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South African doctor who first spotted the Covid omicron variant says symptoms seem 'mild' so far
By Holly Ellyatt | Nov 29 2021



Covid symptoms linked to the new omicron variant have been described as "extremely mild" by the South African doctor who first raised the alarm over the new strain.

Dr. Angelique Coetzee, chair of the South African Medical Association, told the BBC on Sunday that she started to see patients around Nov.18 presenting with "unusual symptoms" that differed slightly from those associated with the delta variant, which is the most virulent strain of the virus to date and globally dominant.

"It actually started with a male patient who's around the age of 33 ... and he said to me that he's just [been] extremely tired for the past few days and he's got these body aches and pains with a bit of a headache," she told the BBC.

The patient didn't have a sore throat, she said, but more of a "scratchy throat" but no cough or loss of taste or smell — symptoms that have been associated with previous strains of the coronavirus.

Coetzee said she tested the male patient for Covid, and he was positive, as was his family, and then said she saw more patients that day presenting with the same kinds of symptoms that differed from the delta variant.

This prompted her to raise the alarm with South Africa's vaccine advisory committee, of which she is a member.

Other patients Coetzee had seen so far with the omicron variant had also experienced what she described as "extremely mild" symptoms, and she added that her colleagues had noted similar cases.

"What we are seeing clinically in South Africa — and remember I'm at the epicenter of this where I'm practicing — is extremely mild, for us [these are] mild cases. We haven't admitted anyone, I've spoken to other colleagues of mine and they give the same picture."

Investigations ongoing

The WHO has said it will take weeks to understand how the variant may affect diagnostics, therapeutics and vaccines.

Coetzee's initial observations are only based on a very small number of cases and experts are worried about omicron's large number of mutations. Preliminary evidence suggests the strain has an increased risk of reinfection, according to the WHO.

Early data suggests that the variant is spreading in South Africa more rapidly than previous strains did and that the variant, known formally as B.1.1.529, could be starting to trigger a new wave of infections, according to analysis by the Financial Times.

It could take a while to fully understand what specific symptoms, if any, are attributable to the new omicron variant on a wider scale.

Covid symptoms have changed since the virus first emerged in China in late 2019. The "alpha" and "delta" variants, first discovered in the U.K. and India, respectively, were seen to cause different symptoms, for example, with the latter causing more headaches, sore throat, runny nose and fever.

The U.S. CDC has highlighted the variety of Covid symptoms that have been reported, noting "anyone can have mild to severe symptoms" that may appear two to 14 days after exposure to the virus.

On the list of symptoms from the CDC are fever or chills, a cough, fatigue, shortness of breath or difficulty breathing, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or a runny nose, nausea or vomiting and diarrhea.

Unnecessary panic?

A swath of countries has now temporarily banned travel from several southern African countries where the variant has been found, a move slammed as a "knee-jerk, draconian" reaction by South Africa's health minister on Friday.

Asked by the BBC's Andrew Marr whether countries like the U.S., U.K., Israel and EU were "panicking unnecessarily," Coetzee stressed that the omicron variant had already likely spread to those nations.

"I think you already have it there in your country without even knowing it so I would say at this stage, definitely. Two weeks on, maybe we will say something different," she added.

Margaret Harris, spokesperson for the WHO, told CNBC on Monday that "we have South Africa to thank" for raising the alarm over the new variant, which has already been found in the U.K., France, Israel, Belgium, the Netherlands, Germany, Italy, Australia, Canada and Hong Kong, but not yet in the U.S.

Harris said the organization didn't like to see travel restrictions but understood that countries needed to take precautions based on their own epidemiological situations and risk-based analysis of the current data.

The U.N. health agency said Monday that the delta variant is still responsible for most of the current infections globally and, as such, was still its biggest concern.

"Over 99% of cases around the world are due to the delta variant and more deaths are occurring in the unvaccinated," WHO Chief Scientist Dr. Soumya Swaminathan told CNBC's "Squawk Box Asia" on Monday.

"I think that's our priority while we wait to find out more about [the omicron] variant."

Whether fresh restrictions and lockdowns might have to be introduced to counteract this new variant remain to be seen, experts say.

"The big issue and the big uncertainty is how severe illness will be with this new variant. There are signs from South Africa that, maybe, the illness is less severe than with delta but we don't really know if that is the case, and if it is, why that's happening," Paul Hunter, professor of medicine at the Norwich School of Medicine at the University of East Anglia, told CNBC on Monday.

"Maybe that's because it's reinfecting people who have already got some degree of immunity," he added. "If it generally is causing mild disease and if, as I suspect, the booster campaign will go a long way to still reduce hospitalizations and deaths, hopefully we won't have to live under restrictions again."

https://www.cnbc.com/amp/2021/11/29/omicron-covid-variant-symptoms-heres-what-we-know-so-far.html


One can only hope, but we need more data


Yup she’s only referencing built African alphas in a land where the genetically weak succumb to death.

Overweight chubbies and grandma who’s on 20 different prescriptions to stay alive still at risk.

Shut her back down
 
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Israel's Health Minister on first signs that vaccine protects against Omicron
By ROSSELLA TERCATIN, MAAYAN JAFFE-HOFFMAN | DECEMBER 1, 2021

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So far, Israel has registered four cases infected with the new variant, while general morbidity remains low.

There are indications that individuals fully vaccinated against corona within six months or with the booster are also protected against the Omicron variant, Health Minister Nitzan Horowitz said on Tuesday, after another two cases were identified, bringing the total to four.

“In the coming days we will have more accurate information about the efficacy of the vaccine against Omicron, but there is already room for optimism, and there are initial indications that those who are vaccinated with a vaccine still valid or with a booster will also be protected from this variant,” Horowitz said while visiting the Soroka Medical Center in Beersheba with Finance Minister Avigdor Liberman.

“The vaccine is really crucial right now,” said Horowitz. “Anyone who is exposed to the variant without a vaccine will put themselves at unnecessary risk.”

Later in the evening, a report by Channel 12 said the Pfizer vaccine is just slightly less effective in preventing infection with Omicron than with Delta – 90% as opposed to 95% – while it is as effective – around 93% – in preventing serious symptoms at least for those vaccinated with a booster.

According to the report, the ability of the variant to infect is higher than Delta but not as much as feared – around 1.3 times higher.

At the same time, those not inoculated have a 2.4 times greater chance of developing serious symptoms, a significant figure.

A spokesperson for the Health Ministry said the ministry was not yet in possession of the data published by Channel 12.

Head of Public Health Services Dr. Sharon Alroy-Preis said the first data about the efficacy of the corona vaccines against Omicron were expected to be shared with Israel by South Africa on Tuesday. However, the ministry had not yet received the information as of press time.

“The greatest concern for us is the very rapid spread of this variant in South Africa,” Alroy-Preis told the Knesset Foreign Affairs Committee, describing how the daily cases there rose from 200 cases to 2,000 cases in 10 days.

“From what we hear, those vaccinated do not have significant symptoms, it is a mild disease, but for now this is preliminary information,” she noted. “Today there will be the first data on the efficacy of the vaccine.”

https://m.jpost.com/health-and-well...y-against-omicron-expected-tuesday-687392/amp
 
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Most Omicron cases are 'mild', says WHO official
Wednesday 1 December 2021
Early indications suggest most Omicron coronavirus cases are "mild", an official at the World Health Organisation (WHO) has said.

Speaking on behalf of the organisation, the official said there is no evidence to suggest the efficacy of vaccines has been reduced by the new strain - but did say some mutations of the virus indicate an increased risk of quicker transmission.

They said more than 40 different mutations have been identified with the Omicron variant.

The WHO official, quoted by Reuters, added there is still a lot unknown about the new strain.

A top official in Botswana's health ministry said on Tuesday that 16 out of the 19 cases of the Omicron variant detected in the country were asymptomatic.

Giving evidence at the government's science and technology committee on Wednesday, Professor Neil Ferguson, said it could be towards "the end of the month" before there is a clearer picture of how worrying Omicron is.

He said: "Viruses will evolve to become more transmissible.

"They can do this by becoming more intrinsically transmissible, more infectious like the Alpha variant was compared with the original strain of COVID, like the Delta variant was more infectious, in the highly immune population they can gain transmissibility by evading immunity.

"It looks like, but we haven't had it proven yet, the Omicron variant may confirm to be that latter type of evolution."

He added: "What we have seen is Alpha has been more severe than the previous strain, a little, and Delta more severe again, so the trend we've seen is greater severity, not less severity - thankfully countered by better treatment by monoclonal antibodies, antivirals and all the other drugs, that mean people have a better chance of surviving severe COVID today than they did at the start of the pandemic."

https://news.sky.com/story/covid-19...fective-against-the-variant-says-who-12483729
 
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First image of Omicron shows many more mutations than Delta
By AFP | 29 November 2021

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The new Covid variant Omicron has many more mutations than the Delta variant, according to a first “image” of this new variant initially detected in South Africa, produced and published by the prestigious Bambino Gesu hospital in Rome.

On the three-dimensional “image”, which looks like a map, “we can clearly see that the Omicron variant presents many more mutations than the Delta variant, concentrated above all in one area of the protein that interacts with human cells”, the team of researchers said in a statement Sunday.

“This does not automatically mean that these variations are more dangerous, just that the virus has further adapted to the human species by generating another variant,” the researchers said.

“Other studies will tell us if this adaptation is neutral, less dangerous or more dangerous,” they added.

The research team focused on the search for mutations in “the three-dimensional structure of the spike protein”, Claudia Alteri, professor of clinical microbiology at Milan State University and a researcher at Bambino Gesu, told AFP.

The image was produced “from the study of the sequences of this new variant made available to the scientific community” coming mainly “from Botswana, South Africa and Hong Kong.”

“This image, which represents a map of all the variations, describes the mutations of Omicron but does not define its role,” she said.

“It will now be important to define through laboratory experiments whether the combination of these mutations can have an impact on transmission or on the effectiveness of vaccines, for example,” she added.

https://www.timesofisrael.com/first-image-of-omicron-shows-many-more-mutations-than-delta/amp/
 
How Israeli Scientists Are Trying to Determine COVID Vaccine Efficiency Against Omicron
The COVID omicron genome includes about 50 mutations that did not exist in the original version of the virus, and 32 of them are in the spike protein that binds the virus to cells in the body
By Ido Efrati | Dec. 2, 2021

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What is the level of effectiveness of current coronavirus vaccines against the newly surfaced omicron variant? The question is worrying health officials in Israel – and around the world. In other words: Is the omicron variant capable of breaking through the immune system’s protection – immunity created either naturally after recovering from COVID-19 or artificially from being vaccinated.

The omicron genome includes about 50 mutations that did not exist in the original version of the virus, and 32 of them are in the spike protein that binds the virus to cells in the body and is responsible for evading the immune system. Today’s vaccines are based on the immune response to the spike protein.

Of the 32 mutations on the spike protein, 15 are in the receptor-binding domain, the region to which most of the antibodies manufactured by the vaccine are directed. No more than three mutations were identified in the critical region of the binding domain on previous variants of the coronavirus, and the large number of the mutations in the omicron variant has led experts to expect that the effectiveness of the existing vaccines will be lower.

So how much lower? And what level of protection do the vaccines provide against symptomatic infection, serious illness and death from the omicron variant? What is their effectiveness in preventing infection from a variant that is more infectious? The answers to all these questions should begin to become known in the next few weeks – either through laboratory testing or analysis of real-world global epidemiological data as the new variant spreads.

At this stage, however, the experts are watching and waiting for lab test results to determine how well the vaccines work against the omicron variant. The steps to be taken against it will be based on these results. In Israel, the testing is being carried out at the national virology lab at the Sheba Medical Center at Tel Hashomer.

“The bottleneck in tests of this kind is the amount of time it takes for the virus, which comes from clinical samples, to grow and reproduce in cell cultures. At the moment, we’re still waiting,” said Prof. Ella Mendelson, the director of the lab. Omicron, she explained, does not grow that quickly. “In this way, it's reminiscent of the British [alpha] variant, which also grew more slowly in cultures,” she remarked.

“From the moment we begin seeing a lot of dead cells, it means that it has started to grow. This stage of the test is not a process that can be speeded up, and in general, it lasts between five and 10 days. The other stages of the testing are more limited in time,” she said.

The entire testing process involves eight stages and will last between 15 days and three weeks. The first stage involves obtaining appropriate samples: It requires extracting a sample from a patient’s nasal and pharynx area at the height of the illness, when there is a high viral load in the throat.

The second stage involves the actual testing of the sample: When it arrives in the lab, a PCR test is conducted to measure the amount of the coronavirus that it contains. At the same time, cell cultures are prepared to be used to grow the cells. The cells used for the cultures are cloned from African green monkeys, and at that point in the process, special safety precautions are taken to prevent the virus from escaping from the laboratory and to protect the lab workers.

Next comes the initial growth of the virus in the cultures. A small amount is then placed in an incubator to permit it to grow further.

The fourth stage is monitoring and waiting: Every day the cells are examined with a special microscope. After a few days, the destruction of the cell tissue begins to be visible, confirming that the virus is replicating inside the cells. That process takes four to 10 days – depending on the virus.

The fifth stage is calibrating the supply of virus that has grown. Another round of seeding of the virus in the culture is carried out to determine the concentration of the virus in the samples. That creates an additional stock of cells that can be tested and analyzed later.

The sixth stage is an attempt to neutralize the virus in the culture. That's the stage at which the antibodies are confronted with the new variant. This is done by diluting the various samples of blood serum – from people who have recovered from COVID or were vaccinated. In the process, the virus’ response to the antibodies is tested.

The seventh stage is reading the results: Each sample of blood serum is studied at every level of dilution. Blood serum samples that contain a large quantity of antibodies, or antibodies that are highly effective against the virus, will manage to delay the destruction of the cells by the virus – until it reaches a very high level of dilution, in other words a very low concentration of antibodies. Blood serum samples that contain fewer antibodies, or less effective antibodies, will only manage to delay the cell destruction when slightly diluted.

“In practice, we examine the relative level of destruction of the cells. The more [the virus] manages to destroy more cells, it is a sign that the antibodies are of lower efficacy. The most resistant variant to the antibodies that we have seen so far in the lab is the beta variant,” Mendelson said, referring to the first variant discovered in South Africa.

The eighth stage is the calculation of the efficacy of the protection: The extent to which the patient's antibodies protect against the new variant is compared to that of other variants. A large range of comparisons is possible, including comparing the efficacy of antibodies from people who have recovered from COVID and those from people who have received various vaccine doses – or haven't been vaccinated at all.

The complexity of the immune system

“It’s a very controlled experiment, carried out in a very orderly process based on an identical protocol to make it possible to compare the different variants,” Mendelson explained. “We hope we’ll have enough of the virus to make the important comparisons soon,” she added.

But testing on cell cultures only simulates part of the human immune system – the antibodies. There are other aspects of the immune system such as killer cells (which are absent from the serum of test patients) and cytokines, which prompt the destruction of infected cells.

“The immune system cells and other mechanisms lead to the killing of infected cells. What we are testing is the first line of defense. That doesn’t mean there aren’t other lines. The other lines of defense, including the immune system cells, can prevent severe illness [and] keep the patient from deteriorating, but they are less effective in preventing infection. We see a correlation between these lines of defense, because in the end, the immune system’s defense depends on its ability to identify the virus and react quickly. Obviously people who have never been vaccinated and have no immune memory are the most vulnerable – because they don’t even have a first line of defense. Time passes until the body builds this line of defense. During this time, the virus isn’t sitting around and waiting. It’s spreading to the lungs and other places in the body, increasing the risk of severe illness,” Mendelson noted.

However, Mendelson added this: "The real test is the epidemiological picture among the population when a wave of cases of the illness arises.”

https://www.haaretz.com/israel-news...ciency-against-omicron-this-is-how-1.10432553
 
Two Doses of Pfizer-BioNTech Vaccine Stops 70% Omicron Hospitalizations in South Africa
The Discovery survey included 78,000 positive Covid-19 test results attributed to omicron infections from Nov. 15 to Dec. 7 in the epicenter of the omicron wave
By Janice Kew and Antony Sguazzin | December 14, 2021



Pfizer Inc. and BioNTech’s Covid-19 vaccine, as well as the shot developed by Johnson & Johnson, appear to largely prevent severe disease from the omicron variant, South African studies show.

The two-shot Pfizer course may offer 70% protection against being hospitalized with the variant that is driving the country’s fourth wave of infections, Discovery Health Ltd., the country’s largest medical-insurance provider that covers 3.7 million clients, said on Tuesday.

That protection is maintained across age groups and in the face of a range of chronic illnesses, Discovery Health Chief Executive Officer Ryan Noach said at a briefing. Pfizer is 33% effective against infection by the omicron variant, he said.

Separate studies disclosed by Pfizer on Tuesday showed that Pfizer’s experimental Covid-19 pill was highly effective at keeping patients out of the hospital, but less adept at erasing milder symptoms often associated with breakthrough infections.

The Discovery survey included about 78,000 positive Covid-19 test results attributed to omicron infections from Nov. 15 to Dec. 7 in South Africa, the epicenter of the omicron wave. Clinical records, vaccination records and pathology-test results were examined.

While there is a relatively high risk of reinfection with the variant, hospital-admission risk linked to omicron infection was 29% lower overall for the general adult population, compared with South Africa’s first wave of infections in mid-2020, Noach said.

The study echoes the initial findings of three other hospital groups that show most Covid patients don’t need oxygen or intensive treatment for the illness. Scientists are still conducting scores of tests in order to get a better grasp of omicron’s risks, and how significant they are will only be known in the coming weeks.

Still, not withstanding the apparent lower severity of omicron, the sheer volume of infections could put “health systems under incredible pressure,” Noach said.

In contrast to adults, children under the age of 18 are more likely to end up in the hospital than during previous waves, even as the risk of children testing positive is significantly lower than in adults.

“The majority of children present with mild disease, with symptoms such as a sore throat, nasal congestion, headache and fever that resolves within three days,” Noach said.

Part of the reason for the lack of severe illness among residents of South Africa could also be the level of prior infection, where 70% or more of the population has been exposed to Covid-19 at some stage during the past 18 months.

“South Africa has seroprevalence data that shows up to 80% of the population in some parts of South Africa” have had a prior infection, Glenda Gray, president of the South African Medical Research Council said at the same briefing. “We don’t know how omicron is going to evolve in countries with low vaccination or prior infection rates.”

No one has died from an infection with the strain, Gray said, citing a separate South African study that includes hundreds of thousands of health workers who received the J&J shot. More details from that study will be made available in coming days, she said.

https://www.bloomberg.com/news/arti...icron-hospitalizations-in-south-african-study
 
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Facing a new flood of COVID patients, Colorado nurses say the stress is unsustainable
December 15, 2021

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Harold Burch lives in a home with a spectacular view in Paonia, a rural part of Colorado's Western Slope. But that's been little consolation to Burch, 60, as he's battled a cascade of health problems during the pandemic.

"It's been a real rodeo," Burch says. "It's been a lot of ups and downs and lately it's been mostly just downers."

Burch has battled chronic osteoarthritis, rheumatoid arthritis and had two major intestinal surgeries. One specialist he was seeing left her practice last year. Another wouldn't accept his insurance. Then, Nov. 1, he started experiencing major stomach pain.

"When we talk terrible problems, I can't leave the house," he says. He says he hasn't eaten anything substantial in three weeks.

Burch had to wait that long to be seen by a primary care doctor. He says the doctor told him: "'If things were different, I would tell you to go to the hospital and be diagnosed, have some tests run and see what's going on with you.' But he says, 'as of today, Delta County hospital is clear full. There are no beds available.'"

The COVID variant delta has overwhelmed the Colorado county of the same name. Hospitals on the Western Slope have been slammed for weeks, and the statewide picture is similarly grim. As of Monday, 1,294 patients were hospitalized with COVID-19, according to the state's coronavirus website. Half of the state's hospitals said they anticipated a staffing shortage in mid-December; more than a third of them anticipated ICU bed shortages at the same time.

And behind those numbers, patients — and health care workers — are feeling the impact.

Burch's doctor told him he might have to wait hours in the ER, perhaps with people who have flu or COVID-19 symptoms. So Burch stayed home.

57% of people in Delta County have at least one dose of vaccine. And 84% of hospitalized COVID-19 patients in Colorado are not vaccinated.

"It's really frustrating because I did the right thing and like so many other people have, and we're being just kind of like told, 'unless you have a really serious problem, like a heart attack, a stroke or something like that, we really don't have time to mess with you,'" Burch says.

Diann Cullen is a 72-year-old retiree from Broomfield, Colorado, whose doctor told her that her hernia surgery would have to be postponed for weeks feels similarly. She says her reaction was: "Extreme frustration, actually anger ... He flat out told me we can't even do it because of too many COVID patients."

A system in crisis
Burch's situation is not uncommon this fall, as the state faces its second-worst COVID-19 surge for hospitalizations and deaths. Hospitals are under tremendous strain and that means delays and changes from normal care, as strapped providers do more with less.

"Hospitals across Colorado are in critical condition. We have been at 90%-plus capacity in our ICU and acute care beds for weeks now. And unfortunately, there doesn't appear to be an end to that situation in the near future," says Cara Welch, a spokesperson for the Colorado Hospital Association.

What's pushing hospitals into crisis is dealing with a surge of COVID patients on top of other patients who have delayed care, all with a shortage of staff, says Robin Wittenstein, the CEO of Denver Health, which runs one of the state's biggest hospital and clinic systems.

"They're coming into hospitals now sicker than ever before. And they're coming in larger numbers than we've ever seen before," Wittenstein says. "Our system is on the brink of collapse."

At the academic medical center UCHealth, ICU Dr. Abbey Lara says the crush of unvaccinated patients means patients face longer waits or they don't get much-needed diagnostic tests. In the worst-case scenario, "patients who could have survived something had their life cut short because they weren't able to access care," she says.

And when there are too many patients being treated by too few staff, Lara says, that ratchets up the difficulty for health care workers.

"I just worry that there's going to be not only a lot of turnover in the near future," Lara says. "But I think that access to health care is just going to get even worse in the future."

Nurses in distress
The situation is driving more nurses to speak out, like at an event earlier this month held across the street from Longmont United Hospital, in Longmont, Colorado, about 50 miles north of Denver.

Critical care nurse Stephanie Chrisley told a crowd that normally a registered nurse would care for two ventilated, sedated, critical care patients.

"And the last few weeks we have regularly had RNs taking three, and sometimes four patients, at a time," she says, which prompted boos from the crowd.

That's unsafe, she says, and now the nurses are looking to unionize. Longmont United says it is focused on the well-being of patients and staff and that its top priority is high-quality care.

Chrisley, a mother of two, says nurses need more hands on deck.

"I have lately been in a state of chronic stress over the crushing guilt that I feel to ensure my patients get the care they need. And yet, somehow still care for myself and my family," Chrisley says.

Kris Kloster has been a nurse for 32 years, much of that in the ICU. So she's seen layoffs and staff reductions even before the pandemic hit. Now ICU nurses are dealing with colleagues quitting, restrictions on visitors, worries about catching the virus, anger from some patients who do not believe they have COVID-19.

At the same time, they must cope with suffering and deaths. It's been "soul sucking," she says. "That's the hardest I've ever worked."

Kloster has been speaking out in hopes that Coloradans will understand the physical, emotional and psychological toll on nurses.

"This kind of staffing, this kind of stress is not sustainable," Kloster says. "And something has to change."

Nearly a third of the hospital's registered nurse staff has left since the start of July and many have not been replaced, she says.

The stress nurses and doctors feel is compounded when they feel powerless to take what they regard as an ethically correct action in treating a patient.

There's a term for that, "moral distress," says Dr. Barbara Statland, a hospitalist at Denver Health. The tension comes "because you can't do what you feel is ethically proper. And I'd say that health care workers have been riddled with this."

'They saved my life'
Despite the stress and distress, many frontline providers are hanging in there, continuing to care for patients every day. That made the difference for at least one COVID-19 patient who said he was able to get care — just in time.

Rob Blessin from Fort Collins caught the virus this fall and spent 30 days in an ICU ward with pneumonia at North Colorado Medical Center in Greeley. The 58-year-old described the efforts of his doctors and nurses as heroic, some working nine or 10 days in a row, many taking overtime.

"They saved my life. I do feel grateful for everything they did,"

Blessin says as more coronavirus patients got admitted staff struggled to keep up. "There was just so many people there and very few staff," he says.

Blessin says he landed in the hospital because he was swayed by internet misinformation and didn't get vaccinated. It's a decision he came to regret.

"I guess my recommendation would be to get vaxxed, you know, even if you're totally against it. Don't fall into the internet hype," Blessin says.

After his experience being hospitalized for a month due to the coronavirus, and having talked with his physicians there, he now plans to get vaccinated.

https://www.npr.org/sections/health...s-colorado-nurses-say-the-stress-is-unsustain
 
Booster based after an original J&J (J&J + mRNA) does not seem to hold up well against Omicron, suggesting a need for 2 boosters for J&J

 
CDC vaccine advisers vote to recommend Pfizer and Moderna COVID-19 vaccines over J&J's
By Maggie Fox | Dec 16, 2021


The U.S. Centers for Disease Control and Prevention changed its recommendations for COVID-19 vaccines Thursday to make clear that shots made by Moderna and Pfizer/BioNTech are preferred over Johnson & Johnson's vaccine.

The new recommendation: "mRNA vaccines are preferred over the Janssen COVID-19 vaccine for the prevention of COVID-19 for those 18 years of age and over."

Earlier Thursday, the CDC's Advisory Committee on Immunization Practices endorsed the updated recommendation after hearing new data indicating that a rare blood clotting syndrome is more common among people who recently got a J&J vaccine than previously believed. CDC Director Dr. Rochelle Walensky accepted the updated recommendation within hours.

The CDC has logged 54 cases in the U.S. of thrombosis with thrombocytopenia syndrome or TTS in the U.S. since the vaccine became available. Nine people have died — seven women and two men.

Rates are higher than previously estimated among both men and women, the CDC's Dr. Isaac See told the meeting. While only a few cases have been seen for every million people vaccinated by age group, they are higher than what was believed when vaccine advisers were last briefed.

"We've been struck on reviewing these cases by how rapidly a patient deteriorates ... to death," See said. Symptoms always begin within two weeks of getting the vaccine and, on average, within nine days.

"The U.S. TTS case reporting rate following Janssen COVID-19 vaccination is higher than what was previously presented to ACIP and the case reporting rate for men 40-49 years and for women 50-64 is similar to that for women 18-29 years," See told the meeting.

Thirty-nine of the 54 reported cases occurred before the CDC and the U.S. Food and Drug Administration paused administration of the vaccine in April to investigate the link. The agencies resumed permission for the vaccine's use later in April. Since then, CDC has learned of more cases, See said.

"The rates are now slightly higher for all age groups," he said. The highest rate of TTS is among women — 10 per million vaccinations given in women ages 30 to 39 and 9 per million in women ages 40 to 49.

Committee weighed risks and benefits
The overall risk of developing TTS is 3.8 cases per million doses given. The death rate is less than one per million doses given: 0.57 per million. Risks are higher for women than for men, but they're higher among men than previously known, the CDC's Dr. Sara Oliver said.

ACIP members considered the new data and weighed it against numerous studies showing J&J's vaccine is less effective than the Moderna and Pfizer/BioNTech vaccines in preventing infection.

"The U.S. supply of mRNA vaccines is abundant — with nearly 100 million doses in the field for immediate use," the CDC said later Thursday in accepting the vote.

"This updated CDC recommendation follows similar recommendations from other countries, including Canada and the United Kingdom. Given the current state of the pandemic both here and around the world, the ACIP reaffirmed that receiving any vaccine is better than being unvaccinated," it added.

"Individuals who are unable or unwilling to receive an mRNA vaccine will continue to have access to Johnson & Johnson's COVID-19 vaccine."

ACIP also discussed the risks of completely removing J&J's vaccine as an option, as well as the potential confusion and mistrust that might be caused by changing recommendations about the vaccine. "We will absolutely emphasize how important education around the risk of these events is," Oliver told the meeting.

"The VE (vaccine effectiveness) is lower for the Janssen vaccine compared to mRNA vaccines," Oliver said.

The risk of myocarditis -- a rare heart inflammatory condition -- is lower for the Moderna and Pfizer/BioNTech vaccines than the risk of blood clots from the J&J vaccine. But younger men may be advised to avoid mRNA vaccines, so Oliver said that complete removal of recommendations for the J&J vaccine would cause problems. "It would remove the option of the vaccine for younger men, who are at higher risk for myocarditis," she said.

Plus, the Janssen vaccine is often the only shot available for prison populations, the homeless and other high-risk groups.

Worries about undermining confidence in vaccines
There could be other fallout from a decision to remove support from the J&J vaccine, Oliver cautioned. "Diminished access could undermine confidence in the COVID-19 vaccine program," she said. "Lack of vaccine choices could contribute to mistrust and misinformation about COVID-19 vaccines available," she added.

Earlier this week, the FDA strengthened language in the fact sheet that goes along with the Janssen vaccine, saying it should not be given to anyone with a history of TTS. There is, however, no clear risk factor for predicting who will develop the condition after getting the vaccine, the CDC said.

The changes to the recommendation should reassure Americans that public health experts are watching over the safety of the vaccines, ACIP members said.

"I want to remind everybody that this is in part a reflection of the strength of our vaccine safety surveillance system," Dr. Matthew Daley of the Institute for Health Research at Kaiser Permanente Colorado told the meeting.

"This whole process should increase confidence in our vaccine safety surveillance system," Dr. Sandra Fryhofer of Emory University and a non-voting liaison to the committee for the American Medical Association, said.

"I do think this vaccine needs to be made available," she added. "We need a variety of vaccine platforms."

The Pfizer/BioNTech and Moderna vaccines use a technology known as messenger RNA or mRNA to elicit an immune response, while the Johnson & Johnson vaccine uses a so-called vector — a non-replicating common cold virus called an adenovirus — to carry the active vaccine material into he body.

Different vaccine types stimulate different immune responses. That could be important, Fryhofer said. "We don't know what variant is next," she said.

About 16 million Americans have been given the Janssen vaccine.

Dr. Penny Heaton, global therapeutic head for vaccines at Janssen, told the meeting that the J&J vaccine is unique.

"We are confident in the positive benefit/risk profile of our vaccine. It is saving lives in the US here today and on every continent around the globe. Our vaccine is different. It's long-lasting. It offers high levels of protection, and it offers breadth of protection," Heaton told the meeting. "It's easy to store and transport."

Heaton said the J&J vaccine provides a different type of immunity that grows more slowly but lasts longer. It's a one-dose vaccine, but the CDC now recommends that everyone who gets it receive a booster dose of any available vaccine.

"Even in the US, given its durable protection, it may be the preferred choice for people who can't or won't return for multiple vaccinations," Heaton argued. She said the company has several studies underway to understand risk factors for TTS.

"While TTS continues to be a rare event, unfortunately, cases of Covid-19 are not," she said, noting that COVID-19 carries a much higher risk of blood clots than vaccination does.
https://www.wcvb.com/article/cdc-va...d-pfizer-moderna-vaccines-over-j-j-s/38542192
 
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Good visual.

Also worth nothing that the unvaccinated death was low in summer 2021 BECAUSE of the vaccinated, because the original vaccines stopped transmission for Alpha variant lineage
 
Novavax COVID vaccine shows 90.4% efficacy against infection in Phase 3 trial
By Mary Van Beusekom | | Dec 16, 2021



A phase 3 trial yesterday in the New England Journal of Medicine (NEJM) finds that the Novavax COVID-19 vaccine is 90.4% effective against infection and 100% effective against moderate to severe illness, bringing yet another vaccine one step closer to approval.

Novavax is a new adjuvanted, recombinant spike protein nanoparticle vaccine that has proven effective against COVID-19 infection in the United Kingdom and South Africa. This was the first such trial in North America.

The study, led by Novavax researchers in Gaithersburg, Maryland, involved 29,949 adults who received the Novavax vaccine at 113 sites in the United States and 6 in Mexico from Dec 27, 2020, to Feb 18, 2021, before the emergence of the highly transmissible Delta (B1617.2) and Omicron (B.1.1.529) variants. Participants were followed until Apr 19, 2021.

The researchers randomly assigned participants in a 2:1 ratio to receive either two doses of Novavax vaccine or a saline placebo 21 days apart. Median participant age was 47 years, and 11.8% were 65 years and older, 75.9% were White, 21.5% were Hispanic, 11.0% were Black, and 47.3% had at least one underlying medical condition.

Of 29,582 participants who received at least one dose, 19,714 received vaccine and 9,868 received placebo.

Efficacy against earlier variants was 92.6%

In the full-analysis population, 21.2 cases per 1,000 person-years occurred in the Novavax group, compared with 51.9 per 1,000 in the placebo group.

Over 3 months, 77 participants who received at least one dose tested positive for COVID-19, 14 of them vaccinees and 63 placebo recipients, for a vaccine efficacy of 90.4%. Rates of infection were 3.3 per 1,000 person-years among those given at least one dose, versus 34.0 cases per 1,000 among placebo recipients.

Ten moderate and four severe COVID-19 infections occurred, all in the placebo group, for a vaccine efficacy against moderate to severe illness of 100%. Vaccine efficacy against infection among high-risk recipients was 91.0%. Hispanic participants were the only demographic group in which Novavax effectiveness was lower, at 67.3%.

The rate of new COVID-19 infections among Novavax recipients was higher in the first 42 days of follow-up than during the rest of the study period. As a result, the incidence of new infections fell among the vaccinated while increasing in the placebo group.

Similar vaccine effectiveness was seen in the full-analysis population when observation started 7 days after the second dose, with 85 COVID-19 infections (16 in the Novavax group and 69 in the placebo group). Incidence was 3.7 cases per 1,000 person-years and 34.6 cases per 1000, respectively, for a vaccine effectiveness of 89.3%.

Most sequenced viral genomes (79% of 61) were variants of concern or interest, most of them Alpha (B117) and other variants of concern (89% of 35). Vaccine effectiveness against any variant of concern or interest was 92.6%.

Few severe vaccine-related adverse events

Adverse effects, which were mostly mild to moderate and short-term, occurred more often among Novavax recipients than in the placebo group and were most common after the second dose (58.0% and 21.1%, respectively, after the first dose and 78.9% and 21.7%, respectively, after the second dose).

Systemic adverse events occurred in 47.7% of vaccinees and 40.0% in the placebo group after the first dose and 69.5% and 35.9% after the second. Severe adverse events were reported in 1.1% of Novavax recipients and less than 1% of placebo recipients after the first dose and 6.7% and less than 1%, respectively, after the second.

The study authors said that Novavax's ability to be stored for up to 6 months at normal refrigerator temperatures make it well-suited for international deployment.

"The efficacy of NVX-CoV2373 [Novavax] in preventing moderate-to-severe COVID-19 as well as any symptomatic COVID-19 in people at high risk for acquisition and complications of COVID-19 will make this vaccine a valuable tool in controlling the pandemic and its most serious health and economic consequences," they concluded.

In a related audio interview, NEJM Editor-in-Chief Eric Rubin, MD, PhD, said that, in the context of great global COVID-19 vaccine need, it's good to have another effective vaccine candidate like Novavax. "For now, I think which vaccine is superior is less important than which vaccines work and are available," he said.

"I think we really need to get those vaccines out there, even if there are subtle differences among them in how effective they are or what side effects they have."

https://www.cidrap.umn.edu/news-per...-vaccine-shows-904-efficacy-against-infection
 
WHO Grants Novavax Covid Vaccine Emergency Use Approval
Carlie Porterfield | Dec 17, 2021



A less expensive, easier-to-distribute coronavirus vaccine developed by Maryland-based Novavax was granted emergency authorization by the World Health Organization on Wednesday, raising hopes that it could help increase global inoculation rates as the world braces for new coronavirus outbreaks.

The emergency approval will pave the way for more countries to accept the vaccine and for it to be distributed through the Covax program, the United Nations-backed vaccine-sharing initiative.

Unlike the Pfizer and Moderna coronavirus vaccines, which are based on messenger RNA, the Novavax jab is a protein-based vaccine, similar to shots that have been on the market for decades, boosting hopes it could be a choice for people skeptical of new vaccines.

The vaccine, which is produced by the Serum Institute of India, is also cheaper to make and can be stored in most refrigerators, unlike other coronavirus vaccines that require storage in freezing temperatures as low as -130°F.

Novavax said studies show the vaccine is more than 90% effective against symptomatic infections.

Coronavirus infections have been rising in Africa, Europe and the U.S. amid the spread of the omicron variant, which experts believe may be more infectious than previous strains. First detected last month in southern Africa, officials worldwide have called on wealthy countries to donate more coronavirus vaccine doses to help prevent the variant from spreading in poorer nations with low vaccination rates.

The Novavax vaccine was granted emergency use authorization in November in Indonesia, the first country to do so, and was soon followed by the Philippines. The company has also filed with the U.K. and the European Medicines Agency, with plans to apply to the U.S. Food and Drug Administration before 2022. The vaccine’s development has been delayed by manufacturing difficulties.

https://www.forbes.com/sites/carlie...oval-as-omicron-fears-deepen/?sh=1ec2741cecc0
 
Another nail in the coffin for embattled J&J.

J&J, Sinopharm and Sputnik V Covid shots not as effective against omicron variant, study finds
Vaccines from Moderna, AstraZeneca, and Pfizer-BioNTech were found to still be active against omicron
By Minyvonne Burke and Reuters | Dec 17, 2021



Covid-19 vaccines from Johnson & Johnson, China’s Sinopharm and Russia’s Sputnik V shot are not as effective against the new omicron variant, according to a new study.

The study, which has yet to be peer-reviewed, also found the decrease was less pronounced for vaccinated individuals who were previously infected with the virus.

The omicron variant has raised concerns regarding its ability to evade protection provided by widely-used vaccines, with drugmakers tailoring their shots to target the variant while testing the effectiveness of their existing shots.

Vaccines from Moderna, AstraZeneca and Pfizer and partner BioNTech were found to still be active against omicron, but the antibody response was greatly reduced when compared with the original virus strain first detected in China, according to the study.

The Gamaleya Research Institute of Epidemiology and Microbiology in Russia responded to the study.

“A recently published small study addresses Sputnik vaccine’s efficacy against omicron variant deliberately using serum samples that are not representative," the company said. "For example, this study used Sputnik samples with a lower virus neutralization ability against SARS-COV-2 than AstraZeneca’s vaccine while a much larger study in Argentina based on representative serum samples demonstrated 1.8 times higher virus neutralizing titers against SARS-COV-2 for Sputnik, which is explained by its heterologous boosting advantage."

They added: "Therefore, conclusions about Sputnik efficacy against omicron based on wrong serum samples, cannot be made."

The institute said within the next seven days it plans to publish its own data on the topic.

The omicron variant is highly contagious and has more than 30 mutations of the coronavirus spike proteins, which cover the outside of the virus and are the main targets of vaccines and treatments like monoclonal antibodies.

The World Health Organization has said that the omicron variant is spreading faster than any previously detected strain of the coronavirus.

While the omicron variant has been a concern for scientists, the evidence so far shows that it may cause less severe illness than the delta variant.

https://www.nbcnews.com/news/amp/rcna9135
 
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EU approved Novavax shot as region's fifth COVID-19 vaccine
By Pushkala Aripaka and Francesco Guarascio | December 20, 2021



The European Union on Monday approved the use of Novavax's COVID-19 vaccine in people 18 years and older, giving a boost to the U.S. biotech after long delays and paving the way for a fifth shot in the EU as the Omicron variant spreads.

Data from two large studies showed the vaccine has an efficacy of around 90%, the European Medicines Agency (EMA) said. read more

It is not clear yet how Novavax performs against the Omicron variant, or whether a booster dose will be needed. Some early data has suggested that many two-dose vaccines do not work well against the variant while a third shot improves their efficacy.

Novavax said earlier this month it could begin manufacturing a vaccine tailored for Omicron in January.

Novavax said it would start shipping vaccines to the EU's 27 member states in January as part of its deal to supply up to 200 million doses.

Member states have ordered around 27 million doses for the first quarter, enough to inoculate about 13.5 million people, the Commission said.

COVID-19 infections have broken records in parts of Europe in recent weeks, with governments and researchers scrambling to bolster defences against the fast-spreading Omicron, prompting renewed curbs ahead of the Christmas holidays.

"May this authorisation offer a strong encouragement to everyone who has not yet been vaccinated or boosted, that now is the time to do so," said the head of the bloc's executive Commission, Ursula von der Leyen, in a statement.

The endorsement for the two-dose vaccine, branded Nuvaxovid, comes well ahead of possible authorisation in the United States, where Novavax has had to resolve manufacturing issues.

Chief Executive Stanley Erck said he expects Novavax to file for U.S. authorization in the next week to 10 days.

The regulatory process in the EU has taken longer than expected too. The EMA started a real-time rolling review of the data in February.

https://www.reuters.com/world/europ...ax-regions-fifth-covid-19-vaccine-2021-12-20/
 
Early lab studies shows the Omicron variant is much better at evading the immune system and replicates quickly in the upper airways cells, allowing it to spread quickly from people to people with a simple cough.

Fortunately, Omicron's mutations also made it less efficent at invading lungs cells, thus making the infection less severe than the Delta variant that blitzed so many anti-vaxxers' lungs this past summer and made them listen to actual medical doctors again, as they gasped for air in the ICUs and ERs across the country.

That being said, real-world data are limited right now, and we'll soon have more concrete information as it continue to spread and possibly out-competes Delta, particularly among the younger population.
____

Omicron may cause milder disease than Delta. A lab study hints at why.
By Nicoletta Lanese | Dec 25, 2021

ZTYPhZUuAy6fk5QA3z5454-970-80.jpg.webp

The omicron variant of SARS-CoV-2 may be less efficient at infiltrating the lungs and spreading from cell to cell, compared with other versions of the coronavirus, early studies of human cells in a lab dish suggest.

This may help explain why some early data from countries such as South Africa and England suggest the strain causes less severe disease. But although omicron may not invade lung cells efficiently, the new study, posted Tuesday (Dec. 21) to the preprint database bioRxiv, confirmed that the variant dodges most of the antibodies made by fully vaccinated individuals.

And similar to other research, the team showed a "booster" dose of the Pfizer vaccine significantly increased the neutralization power of vaccinated people's antibodies, "though we'd still expect a waning in immunity to occur over time," senior author Ravindra Gupta, a professor of clinical microbiology at the Cambridge Institute for Therapeutic Immunology and Infectious Diseases, said in a statement.

The research has not yet been peer-reviewed or published in a scientific journal, but the findings hint "that omicron's mutations present the virus with a double-edged sword: it's got better at evading the immune system, but it might have lost some of its ability to cause severe disease," Gupta said. That said, scientists still need to confirm that these results from experiments in lab dishes match what happens in human patients, and that omicron's mutations actually influence the severity of infection.

Data from South Africa, England and other countries suggest that omicron infections might be less severe, on average, but background levels of immunity from natural infection and vaccination make these results tricky to interpret, NPR reported.

Omicron has more than 30 mutations in the genes that code for its spike protein, the part of the virus that plugs into cells to trigger infection, Live Science previously reported. Of those, 10 code for parts of the "receptor binding domain" (RBD), or the specific portion of the spike protein that latches onto cells.

To probe how these spike mutations might change how the virus interacts with cells, the researchers engineered synthetic viruses, called pseudoviruses, that carry the omicron spike protein. For comparison, they also generated pseudoviruses with the delta spike protein and some with the Wuhan-1 spike, or that of the original SARS-CoV-2 virus.

The team wanted to understand how three omicron-specific mutations in the so-called polybasic cleavage site (PBCS) affect the virus's ability to enter cells. After the spike protein plugs into a cell, the PBCS cleaves, or splits open, to allow genetic material from the virus to enter the host cell; the alpha and delta variants carry PBCS mutations that help them enter cells more easily, according to a previous study by the researchers, published June 8 in the journal Cell Reports.

Omicron carries similar mutations in its PBCS genes, so the team predicted that it might slip into cells as easily as alpha and delta do. They tested this theory by using their pseudoviruses to infect human lung cells in lab dishes, as well as lung organoids — 3D clusters of cells made to mimic features of full-size lungs. They found that, despite its concerning PBCS mutations, omicron entered the lung cells and organoids less efficiently than delta and instead more closely resembled Wuhan-1.

Delta also outperformed omicron in a second experiment. Upon entering a cell, the delta pseudoviruses triggered cell fusion, a phenomenon that sticks neighboring cells together and allows the virus to quickly spread between them. Widespread cell-cell fusion in the lungs is often seen in the context of severe COVID-19, the researchers noted in their report. However, in their experiments, omicron initiated cell fusion less efficiently than delta, and this seemed to hinder the virus's ability to replicate in lung cells.

A separate study, also not peer reviewed, found that omicron replicated much more efficiently than delta in upper airway cells, but less efficiently than even the original strain of SARS-CoV-2 in lung cells.

"We speculate that the more efficient the virus is at infecting our cells, the more severe the disease might be," Gupta said in the statement. "The fact that omicron is not so good at entering lung cells and that it causes fewer fused cells with lower infection levels in the lab suggests this new variant may cause less severe lung-associated disease."

Future studies will need to confirm that these experiments in lab dishes translate to the human body. In the meantime, the team's experiments with antibodies affirm that to achieve maximum protection against the variant, people should get booster shots ASAP, Gupta said in the statement.

"Individuals who have only received two doses of the vaccine — or worse, none at all — are still at significant risk of COVID-19, and some will develop severe disease," he said. "The sheer number of new cases we are seeing every day reinforces the need for everyone to get their boosters as quickly as possible."

https://www.livescience.com/omicron-less-severe-disease-early-evidence
 
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does anyone now the likelihood of the Novavax Covid Vaccine being approved in the states?
 
does anyone now the likelihood of the Novavax Covid Vaccine being approved in the states?

They would have to submit their Phase 3 clinical trials data to the FDA to verify first.

Novavax is confident they'll get the FDA approval sometime in early 2022, because that same data had already been checked and approved by the European Union's EMA this month.

Novavax CEO: 'We will be filing within the next few days' with FDA
By Anjalee Khemlani | December 21, 2021,
Novavax is finally ready to submit its application for emergency use authorization (EUA) in the U.S., and could do so as early as this week, according to CEO Stanley Erck.

"We will be filing within the next few days in the U.S.," Erck told Yahoo Finance Live on Tuesday.

The company has made significant progress on its path to its first commercial product, the two-dose COVID-19 vaccine, marking three major milestones in the past week.

Novavax has now received four emergency use approvals, including a listing from the World Health Organization, making it the ninth vaccine authorized by the agency, as well as conditional marketing in the European Union. In addition, the company announced administering its first dose in Indonesia Tuesday, where it recently received emergency use authorization.

Erck said the company anticipates beginning delivery of its COVID-19 vaccines to the European Union by January, and has a target production output of 2 billion doses for this year. It already shipped, through its manufacturing partner Serum Institute of India, 20 million doses to Indonesia.

"In addition to shipping the doses to Indonesia, we're prepared to ship doses ... to Europe, starting next month," he added.

Novavax also has manufacturing partners in South Korea and Japan and owns a facility in the Czech Republic. The company has emergency use submissions pending in Japan, India, Australia, New Zealand, Canada, Singapore, the U.K. and United Arab Emirates.

In the U.S., the company has lagged behind competitors in getting to the finish line, running into manufacturing issues — which have since been resolved — as well as delays from interactions with the FDA.

While the company faces stiff competition from mRNA vaccines from Pfizer/BioNTech and Moderna, its efficacy data is similar, and its technology sets it apart from others. The CDC recently issued guidance giving preference to mRNA doses, citing concerns over blood clots after Johnson & Johnson vaccines, which uses a similar platform to AstraZeneca.

The shift could open up the U.S. market, which is hovering at 65% vaccinated for ages 5 and up, according to the latest CDC data.

"Our hope is that the U.S. will look at this as an important new vaccine and approve it in due time," Erck said.

The company hasn't yet revealed data on how the vaccine stands up to Omicron, but is also working on an Omicron-specific dose.

While the new milestones have positively impacted the company's stock price, Erck anticipates it will in due course.

"I've taught my folks not to look at it on a day-to-day basis, as we take care of our business it will find it's way," Erck said.

He added that he hopes the FDA will make a decision on emergency use early in 2022.

https://finance.yahoo.com/news/nova...hin-the-next-few-days-with-fda-180341062.html
 
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