Coronavirus 2019-2020 thread (no unsubstantiated rumours!)
- Thread starter localizer
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A few pages back someone posted a copy of a Twitter account in which a female phd student was asking for contributions from the public to substantiate that covid came from the Wuhan Lab. Now its all for nothing, can't say I feel sorry for her.
vesicles
Colonel
Well, they are rushing it. No doubt. Is it for business purposes, or political purposes (federal and local governments all across the country must be pulling their hair out and desperately waiting for the vaccines to be out)? Most likely both. I think these companies have been under tremendous pressure from the government to make something work ASAP. Is it also a calculated strategy aimed to tackle a medical emergency? Hell yeah!!!
Is it misleading or premature? I don't think so. They published the data available and made recommendation according to their available findings. Please note that this is the key. All their decisions have been based on their available data at the time. For example, at this time, they only have enough data on people >16. So now only people >16 can be inoculated. Since they don't have the data for young kids yet, they strictly prohibit inoculating kids at this point. So it is not misleading at all. They are not telling people something they don't know about. No speculation. No extrapolation.
Take for example, their existing data are already telling them that it's safe to give it to people >16. Should they hold their data and wait until they finish the analysis of young kids? In that time, hundreds of thousands of older adults may have died. Keep in mind that we are experiencing ~4000 deaths on a single day and every day and most of these deaths are older adults. The longer we wait, the more people will die. This is an emergency. They know it's safe to give it to adults now. So let's start the inoculation now. Since vaccination of the whole population will take months to finish and young kids have the lowest risk, we can let the kids wait a little longer while we wait for new data to come in. In the meantime, we need to get these vaccines into older adults who are at a much higher risk of serious symptoms and even death. I think this is a sound strategy.
China is also doing something similar. Their initial phase 3 clinical trial (forget which vaccine) excluded people >59. So now they are giving it to people < 59. They strictly prohibit vaccination of people older than 59. Again, this is a similar strategy. These massive data sets always come in in waves. We need to make quick decisions based on what we already have since time means life. Save as many people as we can. Since vaccination in such massive scale takes time any way, someone will have to wait a long time no matter how complete the data sets are. So the plan at the very beginning would be to identify efficacy and safety for the most high-risk groups. Once we are sure of those, let's go ahead and vaccinate them ASAP while we wait for later data to come in and vaccinate those with lower risk and those who can wait. Nothing wrong with that at all.
This is of course very different from a situation where they start telling people it's safe to give it to young kids while they have no actual data to back it up. That would be misleading. When the UK wanted to stretch the gap between the first and second shot, if Pfizer says "it should be fine", it would be misleading. Yet, Pfizer tells the UK a big fat "NO". Why? They only have data for a gap of 21 days. And that should be the gap. They flat out told the British that they have no data and no idea what would happen if they change the gap. This is not misleading.
Lastly, I would like to say something. Biology/medicine is a messy business. There are so much we don't know about. So much confusion. A lot of times, people have to make decisions, urgent ones, based on incomplete information. This is true for almost all diseases in every corner of the globe. No exceptions. The key is to base your decision on what is available to you. Don't speculate and don't extrapolate. Only make decisions based on what you have, however limited that may be. Sadly, this is where we are in medicine in general. If you are not happy about the current situation, tell your local/federal officials to provide more funding to biomedical research. The more we know, the better we can make more informed decisions.
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The data was not complete, so that the longer term efficiency (how fast anti-body level decline) is unknown, only the early efficiency is 90% above. That is rosy for everybody. Even if there is a second (final) report after (just saying) three month with all data collected, which number will stuck in people's head? What if there is only one report with less rosy result? My point of misleading is that "partial truth is deceiving", an emergent approval is a necessary short-cut in extraordinary time, but a report based on partial data should not be made public unless the company, the media and the authorities always put "according to partial data collected" in front of the headline. None of them did, it is only inside the professional report that commoners never read.
I think we need to be vigilance. We still need to ask hard questions and can't blindly trust the big corporate or scientists or politicians. From the first article, we notice that after data cutoff, more cases have occurred in those vaccinated with Moderna vaccines. So we need to ask if these data are included, would the efficacy rate be lowered.
From the second article, Israel health ministry claims only 1% of people who received the second dose reported side effects. My parents have contacted many friends and relatives and many of them complained about the side effects after second dose. So saying only 1% of people reported side effects is certainly not accurate and deliberately downplayed the side effects. Israel government might have a good reason to do so but it is still a misinformation intended to induce more people to vaccinate.
From the last article, the efficacy rate has come down from 95% to 91% after less than a month. So we still need to monitor if the efficacy rate would continue to decrease going forward. It is too early to say the efficacy rate is as good as Pfizer claimed to be.
Key limitations of the data are the short duration of safety and efficacy follow-up. The trial is ongoing, and a follow-up duration of 2 years is planned, with possible changes to the trial design to allow participant retention and ongoing data collection. Another limitation is the lack of an identified correlate of protection, a critical tool for future bridging studies. As of the data cutoff, 11 cases of Covid-19 had occurred in the mRNA-1273 group, a finding that limits our ability to detect a correlate of protection. As cases accrue and immunity wanes, it may become possible to determine such a correlate.
Of over 3,000,000 who’ve received the first dose of the Pfizer/BioNTech vaccine, 7,039 reported side effects — less than a third of one percent.
Of over 1,700,000 to receive the second dose, 4,469 reported side effects, again less than a third of a percentage point.
As of Thursday, only 254 individuals out of the 416,900 who were already a week after the second Pfizer shot – the time where the immunity is considered to kick in – got infected with the virus, the organization reported. Moreover, those who were found to be positive only had light symptoms, with just four of them being hospitalized, all of them in light condition.
Over the same period of time, some 12,944 new cases of COVID-19 emerged in the control group of some 778,000 people having a diverse health profile.
A comparison between the data from the two groups shows that the vaccine is 91% effective seven days or more after the second injection is administered.
From the second article, Israel health ministry claims only 1% of people who received the second dose reported side effects. My parents have contacted many friends and relatives and many of them complained about the side effects after second dose. So saying only 1% of people reported side effects is certainly not accurate and deliberately downplayed the side effects. Israel government might have a good reason to do so but it is still a misinformation intended to induce more people to vaccinate.
From the last article, the efficacy rate has come down from 95% to 91% after less than a month. So we still need to monitor if the efficacy rate would continue to decrease going forward. It is too early to say the efficacy rate is as good as Pfizer claimed to be.
Key limitations of the data are the short duration of safety and efficacy follow-up. The trial is ongoing, and a follow-up duration of 2 years is planned, with possible changes to the trial design to allow participant retention and ongoing data collection. Another limitation is the lack of an identified correlate of protection, a critical tool for future bridging studies. As of the data cutoff, 11 cases of Covid-19 had occurred in the mRNA-1273 group, a finding that limits our ability to detect a correlate of protection. As cases accrue and immunity wanes, it may become possible to determine such a correlate.
Of over 3,000,000 who’ve received the first dose of the Pfizer/BioNTech vaccine, 7,039 reported side effects — less than a third of one percent.
Of over 1,700,000 to receive the second dose, 4,469 reported side effects, again less than a third of a percentage point.
As of Thursday, only 254 individuals out of the 416,900 who were already a week after the second Pfizer shot – the time where the immunity is considered to kick in – got infected with the virus, the organization reported. Moreover, those who were found to be positive only had light symptoms, with just four of them being hospitalized, all of them in light condition.
Over the same period of time, some 12,944 new cases of COVID-19 emerged in the control group of some 778,000 people having a diverse health profile.
A comparison between the data from the two groups shows that the vaccine is 91% effective seven days or more after the second injection is administered.
vesicles
Colonel
You need to change your idea of "incomplete". For the data they have published, they are complete, including efficacy and safety, etc for a defined group of people. It is definitely ok to publish them. They didn't hold parts of the data, such as some older adults died or some people developed serious side effects, etc. They listed them all in their studies. At the time when they published the trial data, they hadn't finished the data collection for other groups yet. They clearly indicated those. that is not incomplete data.
Their clinical trials only lasted 3 months. Everyone knows it. Media knows it. The general public knows it. How can anyone know what will happen 10 years from now when you only came up with the vaccine 6 months ago? No one expect them to wait 10 more years to publish their data. And no one can afford to wait.
The nuances of the available data are for professionals to evaluate any ways. No lay person in the general public can make sense of any of their data any ways. It is up to the professionals to figure out what can be done and what cannot be done. They make recommendations and the governments take recommendations from the professionals and implement them. Again as an example, they don't have data for young kids yet. So they tell the government "we cannot give it to the kids yet." So the government issues order "no vaccines for kids yet". Their data show it is safe for adults to have it. Based on this data, they recommend to give it to all adults. Then the government starts advertisement and encourages everyone to get it. This is how a policy is made in every country.
vesicles
Colonel
I agree with the vigilant part. A clinical trial, as I've described before, has limitations. The real-world data is key. This is why I keep saying how important Israel is now. 95% and 91% are essentially identical in biology. that's a ~4% difference. That's amazingly consistent. Even in labs, if we repeat the same experiments, we would be happy if we can keep the differences between different trials below 10% under well-controlled lab conditions. So essentially, efficacy hasn't changed much in a month.
About the side effects, it must be an error. Pfizer's published data show 70-80% of the subjects experienced various kinds of side effects (in their Figure 2). That means vast majority of the subjects in their clinical trial reported side effects. The 1% thing is plainly wrong. Most likely the journalists or the officials messed up with numbers.
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vesicles
Colonel
A frustrating thing about Israel is that they keep issuing reports and preliminary findings through media. A lot of times, numbers conflict. One good example would be the efficacy after one shot. They show ~30% efficacy while the UK shows ~50% efficacy. Their second shot efficacy is amazing, too amazing actually... It's almost identical to the clinical trial data published by Pfizer. I would expect some kind of a drop with the real-world application. We are talking about millions of people vs. 30,000 in a trial. Some sizable difference should be expected. They need to publish their data in a peer-reviewed journal for us to evaluate...