I came across this article on Yahoo from Time magazine? It is about possible approval soon of a booster for a few Omicron variants of COVID.
As I like to say, the media tells stories mostly fiction as well as say that media is now used NOT to report the news, but instead to sway public opinion in the direction their bosses and or advertisers/funders decide.
So I decided to rewrite the article with some questions/comments included.
Why?
1- I was brought up and trained to use Critical Thinking skills.
2- In my medical training I was also always told to provide full Informed Consent, at least to the best of my ability.
In other words my job is to think about the individual health ramifications of different interventions as it effects the “individual” in front of me, moreso than the insurer/government recommendations/strategies. A key word may be “moreso”, if that is actually a word. Maybe I spelled “moreso” wrong again as it keeps getting that red underline in my draft. Any English majors out there want to give a doc some help here???
My other job in critical thinking is to always see if the Evidenced Based Medicine (EBM) guidelines are actually working well for the individuals in my practice. If they are we move forward with their recommendation. If not, we ALSO discuss other safe alternatives.
Remember it is always for the individual patient to decide on treatment choices, not the physician. I am just here to evaluate and offer safe and healthy options to help you improve your overall health. I am not your boss. You get to make your own decision.
So in the spirit of Informed Consent and Critical Thinking I decided to take this recent news article and critique it, ask some questions about it, add in some other thoughts that go through my head as I read it, in other words use critical thinking skills to develop an improved informed consent. I would hope that you do the same when reading media news stories whether it’s on healthcare or any subject.
So here goes as that was enough of a rambling introduction.
My comments, sometimes true questions, other times just sarcasm are bolded usually within a (( ))
This story came from Yahoo News with a TIME magazine icon as well.
Omicron Boosters Are Coming, But They Weren’t Tested on People. Here’s What You Need to Know
Alice Park
Fri, August 26, 2022 at 10:15 AM
With nearly all the new COVID-19 infections in the U.S. coming from the Omicron BA.4 and BA.5 subvariants, it makes sense that health officials are considering switching to a different vaccine to protect the public.
(( Do we still need a vaccine for COVID ?? ))
White House COVID-19 response coordinator Dr. Ashish Jha expects the first Omicron-specific booster to be available in mid-September at the earliest, if the U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) authorize and recommend the shot.
(( Does anyone really believe the FDA and CDC won’t approve the new Omicron based booster shot? ))
In late August, both Pfizer-BioNTech and Moderna submitted requests to the FDA for authorization of their Omicron-specific boosters.
(( Umm, I think they left out the words EMERGENCY USE before authorization. Why did the author not include those words here? ))
But with the fall and winter fast approaching—the seasons when respiratory viruses like SARS-CoV-2 spread even more efficiently, as students return to school and people huddle indoors—getting the booster ready requires a more efficient review and regulatory process.
(( By “efficient” me thinks they mean how to manipulate things to get fast approval to something that has probably already been preapproved politically, not necessarily medically ))
And that includes considering safety and efficacy data from animals, not people.
(( Wow! These new proposed booster shots have not yet been tested on people yet will probably be pushed through and approved ))
Back in June, the FDA’s panel of independent vaccine experts met to consider switching the country to a new booster that targets Omicron, given how quickly that variant is dominating new infections.
(( INDEPENDENT vaccine experts. I’d like to know just how “independent” they are, especially how many have worked for or are still working for Big Pharma who makes the “vaccines”. Is the fox guarding the hen house? It’s a bit unreal when you realize the power this select group of “independent vaccine experts” have on the country and the world, moreso (oops, there goes that word again) due to all the treatment mandates/coercion etc. ))
At the time, the two largest COVID-19 vaccine makers, Pfizer-BioNTech and Moderna—which both make mRNA-based vaccines—had developed shots against an earlier Omicron variant, BA.1. The panel decided that if health authorities were going to change the booster shot to target Omicron, the next one should protect against the BA.4 and BA.5 subvariants, which would continue to account for almost all cases in the winter season.
(( At the rate COVID is mutating, there is no proof that BA.4 and BA.5 will continue to be circulating let alone account for almost all the cases this upcoming winter. This is a “guess” on their part. If new variants do arise and take over, then we will again be treating for a virus that is no longer in circulation. Here is a link to a research article showing a newer variant has already emerged that appears to be more contagious than BA.4 or BA.5 Omicron variants. It is BA.2.75. Yes I too would like to know how they name these variants, but, will a booster for BA.4/BA.5/Wuhan have much effect on a new strain BA.2.75? ))
They asked the vaccine manufacturers to develop a new vaccine, one that combined the original vaccine and also targeted Omicron BA.4 and BA.5.
(( Why do we need a “vaccine” that contains the original variant when the original variant has not circulated since probably early 2021? It’s like paying extra homeowners insurance for an old appliance that hasn’t been in use for years and is outdated”. Have you recently added home owners insurance to protect your electric stove even though you replaced it with a gas stove a year and a half ago?? ))
At the end of August, both companies submitted data on their new, bivalent vaccines to the FDA for emergency use authorization.
(( OK- now they say “emergency use authorization “, but may I ask, What is the emergency now?” ))
Given the short time they had to develop the shot, however, the data only included information on the safety and efficacy of the booster in animals.
(( Just on animals. So the real human trials will be when people start getting the shots. Think about that a moment. You may indeed be the lab rat they are studying. We won’t know how it really works, or doesn’t, until everyone starts using it ))
Human studies are planned and will be ongoing even if the FDA and CDC decide to authorize the shots and the government starts distributing them. The FDA has also decided to review the animal study data without consulting its advisory committee again.
(( Wow. The FDA will not re-consult their advisory committee. So they are cutting corners again. So this is just a political decision? I also believe I heard the government has already preordered and paid for these boosters in advance. So why the hedging “If the FDA and CDC decide”? ))
That has vaccine experts divided.
(( Divided?? They don’t want to have an open debate which may be why no further re-consult of their advisory committee, not that we know how independent the committee actually is. Perhaps they are as independent as Social Media Fact Checkers?? ))
Dr. Paul Offit, a member of the advisory committee, says this strategy makes him “uncomfortable” for several reasons. He notes that the data presented from Pfizer-BioNTech and Moderna in June involving their BA.1 booster shot, which focused on the levels of virus-fighting antibodies the vaccine generated, were underwhelming. “They showed that the neutralizing antibody titers were between 1.5- and two-fold greater against Omicron than levels induced by a booster of the ancestral vaccine,” he says. “I’d like to see clear evidence of dramatic increase in neutralizing antibodies, more dramatic than what we saw against BA.1, before launching a new product. We’re owed at least that.”
(( Problem is that antibody levels do not necessarily mean you won’t contract the virus or spread the virus. We have seen that with the present mRNA injections. The better metric is and should always be:
“Did it prevent illness, spread, hospitalizations and death from the virus?” ))
While conducting human studies does take more time,
(( Always for proper long term safety and efficacy reasons, but I guess that is no longer important to the FDA which is in charge of determining safety and efficacy ?? - That tongue twisting hurt to say and write ))
Offit says even a small trial involving about 100 people to measure their antibody levels after getting a BA.4/5 booster would be helpful. “You can boost people and measure their neutralizing antibodies two weeks later,” he says. Such information could also be critical in setting realistic expectations for the Omicron booster.
(( Ummm, it has been shown that antibodies from the present COVID mRNA shot, whether neutralizing or not, do not last more than a few months before dropping steadily. So how can he say measure their antibodies 2 weeks later and believe that is helpful science? ))
The public might feel it’s a panacea that signals the end of the pandemic, but without any data showing how well the booster will protect people from not only getting sick, there might be unrealistic expectations about what the boost can do. “I get a little nervous, frankly, when I hear this [booster] is going to be miraculous,” Offit says.
(( Again, short term neutralizing antibodies are not the proper metric to use ))
Other experts see it a little differently. Based on the fact that the mRNA vaccines have been administered to millions of people so far, with relatively few safety concerns,
(( Wow! Relatively few safety concerns!! What rock have they been hiding under? ))
and given that the vaccines have been effective in protecting people from getting hospitalized or dying of COVID-19, even during the latest Omicron surges,
(( There is little to any proof of the above with Omicron, while there is some proof it was helpful against the initial Wuhan strain of COVID ))
they argue that changing the strain of virus in the vaccine doesn’t require the same extensive testing that the original shot did. “The totality of evidence is relevant here,” says Dr. Ofer Levy, director of the precision vaccines program at Boston Children’s Hospital, and also a member of the FDA’s vaccine advisory committee. “We are in a situation where we need to pivot as variants emerge, and if we try to be too rigid in our approach, we will always be behind, and not giving the population optimal protection.”
(( The coronaviruses mutate so quickly we will never get ahead let alone catch up. This is why we have never had a successful cold (coronavirus) vaccine. Throughout evolution our natural immune systems have protected us.
Why do we all of a sudden now believe a new medical treatment using mRNA vaccines will give us a more “optimal” protection without possibly causing harm as well? To actually answer that question we need long term safety and efficacy studies, none of which have been done, unless we count the mass use of these mRNA treatments on the world and seeing what happens? ))
Levy says that the latest Omicron-specific boosters that the FDA is considering contain a combination of mRNA targets against both the original virus and Omicron BA.4/BA.5, so the data on safety and efficacy from the original vaccine in protecting against hospitalization and death is relevant.
(( If it was relevant then we would no longer be mandating/coercing these as treatments. Also, what are the “targets”? Is it still the spike protein portion of the virus ?? ))
While the data on this vaccine does come from animals, using that data to decide whether or not to authorize the booster is a matter of “hedging bets.”
(( So they are betting/gambling, (hedging bets) their strategy will work, but they are betting with your health on the line ))
There is data showing that even vaccinated and boosted people can get mild to moderate COVID-19 disease, because their vaccine-induced protection is waning,
(( They can get mild-moderate-severe disease regardless of their vaccine induced immune system changes. They appear to be ignoring the data showing vaccinated people being hospitalized at the same or higher rate than non-vaccinated ))
so boosting with a shot that is better matched to the Omicron subvariants circulating now is a reasonable bet, even if the data on its efficacy comes from animals and not people. “I think it’s the right decision,” says Levy.
(( Time may tell if Levy is correct to gamble with your health ))
There’s no guarantee that the FDA will authorize the new bivalent vaccines,
(( Ha, that’s a funny one. Like it isn’t already written into the script ))
although all signs point to an authorization that could come in a week or so. If the shots are released and people get boosted, health officials will be carefully monitoring data from those vaccines to ensure that the assumptions they made about the safety and efficacy of the booster hold.
(( They will probably ignore data that goes against their pre-held beliefs, because , well, that is what those in power almost always do ))
And hospitalization rates in the coming winter will reveal whether betting on the new Omicron-specific booster was the right decision.
(( I guess this is proof that they are gambling on the booster, again with your health. I understand gambling during an emergency or life and death situation. So a big question is really,
“Do you believe the COVID strains now in circulation are so dangerous and life threatening that you need to gamble, that it is worth a “reasonable bet” to take, even WITHOUT any human safety and efficacy data? ))
The above is critical thinking, informed consent, and asking questions that need to be asked, researched further and answered, along with a bit of skepticism and sarcasm, which is actually always needed with critical thinking as it leads to more questions, research and answers. We learn more in science from questioning everything. Stifling debate and censorship does NOT advance science. It advances politics and power.
The above is NOT misinformation.
The above is NOT disinformation.
The above is not media political spin like shown below.
Critical thinking and Full informed consent is a structure that should be followed before any medical/health intervention.
The beauty of it is that you alone should get to choose a health intervention, not Big Pharma, WHO, your boss, or any government agency that contains 3-4 letters.
I believe you know best what is right for you and that you should take the responsibility for the outcome, whether good or bad, as it should be your decision to make. When you give up that right to make your own medical decision then you cannot blame others for what happens.
The new booster could actually work. Believe me when I say I hope it does. I am rooting for it. The question though is am I willing to use it before proper long term safety and efficacy data are in? Everyone should get that choice and decide for themselves. I am not trying to sway your opinion. I am just hoping that you will think through all of this and make an informed individual decision based on your own health and risk factors. I ALWAYS respect the decisions of people regardless of whether it is what I would do or not do. You and only you are in charge of your health.
Listen to quarterback Aaron Rodgers explain his critical thinking and the coercion that was being employed.
If you want to read what others thought of the Yahoo article, click back on the link and read the comments at the end of article. It appears that people are beginning to use their own critical thinking skills. Let’s hope that continues.
I am putting this here so as not to solely focus on COVID today.
Do you ever see these studies in mainstream news??
While I am known as being just a tad sarcastic at times, I just want to say how much I appreciate all the subscribers to my Substack, Common Sense Health and Wellness, especially the paid ones! Your support is so greatly appreciated.
P.S. Dr. Steven Horvitz is now licensed to practice in the State of Florida. While the home base of Dr. Horvitz and the Institute for Medical Wellness is presently is New Jersey, we are now able to Virtually evaluate and treat Florida residents using a HIPAA secure video messaging app. Our evaluations have a special focus on root cause evaluations and treatment guidance of Nutritional, Metabolic, Inflammatory and AutoImmune health issues. We can order traditional, nutritional and functional testing to help guide you on your wellness journey.
If anyone needs our help, feel free to visit our website at www.drhorvitz.com
I will forgo the booster, for now, and take that spin cycle ride for never.
Obviously, anyone capable of independent critical thought has long stopped paying attention to any of the controlled corporate media. It’s not spin, it’s straight up propaganda. There are now bigger issues at hand than non-effective jabs for seasonal respiratory viruses(aka The Cold).
Excellent overview of the big picture.
Great chat below, to start getting an idea of the bigger issues at hand.
https://www.oval.media/en/mrglobal-2/