a level playing field for J&J when accounting for the time spans between injection and measuring efficacy? i.e. If the Pfizer and Moderna official efficacies are officially measured say, 7 days after the 2nd injection has been administered, one would feel that they should wait at least one month until after the single injection J&J shot to get more of an apples to apples comparison. Thoughts? Thanks in advance.
If preventing death is #1, #2, and #3, and preventing hospitalization and severe disease are #4 and #5, the J&J trial data is equivalent, or possibly better, than the Moderna or Pfizer data.
Don't forget that in the J&J trial, there were no cases of severe disease after day 49. The clinical endpoint date for the Moderna trial was 2 weeks after dose 2, which is day 42. If the J&J clinical endpoint date was day 42 rather than day 28, the efficacy against severe disease would be well above 85%. If the endpoint date was day 49, the efficacy rate against severe disease would be 100%.
Looking at 49 days post-vaccination, the J&J trial data shows complete protection against severe disease, complete protection against hospitalization, and complete protection against death. And that includes complete protection against the new variants of the virus.
With the Moderna and Pfizer vaccines, we don't know if they offer protection against the new variants, although there should be real world data available within the next few months.
While the Moderna and Pfizer vaccines seem to offer significantly better protection against moderate disease than the J&J vaccine, we don't know if that holds true for the new variants of the virus. But there should be real world data available within the next few months.
So if your goal is to prevent severe disease (49 days post-vaccination), hospitalization, and death, then right now the J&J vaccine seems to be the better choice since we know that the protection is also against new variants of the disease, but we don't know yet if that is true for the Moderna and Pfizer vaccines. Nonetheless, since it is unlikely that you would have a choice in which vaccine you receive, you should take whichever one you are offered.
Six months or a year from now, as additional trial and real world data is available, we will have a better understanding the protection each vaccine offers against new variants, how each vaccine works in preventing spread of the virus, and the level of durability of protection for each vaccine.
The primary endpoint date for the J&J trial is 28 days following injection.
The primary endpoint date for the Pfizer trial is 28 days following 1st injection (7 days following 2nd injection).
The primary endpoint date for the Moderna trial is 42 days following 1st injection (14 days following 2nd injection).
As I noted in my previous post, that difference is meaningful if you are only looking at the headlines to compare vaccines. But since it is possible to dig deeper into the data (perhaps looking at day 49, as I noted in my previous post), you can compare data.
The more significant difference between the data is that the Moderna and Pfizer trial data is from a period when there were lower overall infection rates and fewer variants of the virus, while the J&J trial data is from a period with higher overall infection rates and multiple new and more virulent variants of the virus.
Thanks. I came back to check out comments following the drubbing of MSU, and stumbled on this thread. But unless Rutgers wins the B10 or gets to the sweet sixteen, I'm probably gone from these boards again soon.
Stick around on this thread for awhile. The most concise explanation of why JJ maybe better than Pfizer and Moderna especially because it is a one dose shot. I was thrilled when their info was released! People are ignoring how important that is. Great input.
Numbers is a good guy he deserves an explanation!
Agree with all of this, except as Lowe said and I said early yesterday, J&J still needs to clarify the "no hospitalizations" comment vs. the 85% protection against severe COVID comment, as that implies hospitalizations. I would also note, as per previous posts, that both Pfizer and Moderna have shown at least strong in vitro data with pseudoviruses of the UK/SA variants suggesting good protection of these vaccines (not as good as real world data, but a good sign). As an aside, welcome back and can you keep posting at least through Tuesday? Trying to keep up with the impending snowstorm and all the COVID news and trying to get some work done is killing me, lol.
Agree the company information is ambiguous regarding whether the severe disease between day 28 and day 49 includes or excludes hospitalization. But there is no ambiguity in the company information which indicates that there were no cases of severe disease, no cases of hospitalization, and no cases of death in the vaccination group after 49 days.
Certainly complete protection against severe disease and hospitalization after 28 days is 3 weeks better than complete protection after 49 days. And maybe that difference makes a difference if you have a choice of which vaccine to get. But if you have to wait for the vaccine you prefer, then you've already minimized or eliminated that difference.
As far as Pfizer and Moderna showing good in vitro data with the new variants, I thought the reports said the data was mixed (which is why Moderna is developing a new booster for the variant first seen in South Africa). I certainly expect (and hope, especially since I received one of the existing vaccines) that the Moderna and Pfizer vaccines will provide complete or near-complete protection against the new variants. But we won't really know that until we see real-world data in a few months.
Well knowing @RU848789 has a PhD from our great institution, I bet he could have figured out what you meant on his own.
A dissertation was not required.😝
OT: NEW EVERYTHING / ANYTHING COVID-19 THREAD
After much discussion, our staff has decided to start a new COVID thread, HERE is the link to the old one should you feel the need to go back and reference something. The old thread was extremely long and people started to bring politics into it. With that being said, NO POLITICS in this thread...
rutgers.forums.rivals.com
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