Category: Corona Virus Vaccine

United Airlines, which was one of the first major businesses to mandate vaccination against the coronavirus, will allow workers who were granted religious or medical exemptions from receiving a shot to return to their jobs at the end of this month.

About 2,200 United employees received exemptions last year. They were placed on unpaid leave or were moved to roles that did not involve in-person contact with customers. Those employees will be able to return to their normal positions on March 28.

We expect Covid case counts, hospitalizations and deaths to continue to decline nationally over the next few weeks, and, accordingly, we plan to welcome back those employees, Kirk Limacher, Uniteds vice president for human resources, said in a note to employees on Thursday.

The airlines plans were reported earlier by The Wall Street Journal.

United announced its vaccine mandate in early August, one of the first major corporations to do so. By October, nearly all of the airlines 67,000 employees had been inoculated in one of the largest and most successful corporate vaccination efforts at the time. About 200 employees were later fired for failing to comply with the policy, and all new hires are required to be vaccinated.

Since the beginning of the pandemic, Scott Kirby, the airlines chief executive, had written letters to the families of employees who had died from the virus, a practice that he once described as the worst thing that I believe I will ever do in my career. As the Delta variant began its spread over the summer, he decided to do something about it.

We concluded enough is enough, he said in an interview with The New York Times last year. People are dying, and we can do something to stop that.

In January, Mr. Kirby said the vaccine mandate had saved the lives of an estimated eight to 10 United employees since late September. In his note on Thursday, Mr. Limacher said vaccinated employees were remarkably safe compared with those who had been approved for an exemption, five of whom had died since November.

The nation is easing pandemic restrictions as the Omicron virus wave recedes. If a new variant emerges or case counts rise again, the airline may adjust course, Mr. Limacher said.

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United Airlines Workers With Vaccine Exemptions Can Return to Jobs - The New York Times

Estimating excess mortality due to the COVID-19 pandemic: a systematic analysis of COVID-19-related mortality, 202021  The Lancet

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Estimating excess mortality due to the COVID-19 pandemic: a systematic analysis of COVID-19-related mortality, 202021 - The Lancet

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POLL: DO ANY OF THE COVID VACCINES STOP OR EVEN HINDER the ...

G. Douaud, in collaboration with Anderson Winkler and Saad Jbabdi, University of Oxford and NIH.

CNN

People who have even a mild case of Covid-19 may have accelerated aging of the brain and other changes to it, according to a new study.

The study, published Monday in the journal Nature, is believed to be the largest of its kind. It found that the brains of those who had Covid-19 had a greater loss of gray matter and abnormalities in the brain tissue compared with those who didnt have Covid-19. Many of those changes were in the area of the brain related to the sense of smell.

We were quite surprised to see clear differences in the brain even with mild infection, lead author Gwenalle Douaud, an associate professor of neurosciences at the University of Oxford, told CNN in an email.

Douaud and her colleagues evaluated brain imaging from 401 people who had Covid-19 between March 2020 and April 2021, both before infection and an average of 4 months after infection. They compared the results with brain imaging of 384 uninfected people similar in age, socioeconomics and risk factors such as blood pressure and obesity. Of the 401 infected people, 15 had been hospitalized.

The 785 participants were between the ages of 51 and 81 and were all part of the UK Biobank, an ongoing government health database of 500,000 people begun in 2012.

Douaud explained that it is normal for people to lose 0.2% to 0.3% of gray matter every year in the memory-related areas of the brain as they age, but in the study evaluation, people who had been infected with the coronavirus lost an additional 0.2% to 2% of tissue compared with those who hadnt been infected.

In addition to imaging, the participants were tested for their executive and cognitive function using the Trail Making Test, a tool used to help detect cognitive impairments associated with dementia and test a persons brain processing speed and function. The researchers found that those who had the greatest brain tissue loss also performed the worst on this exam.

Although the areas of the brain most affected appear to be related to the olfactory system, Douaud said it wasnt clear why that was the case.

Since the abnormal changes we see in the infected participants brains might be partly related to their loss of smell, it is possible that recovering it might lead to these brain abnormalities becoming less marked over time. Similarly, it is likely that the harmful effects of the virus (whether direct, or indirect via inflammatory or immune reactions) decrease over time after infection. The best way to find out would be to scan these participants again in one or two years time, she said.

Douaud added that the researchers anticipate reimaging and testing the participants in one or two years.

And while the study finds some association between infection and brain function, its still not clear why. Previous studies have shown people with significant and repeated loss of smell also have an associated loss of gray matter. However, this study did not evaluate whether people actually had a loss of smell.

The authors cautioned that the findings were only of a moment in time but noted that they raise the possibility that longer-term consequences of SARS-CoV-2 infection might in time contribute to Alzheimers disease or other forms of dementia.

The findings were noticeable, but they werent enough to cause alarm, said Dr. Richard Isaacson, a neurologist and director of the Florida Atlantic University Center for Brain Health. Isaacson was not involved in the study.

Isaacson said the findings were noticeable for clinicians, but he added that the overall impact on individuals was difficult to determine and could be small. Its really hard to know the long-term clinical impact and quality of life impact in a situation like this, he said.

The brain may be affected by other mechanisms such as immune, inflammatory, vascular or psychological/behavioral change but not direct infection, said Dr. Alan Carson, a professor of neuropsychiatry at the Center for Clinical Brain Sciences at the University of Edinburgh, who was not involved in the study.

What this study almost certainly shows is the impact, in terms of neural changes, he said. But I dont think it helps us understand the mechanisms underpinning cognitive change after Covid infection.

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Study links even mild Covid-19 to changes in the brain - CNN

The coronavirus vaccine made by Pfizer-BioNTech is much less effective in preventing infection in children ages 5 to 11 years than in older adolescents or adults, according to a large new set of data collected by health officials in New York State a finding that has deep ramifications for these children and their parents.

The Pfizer vaccine is the only Covid shot authorized for that age group in the United States. It still prevents severe illness in the children, but offers virtually no protection against infection, even within a month after full immunization, the data, which were collected during the Omicron surge, suggest.

The sharp drop in the vaccines performance in young children may stem from the fact that they receive one-third the dose given to older children and adults, researchers and federal officials who have reviewed the data said.

The findings, which were posted online on Monday, come on the heels of clinical trial results indicating that the vaccine fared poorly in children aged 2 to 4 years, who received an even smaller dose.

Experts worried that the news would further dissuade hesitant parents from immunizing their children. Other studies have shown the vaccine was not powerfully protective against infection with the Omicron variant in adults, either.

Its disappointing, but not entirely surprising, given this is a vaccine developed in response to an earlier variant, said Eli Rosenberg, deputy director for science at the New York State Department of Health, who led the study. It looks very distressing to see this rapid decline, but its again all against Omicron.

Still, he and other public health experts said they recommend the shot for children given the protection against severe disease shown even in the new data set.

We need to make sure we emphasize the doughnut and not the hole, said Dr. Kathryn M. Edwards, a pediatric vaccine expert at Vanderbilt University.

In their study, Dr. Rosenberg and his colleagues analyzed data from 852,384 newly fully vaccinated children aged 12 to 17 years and 365,502 children aged 5 to 11 years between Dec. 13, 2021, and Jan. 31, 2022, the height of the Omicron surge.

The vaccines effectiveness against hospitalization declined to 73 percent from 85 percent in the older children. In the younger children, effectiveness dropped to 48 percent from 100 percent. But because few children were hospitalized, these estimates have wide margins of error.

The numbers for protection from infection are more reliable. Vaccine effectiveness against infection in the older children decreased to 51 percent from 66 percent. But in the younger children, it dropped sharply to just 12 percent from 68 percent.

The numbers change drastically between ages 11 and 12. During the week ending Jan. 30, the vaccines effectiveness against infection was 67 percent in 12-year-olds but just 11 percent in 11-year-old children.

The difference between the two age groups is striking, said Florian Krammer, an immunologist at the Icahn School of Medicine at Mount Sinai.

The biological difference between the two ages is likely to be minimal, but while 12-year-old children got 30 micrograms of the vaccine the same dose given to adults children who were 11 received only 10 micrograms, he noted.

This is super interesting because it would almost suggest that its the dose that makes the difference, he added. The question is how to fix that.

There have been at least 851 deaths involving Covid-19 in children under 17, and nearly 7,000 cases of multisystem inflammatory syndrome in children, a rare but serious condition associated with Covid. More children were hospitalized during the Omicron surge than at any other point in the pandemic.

The findings underscore the need to gather more information on the best dose, number and timing for the shots given to children, Dr. Rosenberg said. They also underscore vaccines as just one measure of protection from the virus, along with masks and social distancing, he said.

March 5, 2022, 7:14 p.m. ET

Dr. Rosenbergs research was posted just days after the Centers for Disease Control and Prevention released new recommendations that would allow the majority of Americans to stop wearing masks, including in schools.

The new data also raises important questions about the Biden administrations strategy for vaccinating children. Only about one in four children aged 5 to 11 years has received two doses of the vaccine. (The C.D.C. has not yet recommended booster doses for this age group.)

The vaccine has not yet been authorized for children younger than 5. Scientific advisers to the Food and Drug Administration were scheduled to meet on Feb. 15 to evaluate two doses of the vaccine for the youngest children, while three doses were still being tested. But the meeting was postponed after Pfizer submitted additional data suggesting two doses were not strongly protective against the Omicron variant of the virus.

Dr. Rosenberg briefed top C.D.C. officials, including Dr. Rochelle P. Walensky, the agencys director, with findings in early February. F.D.A. leaders learned of the data around the same time. Some federal scientists pushed for the data to be made public ahead of the F.D.A. expert meeting scheduled for Feb. 15, viewing it as highly relevant to the discussion about dosing in children under 5, federal officials and others familiar with their responses to it said.

The data is generally consistent with a report from Britain showing that vaccine effectiveness against symptomatic infection in adolescents aged 12 to 17 years drops to 23 percent after two months. The C.D.C. has been compiling its own data on the vaccines effectiveness in younger children and is expected to release at least some of it as early as this week, according to people familiar with the agencys plans.

Israeli researchers have also been assessing the vaccines performance in young children since the country made it available to them in November.

We continue to study and assess real-world data from the vaccine, Amy Rose, a spokeswoman for Pfizer, said in response to queries about the new data.

Mask guidance. The Centers for Disease Control and Prevention released updated data that suggests 90 percent of the U.S. population are in a location with low or medium Covid-19 community levels and can now stop wearing masks.

N.F.L. drops protocols. The National Football League and the players union agreed to suspend all Covid-19 protocols, effective immediately. The league, which is not in season, is the first of the major professional sports leagues in the United States to halt its coronavirus-related policies

Dr. Philip Krause, who recently retired from the F.D.A. as a senior vaccine regulator, said assumptions about certain antibody levels being predictive of vaccine effectiveness should be re-evaluated in light of the new results.

It certainly weakens the argument for mandating that people get that lower dose, he said.

It is not unusual for experts to revisit the dosing and interval for pediatric vaccines as more evidence becomes available. But in this case, giving the children a higher dose to kick up the immune response may not be an option because some data suggest that it may cause too many fevers, an unwelcome and potentially dangerous side effect in young children.

There are other alternatives that may improve immunity in young children, said Deepta Bhattacharya, an immunologist at the University of Arizona.

Pfizer and BioNTech are testing a third dose in children under 5, as well as in those aged 5 to 11, with the idea that, as in adults, an extra shot may significantly augment immunity. Results from these trials are expected in several weeks. Studies in adults suggest that three doses of the vaccine were more protective against the Omicron variant than two doses.

Dr. Bhattacharya said he and his wife spaced the two doses for their children, who are 8 and 10, by eight weeks rather than the currently recommended three, based on studies suggesting that a longer gap between doses may improve protection. The C.D.C. last week encouraged some people older than 12, especially boys and men between 12 to 39 years, to wait eight weeks between the first and second shot.

Another option may be a version of the vaccine designed to thwart the Omicron variant, or one that has a mix of several variants. Pfizer-BioNTech, Moderna and Johnson and Johnson are all testing Omicron-specific versions of their vaccines.

The next variant may differ widely from Omicron, much as Omicron did from the Delta variant. But training the body to recognize multiple versions would still offer a better chance at preventing infection with newer forms of the virus. Deciding when and how best to update these vaccines, I think thats really still the key conversation going forward here, Dr. Bhattacharya said.

Newer vaccines that use different approaches than the ones currently authorized in the United States may also work better for children. A protein-based vaccine made by Novavax is under review at the F.D.A., and the pharmaceutical companies Sanofi and GSK said this month that they plan to submit their vaccine for evaluation soon.

Many parents want to vaccinate their children to prevent them from spreading the virus to vulnerable relatives, to keep them in school or to avoid the possibility of long Covid, the poorly understood set of lingering symptoms that can occur even after a mild infection. Experts acknowledged that the vaccines low effectiveness against infection does not ease those concerns.

Still, the vaccines provide more protection than we think, said Jessica Andriesen, a vaccine data expert at the Fred Hutchinson Cancer Research Center in Seattle.

They may also make it so that your kid who brings home Covid isnt shedding virus as much as they would be if they werent vaccinated, and they also may have it for a shorter amount of time, she said.

The virus is here to stay, and childrens risk of severe outcomes increases with age. So inoculating children early is a good idea, said Paul Offit, director of the Vaccine Education Center at Childrens Hospital of Philadelphia and an adviser to the F.D.A.

The argument I make to parents when I talk to them about this vaccine is, your children are going to grow up, he said. Theyre going to need to be protected against this virus for years.

Sharon LaFraniere and Isabel Kershner contributed reporting.

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Pfizer Shot Is Far Less Effective in 5- to 11-Year-Olds Than in Older Kids, New Data Show - The New York Times

Few of Covid-19s peculiarities have piqued as much interest as anosmia, the abrupt loss of smell that has become a well-known hallmark of the disease. Covid patients lose this sense even without a stuffy nose; the loss can make food taste like cardboard and coffee smell noxious, occasionally persisting after other symptoms have resolved.

Scientists are now beginning to unravel the biological mechanisms, which have been something of a mystery: The neurons that detect odors lack the receptors that the coronavirus uses to enter cells, prompting a long debate about whether they can be infected at all.

Insights gleaned from new research could shed new light on how the coronavirus might affect other types of brain cells, leading to conditions like brain fog, and possibly help explain the biological mechanisms behind long Covid symptoms that linger for weeks or months after the initial infection.

The new work, along with earlier studies, settles the debate over whether the coronavirus infects the nerve cells that detect odors: It does not. But the virus does attack other supporting cells that line the nasal cavity, the researchers found.

The infected cells shed virus and die, while immune cells flood the region to fight the virus. The subsequent inflammation wreaks havoc on smell receptors, proteins on the surface of the nerve cells in the nose that detect and transmit information about odors.

The process alters the sophisticated organization of genes in those neurons, essentially short-circuiting them, the researchers reported.

Their paper significantly advances the understanding of how cells critical to the sense of smell are affected by the virus, despite the fact that they are not directly infected, said Dr. Sandeep Robert Datta, an associate professor of neurobiology at Harvard Medical School, who was not involved in the study.

Its clear that indirectly, if you affect the support cells in the nose, lots of bad things happen, Dr. Datta said. The inflammation in the adjacent cells triggers changes in the sensory neurons that prevent them from working properly.

Indeed, many complications of Covid appear to be caused by the immune systems friendly fire as it responds to infection by flooding the bloodstream with inflammatory proteins called cytokines, which can damage tissue and organs.

This might be a general principle: that a lot of what the virus is doing to us is a consequence of its ability to generate inflammation, Dr. Datta said.

March 3, 2022, 9:38 p.m. ET

The new study is based on research carried out at Zuckerman Institute and Irving Medical Center at Columbia University in New York; the New York University Grossman School of Medicine; the Icahn School of Medicine at Mount Sinai in New York; Baylor Genetics in Houston; and the School of Medicine at the University of California, Davis. The research was published online in Cell in early February.

The scientists examined golden hamsters and human tissue specimens from 23 patients who succumbed to Covid. After the hamsters were infected with the original coronavirus, scientists tracked the damage to their olfactory systems over time.

(How do you know a golden hamster has lost its sense of smell? You dont feed it for several hours and then bury Cocoa Puffs in its bedding, said Benjamin tenOever, a professor of microbiology at NYU Langone Health and an author of the new research. Hamsters that can smell will find the cereal in seconds.)

The virus did not invade neurons, the researchers learned, only the cells that play supporting roles in the olfactory system. But that was enough to alter the function of the nearby neurons, leading to a loss of smell.

New Zealands Covid reckoning. For much of the past two years, the coronavirus was a phantom presence in New Zealand. Now, the island nation is being hit by a major outbreak of the Omicron variant, with the virus spreading at an extremely fast rate.

N.F.L. drops protocols. The league and the players union agreed to suspend all Covid-19 protocols, effective immediately. The N.F.L., which is not in season, is the first of the major professional sports leagues in the United States to halt its coronavirus-related policies

The immune response altered the architecture of genes in the neurons, disrupting production of odor receptors, said Marianna Zazhytska, a postdoctoral fellow at the Zuckerman Institute and one of the papers first authors, along with a graduate student, Albana Kodra.

It is not the virus itself causing all this reorganization its the systemic inflammatory response, Dr. Zazhytska said. The nerve cells are not hosting the virus, but they are not doing what they did before.

The ability of the olfactory receptors to send and receive messages is disrupted. But the neurons dont die, and so the system can recover after the illness resolves.

Earlier work at the Zuckerman Institute showed that neurons that detect smells have complex genomic organizational structures that are essential to the creation of odor receptors, and the receptor genes communicate among themselves very intensively, said Stavros Lomvardas, one of the papers corresponding authors.

We saw early on that upon infection, the genomic organization of these neurons changes completely theyre unrecognizable compared to how they normally are, Dr. Lomvardas said.

There is a signal released from the infected cells that is received by the neurons that normally detect odors, and tells them to reorganize and stop expression of olfactory receptor genes, he said.

He suggested this may represent an evolutionary adaptation that offers a form of antiviral resistance and whose main purpose may be to prevent the virus from entering the brain. That was a relief for us, he said. That was one piece of good news.

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How the Coronavirus Steals the Sense of Smell - The New York Times

'Pancorona virus vaccine will combat all corona virus variants: Dr Drew Weissman

Hyderabad, Feb 24 (UNI) BioAsia 2022 Genome Valley Excellence Award recipient, Dr. Weissman on Thursday said we are making a ' pancorona virus' vaccine which will protect against all coronavirus variants.The 19th edition of BioAsia, on its inaugural day held in virtual mode Thursday , held a special fireside chat, which witnessed a revolutionary revelation on the future of the coronavirus vaccination by Dr. Drew Weissman.In a conversation with Apollo Hospitals Managing Director Dr. Sangita Reddy, Dr Wissman elaborate extensively on the pancorona viruses, the state of costs in healthcare, and the future of mRNA in therapeutics.There have been three coronavirus epidemics in last years and there are going to be more. So, we want to create a vaccine that will stop any coronavirus from infecting humans. We are developing a few and they look promising, he said.The future of mRNA technology is noted to be tremendously promising, with an array of uses. It can also be used in therapeutics, he said.Dr. Weissman and his lab envision developing mRNA therapy for neurologic events, strokes, embolic events, as a way for reducing inflammation. My biggest hope is its use in gene therapy. Someday, it might be possible to treat genetic diseases like Cystic fibrosis, he told.Dr. Weissman also indicated an optimistic outlook for India in terms of collaborations to build mRNA production sites. In his closing remarks, he voiced strongly against the misinformation on vaccines.He said On a societal and systematic level, equality of therapeutics is important. Cost being the main problem, government and privately funded research can magnanimously help in bringing down costs and make it accessible across the world.A globally renowned researcher in mRNA technology for the rapid development of effective COVID-19 vaccines, Dr. Weissman, in collaboration with Dr. Katalin Karik, discovered the ability of modified nucleosides in RNA to suppress activation of the innate immune sensors and increase the translation of the nucleoside-modified mRNA. This outstanding discovery was used in the first two approved COVID-19 vaccines by Pfizer and Moderna.The striking result of the modified RNA vaccines was the incredibly high efficacy.Within 12- days of the second dose, the infections in the vaccinated people were extinct, with nearly 95 percent efficacy, he said. When you inject mRNA, it kills the tissue due to severe inflammation. But we developed a new type of RNA that is not inflammatory this RNA used in vaccines is incredibly effective and safe, the researchers said.Over a billion people have received the RNA vaccines so far and there have been almost no adverse events, he said during BioAsia 2022.RNA is a complex molecule that is simple to make, making it an ideal, cost-effective technology to introduce to other vaccine development.Dr. Weissman continues to develop other vaccines to induce potent antibody and T-cell responses with mRNA-based vaccines.Speaking on the development of future vaccines, he said, We are working on many different vaccines for a variety of pathogens including HIV, HCV, HSV, Malaria, Influenza, and pancorona viruses. We are also working on vaccines for food allergies, cancer vaccines, autoimmune diseases, therapeutics and In vivo gene therapy.Dr. Weissman observed that Coronavirus like any other RNA viruses is prone to a lot of mutations. The variants are going to keep coming as long as there's widespread infection. We have only vaccinated 15 percent of Africa and we've immunized low levels of many countries in the world. Until the world is fully vaccinated, the virus will continue to mutate, he stated.There are 2 options here, observes Dr. Weissman, you can keep making new vaccines every time there is a new variant. But it is important to note the low life span of these variants to keep up with this cycle, he added.UNI KNR SY 1531

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'Pancorona virus vaccine will combat all corona virus ...

One shot, two shot; red shot, blue shot. The vaccines might not have been successful in slowing the spread of SARS-CoV-2 one iota, but they were successful in earning profits for the manufacturers. Logically, they would like to repeat this pleasurable experience with other viruses safety, past failures, and common sense be damned.

If you like the success of the mRNA vaccines against SARS-CoV-2 in stopping the virus, you will love the slate of new mRNA vaccines coming to a neighborhood near you, according to Modernas CEO. Once upon a time, we could rely on our government and even the pharmaceutical companies to abort efforts to pursue failed vaccines when they proved to be dangerous during clinical trials, such as with the attempted dengue fever and RSV vaccines. Now that they plan to develop more vaccines by 2023, do you really have the confidence that they will still act upon dangerous safety signals?

During a World Economic Forum panel discussion last week titled, COVID-19: Whats Next? Moderna CEO Stphane Bancel revealed (at 7:20) the next step of the vaccine wars:

When moderator Francine Lacqua asked Bancel how close the company is to achieving this goal, here was his response:

So the RSV program is now in Phase 3, the flu program is in Phase 2 and soon in Phase 3, I hope as soon as second quarter of this year. So the best-case scenario would be the fall of 2023, as a best-case scenario, I dont think it would be in every country, but we believe its possible to operate in some countries next year.

Judging by the past two years, this means that no number of negative safety signals will stop this shot. After all, they want to make sure there are no compliance issues.

The public needs to be aware of the fact that there is no effective vaccine against respiratory viruses. We now see that the COVID vaccines never stopped transmission and likely turned negative after a few months, which is why they pushed the boosters and Fauci is now floating a second booster. Flu shots as well are spotty at best. One could not possibly conjure up a worse collection of illnesses for which to pursue vaccines. Respiratory virus vaccines have always failed in the past, and now we know why. Both the RSV and dengue fever vaccines have failed because they created antibody-dependent disease enhancement (ADE), where they made the vaccinated sicker from the pathogen.

Childrens Hospital of Philadelphia (CHOP) has a page on its website about ADE and its history with the failed RSV and dengue fever vaccines. ADE occurs when the antibodies generated during an immune response recognize and bind to a pathogen, but they are unable to prevent infection, writes CHOP. Instead, these antibodies act as a Trojan horse, allowing the pathogen to get into cells and exacerbate the immune response.

Sound familiar? What recent vaccine do we know failed to stop transmission and in fact, in later months, caused the vaccinated to get infected at higher rates? Oh, thats right, a coronavirus vaccine.

CHOP explains that this is exactly what happened with the failed RSV vaccine in 1967:

In clinical trials, children who were given the vaccine were more likely to develop or die from pneumonia after infection with RSV. As a result of this finding, the vaccine trials stopped, and the vaccine was never submitted for approval or released to the public.

Indeed, the RSV vaccine was an utter disaster, resulting in the hospitalization of 80% of the infants and toddlers in the clinical trial. There has not been a successful RSV vaccine since then.

This was back when we actually nixed dangerous vaccines. Do you have any confidence that the company would respond in kind and be transparent about it today were the trials to pick up inchoate signs of injuries, ADE, or leaky vaccine hypothesis?

More recently, in 2016, hundreds of thousands of children in the Philippines were injected with a vaccine that made some of them very sick. Fourteen children reportedly died. The concern at the time was that those without prior infection wound up getting more seriously ill from the pathogen after having had the vaccine, which is why the shot is only available today for those who, ironically, already had the disease.

In other words, ADE is a real concern with respiratory virus vaccines, especially one of them mentioned by Bancel. Lets not forget that on page 52 of the FDA's "Emergency Use Authorization (EUA) for an Unapproved Product Review Memorandum," it states that there appears to be no concern of ADE in the short run (during the original strain), but "risk of vaccine-enhanced disease over time, potentially associated with waning immunity, remains unknown and needs to be evaluated further in ongoing clinical trials and in observational studies that could be conducted following authorization and/or licensure."

Well, why is this not revisited a year later, now that everyone agrees there is waning immunity?! We see record infections across the board, a higher rate of infection among the vaccinated, waning immunity, and a need for endless boosters, and we know they never ruled out ADE, by their own admission. Yet now they want to tether this vaccine to yet another respiratory virus that already had a proven manifestation of ADE in a failed vaccine candidate!

The other candidate for the mRNA deluxe triple combo is an annual influenza vaccine. But we already know that the flu vaccine is clearly non-sterilizing, and furthermore, there is already evidence of instances of negative efficacy. A Canadian study published in Euro Surveillance just days before the start of the coronavirus pandemic found a -346% vaccine efficacy rate of the flu shot for those ages 35-54 during the 2018-19 late-season influenza A(H3N2) epidemic. H3N2 is the predominant flu circulating this season. Clade 3C.3a VE showed a pronounced negative dip among 3554-year-olds in whom the odds of medically attended illness were>4-fold increased for vaccinated vs unvaccinated participants (p<0.005), concluded the authors.

Shouldnt we have an independent audit of consumer advocates studying these vaccines before we allow the government and the people who stand to make billions of dollars foist them upon us with liability protection?

Fauci himself was also a speaker at this forum with Bancel. Lets not forget that at the beginning of the pandemic, he warned that part of the safety concern of a rushed vaccine is that it might make the pathogen worse. Theres another element to safety, and that is: If you vaccinate someone and they make an antibody response, and then they get exposed and infected, does the response that you induced actually enhance the infection and make it worse? warned Fauci in an interview with Facebook CEO Mark Zuckerberg in March 2020. In cautioning why you cant just produce a vaccine out of thin air, Fauci explained, The only way youll know that [if the vaccine makes the pathogen worse] is if you do an extended study, not in a normal volunteer who has no risk of infection, but in people who are out there in a risk situation. This would not be the first time, if it happened, that a vaccine that looked good in initial safety actually made people worse.

Which example did he give? The very virus for which Moderna is now working on an mRNA vaccine. There was a history of the respiratory syncytial virus vaccine in children which, paradoxically, made the children worse, continued Fauci. One of the HIV vaccines that we tested several years ago actually made individuals more likely to get infected. So, you cant just go out there and give it unless you feel that, in the field, when someone is getting infected and exposed, being vaccinated doesnt make them worse.

During the forum with Fauci, the Moderna CEO said he is collaborating with Dr. Faucis team on this proposed triple combo vaccine. He also said (at 44:01) that he would be working on targeting 20 other pathogens, including Nipah and Zika. All of these vaccines for respiratory viruses run the risk of causing some form of ADE and original antigenic sin, especially if the new modus operandi is to release them to the public before conducting studies that rule out these pernicious unintended consequences of imperfect vaccines.

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Horowitz: Moderna CEO promises triple combo corona/flu/RSV ...

CNN

Plummeting Covid-19 case counts across the United States are leading to lifted mask mandates and more conversations about steps toward normalcy but more people are dying of the coronavirus now than during most points of the pandemic.

More than 2,000 Covid-19 deaths have been reported in the United States each day for the past month. Average daily deaths are falling, but from a very high point. They dipped just below that mark in recent days, to about 1,900 on Monday; the federal holiday may have delayed reporting.

Before Omicron became the dominant coronavirus strain in the US, there were only about 100 other days when there were more than 2,000 Covid-19 deaths, according to data from Johns Hopkins University.

The only other time that deaths have been this high for this long was during the first winter surge, before vaccines were available. The Omicron wave has also been deadlier for longer than the Delta surge: In September, when Delta was dominant, average daily deaths topped 2,000 for half as long.

More than 120,000 people in the US have died of Covid-19 since Omicron became the dominant variant in December, and Covid-19 has accounted for more than 1 in 5 deaths reported in 2022.

A common refrain early in the pandemic was that Covid-19 was most deadly for the elderly and people with certain health conditions. The people dying from Covid-19 now tend to be younger than before, and theyre overwhelmingly unvaccinated, experts say.

Ive long since lost track of the number of people Ive seen die of the disease, but the reality is that almost everybody who is critically ill, in the ICU or dying now remains unvaccinated. That has been true since the beginning. But in the beginning, people didnt have the opportunity to be vaccinated, said Dr. Stephen Threlkeld, medical director of the infectious diseases program at Baptist Memorial Health Care in Memphis.

None of us taking care of Covid patients need CDC statistics or anyone else to tell us that, because we simply see that reality play out every day and have for quite some time.

But the data from the US Centers for Disease Control and Prevention is clear. In December, the risk of dying from Covid-19 was 14 times higher for unvaccinated adults than it was for adults who were fully vaccinated with their initial series. The gap was even larger when looking at those who also got their booster shot: 51 times higher.

Throughout the pandemic, the majority of Covid-19 deaths have happened in hospitals. But that share is even larger now, as nursing homes have become less of a hotspot. In 2020, more than 1 in 5 Covid-19 deaths was in a nursing home. But in 2022, fewer than 1 in 10 deaths have been in nursing homes, according to provisional data from the CDC.

Vaccination rates are higher among older people in the US, leaving a larger share of younger, unvaccinated people at higher risk for severe outcomes.

Nearly 90% of seniors 65 and older are fully vaccinated with their initial vaccine series, and about two-thirds of those eligible have gotten their booster shot. But less than two-thirds of adults under the age of 40 and less than a third of children are fully vaccinated.

And the vaccines are working. Seniors accounted for 81% of Covid-19 deaths in 2020, a number that dropped to 69% in 2021 and has stayed at 76% so far in 2022, despite the increased risk for breakthrough infection amid exponential community spread.

The virus simply went to the fuel that it had remaining, Threlkeld said.

Racial disparities in Covid-19 deaths persist, but have decreased over time. Black, Hispanic and American Indian people are still about twice as likely to die of Covid-19 than White people, but that risk has fallen from about three times higher at the end of 2020.

And White people, who are less likely to be vaccinated than Hispanic people, have accounted for a growing share of deaths recently. An analysis by the Kaiser Family Foundation found that early in the Omicron surge, the death rate for Hispanic people remained lower than the rate for White people, but death rates among Black people rose.

And as the virus spread rapidly throughout the country, social determinants of health have started to play a larger role in who becomes seriously ill and dies from Covid-19.

Delta was much more deadly. But Omicron is so widespread, said Dr. Faisal Masud, director of the critical care center at Houston Methodist.

Extremely high transmission rates mean the virus is reaching everyone, but its hitting those from disadvantaged neighborhoods especially hard, he said. These are the people who are more likely to be uninsured and who may delay care, leaving chronic conditions such as diabetes and hypertension untreated.

Patients who start with poor health come at a disadvantage, he said.

Texas has reported more Covid-19 deaths than any other state in the past week and is on track to soon outpace California in terms of total Covid-19 deaths. Its important to note the significant differences in health insurance rates and vaccination rates in the two states, Masud said. More than 70% of Californians are fully vaccinated, compared with about 60% of Texans, according to CDC data.

Overall, the proportion of Omicron cases that have resulted in deaths appears to be lower than the case-mortality ratio for Delta.

But its a denominator phenomenon, Threlkeld said, meaning a lower percentage of a much larger number is still going to be large.

I think thats what people have forgotten: Just because something is a little less likely in a given person to cause severe disease, there are so many more people whove contracted this infection that youre going to have a lot of people who are ill, he said.

Weve certainly seen a lot of unvaccinated people whove done very poorly.

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Think back to late June 2021, when there was containment of the American COVID-19 pandemic with fewer than 12,000 new cases a day and a total of 15,000 patients in the hospital. There was a declaration of independence from the virus on July 4, just as the Delta variant was starting its exponential growth. A major surge ensued, which was followed by yet another one with the Omicron variant, peaking with nearly 160,000 people hospitalized and almost 2,700 deaths per day the most deaths since vaccinations became widely available.

Even now, as we are descending from the Omicron wave, we still have more than 60,000 patients in the hospital and more than 2,000 deaths per day.

The SARS-CoV-2 virus is still with us and is adroit at finding new ways to infect us at scale. As it evolved from the original strain in late 2019, and progressed to the Alpha and Delta variants, it became more virulent and infectious, not less. There is a misconception that the virus is destined to evolve to a more benign form. If weve learned anything from the pandemic, its that the virus has an extraordinary ability to adapt and it is unpredictable.

You can just look at the more than 50 new mutations present in Omicron to know there are seemingly infinite ways for it to further mutate and rearrange the 30,000 base pairs in its genome. Although wed be fortunate for it to morph into a common cold coronavirus cousin, we certainly cant count on that. There are just too many vulnerable hosts out there for more evolution of the virus to take place, including a wide variety of animals, with potential to spill over to humans.

There are more than 7 million Americans who are immunocompromised, who are not only highly vulnerable to infections, but also may provide an opportunity for the virus to evolve inside a person and then infect others. That path may indeed be the way Omicron was created and spread.

Around the world, there are billions of people unvaccinated and likely without any protection from prior infection. In the U.S., there are more than 19 million children under the age 5 for whom there is no vaccine approved, and tens of millions of people have not been vaccinated. We currently rank 67th in the world for being fully vaccinated and 54th for having its population get an all-important booster shot that preserves a high level of protection against hospitalizations and deaths. When the virus is not contained, as is the case in the world now, its spread creates the potential for new variants.

In these new hosts, the virus could possibly evolve to a new, more deleterious version that attaches better and infects other organs, like the heart or gastrointestinal tract, instead of the lungs. We have already seen people with simultaneous co-infections of two different variants, which enables the swapping of RNA between them and generating a hybrid, potentially worse version of the virus. That swap could also be between an animal and human source, akin to human and bird flu recombination.

The result would be much more difficult for humans to recognize, overriding protection from our spike-protein vaccines or infection-induced immunity. While unlikely, full immune escape by a new variant would put us back to square one of the pandemic.

Even if these scenarios dont materialize, lets remember that Omicron, despite being characterized as a milder form of the virus, can still be deadly for people without immunity. The original Omicron known as BA.1 has sister variants, including BA.2 and BA.3, each with many new and different mutations. A recent study in a lab using an animal model suggested that BA.2 is more disease-causing and more immune-evasive than BA.1.

BA.2 has spread rapidly in some countries such as Denmark, South Africa, India and Sweden. However, all the data to date for BA.2 in people do not support any sign of worse disease or lack of protection from vaccines. BA.2 is not gaining legs in the U.S., but the explanations for this and for the rapid decline of Omicron in many countries remain elusive. At this moment, it does not look like BA.2 poses a threat as a major new variant, but it would not be surprising if we see another variant in future months that deserves a separate Greek letter designation.

The good news is that were probably moving to a relatively quiescent phase, with low numbers of cases and limited severe disease, representing containment of the virus. That is not the same as the pandemic being over. Unfortunately, when states or countries proclaim that we just need to live with the virus and end all restrictions, many people interpret that message as meaning the pandemic is actually over for good. That would be a fantasy given the myriad opportunities for the virus to haunt us in the months and years ahead.

We have been extraordinarily lucky to date getting such highly effective vaccines into the arms of billions of people in a time frame that would never have been considered possible before. These vaccines, with boosters, have held up solidly, protecting vaccinated people against severe disease even though they are directed toward the original strain of the SARS-CoV-2 virus.

Lets hope our luck does not run out. Getting prepared for worst-case scenarios is our best defense, with better genomic, wastewater and digital tracking of the virus, and bolstering protection with everything from better air filtration to accelerating efforts for a variant-proof, pan-coronavirus vaccine. Better to be smart against this formidable virus than lucky.

Eric J. Topol is a professor of molecular medicine at Scripps Research and author of the newsletter Ground Truths.

Read more from the original source:

Op-Ed: Omicron won't be the last coronavirus variant to haunt us - Los Angeles Times