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	<title>Comments on: Opinion on the Pfizer vaccine trial</title>
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	<link>https://habitablezone.com/2020/12/16/opinion-on-the-pfizer-vaccine-trial/</link>
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		<title>By: Vitruvius</title>
		<link>https://habitablezone.com/2020/12/16/opinion-on-the-pfizer-vaccine-trial/#comment-46404</link>
		<dc:creator>Vitruvius</dc:creator>
		<pubDate>Fri, 25 Dec 2020 20:50:37 +0000</pubDate>
		<guid isPermaLink="false">https://habitablezone.com/?p=86447#comment-46404</guid>
		<description>Honestly, I&#039;m also concerned for family members who &lt;em&gt;are&lt;/em&gt; currently eligible - noone wants to see their loved ones be guinea pigs.  I&#039;m not forseeing any apocalyptic results - merely complications that might negate the vaccine&#039;s effectiveness, or side-effects comparable to &lt;a href=&quot;https://en.wikipedia.org/wiki/Gulf_War_syndrome#Anthrax_vaccine&quot; rel=&quot;nofollow&quot;&gt;Gulf War Syndrome&lt;/a&gt;.

The politics, however, are the largest threat.  To me, it appears that Donnie Darko is pushing the potential vaccines out as fast as possible in order to make himself look less terrible, and the protections against prosecution for any potential side effects being granted by his administration look as sketch as the pardons he&#039;s tossing out like benjamins to a stripper.

Back when Russia was doing the same thing we are now with their vaccine, which came first, everyone here was suspicious of the effectiveness and motives behind it, and rightwfully so.  I don&#039;t see how us doing the exact same thing they&#039;re doing is any different.</description>
		<content:encoded><![CDATA[<p>Honestly, I&#8217;m also concerned for family members who <em>are</em> currently eligible &#8211; noone wants to see their loved ones be guinea pigs.  I&#8217;m not forseeing any apocalyptic results &#8211; merely complications that might negate the vaccine&#8217;s effectiveness, or side-effects comparable to <a href="https://en.wikipedia.org/wiki/Gulf_War_syndrome#Anthrax_vaccine" rel="nofollow">Gulf War Syndrome</a>.</p>
<p>The politics, however, are the largest threat.  To me, it appears that Donnie Darko is pushing the potential vaccines out as fast as possible in order to make himself look less terrible, and the protections against prosecution for any potential side effects being granted by his administration look as sketch as the pardons he&#8217;s tossing out like benjamins to a stripper.</p>
<p>Back when Russia was doing the same thing we are now with their vaccine, which came first, everyone here was suspicious of the effectiveness and motives behind it, and rightwfully so.  I don&#8217;t see how us doing the exact same thing they&#8217;re doing is any different.</p>
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		<title>By: ER</title>
		<link>https://habitablezone.com/2020/12/16/opinion-on-the-pfizer-vaccine-trial/#comment-46403</link>
		<dc:creator>ER</dc:creator>
		<pubDate>Fri, 25 Dec 2020 17:01:32 +0000</pubDate>
		<guid isPermaLink="false">https://habitablezone.com/?p=86447#comment-46403</guid>
		<description>Since the initial doses of the new vaccines are being reserved for people of high risk or essential occupations, if anything does go wrong with the inoculations it will not affect the bulk of the population--at least, if the ill effects manifest themselves quickly.  Granted, this may have dire consequences for those affected, and it may cause distress to the rest of us (if medical or emergency personnel fall victim) still, it forms another layer of protection for the rest of us.

In my own case, as an elderly person in good health but with pre-existing medical conditions, I will probably be eligible for my shots in a couple of months.  By that time, we will have already accumulated a great deal of experience in how the vaccines work, or don&#039;t.  Unless any potential ill effects show up immediately, I can proceed with increased confidence.  By the time the general population is eligible, I will have joined the ranks of the guinea pigs that can provide them with some assurance. I recognize I may suffer because of this, but I have determined that my chances of dying from this bug are even greater if I do nothing.  In your case, this means use my ability to survive the vaccine to guide your decision on whether or not to take it as soon as you can. If I&#039;m unlucky, at least you can benefit from my misfortune.

This is why we have Health Authorities, like the CDC and WHO, experts who have experience and training in these matters.  Its no guarantee they are always right, or that they are incorruptible, but I&#039;m more willing to trust their judgement in these matters than my own.

Wisdom can be defined as the ability to make the right decision (at least, most of the time) even when handicapped by a lack of sufficient information.</description>
		<content:encoded><![CDATA[<p>Since the initial doses of the new vaccines are being reserved for people of high risk or essential occupations, if anything does go wrong with the inoculations it will not affect the bulk of the population&#8211;at least, if the ill effects manifest themselves quickly.  Granted, this may have dire consequences for those affected, and it may cause distress to the rest of us (if medical or emergency personnel fall victim) still, it forms another layer of protection for the rest of us.</p>
<p>In my own case, as an elderly person in good health but with pre-existing medical conditions, I will probably be eligible for my shots in a couple of months.  By that time, we will have already accumulated a great deal of experience in how the vaccines work, or don&#8217;t.  Unless any potential ill effects show up immediately, I can proceed with increased confidence.  By the time the general population is eligible, I will have joined the ranks of the guinea pigs that can provide them with some assurance. I recognize I may suffer because of this, but I have determined that my chances of dying from this bug are even greater if I do nothing.  In your case, this means use my ability to survive the vaccine to guide your decision on whether or not to take it as soon as you can. If I&#8217;m unlucky, at least you can benefit from my misfortune.</p>
<p>This is why we have Health Authorities, like the CDC and WHO, experts who have experience and training in these matters.  Its no guarantee they are always right, or that they are incorruptible, but I&#8217;m more willing to trust their judgement in these matters than my own.</p>
<p>Wisdom can be defined as the ability to make the right decision (at least, most of the time) even when handicapped by a lack of sufficient information.</p>
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		<title>By: ER</title>
		<link>https://habitablezone.com/2020/12/16/opinion-on-the-pfizer-vaccine-trial/#comment-46401</link>
		<dc:creator>ER</dc:creator>
		<pubDate>Fri, 25 Dec 2020 15:46:13 +0000</pubDate>
		<guid isPermaLink="false">https://habitablezone.com/?p=86447#comment-46401</guid>
		<description>Even if there are unforeseen side-effects, or if the efficacy of the vaccine is not as good as expected, its highly unlikely it will lead to widespread problems or downright failure. The fact that there are several competing vaccines developed independently is also another safeguard.

Of course, its always possible that its all an untested, hastily-concocted effort doomed to failure or an elaborate conspiracy designed to further some villain&#039;s goals of world domination, but I think either is highly unlikely.  

Ironically, one of the few worthwhile things Trump can be credited for, rushing the development of Covid vaccines, will probably never be fully acknowledged because of his failure to take the pandemic seriously and his assault on those who did.  Instant Karma: Biden will get the credit if it works, and Trump will be blamed if it doesn&#039;t. And maybe that&#039;s the way it should be.

I believe the odds are way in favor the vaccine program will save many lives and return society to some semblance of normalcy.   Its not that I believe Trump is incapable of carrying out an elaborate conspiracy, I just don&#039;t think he had the competence to pull it off.

I have personally made the calculation that I am much more likely to have my life saved by getting the shot &lt;em&gt;as soon as possible&lt;/em&gt; than I am to survive by delaying it until &quot;all the facts are in&quot;.</description>
		<content:encoded><![CDATA[<p>Even if there are unforeseen side-effects, or if the efficacy of the vaccine is not as good as expected, its highly unlikely it will lead to widespread problems or downright failure. The fact that there are several competing vaccines developed independently is also another safeguard.</p>
<p>Of course, its always possible that its all an untested, hastily-concocted effort doomed to failure or an elaborate conspiracy designed to further some villain&#8217;s goals of world domination, but I think either is highly unlikely.  </p>
<p>Ironically, one of the few worthwhile things Trump can be credited for, rushing the development of Covid vaccines, will probably never be fully acknowledged because of his failure to take the pandemic seriously and his assault on those who did.  Instant Karma: Biden will get the credit if it works, and Trump will be blamed if it doesn&#8217;t. And maybe that&#8217;s the way it should be.</p>
<p>I believe the odds are way in favor the vaccine program will save many lives and return society to some semblance of normalcy.   Its not that I believe Trump is incapable of carrying out an elaborate conspiracy, I just don&#8217;t think he had the competence to pull it off.</p>
<p>I have personally made the calculation that I am much more likely to have my life saved by getting the shot <em>as soon as possible</em> than I am to survive by delaying it until &#8220;all the facts are in&#8221;.</p>
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		<title>By: Vitruvius</title>
		<link>https://habitablezone.com/2020/12/16/opinion-on-the-pfizer-vaccine-trial/#comment-46400</link>
		<dc:creator>Vitruvius</dc:creator>
		<pubDate>Fri, 25 Dec 2020 11:15:30 +0000</pubDate>
		<guid isPermaLink="false">https://habitablezone.com/?p=86447#comment-46400</guid>
		<description>&lt;img src=&quot;https://i.pinimg.com/originals/13/77/47/1377473caa22b92a5701ea879b7b2a1d.gif&quot; alt=&quot;Calvin &amp; Hobbes&quot; /&gt;
I&#039;m staunchly pro-vax (one of Man&#039;s greatest inventions), but clinical trials exist for a reason - trials which we&#039;re hopscotching through for suspiciously simple reasons.  Should it pan out well over the next year, I&#039;ll line up myself, but I&#039;m still going to be doing some &lt;em&gt;deep&lt;/em&gt; digging on it&#039;s results.  I want it to work, but I have my concerns.</description>
		<content:encoded><![CDATA[<p><img src="https://i.pinimg.com/originals/13/77/47/1377473caa22b92a5701ea879b7b2a1d.gif" alt="Calvin &#038; Hobbes" /><br />
I&#8217;m staunchly pro-vax (one of Man&#8217;s greatest inventions), but clinical trials exist for a reason &#8211; trials which we&#8217;re hopscotching through for suspiciously simple reasons.  Should it pan out well over the next year, I&#8217;ll line up myself, but I&#8217;m still going to be doing some <em>deep</em> digging on it&#8217;s results.  I want it to work, but I have my concerns.</p>
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		<title>By: RL</title>
		<link>https://habitablezone.com/2020/12/16/opinion-on-the-pfizer-vaccine-trial/#comment-46377</link>
		<dc:creator>RL</dc:creator>
		<pubDate>Mon, 21 Dec 2020 06:15:39 +0000</pubDate>
		<guid isPermaLink="false">https://habitablezone.com/?p=86447#comment-46377</guid>
		<description>More from my uncle.. 
&lt;blockquote&gt;On adenovirus vector vaccines:
A while back I posted a brief summary of vaccine types and how they differ. I left out a sub-category that appears to be more important than I expected. That category is the adenovirus vector vaccine. It is a subcategory of live virus vaccines, but it has not been widely used in humans until now. Several of the vaccine candidates that are now in the developmental pipeline are of the adenovirus vector type. One (the Johnson and Johnson candidate) may be up for emergency use authorization within a few weeks.
The theory behind the adenovirus vector vaccines is one of those goofy ideas that get kicked around in brainstorming sessions and are never heard of again. But somebody was crazy enough to try one – and competent enough to pull it off! It is a live virus vaccine (like the Sabine polio vaccine or the smallpox inoculation) but it uses an artificial version of a harmless virus that has been ‘disguised’ as the Covid-19 virus. It’s kind of a microbiological ‘false-flag’ operation. (Bear with me.)
Adenoviruses are a class of viruses that were discovered in the ‘50s and were thought to be pretty unimportant at the time. There are several dozen species of this class that infect primates and most of them do not result in any symptoms in people. The body does, however, mount a strong defense after being infected by an adenovirus.
In recent years, some adenovirus types have gotten a lot of attention as vehicles for inserting modified genes into human hosts. This line of gene therapy research has been rich in promise and poor in delivery for some time and it remains controversial for a number of reasons. Along the way, however, the experience gained in jiggering the genetic code of adenoviruses has led to some interesting vaccine strategies. It has led to a few vaccines for certain exotic diseases (dengue and ebola, for example) but it has never been widely used in humans.
So, how does one go about recruiting an unsuspecting virus into carrying out a suicidal ‘false flag&#039; operation?’ (First, let me assure you that if I were making this up I would surely try to tell you something more believable.) The unlikely process goes something like this:
1. Identify the DNA that codes for some feature of the disease-causing virus that is vital to its survival in the human host. Most experts believe that the soft underbelly of Covid-19 is the spike protein structure. It is vital to the way in which the virus invades a human cell.
2. Choose a type of virus that the human subject is unlikely to have been exposed to in the environment but is unlikely to cause a serious disorder in humans. Most researchers have settled on an adenovirus that is found chimpanzees and is rare in humans.
3. Alter the DNA of the adenovirus to cause it to develop a Covid-like spike on its outer shell and to render it incapable of reproducing.
4. Breed industrial quantities of these ‘castrated’ viruses….  Wait a minute….  Didn’t we just render this step impossible?!!!  Not entirely. You can knock out a gene that codes for some essential protein in the virus and then develop a human cell culture line that has been genetically altered to supply that protein for the virus that infects it. (Nature does not require facts to be believable.) Now you have a human cell line that is the only environment where the lab-generated virus can reproduce. (I wonder if that’s how they grow seeds for seedless watermelons… I’ll google that later.)
5. Filter the human cells out of the culture dish and you now have a few drops vaccine made of harmless virus particles disguised as Covid-19 virus and incapable of reproducing in the environment. When injected into a human subject, the immune system recognizes a new virus with spike on its jacket and goes to work building antibodies.
By all accounts, the Johnson and Johnson adenovirus vector-based vaccine has shown satisfactory results in clinical trials. If these results hold up to the review process, we may see an EUA application sometime in January. Astra Zeneca / Oxford, Russia’s Sputnik V, and several other adeno vaccines are being tested around the world. Some of them are likely to show up at your local drug store soon.
These developments are probably good news. While we have two seemingly attractive mRNA-based vaccines being rolled out, we are still early in the game. We don’t know what adverse events might show up as the roll out proceeds. Also, producing these vaccines requires bulk supplies of reagents that are normally ordered by the eye dropper full. Shortages have been rumored but not proven. It would be good to have a competing alternative that uses a different process. Also, there are always a few people who can’t or won’t take one treatment or another. We may be glad to have options.&lt;/blockquote&gt;

</description>
		<content:encoded><![CDATA[<p>More from my uncle.. </p>
<blockquote><p>On adenovirus vector vaccines:<br />
A while back I posted a brief summary of vaccine types and how they differ. I left out a sub-category that appears to be more important than I expected. That category is the adenovirus vector vaccine. It is a subcategory of live virus vaccines, but it has not been widely used in humans until now. Several of the vaccine candidates that are now in the developmental pipeline are of the adenovirus vector type. One (the Johnson and Johnson candidate) may be up for emergency use authorization within a few weeks.<br />
The theory behind the adenovirus vector vaccines is one of those goofy ideas that get kicked around in brainstorming sessions and are never heard of again. But somebody was crazy enough to try one – and competent enough to pull it off! It is a live virus vaccine (like the Sabine polio vaccine or the smallpox inoculation) but it uses an artificial version of a harmless virus that has been ‘disguised’ as the Covid-19 virus. It’s kind of a microbiological ‘false-flag’ operation. (Bear with me.)<br />
Adenoviruses are a class of viruses that were discovered in the ‘50s and were thought to be pretty unimportant at the time. There are several dozen species of this class that infect primates and most of them do not result in any symptoms in people. The body does, however, mount a strong defense after being infected by an adenovirus.<br />
In recent years, some adenovirus types have gotten a lot of attention as vehicles for inserting modified genes into human hosts. This line of gene therapy research has been rich in promise and poor in delivery for some time and it remains controversial for a number of reasons. Along the way, however, the experience gained in jiggering the genetic code of adenoviruses has led to some interesting vaccine strategies. It has led to a few vaccines for certain exotic diseases (dengue and ebola, for example) but it has never been widely used in humans.<br />
So, how does one go about recruiting an unsuspecting virus into carrying out a suicidal ‘false flag&#8217; operation?’ (First, let me assure you that if I were making this up I would surely try to tell you something more believable.) The unlikely process goes something like this:<br />
1. Identify the DNA that codes for some feature of the disease-causing virus that is vital to its survival in the human host. Most experts believe that the soft underbelly of Covid-19 is the spike protein structure. It is vital to the way in which the virus invades a human cell.<br />
2. Choose a type of virus that the human subject is unlikely to have been exposed to in the environment but is unlikely to cause a serious disorder in humans. Most researchers have settled on an adenovirus that is found chimpanzees and is rare in humans.<br />
3. Alter the DNA of the adenovirus to cause it to develop a Covid-like spike on its outer shell and to render it incapable of reproducing.<br />
4. Breed industrial quantities of these ‘castrated’ viruses….  Wait a minute….  Didn’t we just render this step impossible?!!!  Not entirely. You can knock out a gene that codes for some essential protein in the virus and then develop a human cell culture line that has been genetically altered to supply that protein for the virus that infects it. (Nature does not require facts to be believable.) Now you have a human cell line that is the only environment where the lab-generated virus can reproduce. (I wonder if that’s how they grow seeds for seedless watermelons… I’ll google that later.)<br />
5. Filter the human cells out of the culture dish and you now have a few drops vaccine made of harmless virus particles disguised as Covid-19 virus and incapable of reproducing in the environment. When injected into a human subject, the immune system recognizes a new virus with spike on its jacket and goes to work building antibodies.<br />
By all accounts, the Johnson and Johnson adenovirus vector-based vaccine has shown satisfactory results in clinical trials. If these results hold up to the review process, we may see an EUA application sometime in January. Astra Zeneca / Oxford, Russia’s Sputnik V, and several other adeno vaccines are being tested around the world. Some of them are likely to show up at your local drug store soon.<br />
These developments are probably good news. While we have two seemingly attractive mRNA-based vaccines being rolled out, we are still early in the game. We don’t know what adverse events might show up as the roll out proceeds. Also, producing these vaccines requires bulk supplies of reagents that are normally ordered by the eye dropper full. Shortages have been rumored but not proven. It would be good to have a competing alternative that uses a different process. Also, there are always a few people who can’t or won’t take one treatment or another. We may be glad to have options.</p></blockquote>
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		<title>By: podrock</title>
		<link>https://habitablezone.com/2020/12/16/opinion-on-the-pfizer-vaccine-trial/#comment-46363</link>
		<dc:creator>podrock</dc:creator>
		<pubDate>Thu, 17 Dec 2020 00:49:41 +0000</pubDate>
		<guid isPermaLink="false">https://habitablezone.com/?p=86447#comment-46363</guid>
		<description>Well said</description>
		<content:encoded><![CDATA[<p>Well said</p>
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		<title>By: RL</title>
		<link>https://habitablezone.com/2020/12/16/opinion-on-the-pfizer-vaccine-trial/#comment-46362</link>
		<dc:creator>RL</dc:creator>
		<pubDate>Thu, 17 Dec 2020 00:49:11 +0000</pubDate>
		<guid isPermaLink="false">https://habitablezone.com/?p=86447#comment-46362</guid>
		<description>Key results from Pfizer and Moderna vaccines:
At day 11 after the first dose the results are dramatic

&lt;img src=&quot;https://i.imgur.com/MAH1elz.png&quot; alt=&quot;&quot; /&gt;</description>
		<content:encoded><![CDATA[<p>Key results from Pfizer and Moderna vaccines:<br />
At day 11 after the first dose the results are dramatic</p>
<p><img src="https://i.imgur.com/MAH1elz.png" alt="" /></p>
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		<title>By: podrock</title>
		<link>https://habitablezone.com/2020/12/16/opinion-on-the-pfizer-vaccine-trial/#comment-46361</link>
		<dc:creator>podrock</dc:creator>
		<pubDate>Thu, 17 Dec 2020 00:44:30 +0000</pubDate>
		<guid isPermaLink="false">https://habitablezone.com/?p=86447#comment-46361</guid>
		<description>mRNA vaccines&#039; possibilities finally realized. It&#039;s a bigger breakthrough than just SARS-2.</description>
		<content:encoded><![CDATA[<p>mRNA vaccines&#8217; possibilities finally realized. It&#8217;s a bigger breakthrough than just SARS-2.</p>
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		<title>By: RL</title>
		<link>https://habitablezone.com/2020/12/16/opinion-on-the-pfizer-vaccine-trial/#comment-46360</link>
		<dc:creator>RL</dc:creator>
		<pubDate>Thu, 17 Dec 2020 00:36:51 +0000</pubDate>
		<guid isPermaLink="false">https://habitablezone.com/?p=86447#comment-46360</guid>
		<description>Here is what he had to say on the vaccine Prior to it&#039;s release:



&lt;blockquote&gt;Some Thoughts on Vaccines:
It is likely that we shall see the rollout of a vaccine for covid-19 in the next few weeks. Because I’ve had some experience in pharmaceutical development, some of my friends have asked for my opinion about the advisability of taking a new vaccine. I should note up front that I do not have the credentials to give medical advice of any kind. Neither do I have the clinical trials data that would enable me to offer any statistical opinion on the safety or efficacy of any of the vaccine candidates under consideration. That said, I can point out some of the issues we will all face as we roll up our sleeves.
Vaccines have been around for quite a while and are well understood by the scientific community. Historically, there have been two kinds of vaccines for viral diseases. Killed virus vaccines, (like the familiar flu vaccine) are made by culturing and killing huge quantities of virus. When these dead virus particles are injected into patients their immune systems recognize them as foreign material. The body responds to some portion of the foreign protein by generating an antibody response to that protein. If the body happens to choose a protein molecule that is vital to the survival of live viruses in the environment the patient will become resistant to any infectious agent that includes that molecule.
Live virus vaccines (like those sugar cubes laced with the Sabine vaccine for polio that we all took in grade school) expose patients to a weakened variety of the virus that can induce a mild infection. A normal patient will mount an immune response that will fend off not only the weakened virus but also the more virulent strain. This type of vaccine has the advantage of spreading the weakened infection to contacts of the patient. Just as the virulent virus spreads by social contact, so the weakened strain spreads to untreated subjects and gives them the same level of immunity. However, there is also the small risk that some rare individuals will develop the full disease as a result of the treatment.
There has been speculation for several years that a better immune response could be induced by injecting only a selected portion of the viral protein material. This would allow scientists to choose what fragment would trigger the response. A variant of that strategy is to inject synthesized Messenger RNA which would induce the subject’s own cells to produce a portion of the viral protein coat. This would trick the immune system into responding to the exact protein that is believed to be essential to the functioning of the virulent virus. Further, this approach would allow a vaccine to be engineered as soon as the genetic code of the virus has been identified. While an exciting theory, this strategy has never actually been used to develop a vaccine for human use before. Several of the vaccine candidates currently being developed for covid-19 (including the Pfizer and Moderna versions) are of this new type.
Are vaccines risk free? No medical intervention is without risk! The decision to undergo a medical intervention is ALWAYS an exercise in risk/benefit analysis. Clinical trials exist to quantify the probability of bad outcomes as well as the probability of good outcomes. This is done by using carefully controlled experiments involving several thousand volunteer subjects over an extended period of time. There is the rub. There has been no shortage of volunteers and no lack of incentive. There has been insufficient time for the normal process to be completed. This one will have some risk and that risk can not at this time be properly quantified. We are going to have to make some guesses.
Whenever it is believed that a developmental drug is needed for emergency use before it has been given final FDA approval one can request an Emergency Use Authorization. This is an exception to the normal New Drug Approval process. It is usually temporary and usually restricted as to scope. The  approval will be based on the seriousness of the threat posed by the disease and the likely risk imposed by shortchanging the safety testing process. There are some data points that can make this an educated guess rather than a shot in the dark.
(1) The vaccines (at least the ones being considered at this writing) are NOT made from actual covid-19 virus. There is NO chance the vaccine will directly cause the disease.
(2) The most likely time for adverse events to show up in vaccine trials is in the first few days after treatment. While long term follow-up is normal, it is less important in the safety analysis of vaccine trials.
(3) Both of the vaccine candidates have been tested on about half the optimal number of phase 3 subjects and no catastrophic adverse events have been detected. While one might desire more subjects, it is possible to say that a HIGH probability of serious adverse events can be ruled out.
(4) It appears that the worst possible outcome of the treatment is far less objectionable than the worst outcome of the virus.
I wish we had more data and I wish we had more time to study these data. However, it looks like we are heading into a very grim phase of the pandemic and there appears to be no will to invoke the marginally successful public health measures that might buy us more time. It seems to me that until the number of mobile morgues parked behind the vaccination sites is greater than the number parked behind the hospital, I’ll opt for the vaccination.&lt;/blockquote&gt;

</description>
		<content:encoded><![CDATA[<p>Here is what he had to say on the vaccine Prior to it&#8217;s release:</p>
<blockquote><p>Some Thoughts on Vaccines:<br />
It is likely that we shall see the rollout of a vaccine for covid-19 in the next few weeks. Because I’ve had some experience in pharmaceutical development, some of my friends have asked for my opinion about the advisability of taking a new vaccine. I should note up front that I do not have the credentials to give medical advice of any kind. Neither do I have the clinical trials data that would enable me to offer any statistical opinion on the safety or efficacy of any of the vaccine candidates under consideration. That said, I can point out some of the issues we will all face as we roll up our sleeves.<br />
Vaccines have been around for quite a while and are well understood by the scientific community. Historically, there have been two kinds of vaccines for viral diseases. Killed virus vaccines, (like the familiar flu vaccine) are made by culturing and killing huge quantities of virus. When these dead virus particles are injected into patients their immune systems recognize them as foreign material. The body responds to some portion of the foreign protein by generating an antibody response to that protein. If the body happens to choose a protein molecule that is vital to the survival of live viruses in the environment the patient will become resistant to any infectious agent that includes that molecule.<br />
Live virus vaccines (like those sugar cubes laced with the Sabine vaccine for polio that we all took in grade school) expose patients to a weakened variety of the virus that can induce a mild infection. A normal patient will mount an immune response that will fend off not only the weakened virus but also the more virulent strain. This type of vaccine has the advantage of spreading the weakened infection to contacts of the patient. Just as the virulent virus spreads by social contact, so the weakened strain spreads to untreated subjects and gives them the same level of immunity. However, there is also the small risk that some rare individuals will develop the full disease as a result of the treatment.<br />
There has been speculation for several years that a better immune response could be induced by injecting only a selected portion of the viral protein material. This would allow scientists to choose what fragment would trigger the response. A variant of that strategy is to inject synthesized Messenger RNA which would induce the subject’s own cells to produce a portion of the viral protein coat. This would trick the immune system into responding to the exact protein that is believed to be essential to the functioning of the virulent virus. Further, this approach would allow a vaccine to be engineered as soon as the genetic code of the virus has been identified. While an exciting theory, this strategy has never actually been used to develop a vaccine for human use before. Several of the vaccine candidates currently being developed for covid-19 (including the Pfizer and Moderna versions) are of this new type.<br />
Are vaccines risk free? No medical intervention is without risk! The decision to undergo a medical intervention is ALWAYS an exercise in risk/benefit analysis. Clinical trials exist to quantify the probability of bad outcomes as well as the probability of good outcomes. This is done by using carefully controlled experiments involving several thousand volunteer subjects over an extended period of time. There is the rub. There has been no shortage of volunteers and no lack of incentive. There has been insufficient time for the normal process to be completed. This one will have some risk and that risk can not at this time be properly quantified. We are going to have to make some guesses.<br />
Whenever it is believed that a developmental drug is needed for emergency use before it has been given final FDA approval one can request an Emergency Use Authorization. This is an exception to the normal New Drug Approval process. It is usually temporary and usually restricted as to scope. The  approval will be based on the seriousness of the threat posed by the disease and the likely risk imposed by shortchanging the safety testing process. There are some data points that can make this an educated guess rather than a shot in the dark.<br />
(1) The vaccines (at least the ones being considered at this writing) are NOT made from actual covid-19 virus. There is NO chance the vaccine will directly cause the disease.<br />
(2) The most likely time for adverse events to show up in vaccine trials is in the first few days after treatment. While long term follow-up is normal, it is less important in the safety analysis of vaccine trials.<br />
(3) Both of the vaccine candidates have been tested on about half the optimal number of phase 3 subjects and no catastrophic adverse events have been detected. While one might desire more subjects, it is possible to say that a HIGH probability of serious adverse events can be ruled out.<br />
(4) It appears that the worst possible outcome of the treatment is far less objectionable than the worst outcome of the virus.<br />
I wish we had more data and I wish we had more time to study these data. However, it looks like we are heading into a very grim phase of the pandemic and there appears to be no will to invoke the marginally successful public health measures that might buy us more time. It seems to me that until the number of mobile morgues parked behind the vaccination sites is greater than the number parked behind the hospital, I’ll opt for the vaccination.</p></blockquote>
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