Covid is an illness of the old.
We again see excess mortality among age group > 65. Nothing can be seen for age <65.
Same for death statistics. 158 deaths so far counted any only 7 are younger than 60 years. (week ending 12 December. They use a different grouping).
Important news from Honkong:: https://www.med.hku.hk/en/news…tm_campaign=press_release
The researchers found that Omicron SARS-CoV-2 infects and multiplies 70 times faster than the Delta variant and original SARS-CoV-2 in human bronchus, which may explain why Omicron may transmit faster between humans than previous variants. Their study also showed that the Omicron infection in the lung is significantly lower than the original SARS-CoV-2, which may be an indicator of lower disease severity. This research is currently under peer review for publication.
In fact its about a factor 50 less virulent in deep lung. 100x less than Alpha!
As an archive here also the screen PDF: med.hku.hk-NewsHKUMed finds Omicron SARS-CoV-2 can infect faster and better than Delta in human bronchus but wit.pdf
Here the facts from South Africa.
Definitely less CoV-19 hospital cases in total last week!
Last day just a tiny increase/decrease in ICU numbers.
Covid-19 Vaccine Injured Victims Share Stories of Being Ignored, Dismissed and Neglected by Medical Doctors
Aubrey Marcus, founder of holistic health and lifestyle brand, Onnit, and New York Times best-selling author, invites 3 guests on his self-titled podcast. According to the podcast page, guests provide “expertise in mindset, relationship health, business and spirituality.” Episode #337, titled “The Inconvenient Injured w/ Vaccine Advocates Dr. Aditi Bhargava, Kyle Warner and Brianne Dressen,” explores the issues with discounting the vaccine injured population.
Part II provides details into the immediate health decline of Dressen and Warner upon vaccination. Bhargava is a molecular biologist, and Director of Laboratory Research at UCSF who develops mRNA technology. She provides context to the unintended consequences of these vaccines. Even more of her insights are detailed in Part I, where she advocates for science to recognize the vaccine-injured and what their data can reveal about Sars-CoV-2 and Covid-19.
Brianne Dressen’s Story
— “You are just trapped in a body that is attacking itself 24 seven.” —
In November of 2020, Dressen was invited into the Utah-based AstraZeneca clinical trial (which has since been rescinded) because of her qualifications as a healthy participant. Dressen was in prime physical condition: a hiker who could finish a 9-hour trail with two hours to spare.
Her reason for entering the trial? “I do not want to be the reason that someone gets ill and dies.” The conductors of the trial put her at ease when they contractually promised Dressen “a safety net” through compensation and support for any type of debilitating reaction.
Dressen’s Steep Health Decline
After her first dose, symptoms began with tingling within the hour. By nighttime, she experienced double vision, amplified hearing, and trouble walking with her left leg. At the test clinic, they suspected she had multiple sclerosis or transverse myelitis, but ER doctors ruled it out.
Her health continued to unravel when sensitivity to the slightest of sounds and touch became unbearable. “I felt like my body was on fire.” As a preschool teacher and mother of young children, Dressen said she “thrived in chaotic and loud environments.” However, as her side effects began to worsen, she could barely manage in her classroom. In the beginning, she made it through the day with movies on and lights out.
At home, her daughter’s singing boomed, the squeeze of her young son’s hand was too agonizing, even the shuffle of her husband’s pants couldn’t be tolerated. Eventually, she had to shut herself out from the world, including her family and virtually all activity.
To put her emotional health in perspective: imagine not only being in lockdown, but with no way to escape from the toll of social isolation with music, TV, reading, exercise, or any activity to get by, Dressen explains. To cope with her suffering, she spent her days in a dark room, like a prisoner in solitary confinement. Dressen says she became emaciated to a point where all her ribs were visible.
When her health decline rendered her unable to walk, and she became incontinent, she was finally admitted to the hospital. The doctor’s discounted the vaccine as the cause. Instead, they attributed her extreme neurological disorders to anxiety, and recommended intensive out-patient physical therapy. Dressen says they wrote on her chart: “anxiety due to the covid vaccine.”
Months later the National Institutes of Health properly diagnosed her with a handful of neurological disorders: Neuropathy, Short Term Memory Loss, Severe Postural Orthostatic Tachycardia Syndrome (POTS), Mass Cell Activation Syndrome (MCAS), and Dysautonomia.
Removed from the Trial
Adverse events are tragic and unfortunate, but that’s why clinical trials exist right? Logically, it is assumed that participants who experience these side effects will get proper documentation of said events. And of course, these results will be considered when determining if a new vaccine is safe for the public.
But what should we make of a clinical trial that witnessed the severity of Dressen’s health decline and eliminated her —and her alarming results— from the study?
Yes, they did. Dressen was removed because the protocol requires two doses for completion. Her access to the app where patients could log symptoms was revoked. Her reactions were never described in the clinical trial report, says Dressen.
What legitimate reason is there not to include first-dose adverse reactions in the data?
Still Dressen remained silent about her injuries, (with a few exceptions in terms of her employment), because she still did not want to cause vaccine hesitancy. However, “this cascade of neurological decline,” was a commonality she found among many participants she met while attending a recent vaccine-injury conference held by Sen. Ron Johnson in D.C., says Dressen.
These victims are not just denied their injuries, they are mocked and attacked with comments accusing them of faking their injuries for attention, says Warner. One example he met was Maddie de Garay, a teen in the Phase III clinical trial for Pfizer, who is now a paraplegic and must eat through a feeding tube.
Dressen and Warner also say another commonality is that the victim’s doctors attributed these injuries to anxiety 80% of the time.
Kyle Warner’s Story
––“By admitting there is collateral damage, you have to first admit that there is a risk.” ––
Unfortunately, adverse reactions of this severity are not confined to the AstraZeneca recombinant vaccine, (in which the method-of-action is to fuse an adenovirus with the spike protein of Sars-CoV-2 to recognize Covid-19, then stop the virus from latching to the cells.) There are also troubling effects from mRNA vaccines as well.
Warner received his second dose of the Pfizer vaccine in June of 2021. He runs a YouTube channel with his girlfriend and planned to travel around the country teaching free skills clinics for mountain biking. “I didn’t want to be the guy that got someone else sick” when they came to learn something, says Warner.
Unintended Intravenous Injection Issues
Unlike his first dose, Warner says he experienced a saline or metallic-like taste in his mouth with dose two. His administrators admitted that wasn’t typical but can occur when an injection nicks a vein. This is troubling, as the mRNA vaccine is intended to work by injection into the deltoid muscle cells to produce the spike protein.
“In a lot of studies they did, they found that if they administered intravenously, the mice would have heart failure,” Warner added. This resulted in Pfizer and Moderna specifying in their administration guidelines to “make sure you aspirate, make sure you get it in the deltoid muscle, don’t get it in the bloodstream,” says Warner. (Aspiration is the practice of pulling back on the needle after injection before removing it from the arm to see if any blood enters the syringe. This can confirm if it was done correctly.) However, the CDC changed the protocol, directing professionals not to aspirate, “because it will cause slightly less arm pain.”
Warned also noticed, unlike his first injection, he did not experience soreness in his arm—another possible sign of error.
Could this mistake explain why some recipients experience no issues, while others experience adverse effects. After all, says Marcus, there is no technology which allows the professional to know how to pierce the deltoid and avoid a vein with certainty.
Bhargava added that proper temperature storage, as well as proper concentration mixing also contribute to varying reactions. “There have never been any studies done to determine whether or not you are getting exactly 30 micrograms” of mRNA. Furthermore, says Bhargava, antibodies are not being thoroughly evaluated, and each person’s immune system will have different reactions. Bhargava said those who have had other coronaviruses could “neutralize” the mRNA vaccine, rendering it ineffective.
“So far, the average age of injury is 33 years old, and why is that?” Warner asks. Dressen confirms that this number does not include teens or children which could lower the average as well. Moderna, another mRNA vaccine, has been halted in Europe for people under 30, citing the concern of myocarditis.
The Consequences for Warner, a Professional Athlete
Two weeks into dose two, heart palpitations began, so Warner cut out caffeine just in case. Since he felt awful, he stopped biking for a few weeks too. When he picked up biking again, his heart rate was unusually high for a “very mellow climb (160 BPMs), and I couldn’t get it to come down.” He tried laying down and meditating, but his resting heart rate remained at 130 for over two hours, when usually it’s 50-60.
During triage at an ER in Boise, Idaho, he shared his suspicion of heart inflammation due to the vaccine, and of course was discounted. The medic instead told him to try to eliminate his bowels. Squeezing his core, said the medic, would “reset” his heart.
A three hour wait with “burning” chest pain followed, other symptoms crept in: severe joint pain, “almost felt like rheumatoid arthritis,” and “an equally distributed pressure headache.” When he explained his newly emerging symptoms, and wondered if a CAT scan would be appropriate, his doctor implied it wasn’t necessary, and assumed it was an anxiety attack. He treated Warner with an injectable anti-inflammatory, and some of Warner’s pain was reduced. His heart rate lowered to 110, and his doctor took that as a sign that Warner was improving. Warner didn’t agree. The doctor then suggested therapy and antidepressants, “and sent me on my way.”
“Looking back on my paperwork, they ran my troponin levels… (which is a marker of damage to the heart,) anything above one is considered damaged, and my troponin was a 25.” The doctor wrote in his chart: “‘elevated troponin levels, chronically sick or older people will have a baseline similar to this,’ and I’m a professional athlete.” Warner is 29, with a cardiac case so severe he was “in bed for three months solid.” He was eventually diagnosed with pericarditis, POTS, and reactive arthritis.
Confirmation Bias in the Medical Field
“Confirmation bias is such a strong psychological force,” says Marcus, that even well-meaning doctors can overlook the signs of vaccine injury because they are following the determinations of public health officials.
Dressen and Warner both shared their sympathy for doctors, who are being told that these reactions are not an issue. Warner wants to help doctors understand that CDC guidance is creating this confirmation bias so that this issue can be considered when vaccine recipients present with similar symptoms.
Warner suspects a reason why the vaccine-injured are ignored by public health officials and the vaccine makers. “By admitting there is collateral damage, we must first admit there is a risk…I believe where there is risk there must be choice.” By not acknowledging the vaccine-injured, mandates can be justified.
Sen. Johnson invited the head of the NIH, CDC, and the heads of Pfizer, Moderna, AstraZeneca, Johnson & Johnson, to his vaccine injury press conference, but no one bothered to show, “or even send a representative,” said Dressen. To help other vaccine injury victims, Dressen has built a non-profit site React19.org
Denying the Existence of the Vax-Injured is Counterproductive
Regarding vaccine hesitancy, says Warner, denial of vaccine injuries by health officials is counterproductive to their goal of vaccinating more people. Instead of allowing and respecting an individual’s decision to weigh the risk of vaccine injury, along with their risk of getting a severe case of Covid-19, we ostracize the hesitant and condemn them for their lack of trust in “the science.”
Yet this social and highly politicized pressure to get the vaccine against a person’s will deter them further, due to the censorship and dismissal of their stories. Why? The rationale, according to Warner, is that it’s less risky to get Covid as a healthy person, knowing when it is contracted, medical professionals won’t deny it. Whereas if someone becomes injured by the vaccines, they will be gaslit for claiming their injury, and turned away from necessary care with an inappropriate anxiety prescription for Xanax ® in its place. Just take a guess, if you will, at who owns Xanax®.
Also the chat area
Covid is an illness of the old.
and healthy15 year olds too...
and everyone in between.
This 65 year old cutoff thing (just remember you will be over it soon) is silly. The mortality versus age graph is continuous.
and healthy15 year olds too...
Fear monger again! Soap slipping also affect all ages...
We have no death from CoV-19 at age below 30 point end. But we have some from vaccines age below 30...
But we have 10'000 deaths age >70 from CoV-19.
So it is per definition an illness of the old.
New Zealand links death to Pfizer COVID vaccine: 'it remains safer to be vaccinated'
Health authorities in New Zealand have said they believe a 26-year-old man's death is connected to a side effect from Pfizer's COVID-19 vaccine.
A preliminary post-mortem analysis indicated that the probable cause of the man's death was myocarditis, which is a rare side effect of the vaccine that causes the heart muscle wall to become inflamed, according to Bloomberg.
"With the current available information, the Board has considered that the myocarditis was probably due to vaccination in this individual," a statement from New Zealand's Covid-19 Vaccine Independent Safety Monitoring Board said of the man, who died within two weeks of receiving his first Pfizer vaccine, per Bloomberg.
The statement noted that "Covid-19 infection can itself be a cause of myocarditis" and said "it remains safer to be vaccinated than to be infected with the virus."
The board also highlighted that "the benefits of vaccination with the Pfizer vaccine for Covid-19 continue to greatly outweigh the risk of such rare side effects."
The World Health Organization (WHO) has acknowledged that "a very rare signal of myocarditis" has been reported from some COVID-19 vaccines. The organization added that most myocarditis cases occur in young men between the ages of 16 and 24, typically within a few days of their second vaccination.
The Centers for Disease Control and Prevention (CDC) has also said it is "actively monitoring reports of myocarditis" but that it "continues to recommend that everyone ages 5 years and older get vaccinated for COVID-19."
New Novavax COVID-19 Vaccine Found To Be Safe and Effective in Trial – “Highly Efficacious and Very Safe
An investigational COVID-19 vaccine made by Novavax was found to be 90 percent effective at preventing COVID-19 illness, according to results from a Phase 3 clinical trial published on December 15, 2021, in the New England Journal of Medicine. The University of Maryland School of Medicine’s (UMSOM) Center for Vaccine Development and Global Health served as one of the trial sites, and Karen Kotloff, MD, Professor of Pediatrics at UMSOM, served as Co-Chair for the trial protocol.
In the study, researchers recruited nearly 30,000 adult volunteers at 113 clinical sites in the United States and six sites in Mexico. Approximately 20,000 participants received two doses of the vaccine spaced three weeks apart and 10,000 received placebo. In addition to being highly effective in preventing COVID illness of any severity, the vaccine was 100 percent effective in preventing moderate and severe disease that required hospitalization.
“Our study results indicate that this vaccine is highly efficacious and very safe.” — Karen Kotloff, MD, Professor of Pediatrics at UMSOM
During the first few months of 2021 when the study was conducted in the U.S. and Mexico, the predominant circulating strain was Alpha. The assessment did not include Delta or Omicron, the newest variant of concern, which had not begun to circulate.
Most side effects were mild to moderate and transient. Fever was very rare. The most common side effects in the vaccine recipients included pain and tenderness at the injection site, headache, muscle aches, and fatigue that lasted a day on average. None of the recipients developed serious reactions like heart inflammation (myocarditis) or blood clots.
“Our study results indicate that this vaccine is highly efficacious and very safe. In addition, this vaccine has many attractive features. It is made from a small piece of protein, like many currently licensed vaccines in the U.S. and has convenient refrigerator storage requirements, so it will be an important addition to the COVID-19 vaccine portfolio, in the U.S. and in countries where supply is lacking,” said Dr. Kotloff.
The UMSOM site enrolled nearly 500 participants over 18 of age. The participants were demographically diverse to reflect those in the general population at highest risk for infection and illness, including under-represented minority groups who were disproportionately affected by the pandemic. About 12 percent of the study participants were in the high-risk group of those over age 65 years. About 27 percent of the study participants at UMSOM identified as Black, 19 percent Hispanic, 16 percent Asian, and 7 percent American Indian or Alaska Native.
The mRNA Vaccines Are Extraordinary, but Novavax Is Even Better
Persistent hype around mRNA vaccine technology is now distracting us from other ways to end the pandemic.
By Hilda Bastian
At the end of January, reports that yet another COVID-19 vaccine had succeeded in its clinical trials—this one offering about 70 percent protection—were front-page news in the United States, and occasioned push alerts on millions of phones. But when the Maryland-based biotech firm Novavax announced its latest stunning trial results last week, and an efficacy rate of more than 90 percent even against coronavirus variants, the response from the same media outlets was muted in comparison. The difference, of course, was the timing: With three vaccines already authorized for emergency use by the U.S. Food and Drug Administration, the nation is “awash in other shots” already, as the The New York Times put it.
Practically speaking, this is true. If the FDA sees no urgency, the Novavax vaccine might not be available in the U.S. for months, and in the meantime the national supply of other doses exceeds demand. But the asymmetry in coverage also hints at how the hype around the early-bird vaccines from Pfizer and Moderna has distorted perception. Their rapid arrival has been described in this magazine as “the triumph of mRNA”—a brand-new vaccine technology whose “potential stretches far beyond this pandemic.” Other outlets gushed about “a turning point in the long history of vaccines,” one that “changed biotech forever.” It was easy to assume, based on all this reporting, that mRNA vaccines had already proved to be the most effective ones you could get—that they were better, sleeker, even cooler than any other vaccines could ever be.
But the fascination with the newest, shiniest options obscured some basic facts. These two particular mRNA vaccines may have been the first to get results from Phase 3 clinical trials, but that’s because of superior trial management, not secret vaccine sauce. For now, they are harder and more expensive to manufacture and distribute than traditional types of vaccines, and their side effects are more common and more severe. The latest Novavax data confirm that it’s possible to achieve the same efficacy against COVID-19 with a more familiar technology that more people may be inclined to trust. (The mRNA vaccines delivered efficacy rates of 95 and 94 percent against the original coronavirus strain in Phase 3 trials, as compared with 96 percent for Novavax in its first trial, and now 90 percent against a mixture of variants.
Pandemic-vaccine success, as I wrote last year, was never just about the technology. You needed a good vaccine, sure—but to get it out the door quickly, you also had to have a massive clinical-trial operation going, and it had to be situated in places where the virus would be spreading widely at just the right time. Even if your candidate worked amazingly well, if you weren’t testing it in the middle of a huge outbreak, you’d have to wait a very long time for the evidence to build.
The precise timing of these studies mattered a great deal in practice. The Phase 3 clinical trials for Pfizer and Moderna, for example, were up and running in the U.S. by late summer 2020, and so they caught the nation’s giant wave of infections in the fall. By the time Novavax had finished recruiting in the U.S. and Mexico, in February, case rates had been dropping precipitously. This fact alone, independent of any aspect of vaccine technology, did a lot to shape the outcome.
Corporate strategy was another crucial factor. To “win” the vaccine race, a company would need to be able to produce high-quality vaccine doses reliably and quickly, and in vast numbers. It would also need to field the challenges of working with multiple regulatory agencies around the world. And it would need to do all of this at the same time.
BioNTech, the German company that developed the Pfizer mRNA vaccine, could not have accomplished so much, so quickly by itself. Last October, the company’s CEO, Uğur Şahin, told German interviewers that BioNTech had sought out Pfizer for help because of the scale of the clinical-trial program necessary for drug approvals. That strategic partnership, and not simply the “triumph of mRNA,” was what propelled them past the post. (Moderna had the advantage of its partnership with the National Institutes of Health.) Consider this: The BioNTech-Pfizer first-in-human vaccine study appeared on the U.S. government’s registry of clinical trials on April 30, 2020—the same day as the first-in-human vaccine study for Novavax, which would be going it alone. In a parallel universe where Novavax had paired up with, say, Merck, this story could have come out very differently.
In the meantime, the early success of two mRNA vaccines pulled attention away from the slower progress of other candidates based on the same technology. Just two days after last week’s Novavax announcement came the news that an mRNA vaccine developed by the German company CureVac had delivered a weak early efficacy rate in a Phase 3 trial, landing below even the 50 percent minimum level set by the World Health Organization and the FDA. “The results caught scientists by surprise,” The New York Times reported. CureVac is the company that President Donald Trump reportedly tried to lure to the U.S. early in the pandemic, and the one that Elon Musk said he would supply with automated “RNA microfactories” for vaccine production. In the end, none of this mattered. CureVac’s mRNA vaccine just doesn’t seem to be good enough.
The “sobering” struggles of CureVac perfectly illustrate what epidemiologists call “survivor bias”—a tendency to look only at positive examples and draw sweeping conclusions on their basis. When the Pfizer and Moderna vaccines triumphed, The Washington Post suggested that a bet on “speedy but risky” mRNA technology had paid off with a paradigm-shifting breakthrough. Anthony Fauci called the gamble “a spectacular success.” Such analyses usually had less to say about the non-mRNA vaccines that had gotten into clinical trials just as quickly—and about the other mRNA vaccines that were hitting snags along the way.
Now we’ve seen what happened to CureVac, and that some mRNA formulations clearly work much better than others. By one count, nine groups were testing mRNA COVID-19 vaccines in animal studies as of May 2020, and six were expected to be in clinical trials a few months later. By the end of the year, only BioNTech-Pfizer, Moderna, and CureVac had reached Phase 3 testing, compared with 13 non-mRNA vaccines. Of the nine mRNA-vaccine candidates that were already testing in animals in mid-2020, just two have proved efficacy at this point, while no fewer than nine vaccines based on more traditional technologies have reached the same mark.
These other, non-mRNA vaccines have been widely used throughout the world—and some could still make an important difference in the U.S. Although the U.S. has plenty of doses of the Pfizer and Moderna vaccines available right now, demand for them has cratered. The Washington Post reports that in 10 states, fewer than 35 percent of American adults have been vaccinated. An international study of COVID-19 vaccine misinformation, published in May, found that among the most common online rumors were those alleging particular dangers of mRNA technology—that it leads, for example, to the creation of “genetically modified human beings.” The CDC has also made a point of debunking the circulating falsehood that COVID-19 vaccines can change your DNA. For a time, it looked as though the Johnson & Johnson vaccine would help address this worry. It’s based on a fairly new technology, but not as new as mRNA. However, concerns about tainted doses made at a Baltimore factory and the emergence of a very rare but serious side effect have pretty much dashed that hope. The Johnson & Johnson single-dose vaccine has reportedly accounted for fewer than 4 percent of doses administered in the country.
In this context, the success of the Novavax vaccine should be A1 news. The recent results confirm that it has roughly the same efficacy as the two authorized mRNA vaccines, with the added benefit of being based on an older, more familiar science. The protein-subunit approach used by Novavax was first implemented for the hepatitis B vaccine, which has been used in the U.S. since 1986. The pertussis vaccine, which is required for almost all children in U.S. public schools, is also made this way. Some of those people who have been wary of getting the mRNA vaccines may find Novavax more appealing.
The Novavax vaccine also has a substantially lower rate of side effects than the authorized mRNA vaccines. Last week’s data showed that about 40 percent of people who receive Novavax report fatigue after the second dose, as compared with 65 percent for Moderna and more than 55 percent for Pfizer. Based on the results of Novavax’s first efficacy trial in the U.K., side effects (including but not limited to fatigue) aren’t just less frequent; they’re milder too. That’s a very big deal for people on hourly wages, who already bear a disproportionate risk of getting COVID-19, and who have been less likely to get vaccinated in part because of the risk of losing days of work to post-vaccine fever, pain, or malaise. Side effects are a big barrier for COVID-vaccine acceptance. The CDC reported on Monday that, according to a survey conducted in the spring, only about half of adults under the age of 40 have gotten the vaccine or definitely intend to do so, and that, among the rest, 56 percent say they are concerned about side effects. Lower rates of adverse events are likely to be a bigger issue still for parents, when considering vaccination for their children.
Practically speaking, this is true. If the FDA sees no urgency, the Novavax vaccine might not be available in the U.S. for months, and in the meantime the national supply of other doses exceeds demand. But the asymmetry in coverage also hints at how the hype around the early-bird vaccines from Pfizer and Moderna has distorted perception. Their rapid arrival has been described in this magazine as “the triumph of mRNA”—a brand-new vaccine technology whose “potential stretches far beyond this pandemic.” Other outlets gushed about “a turning point in the long history of vaccines,” one that “changed biotech forever.” It was easy to assume, based on all this reporting, that mRNA vaccines had already proved to be the most effective ones you could get—that they were better, sleeker, even cooler than any other vaccines could ever be.
But the fascination with the newest, shiniest options obscured some basic facts. These two particular mRNA vaccines may have been the first to get results from Phase 3 clinical trials, but that’s because of superior trial management, not secret vaccine sauce. For now, they are harder and more expensive to manufacture and distribute than traditional types of vaccines, and their side effects are more common and more severe. The latest Novavax data confirm that it’s possible to achieve the same efficacy against COVID-19 with a more familiar technology that more people may be inclined to trust. (The mRNA vaccines delivered efficacy rates of 95 and 94 percent against the original coronavirus strain in Phase 3 trials, as compared with 96 percent for Novavax in its first trial, and now 90 percent against a mixture of variants.
Pandemic-vaccine success, as I wrote last year, was never just about the technology. You needed a good vaccine, sure—but to get it out the door quickly, you also had to have a massive clinical-trial operation going, and it had to be situated in places where the virus would be spreading widely at just the right time. Even if your candidate worked amazingly well, if you weren’t testing it in the middle of a huge outbreak, you’d have to wait a very long time for the evidence to build.
The precise timing of these studies mattered a great deal in practice. The Phase 3 clinical trials for Pfizer and Moderna, for example, were up and running in the U.S. by late summer 2020, and so they caught the nation’s giant wave of infections in the fall. By the time Novavax had finished recruiting in the U.S. and Mexico, in February, case rates had been dropping precipitously. This fact alone, independent of any aspect of vaccine technology, did a lot to shape the outcome.
Corporate strategy was another crucial factor. To “win” the vaccine race, a company would need to be able to produce high-quality vaccine doses reliably and quickly, and in vast numbers. It would also need to field the challenges of working with multiple regulatory agencies around the world. And it would need to do all of this at the same time.
BioNTech, the German company that developed the Pfizer mRNA vaccine, could not have accomplished so much, so quickly by itself. Last October, the company’s CEO, Uğur Şahin, told German interviewers that BioNTech had sought out Pfizer for help because of the scale of the clinical-trial program necessary for drug approvals. That strategic partnership, and not simply the “triumph of mRNA,” was what propelled them past the post. (Moderna had the advantage of its partnership with the National Institutes of Health.) Consider this: The BioNTech-Pfizer first-in-human vaccine study appeared on the U.S. government’s registry of clinical trials on April 30, 2020—the same day as the first-in-human vaccine study for Novavax, which would be going it alone. In a parallel universe where Novavax had paired up with, say, Merck, this story could have come out very differently.
In the meantime, the early success of two mRNA vaccines pulled attention away from the slower progress of other candidates based on the same technology. Just two days after last week’s Novavax announcement came the news that an mRNA vaccine developed by the German company CureVac had delivered a weak early efficacy rate in a Phase 3 trial, landing below even the 50 percent minimum level set by the World Health Organization and the FDA. “The results caught scientists by surprise,” The New York Times reported. CureVac is the company that President Donald Trump reportedly tried to lure to the U.S. early in the pandemic, and the one that Elon Musk said he would supply with automated “RNA microfactories” for vaccine production. In the end, none of this mattered. CureVac’s mRNA vaccine just doesn’t seem to be good enough.
The “sobering” struggles of CureVac perfectly illustrate what epidemiologists call “survivor bias”—a tendency to look only at positive examples and draw sweeping conclusions on their basis. When the Pfizer and Moderna vaccines triumphed, The Washington Post suggested that a bet on “speedy but risky” mRNA technology had paid off with a paradigm-shifting breakthrough. Anthony Fauci called the gamble “a spectacular success.” Such analyses usually had less to say about the non-mRNA vaccines that had gotten into clinical trials just as quickly—and about the other mRNA vaccines that were hitting snags along the way.
Now we’ve seen what happened to CureVac, and that some mRNA formulations clearly work much better than others. By one count, nine groups were testing mRNA COVID-19 vaccines in animal studies as of May 2020, and six were expected to be in clinical trials a few months later. By the end of the year, only BioNTech-Pfizer, Moderna, and CureVac had reached Phase 3 testing, compared with 13 non-mRNA vaccines. Of the nine mRNA-vaccine candidates that were already testing in animals in mid-2020, just two have proved efficacy at this point, while no fewer than nine vaccines based on more traditional technologies have reached the same mark.
These other, non-mRNA vaccines have been widely used throughout the world—and some could still make an important difference in the U.S. Although the U.S. has plenty of doses of the Pfizer and Moderna vaccines available right now, demand for them has cratered. The Washington Post reports that in 10 states, fewer than 35 percent of American adults have been vaccinated. An international study of COVID-19 vaccine misinformation, published in May, found that among the most common online rumors were those alleging particular dangers of mRNA technology—that it leads, for example, to the creation of “genetically modified human beings.” The CDC has also made a point of debunking the circulating falsehood that COVID-19 vaccines can change your DNA. For a time, it looked as though the Johnson & Johnson vaccine would help address this worry. It’s based on a fairly new technology, but not as new as mRNA. However, concerns about tainted doses made at a Baltimore factory and the emergence of a very rare but serious side effect have pretty much dashed that hope. The Johnson & Johnson single-dose vaccine has reportedly accounted for fewer than 4 percent of doses administered in the country.
In this context, the success of the Novavax vaccine should be A1 news. The recent results confirm that it has roughly the same efficacy as the two authorized mRNA vaccines, with the added benefit of being based on an older, more familiar science. The protein-subunit approach used by Novavax was first implemented for the hepatitis B vaccine, which has been used in the U.S. since 1986. The pertussis vaccine, which is required for almost all children in U.S. public schools, is also made this way. Some of those people who have been wary of getting the mRNA vaccines may find Novavax more appealing.
The Novavax vaccine also has a substantially lower rate of side effects than the authorized mRNA vaccines. Last week’s data showed that about 40 percent of people who receive Novavax report fatigue after the second dose, as compared with 65 percent for Moderna and more than 55 percent for Pfizer. Based on the results of Novavax’s first efficacy trial in the U.K., side effects (including but not limited to fatigue) aren’t just less frequent; they’re milder too. That’s a very big deal for people on hourly wages, who already bear a disproportionate risk of getting COVID-19, and who have been less likely to get vaccinated in part because of the risk of losing days of work to post-vaccine fever, pain, or malaise. Side effects are a big barrier for COVID-vaccine acceptance. The CDC reported on Monday that, according to a survey conducted in the spring, only about half of adults under the age of 40 have gotten the vaccine or definitely intend to do so, and that, among the rest, 56 percent say they are concerned about side effects. Lower rates of adverse events are likely to be a bigger issue still for parents, when considering vaccination for their children.
Don’t get me wrong—the Pfizer and Moderna vaccines have been extraordinary lifesavers in this pandemic, and we may well be heading into a new golden age of vaccine development. (This week, BioNTech started injections in an early trial for an mRNA vaccine for melanoma.) But even the best experts at predicting which drugs are going to be important get things wrong quite a bit, overestimating some treatments and underestimating others. Pharmaceuticals are generally a gamble.
But here’s what we know today, based on information that we have right now: Among several wonderful options, the more old-school vaccine from Novavax combines ease of manufacture with high efficacy and lower side effects. For the moment, it’s the best COVID-19 vaccine we have.
Good news from Moderna booster vaccination fighting Omicron variant...?
"The company said a two-dose course of its vaccine generated low neutralizing antibodies against the Omicron variant, but a 50 microgram booster dose increased neutralizing antibodies against the variant 37 fold. A higher, 100 microgram booster dose of the same vaccine drove antibody levels even higher - more than 80 times pre-boost levels".
Most Covid Infections May Soon Be Breakthroughs. Here’s What That Means.
Omicron — the latest variant of SARS-CoV-2 — is steadily working its way through populations with high levels of immunity around the world. There are going to be many coronavirus cases in the coming days and weeks, with little to stop the spread, even if existing immunity can still prevent serious illness.
The United States, where Delta still reigns supreme for now, is reporting over 120,000 new daily coronavirus cases. In Britain, Omicron cases are surging.
In the United States, so-called breakthrough cases — infections among the vaccinated — were less common before Omicron, affecting just a small percentage of vaccinated people, by most counts. Now breakthrough cases among the vaccinated are fast becoming the status quo.
The highly contagious Omicron stands to make the notion of a surprise breakthrough infection “completely irrelevant,” said Ali Ellebedy, an associate professor of pathology and immunology at Washington University School of Medicine in St. Louis. This was always bound to happen: As more Americans get vaccinated and more variants circulate, more infections are expected among the vaccinated. But Omicron is speeding up the process.
So far, breakthrough cases have caused just a small fraction of the damage, compared to infections among the unvaccinated. “There are many flavors of infection,” said Marc Lipsitch, a professor of epidemiology at Harvard and the director of the Center for Communicable Disease Dynamics. There’s infection, which means the virus is replicating in one’s body, and there’s infectiousness, which means the virus is replicating in parts of the body in such a way that it could infect other people.
Initially, being fully vaccinated meant protection against most flavors of infection and their effects.
In September 2021, cases of Covid in unvaccinated people were about six times as high as the vaccinated, according to Centers for Disease Control and Prevention data. Deaths from Covid among the unvaccinated were also around 12 times as high as deaths from Covid among the vaccinated. Serious illness and hospitalizations were also less common among the vaccinated. And even when they became infected, the vaccinated appeared less likely to spread the virus to others.
But with Omicron, being fully vaccinated does not appear to provide the same level of protection, in terms of infection and transmission. While the vaccinated still appear likely to avoid serious illness, there remains a risk they will experience symptoms. They may also pass the virus to someone else.
But with Omicron, being fully vaccinated does not appear to provide the same level of protection, in terms of infection and transmission. While the vaccinated still appear likely to avoid serious illness, there remains a risk they will experience symptoms. They may also pass the virus to someone else.
With the ability to spread widely and quickly, Omicron is poised to become the dominant variant. It’s unclear how severe or mild Omicron is for someone who has not been vaccinated and thus has no coronavirus immunity. In the United States data suggest that around 61 percent of Americans of all ages are fully vaccinated. There are millions of Americans who are not vaccinated.
Hospitals are already overburdened by Delta patients, and the consequences of many infections in a short period will be increasingly deadly. Even cases among the vaccinated can still lead to long Covid.
Fortunately, there’s mounting evidence that a third shot, which the Food and Drug Administration authorized in November for all adults, can increase people’s defenses. But only around 28 percent of Americans have received a booster.
While policymakers are still urging people to do what they can to avoid spreading or contracting the virus, the response to Omicron has largely been to re-emphasize the need for boosters in order to bolster immunity against an infection that will be hard to keep at bay. More measures will likely be needed to lessen the toll on the health system. Rapid tests for every American could help prevent transmission by identifying infections early, for example.
With the eradication of Covid-19 off the table, the hope has been that one variant — in the best-case scenario, an innocuous one — would finally push the United States toward endemicity, a consistent but relatively contained level of infection. But the world will need a lot more immunity to get there. Ideally, people would be both vaccinated and regularly boosted so that they have protection against disease when they are exposed to any variant and at most feel they have a crummy cold and recover.
Annual shots, as with seasonal flu variants, and boosters, as with tetanus, have always been an accepted part of infectious disease prevention. And outside of the Covid pandemic, no one really speaks of breakthrough infections, though the term may still apply. In the future, getting Covid-19 boosters and breakthroughs will feel like the new normal, Dr. Ellebedy said.
While SARS-CoV-2 infections among the vaccinated may feel like a personal problem, they actually represent a societal and global one. In the United States, for example, the Delta variant has already pummeled health care infrastructure, putting strain on providers and making it more difficult for everyone from cancer patients to people experiencing appendicitis to seek care.
“We will continue to have variants of concern emerging as long as we have large swaths of the human population that are unprotected,” said the bioethicist Nancy Jecker, a professor at the University of Washington School of Medicine.
Every wave of the pandemic has posed its challenges, but Omicron offers the vaccinated a preview of one of the more frustrating aspects of endemicity: regular breakthroughs.
If it don't fit, your mask is shit, but add layer over layer over layer and now that's a mask!
Face mask fit modifications that improve source control performance
Highlights
•
Face masks reduce the expulsion of respiratory aerosols (called source control).
•
Poorly fitted masks allow respiratory aerosols to escape through face seal leaks.
•
Fit modifications improve the performance of face masks as source control devices.
•
Unmodified medical masks blocked ≥56% of cough aerosols and ≥42% of exhaled aerosols.
•
An elastic brace over a mask blocked ≥95% of cough and ≥99% of exhaled aerosols
Fear monger again! Soap slipping also affect all ages...
We have no death from CoV-19 at age below 30 point end. But we have some from vaccines age below 30...
But we have 10'000 deaths age >70 from CoV-19.
Sorry: you left out my point about the mortality/death rate curve being continuous. (Or is that that your knowledge of topology does not extend to such concepts).
There is no magic cutoff. Of course COVID is much less severe for younger people, but it remains a serious disease for some of them. Whereas the vaccines do not kill children (you are as many times before confusing VAERS reports of background illness with vaccine-caused illness).
For below-death things (more relevant) COVID can leave children out of action for a long time, missing school etc, the vaccine has very rare mild myocarditis which typically means a stay in hospital for 48 hours monitoring with the child feeling fine throughout. Just on the subject of heart disease, COVID, like most viral infections, causes occasional myocarditis. The rate and severity of this (in an unvaccinated population of children) is much higher than the equivalent for vaccines. So if your child has to risk COVID or vaccine, better vaccine.
If you reckon your child will not get COVID till the Novavax vaccine that Hilda likes (with reason), or any of the other new vaccines that end up working, are out, you could wait for them. That is quite a risk given how fast COVID variants go through school-age populations.
This is the equation to consider. By providing false figures you are encouraging parents and children not to get vaccinated now - and overall the risk calculus means that results in more deaths, and more illness. You are claiming under 30s should not get vaccinated (I think). If you were arguing over whether healthy 8 year olds would personally benefit - I would not worry - all risks are so low at that age it is not an issue. But 15 year olds, and above, the balance is very clear.
People are not good at comparing risks. You have consistently taken a stance different from almost all other scientists and observers of the science - and aligned with a very few ideological antivaxxers.
I don't think your posts here have any significant effect on people's behaviour, but if I did, I would be concerned.
Aspirate before you vaccinate
Good news from Moderna booster vaccination fighting Omicron variant...?
I recommend only Moderna for boosters as the second protein used in Moderna is not affected by the Omicron mutations and still should work.
Sorry: you left out my point about the mortality/death rate curve being continuous.
May be not in UK. Here Nobody age < 30 died so far from CoV-19 only a hand full age < 50. So there is a very clear cutoff. Unless you claim that a UK chemo patients that died with Corona died from corona...
Be aware that 50% of all PCR+ are fake! So death without deep analysis should not count!
Covid is an illness of the old.
https://www.experimental.bfs.a…vative-methoden/momo.html
We again see excess mortality among age group > 65. Nothing can be seen for age <65.
Same for death statistics. 158 deaths so far counted any only 7 are younger than 60 years. (week ending 12 December. They use a different grouping).
Why do I always need to check what W says? About his own country?
Since when has 322 = 7???
Compared with SARS-CoV2 wild type’s spike protein, the SARS-CoV2 omicron’s receptor binding motif has adopted a more SARS-CoV1 and/or bat/civet-like structure
Abstract
Our study focuses on free energy calculations of SARS-CoV2 spike protein receptor binding motives (RBMs) from wild type and variants-of-concern with particular emphasis on currently emerging SARS- CoV2 omicron variants of concern (VOC). Our computational free energy analysis underlines the occurrence of positive selection processes that specify omicron host adaption and bring changes on the molecular level into context with clinically relevant observations. Our free energy calculations studies regarding the interaction of omicron’s RBM with human ACE2 shows weaker binding to ACE2 than alpha’s, delta’s, or wild type’s RBM. Thus, less virus is predicted to be generated in time per infected cell. Our mutant analyses predict with focus on omicron variants a reduced spike-protein binding to ACE2-receptor protein possibly enhancing viral fitness / transmissibility and resulting in a delayed induction of danger signals as trade-off. Finally, more virus is produced but less per cell accompanied with delayed Covid-19 immunogenicity and pathogenicity. Regarding the latter, more virus is assumed to be required to initiate inflammatory immune responses.
South Africa Records Lowest Number of Covid Cases in Two Weeks
New infections dropped 44% from day earlier, data shows
Most new cases recorded in eastern KwaZulu-Natal province
South Africa’s daily coronavirus cases almost halved amid a fourth wave of infections fueled by the omicron variant.
The country recorded 8,515 new infections in the past 24 hours, data from the National Institute for Communicable Diseases showed Monday. That’s a 44% drop from a day earlier and the lowest number of daily infections since Dec. 6.
The cases were recorded with 29.9% of Covid-19 tests analyzed coming back positive, down from 30.7% a day earlier, the institute said.
At 29%, the majority of new cases were recorded in the coastal KwaZulu-Natal province, a popular destination for domestic tourists during the current summer holiday period, followed by the economic hub of Gauteng at 22%, the data showed. The two provinces make up almost 50% of South Africa’s economic output.
Covid-19 hospital admissions rose to 8,515 from 7,915 a day earlier, the NICD said in a separate report. The number of patients in need of intensive care remained unchanged at 6.7%.
