So is Pfizer and almost every other Pharma company these days...
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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That is really good news.
I watched the Pfizer CEO interview with Margaret Hoover the other day. I was very impressed.
Asymptomatic or presymptomatic, that is the question.
www.statnews.com
Nothing changes based upon these comments.
'We don’t actually have that answer yet': WHO clarifies comments on asymptomatic spread of Covid-19
After strong pushback from public health experts, a top WHO official clarified scientists don’t know yet how often asymptomatic Covid-19 patients are spreading the disease to others.
www.statnews.com
Nothing changes based upon these comments.
At that time everyone in Wuhan was still wearing masks and every person who tested positive was isolated for 14 days, along with all of their contacts - also we're only talking about 300 asymptomatic cases out of 10MM people, as this was done in mid/late May well after the pandemic was brought under control in Wuhan. This is how one stops a pandemic and keeps one from reemerging: with massive testing, tracing and isolating, augmented with wearing masks.not any talk here of the Chinese study that just came out about asymptomatic spread not being a thing
he conclusion is not that asymptomatic spread is rare or that the science is uncertain. The study revealed something that hardly ever happens in these kinds of studies. There was not one documented case. Forget rare. Forget even Fauci’s previous suggestion that asymptomatic transmission exists but not does drive the spread. Replace all that with: never. At least not in this study for 10,000,000.
Asymptomatic Spread Revisited
"We keep hearing about how we should follow the science. The claim is tired by now. We know what’s really happening. The lockdown lobby ignores whatever contradicts their narrative, preferring unverified anecdotes over an actual scientific study of 10 million residents in what was the world’s...www.aier.org
Yes it's true that asymptomatic spread is significantly less likely than symptomatic spread (nobody has ever argued otherwise, although it's hard to differentiate them), but it absolutely occurs and this paper does not say that asymptomatic transmission doesn't occur at all - it just didn't in Wuhan, given their incredible response, testing 10MM in 19 days and tracing all the positives and isolating them. There are countless studies showing examples of asymptomatic transmission - two articles about this are linked below and the CDC agrees.
https://www.nature.com/articles/d41586-020-03141-3
https://www.healthline.com/health-n...pread#Checking-for-symptoms-misses-many-cases
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T was being coy - Merck buys some molecules/companies, but also develops a ton of its own medicines in-house - I've worked on all of the ones in the small molecule arena (internal or external), as all of those went through my department prior to manufacturing and launch, so I would actually know.
Agreed - our process development due diligence team was in my group for my last 5 years at Merck, although the process side of things was mostly there to make sure there weren't any "showstoppers" from a process side and there never were, since we basically said we could handle any process, lol - our input did, however impact the valuation on a couple of deals, when we made it clear that their estimated costs/timelines to get through filing and manufacturing were fantasies. As you know, the clinical and financial sides were the main show. Was still kind of cool to be involved, though.
Good stuff! Normally these deals are lead by commercial and finance, with clinical and I&A (insights and analytics) telling them what to do. :)
Over the past 4-5 years, about half of my direct hands on work (not my team) has been on BD projects. It's nice to get to pick and choose what I delegate versus own. I spend the other time on launches and large scale innovation.
That's where the luck element is so important. MK mostly "bought" (formally merged, but we bought them) Schering Plough for their late stage pipeline, particularly their TPA compound (for strokes), their BACE inhibitor (Alzheimer's) and a few other strong candidates in complementary therapeutic areas to ours.
None of those compounds did much (although the sleep compound, Belsomra, and the reverse anasthetic, BRIDION have made a bit of money) and the merger would've been considered a complete flop if not for Merck actually recognizing the value of SP's (Organon's really, who SP bought) PD-1 checkpoint inhibitor for cancer (and positioning it smartly with respect to the clinical trials), which became Keytruda, now the world's 2nd best selling drug and poised to overtake Humira in a couple of years.
We also blew it completely on Pharmaset's Hep C drug, which we could have outbid Gilead for about 9 years ago, but didn't - and that went on to make $15 billion in 2015 (but is way down now as the patient population wasn't huge and it was a complete cure). I wasn't on that one, but I knew folks who were and even at the time they thought we blew it. We ended up late to market with Zepatier (which was my project), a combo of two antivirals and never caught up.
Doctors say CDC should warn people the side effects from Covid vaccine shots won't be 'a walk in the park'
Dr. Sandra Fryhofer of the American Medical Association noted that both Pfizer's and Moderna's Covid-19 vaccines require two doses at varying intervals. As a practicing physician, she said she worries whether her patients will come back for a second dose because of the potentially unpleasant side effects they may experience after the first shot.
"We really need to make patients aware that this is not going to be a walk in the park," Fryhofer said during a virtual meeting with the Advisory Committee on Immunization Practices, or ACIP, an outside group of medical experts that advise the CDC. She is also a liaison to the committee. "They are going to know they had a vaccine. They are probably not going to feel wonderful. But they've got to come back for that second dose."
www.cnbc.com
Dr. Sandra Fryhofer of the American Medical Association noted that both Pfizer's and Moderna's Covid-19 vaccines require two doses at varying intervals. As a practicing physician, she said she worries whether her patients will come back for a second dose because of the potentially unpleasant side effects they may experience after the first shot.
"We really need to make patients aware that this is not going to be a walk in the park," Fryhofer said during a virtual meeting with the Advisory Committee on Immunization Practices, or ACIP, an outside group of medical experts that advise the CDC. She is also a liaison to the committee. "They are going to know they had a vaccine. They are probably not going to feel wonderful. But they've got to come back for that second dose."
Doctors say CDC should warn people the side effects from Covid vaccine shots won't be 'a walk in the park'
Doctors urge the CDC to be transparent about the side effects people may experience after getting their first shot of a coronavirus vaccine.
Yep, this is correct. These vaccines are activating the body's powerful immune system to the simulated invader, so yeah, it's gonna have an impact on most. Pain at the injection site, mild/moderate fever, headaches, chills, perhaps nausea, but all worth it to not get seriously ill or die (or cause someone you love to get seriously ill and/or die).Doctors say CDC should warn people the side effects from Covid vaccine shots won't be 'a walk in the park'
Dr. Sandra Fryhofer of the American Medical Association noted that both Pfizer's and Moderna's Covid-19 vaccines require two doses at varying intervals. As a practicing physician, she said she worries whether her patients will come back for a second dose because of the potentially unpleasant side effects they may experience after the first shot.
"We really need to make patients aware that this is not going to be a walk in the park," Fryhofer said during a virtual meeting with the Advisory Committee on Immunization Practices, or ACIP, an outside group of medical experts that advise the CDC. She is also a liaison to the committee. "They are going to know they had a vaccine. They are probably not going to feel wonderful. But they've got to come back for that second dose."
Doctors say CDC should warn people the side effects from Covid vaccine shots won't be 'a walk in the park'
Doctors urge the CDC to be transparent about the side effects people may experience after getting their first shot of a coronavirus vaccine.
The dirty little secret. How is this stuff getting approved??Doctors say CDC should warn people the side effects from Covid vaccine shots won't be 'a walk in the park'
Dr. Sandra Fryhofer of the American Medical Association noted that both Pfizer's and Moderna's Covid-19 vaccines require two doses at varying intervals. As a practicing physician, she said she worries whether her patients will come back for a second dose because of the potentially unpleasant side effects they may experience after the first shot.
"We really need to make patients aware that this is not going to be a walk in the park," Fryhofer said during a virtual meeting with the Advisory Committee on Immunization Practices, or ACIP, an outside group of medical experts that advise the CDC. She is also a liaison to the committee. "They are going to know they had a vaccine. They are probably not going to feel wonderful. But they've got to come back for that second dose."
Doctors say CDC should warn people the side effects from Covid vaccine shots won't be 'a walk in the park'
Doctors urge the CDC to be transparent about the side effects people may experience after getting their first shot of a coronavirus vaccine.
Most Common Adverse Events
Reported (>2%)
Pfizer:
Fatigue (3.8%)
Headache (2.0%)
Moderna:
Fatigue (9.7%)
Myalgia (8.9%)
Arthralgia (5.2%)
Headache (4.5%)
Pain (4.1%)
This looks like a meaningful difference, but it may be just due to AE reporting protocols. Not sure yet.
What are you talking about? This disease is killing people and stopping us living our lives. You don’t want a vaccine to get approved because the shot might give you a headache and make you nauseous?
Maybe you should read the stories finally coming out today. It is much more than a headache. Another one fooled by the media! Did you see the headline that Tango posted? A growing numbers of doctors are asking the CDC to disclose all the side effects as most are more than a headache.
I did read it. Sorry muscle pain, fever and chills are possible. Big deal! Who cares? Suck it up.
Most Common Adverse Events
Reported (>2%)
Pfizer:
Fatigue (3.8%)
Headache (2.0%)
Moderna:
Fatigue (9.7%)
Myalgia (8.9%)
Arthralgia (5.2%)
Headache (4.5%)
Pain (4.1%)
This looks like a meaningful difference, but it may be just due to AE reporting protocols. Not sure yet.
No it's more than that. Most disturbing, as the doctors are saying, is the lack of transparency. Some suggesting that you need to takes days off after the 2nd shot. More than a sore arm.
Don't worry I'm tough enough. Just had emergency surgery Thursday. 2 feet of small intestine removed. Released Sunday and walking around normal.
It's always the internet tough guys that are the weakess and most afraid.
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Hope you are doing ok. Abdominal surgery is horrible. My abdomen has no space left to carve up, but I'm still above ground.
There is no media conspiracy. They reported on very positive news and the side effects were published. So many people were talking about how the media spreads fear regarding the virus and now it’s about withholding negative side effects of a vaccine which would create fear. Which is it? It’s also been reported over and over that these are interim results which have yet to be peer reviewed. Come on.
Really? Everything done on the up and up? So why are Doctors urging the the CDC to start warning people about some strong side effects. There is an urgency to get these vaccines out ASAP and rightly so but people need to know what they are walking into before the get a needle in their arm.
The general public watches the media but they aren't reading published medical reports. You really think that is enough?
The main reason they want people warned is so they will receive the second shot and not conclude that the first shot was ineffective. It seems the vast majority of people do not experience much if any side effects, while some will experience side effects not dissimilar to those occasionally brought on by a flu shot.
Transparency is, of course, needed, but the cited side effects do not appear to be cause for alarm.
Looks like the AstraZeneca will be a one shot vaccine and more importantly will not have to be kept deep frozen. No freezing at all.
Because fear sells ....$$$$... it generates clicks... it gives the news media what they crave most viewers and listeners... if the virus is conquered think how much that impacts them... Fear not people they will move on to other news worthy items . Like wars, Trump lawsuits, another Emmy for Cuomo ( sorry couldn’t resist) . Positive news always is a downer for those who report it or sell it to the public.Today’s news about “ all the vaccine side effects” and the deaths of seniors ...Sure no fear factors in the news .
Pfizer, Moderna, and AZ are all 2 shots. The upcoming J&J and Sanofi vaccines will be 1 shot. Only the Pfizer vaccine requires deep freezing.
There was a report on NBC or CBS last night that AZ is looking at one dose based on the Brazil study of 2 full doses actually drops the effectiveness down to 62. US studies are 1/2 dose than full dose but now believe a single full dose might be ideal. Less being more.
Even better, but it is unlikely that the FDA would approved a single dose option without a significant P3 study. It will likely have to be the 1/2 dose + full dose combo for now. We shall see! Obviously, single dose options are ideal.
Yes, but many people will likely receive a two-shot vaccine. I don’t think the side effects will be concealed from people, but I also see why they are not discussed as much as the success of the vaccine trials. I suspect the vast majority of people would gladly accept the mild side effects from the vaccine in exchange for ending the pandemic and conditions of the past 9 months. That’s an easy cost / benefit analysis.
Of course, bad things happening are also news worthy but based upon your logic they would hyping the negative side effects.
Those that are saying "it's just a sore arm, toughen up" certainly are. And that side effects in a report is good enough for the general public certainly don't understand transparency.
Lol Gottlieb op ed about Americans needing to buy better masks is mind blowing if not predictable
They are hyping “ negative “ side effects today in the NJ.com...People being told about the negative things is great but arm soreness... body aches... mild fevers... nausea... some get that with flu shots ...as another expert wrote the overriding factors to get the vaccine is the protection factor. You don’t think the anti Vaxxer lobbyists aren’t working OT to distort. the conversation. That is more than factual...Hey here’s the thing... 40% percent say they are not getting it. Good for them but most in the danger ages will get it ... the alternative is living inside for your remaining years.
I've seen nobody talking about going to a single dose. They are considering the half dose, followed by a full dose regimen, which was 90% effective (albeit in a smaller population tested) vs. the full dose-full dose, which was only 62% effective. They can't choose a regimen that hasn't been tested.
In addition, your posts about lack of transparency are off base, since all three companies have published their adverse effects data at the same time as the efficacy data, and most media outlets have highlighted both the efficacy and safety results. Is that not transparency to you?
The point some are trying to make is to amplify the point that a decent number of people are going to feel like they got the flu with their first shot and might consider not taking the 2nd shot, which would be bad - experts just want people to go in prepared for that, especially since some will also get that flu-like response in the 2nd shot.
While it's always possible that lower doses with less flu-like symptoms could be just as effective, the companies selected dosing to test in phase III which was most likely to raise an immune response to stop infection, while not causing serious side effects. They (and we) didn't have the time to waste trying out 4 different dosing regimens each to find the "perfect" one.
P.S. Best of luck on your surgery recovery...
I found of all the vaccines I ever got the shingles vaccine gave me the most discomfort. That said if I needed to get it every year to avoid shingles I would.
So as long as the reported side effects remain as reported I will get the covid vaccine when it is my turn in the rotation
So as long as the reported side effects remain as reported I will get the covid vaccine when it is my turn in the rotation
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