Vaccine studies results: No evidence of reduced mortality or reduced hospitalization. No evidence regarding safety or side effects. The 95% "effective" is intentional misinformation. Feel safer?
Posted by freedomforall 3 years, 5 months ago to Business
"Pfizer recently announced that its covid vaccine was more than 90 percent “effective” at preventing covid-19. Shortly after this announcement, Moderna announced that its covid vaccine was 94.5 percent “effective” at preventing covid-19. Unlike the flu vaccine, which is one shot, both covid vaccines require two shots given three to four weeks apart. Hidden toward the end of both announcements, were the definitions of “effective.”
Both trials have a treatment group that received the vaccine and a control group that did not. All the trial subjects were covid negative prior to the start of the trial. The analysis for both trials was performed when a target number of “cases” were reached. “Cases” were defined by positive polymerase chain reaction (PCR) testing. There was no information about the cycle number for the PCR tests. There was no information about whether the “cases” had symptoms or not. There was no information about hospitalizations or deaths. The Pfizer study had 43,538 participants and was analyzed after 164 cases. So, roughly 150 out 21,750 participants (less than 0.7 percent) became PCR positive in the control group and about one-tenth that number in the vaccine group became PCR positive. The Moderna trial had 30,000 participants. There were 95 “cases” in the 15,000 control participants (about 0.6 percent) and 5 “cases” in the 15,000 vaccine participants (about one-twentieth of 0.6 percent). The “efficacy” figures quoted in these announcements are odds ratios.
There is no evidence, yet, that the vaccine prevented any hospitalizations or any deaths. The Moderna announcement claimed that eleven cases in the control group were “severe” disease, but “severe” was not defined. If there were any hospitalizations or deaths in either group, the public has not been told. When the risks of an event are small, odds ratios can be misleading about absolute risk. A more meaningful measure of efficacy would be the number to vaccinate to prevent one hospitalization or one death. Those numbers are not available. An estimate of the number to treat from the Moderna trial to prevent a single “case” would be fifteen thousand vaccinations to prevent ninety “cases” or 167 vaccinations per “case” prevented which does not sound nearly as good as 94.5 percent effective. The publicists working for pharmaceutical companies are very smart people. If there were a reduction in mortality from these vaccines, that information would be in the first paragraph of the announcement.
There is no information about how long any protective benefit from the vaccine would persist. Antibody response following covid-19 appears to be short lived. Based on what we know, the covid vaccine may require two shots every three to six months to be protective. The more shots required, the greater the risk of side effects from sensitization to the vaccine.
There is no information about safety. None. Government agencies like the Centers for Disease Control (CDC) appear to have two completely different standards for attributing deaths to covid-19 and attributing side effects to covid vaccines. If these vaccines are approved, as they likely will be, the first group to be vaccinated will be the beta testers. I am employed by a university-based medical center that is a referral center for the West Texas region. My colleagues include resident physicians and faculty physicians who work with covid patients on a daily basis. I have asked a number of my colleagues whether they will be first in line for the new vaccine. I have yet to hear any of my colleagues respond affirmatively. The reasons for hesitancy are that the uncertainties about safety exceed what they perceive to be a small benefit. In other words, my colleagues would prefer to take their chances with covid rather than beta test the vaccine. Many of my colleagues want to see the safety data after a year of use before getting vaccinated; these colleagues are concerned about possible autoimmune side effects that may not appear for months after vaccination.
These announcements by Pfizer and Moderna are encouraging. I certainly hope that these vaccines protect people from the harm of covid-19. I certainly hope that these vaccines are safe. If both of these conditions are true, nobody will need to be coerced into taking the vaccine. However, you should pay even more attention about what is left out of an announcement than about what is stated. The pharmaceutical companies are more than happy for patients to misunderstand what is meant by efficacy. Caveat emptor (buyer beware)!
Author:
Gilbert Berdine, MD
Gilbert Berdine is an associate professor of medicine at Texas Tech University Health Sciences Center and an affiliate of the Free Market Institute at Texas Tech University."
Both trials have a treatment group that received the vaccine and a control group that did not. All the trial subjects were covid negative prior to the start of the trial. The analysis for both trials was performed when a target number of “cases” were reached. “Cases” were defined by positive polymerase chain reaction (PCR) testing. There was no information about the cycle number for the PCR tests. There was no information about whether the “cases” had symptoms or not. There was no information about hospitalizations or deaths. The Pfizer study had 43,538 participants and was analyzed after 164 cases. So, roughly 150 out 21,750 participants (less than 0.7 percent) became PCR positive in the control group and about one-tenth that number in the vaccine group became PCR positive. The Moderna trial had 30,000 participants. There were 95 “cases” in the 15,000 control participants (about 0.6 percent) and 5 “cases” in the 15,000 vaccine participants (about one-twentieth of 0.6 percent). The “efficacy” figures quoted in these announcements are odds ratios.
There is no evidence, yet, that the vaccine prevented any hospitalizations or any deaths. The Moderna announcement claimed that eleven cases in the control group were “severe” disease, but “severe” was not defined. If there were any hospitalizations or deaths in either group, the public has not been told. When the risks of an event are small, odds ratios can be misleading about absolute risk. A more meaningful measure of efficacy would be the number to vaccinate to prevent one hospitalization or one death. Those numbers are not available. An estimate of the number to treat from the Moderna trial to prevent a single “case” would be fifteen thousand vaccinations to prevent ninety “cases” or 167 vaccinations per “case” prevented which does not sound nearly as good as 94.5 percent effective. The publicists working for pharmaceutical companies are very smart people. If there were a reduction in mortality from these vaccines, that information would be in the first paragraph of the announcement.
There is no information about how long any protective benefit from the vaccine would persist. Antibody response following covid-19 appears to be short lived. Based on what we know, the covid vaccine may require two shots every three to six months to be protective. The more shots required, the greater the risk of side effects from sensitization to the vaccine.
There is no information about safety. None. Government agencies like the Centers for Disease Control (CDC) appear to have two completely different standards for attributing deaths to covid-19 and attributing side effects to covid vaccines. If these vaccines are approved, as they likely will be, the first group to be vaccinated will be the beta testers. I am employed by a university-based medical center that is a referral center for the West Texas region. My colleagues include resident physicians and faculty physicians who work with covid patients on a daily basis. I have asked a number of my colleagues whether they will be first in line for the new vaccine. I have yet to hear any of my colleagues respond affirmatively. The reasons for hesitancy are that the uncertainties about safety exceed what they perceive to be a small benefit. In other words, my colleagues would prefer to take their chances with covid rather than beta test the vaccine. Many of my colleagues want to see the safety data after a year of use before getting vaccinated; these colleagues are concerned about possible autoimmune side effects that may not appear for months after vaccination.
These announcements by Pfizer and Moderna are encouraging. I certainly hope that these vaccines protect people from the harm of covid-19. I certainly hope that these vaccines are safe. If both of these conditions are true, nobody will need to be coerced into taking the vaccine. However, you should pay even more attention about what is left out of an announcement than about what is stated. The pharmaceutical companies are more than happy for patients to misunderstand what is meant by efficacy. Caveat emptor (buyer beware)!
Author:
Gilbert Berdine, MD
Gilbert Berdine is an associate professor of medicine at Texas Tech University Health Sciences Center and an affiliate of the Free Market Institute at Texas Tech University."
Well yes, there was mainly anecdotal evidence, but a lot of it, then consider- what if it does not work? What are the alternatives? What is the downside?
65 years of experience ignored.
With these vaccines, it is legit to ask if they are safe given how much we trust their proponents. Re the 90 percent effectiveness, all the usual cautions apply, compared with what, age cohort, side effects, how many people tested, for how long?
Well I am a believer in vaccination, but there are conditions, there are long standing rules. But for this one and some others, the rules are brushed aside and name calling is ramped up.
I'm sad to see how easily the current American population can be so easily led into a state of panic and fear. Where are the historic spines that made Americans resilient to the ravages of war, economic stress, and disease? There was no vaccine for polio when I was a child, but we didn't lock down the country out of fear over it.
Both the CDC and WHO now agree that once the infection rate is beyond 1-2% in a population, lockdowns and masking becomes very ineffective, and they recommend against it. Strange that those who keep harping on "follow the science" now want us to ignore the scientists and obey the bureaucrats, cringing in fear and isolation.
If he isn't legally returned to the office in short order my part of the herd will not comply with anything the new administration orders unless I would have done so under a Trump administration, and a there will likely be number of unapproved actions.
What's telling is that both the CDC and WHO are telling us that the time for lockdowns is long past, but the same bureaucrats who scream at us to follow the science are now telling us to ignore it and obey. It's all about control, and the frightening level of effectiveness is the number of sheeple who call any non mask wearer a murderer. We are seeing the resurrection of the witch trials of the 15th century, where people reacting out of fear were more than willing to accuse neighbors of being evildoers who were inflicting plague on the innocent.
Many here like Candace Owens logic. She discusses this topic here...
https://youtu.be/g7Mj8zOtz14
No one would disagree with streamlining the approval process.
My reservation concerns short cuts with safety and effectiveness - these depend on biological processes occurring over time, these are not subject to what administrators do with approvals.
The world is faced with pandemics almost constantly. We survive. The earth abides. We go on. To have witnessed the greatest manufactured recession in history is astounding. It leaves us with the feeling we are falling and our senses are in our throats. We haven't awoken from this nightmare yet. Without a Trump presidency in January there will be a flatline for the heartbeat of our economy and our constitutional freedoms. Big pharma and big government have won this round.
The Deep State thinks we can be made into subservient workers. We must teach them just how wrong they are.
The doctor cautioned against jumping to conclusions as he said that any trial results published by pretty-much any vaccine developer nowadays should be considered “a very early stage efficacy testing rather than a major trial.”
“So, all the [tests] are at very, very early stages. It is too early for other companies to be jumping up and saying: ‘yours does not work and ours does’.”
In fact, other vaccines developed by AstraZeneca’s rivals across the pond – Moderna and Pfizer, which also collaborates with Germany’s BioNTech – might pose a much greater risk than just a possibility of a vaccine being not as effective, Kendrick warned.
Both American vaccines use messenger RNA (mRNA) to combat the virus. That is an advanced genetic therapy that uses the virus’ own genetic material against it. Kendrick, however, warns that the technology is really new and untested, meaning no one really knows how it could affect human health, since it literally hijacks the cellular reproduction mechanism.
“When you are dealing with something that has never been tried before, the efficacy might not be so important but safety issues should absolutely be looked at very carefully,” he said. “We really do not know what these things might end up doing after a prolonged period of time.”
Then I read, one of the test groups were given half the stated dose, that test group had slightly better results, and they were all under age 50 (from memory).
I think I will sit out for this dance.
How much benefit is there for the people most at risk from COVID and how much additional risk is added for those people from the vaccine itself?
Get ready, my friends. This is going to be a wild ride!
But, bw, it's all the fault of evil white men.
Politicians, oncologists, and lawyers make me ill.
The mental-health profession missed this issue, unanimously. As the old joke goes, “if you think you need a psychiatrist, you’re crazy.”
Objectivism only suggests one look at all the evidence and assess the risk/reward rationally.
But the Govt. has subsidized the Co.s to produce the vaccines at an affordable price. It's the Co.s reputation that's on the line, not Govt.
Stick with the vitamin/supplements/ therapeutics...they work and won't kill you.
The absolute rates are given for an individual, say (0.7% , 0.07%) and also the calculated relative rate (0.007 - 0.0007) / 0.007 = 0.0063 / 0.007 = 0.90 = 90%.
An example for whether to take a treatment or not is my choice of taking medication for heart problems or not. In my case there is a 3% chance of having another heart attack without the medication and a 1.5 % chance with the medication. That does not seem like a lot for an individual but for the population of former heart attack victims that is a 50% reduction which depending upon number involved could even concern some of those on this forum to advocate the use of medications or even become concerned about using a rather rapidly developed vaccine.
We maybe could stand a few more deaths to get to the 675,000 US deaths and about 50 million world wide from the Spanish flu.
It's time to take politics out of public health. That is very difficult when most citizens remain ignorant of even general science and mathematics and cannot understand reality in but little hints here and there and just continue to party on!
Perhaps because the M.D. has an interest in the health of the patients over the health of the Pharma company the M.D. might design a test that determines the quantitative benefits (and detriments) to the people who take the vaccine.
Oncologists similarly use their definition of "respond" to mislead cancer patients.
Perhaps the revolution will start at an airport this time.
If fewer cases, then fewer potential deaths; and coupled with better hospital care now than in the beginning and more antibodies in the body, the risk should be relatively low. In other words, the missing information referred to does not necessarily imply greater risk.
The responses here show how such fear generated perhaps irrationally can lead to people not being willing to take the vaccine. By the time the average person can get the vaccine, we will of course know a lot more about it's safety.
I recognize that as greatly increasing the risk to anyone taking the vaccine. I'll take my chances with the current treatments, not the vaccines.
If businesses - including the travel industry - was smart after the vaccine is available, they would require proof of a vaccine before allowing someone to do business/travel. Don't take it and you remain locked down.
Convenience does not overrule that.