Category: Corona Virus

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House passes bill for research on cognitive effects of coronavirus, 69 Republicans vote no – The Hill

July 27, 2022

The House passed a bill on Tuesday to allow a government agency to award grants into the cognitive effects of COVID-19.

The legislation, titled the Brycen Gray and Ben Price COVID-19 Cognitive Research Act, passed in a 350-69 vote, with all opposition coming from Republicans. Eight Republicans and four Democrats did not vote.

The measure calls on the director of the National Science Foundation to award grants to eligible entities including higher education institutions or other groups made up of universities and nonprofit organizations to assist them in researching the disruption of regular cognitive processes associated with both short-term and long-term COVID-19 infections.

Research eligible under the bill includes studies on the effects COVID-19 infections have on cog4 nition, emotion, and neural structure and function as well as the influence coronavirus-related psychological and psychosocial factors have on the disruption of cognitive processes.

The grants should be awarded on a competitive, merit-reviewed basis, according to the bill.

In a statement announcing the bill in October, Rep. Anthony Gonzalez (R-Ohio), a co-sponsor of the measure, cited research from The Lancet Psychiatry that says roughly 1 in 3 patients diagnosed with COVID-19 received a neurological or psychiatric diagnosis in the six months after their positive test.

The legislation is named after Brycen Gray, 17, and Ben Price, 48, both of whom died by suicide after experiencing mental health issues following their bouts with COVID-19.

During debate on the House floor Tuesday, Gonzalez spoke about Gray and Price, saying the two tragically passed after battles with cognitive impairments caused by COVID-19.

Despite having no history of mental illness, each of them began to battle symptoms such as anxiety, panic and paranoia. The disease took Brycen and Ben from two of the healthiest, most vibrant people you could find to individuals so debilitated that they could not bear to live another day. While they fought to the bitter end, each chose to end their pain, he added.

The Ohio Republican said the bill would help learn why COVID-19 has an impact on the brain.

If we believe in protecting our families, we need to act now and start finding answers to why COVID-19 can have such a significant impact on the brain. The legislation before us today is another important step in that effort, he said.

Rep. Don Beyer (D-Va.) said researchers are raising alarms about the risk of mental health issues and suicide following COVID-19 diagnoses, adding that improved data collection and additional research is needed to better understand the mental health implications of COVID-19 infection.

Republican no votes included Reps. Rick Allen (Ga.), Jodey Arrington (Texas), Jim Banks (Ind.), Jack Bergman (Mich.), Andy Biggs (Ariz.), Dan Bishop (N.C.), Lauren Boebert (Colo.), Mo Brooks (Ala.), Ken Buck (Colo.), Tim Burchett (Tenn.), Michael Burgess (Texas), Kat Cammack (Fla.), Madison Cawthorn (N.C.), Ben Cline (Va.), Michael Cloud (Texas), Andrew Clyde (Ga.), James Comer (Ky.), Warren Davidson (Ohio), Scott DesJarlais (Tenn.), Byron Donalds (Fla.), Ron Estes (Kan.), Pat Fallon (Texas), Scott Fitzgerald (Wisc.), Virginia Foxx (N.C.), Russ Fulcher (Idaho), Matt Gaetz (Fla.), Louie Gohmert (Texas), Bob Good (Va.), Lance Gooden (Texas), Paul Gosar (Ariz.), Mark Green (Tenn.), Marjorie Taylor Greene (Ga.), Morgan Griffith (Va.), Glenn Grothman (Wisc.), Andy Harris (Md.), Diana Harshbarger (Tenn.), Kevin Hern (Okla.), Yvette Herrell (N.M.), Jody Hice (Ga.), Clay Higgins (La.), Ashley Hinson (Iowa), Darrell Issa (Calif.), Ronny Jackson (Texas), Mike Johnson (La.), Jim Jordan (Ohio), John Joyce (Pa.), Debbie Lesko (Ariz.), Barry Loudermilk (Ga.), Nicole Malliotakis (N.Y.), Tracey Mann (Kan.), Thomas Massie (Ky.), Brian Mast (Fla.), Tom McClintock (Calif.), Dan Meuser (Pa.), Marry Miller (Ill.), Barry Moore (Ala.), Troy Nehls (Texas), Ralph Norman (S.C.), Greg Pence (Ind.), Scott Perry (Pa.), August Pfluger (Texas), Chip Roy (Texas), David Schweikert (Ariz.), Mike Simpson (Idaho), Van Taylor (Texas), Claudia Tenney (N.Y.), Tom Tiffany (Wisc.), Jeff Van Drew (N.J.) and Beth Van Duyne (Texas).

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House passes bill for research on cognitive effects of coronavirus, 69 Republicans vote no - The Hill

Could Genetics Be the Key to Never Getting the Coronavirus? – The Atlantic

July 27, 2022

Last Christmas, as the Omicron variant was ricocheting around the United States, Mary Carrington unknowingly found herself at a superspreader eventan indoor party, packed with more than 20 people, at least one of whom ended up transmitting the virus to most of the gatherings guests.

After two years of avoiding the coronavirus, Carrington felt sure that her time had come: Shed been holding her great-niece, who tested positive soon after, and she was giving me kisses, Carrington told me. But she never caught the bug. And I just thought, Wow, I might really be resistant here. She wasnt thinking about immunity, which she had thanks to multiple doses of a COVID vaccine. Rather, perhaps via some inborn genetic quirk, her cells had found a way to naturally repel the pathogens assaults instead.

Carrington, of all people, understood what that would mean. An expert in immunogenetics at the National Cancer Institute, she was one of several scientists who, beginning in the 1990s, helped uncover a mutation that makes it impossible for most strains of HIV to enter human cells, rendering certain people essentially impervious to the pathogens effects. Maybe something analogous could be safeguarding some rare individuals from SARS-CoV-2 as well.

Read: America is running out of COVID virgins

The idea of coronaviral resistance is beguiling enough that scientists around the world are now scouring peoples genomes for any hint that it exists. If it does, they could use that knowledge to understand whom the virus most affects, or leverage it to develop better COVID-taming drugs. For individuals who have yet to catch the contagiona fast-dwindling proportion of the populationresistance dangles like a superpower that people cant help but think they must have, says Paula Cannon, a geneticist and virologist at the University of Southern California.

As with any superpower, though, bona fide resistance to SARS-CoV-2 infection would likely be very rare, says Helen Su, an immunologist at the National Institutes of Allergy and Infectious Disease. Carringtons original hunch, for one, eventually proved wrong: She recently returned from a trip to Switzerland and found herself entwined with the virus at last. Like most people who remained unscathed until recently, Carrington had done so for two and a half years through a probable combination of vaccination, cautious behavior, socioeconomic privilege, and luck. Its entirely possible that inborn coronavirus resistance may not even existor that it may come with such enormous costs that its not worth the protection it theoretically affords.

Of the 1,400 or so viruses, bacteria, parasites, and fungi known to cause disease in humans, Jean-Laurent Casanova, a geneticist and an immunologist at Rockefeller University, is certain of only three that can be shut out by bodies with one-off genetic tweaks: HIV, norovirus, and a malaria parasite.

The HIV-blocking mutation is maybe the most famous. About three decades ago, researchers, Carrington among them, began looking into a small number of people who we felt almost certainly had been exposed to the virus multiple times, and almost certainly should have been infected, and yet had not, she told me. Their superpower was simple: They lacked functional copies of a gene called CCR5, which builds a cell-surface protein that HIV needs in order to hack its way into T cells, the viruss preferred human prey. Just 1 percent of people of European descent harbor this mutation, called CCR5-32, in two copies; in other populations, the trait is rarer still. Even so, researchers have leveraged its discovery to cook up a powerful class of antiretroviral drugs, and purged the virus from two people with the help of 32-based bone-marrow transplantsthe closest that medicine has come to developing a functional HIV cure.

The stories with those two other pathogens are similar. Genetic errors in a gene called FUT2, which pastes sugars onto the outsides of gut cells, can render people resistant to norovirus; a genomic tweak erases a protein called Duffy from the walls of red blood cells, stopping Plasmodium vivax, one of several parasites that causes malaria, from wresting its way inside. The Duffy mutation, which affects a gene called DARC/ACKR1, is so common in parts of sub-Saharan Africa that those regions have driven rates of P. vivax infection way down.

In recent years, as genetic technologies have advanced, researchers have begun to investigate a handful of other infection-resistance mutations against other pathogens, among them hepatitis B virus and rotavirus. But the links are tough to definitively nail down, thanks to the number of people these sorts of studies must enroll, and to the thorniness of defining and detecting infection at all; the case with SARS-CoV-2 will likely be the same. For months, Casanova and a global team of collaborators have been in contact with thousands of people from around the world who believe they harbor resistance to the coronavirus in their genes. The best candidates have had intense exposures to the virussay, via a symptomatic person in their homeand continuously tested negative for both the pathogen and immune responses to it. But respiratory transmission is often muddied by pure chance; the coronavirus can infiltrate people silently, and doesnt always leave antibodies behind. (The team will be testing for less fickle T-cell responses as well.) People without clear-cut symptoms may not test at all, or may not test properly. And all on its own, the immune system can guard people against infection, especially in the period shortly after vaccination or illness. With HIV, a virus that causes chronic infections, lacks a vaccine, and spreads through clear-cut routes in concentrated social networks, it was easier to identify those individuals whom the virus had visited but not put down permanent roots within, says Ravindra Gupta, a virologist at the University of Cambridge. SARS-CoV-2 wont afford science the same ease of study.

Read: Is BA.5 the reinfection wave?

A full analogue to the HIV, malaria, and norovirus stories may not be possible. Genuine resistance can manifest in only so many ways, and tends to be born out of mutations that block a pathogens ability to force its way into a cell, or xerox itself once its inside. CCR5, Duffy, and the sugars dropped by FUT2, for instance, all act as microbial landing pads; mutations rob the bugs of those perches. If an equivalent mutation exists to counteract SARS-CoV-2, it might logically be found in, say, ACE2, the receptor that the coronavirus needs in order to break into cells, or TMPRSS2, a scissors-like protein that, for at least some variants, speeds the invasive process along. Already, researchers have found that certain genetic variations can dial down ACE2s presence on cells, or pump out junkier versions of TMPRSS2hints that there could be tweaks that further strip away the molecules. But ACE2 is very important to blood-pressure regulation and the maintenance of lung-tissue health, said Su, of NIAID, whos one of many scientists collaborating with Casanova to find SARS-CoV-2 resistance genes. A mutation that keeps the coronavirus out might very well muck around with other aspects of a persons physiology. That could make the genetic tweak vanishingly rare, debilitating, or even, as Gupta put it, not compatible with life. People with the CCR5-32 mutation, which halts HIV, are basically completely normal, Cannon told me, which means HIV kind of messed up in choosing CCR5. The coronavirus, by contrast, has figured out how to exploit something vital to its hostan ingenious invasive move.

The superpowers of genetic resistance can have other forms of kryptonite. A few strains of HIV have figured out a way to skirt around CCR5, and glom on to another molecule, called CXCR4; against this version of the virus, even people with the 32 mutation are not safe. A similar situation has arisen with Plasmodium vivax, which we do see in some Duffy-negative individuals, suggesting that the parasite has found a back door, says Dyann Wirth, a malaria researcher at Harvards School of Public Health. Evolution is a powerful strategyand with SARS-CoV-2 spewing out variants at such a blistering clip, I wouldnt necessarily expect resistance to be a checkmate move, Cannon told me. BA.1, for instance, conjured mutations that made it less dependent on TMPRSS2 than Delta was.

Read: The BA.5 wave is what COVID normal looks like

Still, protection doesnt have to be all or nothing to be a perk. Partial genetic resistance, too, can reshape someones course of disease. With HIV, researchers have pinpointed changes in groups of so-called HLA genes that, through their impact on assassin-like T cells, can ratchet down peoples risk of progressing to AIDS. And a whole menagerie of mutations that affect red-blood-cell function can mostly keep malaria-causing parasites at baythough many of these changes come with a huge human cost, Wirth told me, saddling people with serious clotting disorders that can sometimes turn lethal themselves.

With COVID-19, too, researchers have started to home in on some trends. Casanova, at Rockefeller, is one of several scientists who has led efforts unveiling the importance of an alarm-like immune molecule called interferon in early control of infection. People who rapidly pump out gobs of the protein in the hours after infection often fare just fine against the virus. But those whose interferon responses are weak or laggy are more prone to getting seriously sick; the same goes for people whose bodies manufacture maladaptive antibodies that attack interferon as it passes messages between cells. Other factors could toggle the risk of severe disease up or down as well: cells ability to sense the virus early on; the amount of coordination between different branches of defense; the brakes the immune system puts on itself, so it does not put the hosts own tissues at risk. Casanova and his colleagues are also on the hunt for mutations that might alter peoples risk of developing long COVID and other coronaviral consequences. None of these searches will be easy. But they should be at least simpler than the one for resistance to infection, Casanova told me, because the outcomes theyre measuringserious and chronic forms of diseaseare that much more straightforward to detect.

If resistance doesnt pan out, that doesnt have to be a letdown. People dont need total blockades to triumph over microbesjust a defense thats good enough. And the protection were born with isnt all the leverage weve got. Unlike genetics, immunity can be easily built, modified, and strengthened over time, particularly with the aid of vaccines. Those DIY defenses are probably what kept Carringtons case of COVID down to a mild course, she told me. Immune protection is also a far surer bet than putting a wager on what we may or may not inherit at birth. Better to count on the protections we know we can cook up ourselves, now that the coronavirus is clearly with us for good.

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Could Genetics Be the Key to Never Getting the Coronavirus? - The Atlantic

Long COVID fears heightened by new wave of super-infectious variants – Los Angeles Times

July 27, 2022

As highly infectious Omicron subvariants continue to fuel a new coronavirus wave, there is growing concern about long COVID, in which symptoms or increased risk of illness can persist for months or even years.

Efforts to understand the scale of long COVIDs effects have taken on additional urgency given the number of people who have come down with the virus since Omicron was first detected in California shortly after Thanksgiving. Some experts think this latest surge may exceed the record-high case counts seen over the fall and winter, leaving more people at risk of developing the condition.

Because of the sheer volume of people that were infected, we can expect to see more long COVID cases, said Dr. Anne Foster, vice president and chief clinical strategy officer for the University of California Health system.

For these long-haul sufferers, maladies such as a cough, chest pain, shortness of breath, heart palpitations and brain fog have marred their lives and sometimes made it impossible to work. The most enduring cases can trace their initial coronavirus infection as far back as 2020, from the beginning of the pandemic.

Vaccinations and boosters may help reduce the risk of long COVID, but at least one study suggests the protective effect could be relatively limited. Thats why, officials and experts say, it remains important to take reasonable steps to avoid infection.

Its hard to predict the prevalence of long COVID, given the lack of a uniform definition, its sweeping array of symptoms and no easy way to test for it. Different studies have placed the percentage of people reporting symptoms for 12 weeks after an initial infection at anywhere from 3% to 50%.

But there is agreement among a number of experts that its consequences can be significant, including an increase in the risk of death or problems with other organ systems including the heart long after an acute infection has cleared.

An estimated 1 in 13 adults nationwide, and 1 in 14 in California, had current long COVID symptoms in early July, according to data collected by the Census Bureau and analyzed by the U.S. Centers for Disease Control and Prevention. The condition in that study was defined as someone having symptoms lasting three months or longer that werent experienced prior to infection.

About 1 in 7 adults across the U.S., and 1 in 8 in California, reported ever having long COVID symptoms, the data showed. As of early June, adults in their 50s were three times as likely to report long COVID than those 80 or older.

Long COVID has resulted in a mass disabling event, Foster said.

The good news is that most long COVID will resolve, lets say, after a year. But theres going to be some smaller subset that will have lifelong disability and impact to their health, Foster added.

Among those is Hannah Davis, a co-founder of the Patient-Led Research Collaborative that focuses on long COVID.

Davis got COVID-19 in March 2020 and to this day has difficulty driving, reading and walking, and I still have not recovered, she told the U.S. House Select Subcommittee on the Coronavirus Crisis during a recent hearing.

Long COVID must be considered in every step of the COVID response, she said. It has already impacted our workforce. Many people with long COVID cant work or need reduced hours and struggle to apply for disability benefits. The financial impact is devastating and cannot be overstated.

The condition, she added, will disable a huge percentage of our society if we do not decrease new cases and prioritize a cure for existing ones.

A report published by the CDC in May estimated that 1 in 5 adults ages 18 to 64 who had COVID-19 suffered a health condition that might be related to the previous coronavirus infection. Problems can affect the lungs, heart, brain, kidneys, muscles and bones.

The more severe the acute infection, the more likely the risk of long COVID, said Dr. Steven Deeks, a professor of medicine at UC San Francisco and principal investigator of the Long-term Impact of Infection with Novel Coronavirus, or LIINC, study. But its not absolute, and people who are not particularly symptomatic and people who were even asymptomatic can go on to develop long COVID, no question about it.

Researchers are still trying to understand the cause of long COVID symptoms. Theories include that the coronavirus might cause tissue destruction during an acute infection, leading to longer-lasting illness; that the virus persists in the body even after someone is no longer infectious; that the virus revs up the bodys immune response, causing harmful inflammation; that infection triggers the development of antibodies that attack a persons tissues; or that infection leads to blood-clotting issues.

Its such a diverse condition that there probably are multiple different processes or causes for some of the different types of symptoms rather than one unifying disease process, said Dr. Lucy Horton, an infectious disease specialist at UC San Diego Health.

With the ability of the coronavirus officially called SARS-CoV-2 to get into the bloodstream, its thought that infection can provoke more inflammation, which can lead to further disease elsewhere in the body, said Dr. Ziyad Al-Aly, a clinical epidemiologist at Washington University in St. Louis and chief of research and development at the Veterans Affairs St. Louis Healthcare System.

The common thread here is that long COVID is real, Al-Aly said. People are getting diabetes and heart disease and kidney disease and its certainly the result of SARS-CoV-2, which can interact with other cells and lead to organ dysfunction.

Some factors that put patients at higher risk of long COVID include being overweight, high blood pressure or heart disease, said Dr. Nisha Viswanathan, director of the UCLA Health Long COVID Program. Women also appear to be at a relatively higher risk.

Often, underlying medical issues can become uncontrolled after a COVID-19 infection. But even those with no health problems still have some risk.

There are many patients with long COVID who are young and had no preexisting health conditions prior to being infected with COVID, Horton said. We know that children can develop long COVID. So I think anyone who says COVID only affects old, unhealthy people is just ignoring the truth, to be honest.

At UCLA, Viswanathan has an entire group of long COVID patients in their 20s who have no prior history of medical conditions and who werent terribly unwell when they had COVID, either.

Surprisingly, some now struggling most with fatigue are marathon runners, cyclists and others who, before they were initially infected, did quite a bit of cardio exercise, Viswanathan said.

Vaccinations and boosters are believed to be helpful at staving off long COVID, but there is no consensus on the degree to which they provide protection.

One report observing triple-vaccinated Italian healthcare workers who werent hospitalized for COVID-19 found that two or three doses of vaccine was associated with a lower prevalence of long COVID.

Another study, which Al-Aly co-authored and involved on U.S. veterans, found that being vaccinated brought only a 15% reduction in the odds of developing long COVID compared with unvaccinated people.

Other long COVID symptoms include worsening depression, anxiety and neuropathy, which causes pain in various parts of the body, according to Viswanathan. Patients can have isolated symptoms or a combination of any, and treatment plans need to be tailored accordingly, she said.

Symptoms also can include loss of smell or hair, ejaculation difficulty and reduced libido, according to a report published Monday in the journal Nature Medicine.

Some patients with professional degrees who had previously been high functioning are now struggling to work, Viswanathan said. Were talking about patients, who because of the brain fog, because of the fatigue, they either have really substantially decreased their work hours, or theyre completely on disability at this point.

She said most of her patients see some degree of improvement in symptoms, with some more dramatic than others. But it takes work to develop a plan theres no FDA-approved therapy for long COVID at this point, so treatment ideas include using whats known about other medical conditions.

For instance, those with persistent shortness of breath might undergo pulmonary rehabilitation, which is typically used for patients with asthma and chronic obstructive pulmonary disease. In some instances, physical therapy and acupuncture have helped patients with muscle pain.

And some have seen improvements by going on an anti-inflammatory diet with lower portions of refined carbohydrates and red meat which is otherwise suggested to reduce the risk of heart attacks and heart disease.

Sometimes, improving sleep quality helps. For some patients, its literally a matter of they just need to take time off for work ... time to rest, Viswanathan said, which gives the opportunity for their body to probably start focusing on healing itself.

In some cases, antidepressants (even when given to those who do not suffer from depression) can help clear brain fog, Viswanathan said, suggesting the condition may be caused by a hormonal imbalance in the brain. Other times, patients must learn how to live with brain fog, such as making lists, pacing themselves and letting others know of plans.

Some studies have shown how the coronavirus is effectively attacking your frontal part of your brain, Viswanathan said, and there have been autopsies of COVID-19 patients showing brain damage.

The thing with long COVID is we have no way of knowing what is now going to happen going forward. Will [our patients] brains heal with time? Will they not? Viswanathan asked.

There are other viral illnesses that produce a post-viral fatigue syndrome, such as infectious mononucleosis, often referred to as mono, which is more commonly caused by the Epstein-Barr virus. Most people usually feel better within weeks, but occasionally fatigue can persist for six months or a year.

While there are a number of different risk factors, the only surefire way to dodge long COVID is to avoid getting infected with the coronavirus.

Even though I think many people are kind of under a delusion that the pandemic is over, its not, Horton said. So I think its a good time to kind of go back to our basics that have protected us: masking when in crowded indoor settings, using rapid testing before visiting older vulnerable people or groups, and staying up to date on vaccinations.

Although it can be disconcerting that so many questions about long COVID remain, the uncertainty is not new as the virus and the science behind it have continued to evolve throughout the pandemic.

Every time we think weve got this virus figured out, it basically laughs at us, Deeks said. It moves on, it changes, and then we have new riddles to try and figure out. And thats the story of COVID for the last 2 years. As they say: The virus is not done with us yet.

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Long COVID fears heightened by new wave of super-infectious variants - Los Angeles Times

Coronavirus Today: Out of patience with pandemic precautions – Los Angeles Times

July 27, 2022

Good evening. Im Karen Kaplan, and its Tuesday, July 26. Heres the latest on whats happening with the coronavirus in California and beyond.

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Were still in a pandemic. The number of coronavirus infections is high and rising. But something fundamental about COVID-19 has changed: It isnt as scary anymore.

Over the last week, the U.S. has averaged a whopping 120,000 new cases per day. (And those are just the ones reported to authorities; the true number is even higher.)

Contrast that to the early weeks of the outbreak, when society all but shut down in an effort to steer clear of the virus and bend the curve. All it took to get our attention back then was fewer than 30,000 cases per day.

They say familiarity breeds contempt, but in this case its having the opposite effect. The more time we spend with the coronavirus, the less we seem to worry about it.

Indeed, infections are now so commonplace that the fear of the unknown is fading, said Dr. Peter Chin-Hong, an infectious diseases expert at UC San Francisco.

You get it yourself and know tons of people who got it, and you fear it less, he said.

That explains why face masks were few and far between among the shoppers packed into the air-conditioned Westfield Valencia Town Center in Santa Clarita on a recent hot summer day, my colleagues Rebecca Schneid, Heidi Prez-Moreno and Hailey Brandon-Potts report.

People are just exasperated and over it, said Hailey Jimenez, 21, who was mask-free during a recent shift tending a jewelry kiosk there. I know Im over it.

Nicki Spravka knows the feeling. The 20-year-old moved from store to store without a mask or much angst.

I go to school in Colorado, and basically for the past year people have been acting like it doesnt exist anymore, she said of the virus. I mean, I guess I care. But it feels like what we do isnt really going to affect it because infections are still going to happen.

People, with and without masks, shop in L.A.'s Santee Alley in mid-July.

(Irfan Khan / Los Angeles Times)

This attitude is not unique to California or the West. The Pew Research Centers most recent survey about Americans attitudes about the pandemic found that only 41% considered the coronavirus a major threat to public health. Thats the lowest figure Pew has ever recorded. (An additional 45% considered the virus a minor threat and 13% called it not a threat.)

Likewise, only 34% of respondents were either somewhat or very concerned that the virus would land them in the hospital, and 50% were somewhat or very concerned that theyd spread an infection to someone else. Those figures also represent all-time lows for the pandemic.

Nationwide, daily COVID-19 deaths have averaged around 365 over the last week. The count hasnt been that low for a year, since the lull before the Delta surge. The only other time it has been lower was the initial weeks of the outbreak. So perhaps there is less reason to fear the coronavirus.

If your metric is infections, it looks hopeless, Chin-Hong said. But if your metric is people getting seriously ill and dying wow, thats a huge victory.

For the most part, the public is focused on the latter metric. But the health establishment is mostly focused on the former, especially the speed with which new variants are emerging and the possibility that one of them will be impervious to our vaccines and treatments, effectively sending us back to square one.

That helps explain why Los Angeles County is probably on the verge of reinstating an indoor mask mandate. Unless conditions substantially improve in the next couple of days, the county is likely to learn Thursday that it is entering its third consecutive week with a high COVID-19 community level because it has more 200 new infections and more than 10 new COVID-19 hospital admissions per 100,000 people over the last seven days. (As of last Thursday, there were 481 new infections and 11.4 new hospital admissions per 100,000 people per week.)

Bringing those numbers down is necessary to protect the vulnerable among us, such as the elderly and people who are immunocompromised, said Dr. Robert Kim-Farley, an epidemiologist and infectious diseases expert at UCLA.

What we need to do is have a mindset, or social norm, that we are going to expect somewhat of a roller-coaster ride as new variants arise and sweep through the population, he said. We can go back to more business as usual, but when rates are high, we should all do our part in reducing transmission.

Julisa Carrillo hopes people hear that message. She was hospitalized because of COVID-19 twice before the vaccines became available. Both of those hospitalizations included time on a ventilator.

More than a year and a half later, her lungs still dont feel the same. In her view, wearing a mask feels like a reasonable trade-off to help people avoid that same fate.

This is a virus that is hurting so many people, she said as she waited for a bus in Huntington Park. I myself dont feel safe.

California cases and deaths as of 6:30 p.m. Tuesday:

Track Californias coronavirus spread and vaccination efforts including the latest numbers and how they break down with our graphics.

The coronavirus can come for anyone, even the leader of the free world. Then-President Trumps illness in 2020 may have seemed like a bit of bad luck though if were being honest, his White House wasnt being particularly careful but current President Bidens diagnosis confirms that even those who take abundant precautions are vulnerable.

But its not all bad news for Biden. Catching the coronavirus in the summer of 2022 is not at all like catching it in the fall of 2020, my colleague Melissa Healy reports. Unlike Trump, Biden is benefiting from a full 2 years of scientific and medical advances against the once-novel virus. Plus, the virus itself has changed in ways that make it harder to evade but easier to survive.

Biden said Monday that hes feeling better every day. His schedule is lighter than it would have been while hes isolating at the White House, but Im meeting all my requirements that have come before me, he said.

Heres a look at the many advantages for Biden and the roughly 850,000 other Americans who caught the virus in the last week that werent available to Trump:

VACCINES: When Trump was diagnosed in early October 2020, the first COVID-19 vaccine from Pfizer and BioNTech was more than two months away from being authorized for emergency use by the Food and Drug Administration.

By the time Biden was diagnosed, he had received two primary doses of the companies Comirnaty vaccine, plus two booster doses. His most recent shot was on March 30. A letter from Dr. Kevin C. OConnor, the White House physician, described him as maximally protected.

Im doing well, getting a lot of work done, he said in a video. (Hes following Dr. Anthony Faucis lead and trying to power through instead of taking the time to rest and recover.)

Biden himself credited his four shots for his mild illness. His symptoms included a runny nose, cough, sore throat and some body aches.

Data from the Centers for Disease Control and Prevention back him up. Among Americans 65 and older, those who are unvaccinated are 3.8 times more likely to wind up hospitalized with COVID-19 than those who have been vaccinated and boosted at least once.

Whats more, people in Bidens age group 65 to 79 who are unvaccinated are nearly 9 times more likely to die of COVID-19 than their counterparts who are vaccinated and boosted. The second booster is important: The risk of death for Americans 50 and older who received it was four times lower than for their peers who stopped at one booster.

President Biden receives his first booster dose of Pfizer and BioNTechs COVID-19 vaccine on Sept. 27, 2021.

(Anna Moneymaker / Getty Images)

TREATMENTS: By the time Bidens illness was announced, he had already begun a course of Paxlovid. In clinical trials, patients at high risk of becoming severely ill were 88% less likely to be hospitalized or die if they took the antiviral (which is administered in pill form over five days). Biden falls into the high risk category because of his age (hell turn 80 in November).

Paxlovid received emergency use authorization in December, more than a year after Trumps bout with COVID-19. After initial shortages, it is now available at test to treat sites around the country, and as of this month, pharmacists have clearance to prescribe it to patients.

Should Biden take a turn for the worse and develop symptoms such as low oxygen levels, blood clots or problems with his heart or kidney function, there are plenty of other tools available to his doctors.

Remdesivir, which was given to Trump, would be available as a backstop, said Dr. Roy M. Gulick, who co-chaired the National Institutes of Healths panel on COVID-19 treatment guidelines. Today, physicians could also turn to one or more of the specialized drugs that calm an overactive immune system; although these were developed to treat other diseases, theyve been found to help those with COVID-19 as well.

Doctors have refined a variety of treatments while tending to Americas 90-million-plus patients over the course of the pandemic, Gulick said. For instance, theyre quicker to prescribe blood thinners for hospitalized patients to reduce the risk of blood clots. Theyve streamlined their use of steroids. Theyre more cautious about putting patients with breathing difficulties on ventilators, since they have the potential to do more harm than good. Theyve also figured out how to position patients with obesity to help keep their airways clear.

So much has changed since Trump got COVID, Gulick said. We have made substantive progress in treating people with severe COVID who are admitted to hospital, and fewer are dying as a result.

THE VIRUS ITSELF: We may lament the seemingly endless parade of variants and subvariants. But if you had to be infected with the SARS-CoV-2 coronavirus, youd rather have a version of Omicron than the original strain from Wuhan, China.

Trump fell ill before the emergence of the Alpha variant in the U.K., so its a safe bet that he was sickened by a virus that closely resembled the one that left China in late 2019. Virtually all of the SARS-CoV-2 coronaviruses circulating in the U.S. today are some version of Omicron, with the BA.5 subvariant alone accounting for an estimated 82% of specimens, according the CDC, and OConnor said thats probably the strain that got Biden.

For most of the pandemic, the COVID-19 death rate among those infected stood at about 2% of reported cases. But that figure dropped significantly after Omicron arrived, according to Beth Blauer, an associate vice provost at Johns Hopkins University. Now, fewer than 0.5% of reported infections results in death.

Population immunity from vaccines and past infections may help explain that progress, she wrote, but the data trends clearly demonstrate that Omicron is a much less deadly variant.

See the latest on Californias vaccination progress with our tracker.

Through parts of June, Los Angeles County and the San Francisco Bay Area had similar COVID-19 mortality rates. Then July came along, and deaths rose in L.A. but that increase was not matched up north.

As of Monday, the Bay Area had 56 deaths per 10 million residents over the last week. L.A. County, meanwhile, recorded 96 deaths per 10 million residents in the same period, a figure that was 70% higher.

Its not clear why deaths went up here but not there. L.A. has a higher poverty rate and more overcrowded housing. That means if one member of a household is infected, the number of people at risk of exposure is greater. Vaccination rates are also lower here than they are up north. According to The Times tracker, 73.7% of L.A. County residents are fully vaccinated; that percentage is lower than in all but one Bay Area county (Solano).

There are hints that L.A.'s death toll may begin to fall soon. The official count of new infections here has begun to decline, as has the number of infected patients in the countys hospitals. Last Wednesday, that number stood at 1,329; by Friday, it was down to 1,200, before rising somewhat to 1,286 on Monday.

As for coronavirus cases, the county was averaging about 6,100 infections per day over the week that ended Monday. During the previous week, the average number of daily infections was nearly 6,900.

Those improved trend lines are fueling hope that L.A. County Public Health Director Barbara Ferrer might not implement an indoor mask mandate later this week even if the county still has a high COVID-19 community level.

Should we see sustained decreases in cases, or the rate of hospital admissions moves closer to the threshold for medium, we will pause implementation of universal indoor masking as we closely monitor our transmission rates, Ferrer said. No decision will be made until after the CDC updates its community-level assessments on Thursday.

Officials in Beverly Hills would be happy to see the county demur on a mask mandate. The City Council voted unanimously Monday night not to enforce an indoor mask rule, should one materialize.

I support the power of choice, Mayor Lili Bosse said in a statement. This is a united City Council and community that cares about health. We are not where we were in 2020, and now we need to move forward as a community and be part of the solution.

Restaurants and bars, on the other hand, are already bracing for the stink eye they expect to get from customers if they have to go back to enforcing an indoor mask mandate. The job will be even more difficult this time around because the BA.5 subvariant has forced eating and drinking establishments to operate with skeletal staffing.

Im fearful and Im nervous and theres a lot of anxiety behind it, said Robert Fleming, who opened the Capri Club bar in Eagle Rock in June.

Plenty of other employers are dealing with COVID-induced staffing shortages too. Notable among them is the Transportation Security Administration.

The L.A. County health department says at least 233 cases have been confirmed among TSA workers at Los Angeles International Airport since June 9. The federal agency acknowledged an outbreak at LAX but said the figures released by the county overstated the current state of infections.

President Biden wasnt the only politico to catch the coronavirus in the last week. Democratic Sen. Joe Manchin III of West Virginia tweeted Monday that he tested positive for an infection and was experiencing mild COVID-19 symptoms. His Republican colleague Sen. Lisa Murkowski of Alaska tweeted similar news Monday and said she was experiencing flu symptoms.

On the research front, a study from USC has identified some new potential risk factors for developing long COVID. Like previous studies, the analysis found that patients who had obesity prior to their illnesses were more likely to have the lingering symptoms associated with long COVID. The USC team also found that patients who had sore throats, headaches and hair loss after becoming infected with the coronavirus were more likely to have long COVID.

The researchers dont think hair loss itself causes long COVID. Rather, they suspect that hair loss reflects extreme stress, potentially a reaction to a high fever or medications, said Eileen Crimmins, a demographer at USCs Leonard Davis School of Gerontology who worked on the study that appeared in Scientific Reports. So its probably some indication of how severe the illness was.

Separately, a pair of studies by an international team of experts used different analytical approaches to home in on the epicenter of the pandemic that has killed more than 6.4 million people around the world. Both methods point to the same conclusion: The coronavirus probably jumped from animals to humans at the Huanan Wholesale Seafood Market in Wuhan, China. In fact, it probably happened at least twice.

Several researchers who worked on the new papers had been open to the possibility that the virus had escaped from a Wuhan lab. But sleuthing over the last year or so has convinced them that the market is a far more plausible culprit.

In a city covering more than 3,000 square miles, the area with the highest probability of containing the home of someone who had one of the earliest COVID-19 cases in the world was an area of a few city blocks, with the Huanan market smack dab inside it, said one of those researchers, University of Arizona virologist Michael Worobey.

And finally, it looks as though there are no countries left that have more than 100,000 people but are still coronavirus-free. The island nation of Micronesia (population 115,000) appears to have been the last to fall and its outbreak is a doozy. It began last week and has already spread to at least 1,261 people. Eight people have been hospitalized with COVID-19, and one has died.

Turkmenistan is now the only remaining country with a population of at least 100,000 and no official coronavirus cases. Outside experts believe, however, that the virus is there and the countrys autocratic leaders are simply ignoring it.

Todays question comes from readers who want to know: Should I let the county health department know that I got a positive result on a rapid test?

If you live in L.A. County, you dont have to.

That said, there are some calls you should make. If you have a regular healthcare provider, let them know that youve tested positive.

You should also inform your recent close contacts so they can be tested. A close contact is someone whos been within 6 feet of you for a total of 15 minutes over a 24-hour period. Anyone who fits that bill in the two days leading up to your first COVID-19 symptoms or your positive test result (whichever came first) deserves to hear from you.

If you need help tracking down your close contacts, you actually do have a good reason to call the L.A. County Department of Public Health. The department has set up a hotline to assist residents with issues like these. The folks there can also answer questions you may have and can help you get a prescription for an antiviral medication, if warranted. The number for the hotline is (833) 540-0473.

The county health department is keeping track of the positive home test results they hear about. But a spokeswoman told my colleagues Jon Healey and Karen Garcia that department officials dont need you to tell them that youve tested positive and they definitely dont want you to tell them if youve tested negative.

Its not just that health officials are too busy to take your call. Its that they cant gauge the reliability of the home test you (and everyone else) used, or whether you (and everyone else) used it correctly. Thats why they tally only the results of tests performed in a laboratory.

L.A. County is hardly alone in this regard even the CDC takes this approach.

We want to hear from you. Email us your coronavirus questions, and well do our best to answer them. Wondering if your questions already been answered? Check out our archive here.

(Mariah Tauger / Los Angeles Times)

The hands in the photo above belong to chef Genet Agonafer. Shes the proprietor of Meals by Genet, the bistro in L.A.'s Little Ethiopia that helped make the berbere-centered flavors of her native country one of the important pieces of the mosaic that defines Los Angeles cuisine, as my colleague Laurie Ochoa writes.

Ochoa selected Agonafer as The Times 2022 Gold Award honoree. The award is bestowed not just for excellent cooking but also for broadening our culinary horizons.

In light of this praise, you might expect Meals by Genet to have a packed dining room. But when restaurants were able to reopen their dining rooms, Agonafer decided to keep hers closed. (She makes occasional exceptions for weddings and other private parties.) She hadnt missed the stress of full-on restaurant work, but she didnt want to close down altogether. So she opted for a compromise, offering takeout dinners on Thursdays through Sundays.

Although the limited hours mean less money, Agonafer said its a worthy trade-off.

Everything is just peaceful and easygoing, she said. There is still that stress when the rush happens or when we have events here, but things are going so incredibly well.

Resources

Need a vaccine? Heres where to go: City of Los Angeles | Los Angeles County | Kern County | Orange County | Riverside County | San Bernardino County | San Diego County | San Luis Obispo County | Santa Barbara County | Ventura County

Practice social distancing using these tips, and wear a mask or two.

Watch for symptoms such as fever, cough, shortness of breath, chills, shaking with chills, muscle pain, headache, sore throat and loss of taste or smell. Heres what to look for and when.

Need to get a test? Testing in California is free, and you can find a site online or call (833) 422-4255.

Americans are hurting in various ways. We have advice for helping kids cope, as well as resources for people experiencing domestic abuse.

Weve answered hundreds of readers questions. Explore them in our archive here.

For our most up-to-date coverage, visit our homepage and our Health section, get our breaking news alerts, and follow us on Twitter and Instagram.

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Coronavirus Today: Out of patience with pandemic precautions - Los Angeles Times

Coronavirus disease 2019 (COVID-19) WHO Thailand Situation Report 243 – 27 July 2022 – Thailand – ReliefWeb

July 27, 2022

Global COVID-19 (total) cases, deaths and vaccinations to date

Globally, the number of weekly cases has plateaued.

Numbers of new deaths slightly increased in the past week.

At the regional level, the number of weekly cases increased in the Western Pacific Region, the Region of the Americas and the South-East Asia Region, while it decreased in other regions.

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Coronavirus disease 2019 (COVID-19) WHO Thailand Situation Report 243 - 27 July 2022 - Thailand - ReliefWeb

17 counties in worst COVID-19 level – FOX 31 Denver

July 27, 2022

DENVER (KDVR) COVID-19 rates continue to drop across Colorado. Over the last seven days, the states positivity rate dropped, while incidence rates stayed steady.

The Centers for Disease Control and Prevention has moved 16 counties into thehigh level for community transmission:

The CDC said communities with ahigh level of COVID-19transmission should do the following:

As of Monday, the states seven-day positivity rate was 10.78%, which is down from 11.44% one week ago. Positivity rate measures the amount of COVID positive tests to the total amount of tests taken.

Overall, 32 counties saw an increase in COVID-19 positivity, 26 counties saw a decrease, two counties stayed the same, and four counties administered fewer than 10 tests.

According to theColorado Department of Public Health and Environment, incidence rates are similar to what they were last week.

Heres a look atpositivity rates for every county over the last seven days:

According toJohns Hopkins Bloomberg School of Public Health, the percent positive is exactly what it sounds like: the percentage of all coronavirus tests performed that are actually positive, or: (positive tests)/(total tests) x 100%. The percent positive (sometimes called the percent positive rate or positivity rate) helps public health officials answer questions suchas:

The percent positive will be high if the number ofpositive testsis too high, or if the number oftotal testsis too low. A higher percent positive suggests higher transmission and that there are likely more people with coronavirus in the community who havent been tested yet, Johns Hopkins shared.

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17 counties in worst COVID-19 level - FOX 31 Denver

Few Parents Intend to Have Very Young Children Vaccinated Against Covid – The New York Times

July 27, 2022

Barely a month after the Food and Drug Administration authorized Covid-19 vaccines for very young children, the prognosis that large numbers of them will actually get the shots looks bleak, according to a new survey of parents released on Tuesday by the Kaiser Family Foundation, which has monitored vaccine attitudes throughout the pandemic.

A majority of parents polled said they considered the vaccine a greater risk to their children than the coronavirus itself.

For children in the age group, 6 months through 4 years, parental apprehension has so far resulted in the administration of scarcely a trickle of Covid shots. Since June 18, when they became eligible, just 2.8 percent of those children had received shots, the foundation found recently in a separate analysis of federal vaccine data. By comparison, 18.5 percent of children ages 5 through 11, who have been eligible for Covid shots since October, had been vaccinated at a similar point in the rollout of their shots.

The new survey found that 43 percent of parents with children under 5 said they would definitely not have them vaccinated. About 27 percent said they would wait and see, while another 13 percent said they would have their children vaccinated only if required. Even some parents who were themselves vaccinated against Covid said they would not give permission for their youngest children.

The new analysis of parents views comes as vaccine uptake for older children has been slowing markedly. To date, only 40 percent of children 5 to 11 have been vaccinated. In the new survey, 37 percent of parents said they would definitely not get a Covid vaccine for their child in that age group.

The parents chief concerns were about potential side effects of the vaccine, its relative newness and what they felt was a lack of sufficient research. Many parents said they were prepared to let their children take the risk of contracting Covid rather than getting a vaccine to prevent it.

Experts on childhood vaccination said they viewed the parents hesitation with alarm, coming at a time when Covid cases are once again soaring and expected to worsen during the cold weather months, and as the possibility of new and potentially more dangerous coronavirus variants remains.

Although a vast majority of children who come down with Covid get over it easily, some kids get very, very ill from it and some die, said Patricia A. Stinchfield, the president of the National Foundation for Infectious Diseases. She was not involved in the Kaiser study.

How a child will fare with Covid is unpredictable, added Ms. Stinchfield, a nurse practitioner who coordinated vaccine administration for Childrens Minnesota, a childrens hospital system in St. Paul and Minneapolis. We have no marker for that, she said. Half the kids who come down with severe Covid are healthy kids, with no underlying conditions. So the idea of saying Im going to skip this vaccine for my kid, were not worried about Covid is really to take a risk.

Dr. Jason V. Terk, a pediatrician in Keller, Texas, acknowledged the reality that the extremely contagious Omicron subvariant BA.5 is evading both natural immunity and vaccination immunity much more than other variants. Still, he said, The vaccine is the best way to protect younger children from the occasions in which Covid-19 causes more severe illness.

This latest report is based on an online and telephone survey from July 7 to July 17 of 1,847 adults, 471 of whom had a child under 5. The margin of error was plus or minus 3 percentage points for the full sample, and plus or minus 8 percentage points for parents with a child under 5.

Perhaps unsurprisingly, the partisan divide was especially sharp around vaccination for children, with Republican parents three times as likely as Democratic parents to say they will definitely not have their child vaccinated.

A majority of parents said they found information from the federal government about the vaccine for their children to be confusing. Yet 70 percent said they had not yet discussed the shots with a pediatrician. Just 27 percent of those parents who are considering the vaccine said they would make an appointment to have that conversation.

We would see much higher uptake for all ages if every child had a visit with a trusted pediatrician or family doctor who both recommended the vaccine and had it in stock to administer it, said Dr. Sean T. OLeary, a Colorado-based pediatrician who is chairman of the committee on infectious disease at the American Academy of Pediatrics.

I recognize that not every child in America has a medical home, he added, but there are public health departments, federal health clinics and rural health centers throughout the U.S. trying to meet those needs.

Parents who might be predisposed to having their children get Covid shots said that lack of access was a significant barrier, a concern expressed by more Black and Hispanic parents than white parents. About 44 percent of Black parents worried about having to take time off from work to have their children vaccinated or to care for them if the children had side effects. Among Hispanic parents of young children, 45 percent said they were worried about finding a trustworthy location for the shots, and about a third feared they would have to pay a fee.

Ms. Stinchfield said she understood their concerns: Her own daughter had to take off work to get vaccinations for Ms. Stinchfields grandchildren, ages 1 and 3. Ms. Stinchfield went to a clinic with them. The message to clinics is, Make the vaccine for kids available in the evenings and on weekends, she said.

Did her grandchildren have any side effects? No, Ms. Stinchfield said with a chuckle. They felt so good that we put them in a little kiddie pool, she said. And now my granddaughters got a tan line from the Band-Aid from the shot on her leg.

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Few Parents Intend to Have Very Young Children Vaccinated Against Covid - The New York Times

Did COVID-19 change the way doctors view end-of-life care? – study – The Jerusalem Post

July 27, 2022

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Did COVID-19 change the way doctors view end-of-life care? - study - The Jerusalem Post

New studies bolster theory coronavirus emerged from the wild – Daily Independent

July 27, 2022

By LAURA UNGAR

Two new studies provide more evidence that the coronavirus pandemic originated in a Wuhan, China market where live animals were sold further bolstering the theory that the virus emerged in the wild rather than escaping from a Chinese lab.

The research, published online Tuesday by the journal Science, shows that the Huanan Seafood Wholesale Market was likely the early epicenter of the scourge that has now killed nearly 6.4 million people around the world. Scientists conclude that the virus that causes COVID-19, SARS-CoV-2, likely spilled from animals into people two separate times.

All this evidence tells us the same thing: It points right to this particular market in the middle of Wuhan, said Kristian Andersen a professor in the Department of Immunology and Microbiology at Scripps Research and coauthor of one of the studies. I was quite convinced of the lab leak myself until we dove into this very carefully and looked at it much closer.

In one study, which incorporated data collected by Chinese scientists, University of Arizona evolutionary biologist Michael Worobey and his colleagues used mapping tools to estimate the locations of more than 150 of the earliest reported COVID-19 cases from December 2019. They also mapped cases from January and February 2020 using data from a social media app that had created a channel for people with COVID-19 to get help.

They asked, Of all the locations that the early cases could have lived, where did they live? And it turned out when we were able to look at this, there was this extraordinary pattern where the highest density of cases was both extremely near to and very centered on this market, Worobey said at a press briefing. Crucially, this applies both to all cases in December and also to cases with no known link to the market And this is an indication that the virus started spreading in people who worked at the market but then started to spread into the local community.

Andersen said they found case clusters inside the market, too, and that clustering is very, very specifically in the parts of the market" where they now know people were selling wildlife, such as raccoon dogs, that are susceptible to infection with the coronavirus.

In the other study, scientists analyzed the genomic diversity of the virus inside and outside of China starting with the earliest sample genomes in December 2019 and extending through mid-February 2020. They found that two lineages A and B marked the pandemics beginning in Wuhan. Study coauthor Joel Wertheim, a viral evolution expert at the University of California, San Diego, pointed out that lineage A is more genetically similar to bat coronaviruses, but lineage B appears to have begun spreading earlier in humans, particularly at the market.

Now I realize it sounds like I just said that a once-in-a-generation event happened twice in short succession, Wertheim said. But certain conditions were in place such as people and animals in close proximity and a virus that can spread from animals to people and from person to person. So barriers to spillover have been lowered such that multiple introductions, we believe, should actually be expected, he said.

Many scientists believe the virus jumped from bats to humans, either directly or through another animal. But in June, the World Health Organization recommended a deeper probe into whether a lab accident may be to blame. Critics had said the WHO was too quick to dismiss the lab leak theory.

Have we disproven the lab leak theory? No, we have not, Andersen said. But I think whats really important here is there are possible scenarios and there are plausible scenarios and its really important to understand that possible does not mean equally likely.

The pandemic's origins remain controversial. Some scientists believe a lab leak is more likely and others remain open to both possibilities. But Matthew Aliota, a researcher in the college of veterinary medicine at the University of Minnesota, said in his mind the pair of studies kind of puts to rest, hopefully, the lab leak hypothesis.

Both of these two studies really provide compelling evidence for the natural origin hypothesis," said Aliota, who wasn't involved in either study. Since sampling an animal that was at the market is impossible, "this is maybe as close to a smoking gun as you could get."

___

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institutes Department of Science Education. The AP is solely responsible for all content.

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New studies bolster theory coronavirus emerged from the wild - Daily Independent

Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design -…

July 27, 2022

NEW YORK and MAINZ, Germany, July 27, 2022 Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the companies have initiated a randomized, active-controlled, observer-blind, Phase 2 study to evaluate the safety, tolerability, and immune response of an enhanced COVID-19 mRNA-based vaccine candidate at a 30 g dose level. This next-generation bivalent COVID-19 vaccine candidate, BNT162b5, consists of RNAs encoding enhanced prefusion spike proteins for the SARS-CoV-2 ancestral strain (wild-type) and an Omicron variant. The enhanced spike protein encoded from the mRNAs in BNT162b5 has been modified with the aim of increasing the magnitude and breadth of the immune response that could better protect against COVID-19.

This is the first of multiple vaccine candidates with an enhanced design which the companies plan to evaluate as part of a long-term scientific COVID-19 vaccine strategy to potentially generate more robust, longer-lasting, and broader immune responses against SARS-CoV-2 infections and associated COVID-19.

BNT162b5 will be evaluated in a U.S.-based study enrolling approximately 200 participants aged between 18 and 55 who have received one booster dose of a U.S.-authorized COVID-19 vaccine at least 90 days prior to their first study visit. Participants will be stratified by the number of months since their last dose of COVID-19 vaccine received prior to entering the study (three to six months or more than six months). The study does not include a placebo (injection with no active ingredient). For more information about this study please visit http://www.clinicaltrials.govon this link.

The Pfizer-BioNTech COVID-19 Vaccine, BNT162b2, which is based on BioNTechs proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.

U.S. Indication & Authorized Use

Pfizer-BioNTech COVID-19 Vaccine is FDA authorized under Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 6 months of age and older.

Pfizer-BioNTech COVID-19 Vaccine is FDA authorized to provide:

Primary Series

Booster Series

COMIRNATY INDICATIONCOMIRNATY (COVID-19 Vaccine, mRNA) is a vaccine approved for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older.

COMIRNATY AUTHORIZED USESCOMIRNATY (COVID-19 Vaccine, mRNA) is FDA authorized under Emergency Use Authorization (EUA) to provide:

Primary Series

Booster Dose

Emergency Use AuthorizationEmergency uses of the vaccine have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID 19) in individuals 6 months of age and older. The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.

INTERCHANGEABILITYFDA-approved COMIRNATY (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine FDA authorized for Emergency Use Authorization (EUA) for individuals 12 years of age and older can be used interchangeably by a vaccination provider when prepared according to their respective instructions for use.

The formulations of the Pfizer-BioNTech COVID-19 Vaccine authorized for use in individuals 6 months through 4 years of age, 5 through 11 years of age, and 12 years of age and older are different and should therefore not be used interchangeably. The Pfizer-BioNTech COVID-19 Vaccine authorized for use in children 6 months through 11 years of age should not be used interchangeably with COMIRNATY (COVID-19 Vaccine, mRNA).

IMPORTANT SAFETY INFORMATION

Tell your vaccination provider about all of the vaccine recipients medical conditions, including if the vaccine recipient:

Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY (COVID-19 Vaccine, mRNA) may not protect all vaccine recipients

Seek medical attention right away if the vaccine recipient has any of the following symptoms:

Seek medical attention right away if the vaccine recipient has any of the following symptoms after receiving the vaccine, particularly during the 2 weeks after receiving a vaccine dose:

These may not be all the possible side effects of the vaccine. Call the vaccination provider or healthcare provider about bothersome side effects or side effects that do not go away.

Click for Fact Sheets and Prescribing Information for individuals 6 months of age and older:

About Pfizer: Breakthroughs That Change Patients LivesAt Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at http://www.Pfizer.com. In addition, to learn more, please visit us on http://www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at http://www.facebook.com/Pfizer.

Pfizer Disclosure NoticeThe information contained in this release is as of July 27, 2022. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about Pfizers efforts to combat COVID-19, the collaboration between BioNTech and Pfizer to develop a COVID-19 vaccine, the BNT162 mRNA vaccine program, and the Pfizer-BioNTech COVID-19 Vaccine, also known as COMIRNATY (COVID-19 Vaccine, mRNA) (BNT162b2) (including an enhanced mRNA-based vaccine candidate, BNT162b5, including a Phase 2 study to evaluate the safety, tolerability, and immune response of BNT162b5 at a 30-g dose level, the companies long-term scientific COVID-19 strategy, qualitative assessments of available data, potential benefits, expectations for clinical trials, potential regulatory submissions, the anticipated timing of data readouts, regulatory submissions, regulatory approvals or authorizations and anticipated manufacturing, distribution and supply) involving substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preclinical and clinical data (including Phase 1/2/3 or Phase 4 data), including any data for BNT162b2, BNT162b5, any monovalent, bivalent or variant-adapted vaccine candidates or any other vaccine candidate in the BNT162 program in any of our studies in pediatrics, adolescents, or adults or real world evidence, including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the ability to produce comparable clinical or other results, including the rate of vaccine effectiveness and safety and tolerability profile observed to date, in additional analyses of the Phase 3 trial and additional studies, in real world data studies or in larger, more diverse populations following commercialization; the ability of BNT162b2, BNT162b5, any monovalent, bivalent or variant-adapted vaccine candidates or any future vaccine to prevent COVID-19 caused by emerging virus variants; the risk that more widespread use of the vaccine will lead to new information about efficacy, safety, or other developments, including the risk of additional adverse reactions, some of which may be serious; the risk that preclinical and clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when additional data from the BNT162 mRNA vaccine program will be published in scientific journal publications and, if so, when and with what modifications and interpretations; whether regulatory authorities will be satisfied with the design of and results from these and any future preclinical and clinical studies; whether and when submissions to request emergency use or conditional marketing authorizations for BNT162b5, BNT162b2 in additional populations, for a potential booster dose for BNT162b2, any monovalent, bivalent or variant-adapted vaccine candidates or any potential future vaccines (including potential future annual boosters or re-vaccination), and/or other biologics license and/or emergency use authorization applications or amendments to any such applications may be filed in particular jurisdictions for BNT162b5, BNT162b2, any monovalent or bivalent vaccine candidates or any other potential vaccines that may arise from the BNT162 program, including a potential variant-based, higher dose, or bivalent vaccine, and if obtained, whether or when such emergency use authorizations or licenses will expire or terminate; whether and when any applications that may be pending or filed for BNT162b5, BNT162b2 (including any requested amendments to the emergency use or conditional marketing authorizations), any monovalent, bivalent or variant-adapted vaccine candidates, or other vaccines that may result from the BNT162 program may be approved by particular regulatory authorities, which will depend on myriad factors, including making a determination as to whether the vaccines benefits outweigh its known risks and determination of the vaccines efficacy and, if approved, whether it will be commercially successful; decisions by regulatory authorities impacting labeling or marketing, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of a vaccine, including development of products or therapies by other companies; disruptions in the relationships between us and our collaboration partners, clinical trial sites or third-party suppliers; the risk that demand for any products may be reduced or no longer exist which may lead to reduced revenues or excess inventory; risks related to the availability of raw materials to manufacture a vaccine; challenges related to our vaccines formulation, dosing schedule and attendant storage, distribution and administration requirements, including risks related to storage and handling after delivery by Pfizer; the risk that we may not be able to successfully develop other vaccine formulations, booster doses or potential future annual boosters or re-vaccinations or new variant-based or next generation vaccines; the risk that we may not be able to maintain or scale up manufacturing capacity on a timely basis or maintain access to logistics or supply channels commensurate with global demand for our vaccine, which would negatively impact our ability to supply the estimated numbers of doses of our vaccine within the projected time periods as previously indicated; whether and when additional supply agreements will be reached; uncertainties regarding the ability to obtain recommendations from vaccine advisory or technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; challenges related to public vaccine confidence or awareness; uncertainties regarding the impact of COVID-19 on Pfizers business, operations and financial results; and competitive developments.

A further description of risks and uncertainties can be found in Pfizers Annual Report on Form 10-K for the fiscal year ended December 31, 2021 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned Risk Factors and Forward-Looking Information and Factors That May Affect Future Results, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at http://www.sec.gov and http://www.pfizer.com.

About BioNTechBiopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer. For more information, please visit http://www.BioNTech.com.

BioNTech Forward-looking StatementsThis press release contains forward-looking statements of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, statements concerning: BioNTechs efforts to combat COVID-19; the collaboration between BioNTech and Pfizer including the program to develop a COVID-19 vaccine and COMIRNATY (COVID-19 vaccine, mRNA) (BNT162b2) ( including a bivalent mRNA vaccine candidate, BNT162b5, including a Phase 2 study to evaluate the safety, tolerability, and immune response of BNT162b5 at the 30-g dose level, the Companies long-term scientific COVID-19 strategy, qualitative assessments of available data, potential benefits, expectations for clinical trials, the anticipated timing of regulatory submissions, regulatory approvals or authorizations and anticipated manufacturing, distribution and supply); our expectations regarding the potential characteristics of BNT162b2, BNT162b5, any monovalent or bivalent vaccine candidates or any future vaccine in our clinical trials and/or in commercial use based on data observations to date; the ability of BNT162b2, BNT162b5, any monovalent or bivalent vaccine candidates or any future vaccine, to prevent COVID-19 caused by emerging virus variants; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preclinical and clinical data (including Phase 1/2/3 or Phase 4 data), including the data discussed in this release for BNT162b2, BNT162b5, any monovalent or bivalent vaccine candidates or any other vaccine candidate in BNT162 program in any of our studies in pediatrics, adolescents, or adults or real world evidence, including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; that preclinical and clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when additional data from the BNT162 mRNA vaccine program will be published in scientific journal publications and, if so, when and with what modifications and interpretations; the expected time point for additional readouts on efficacy data of BNT162b2 or BNT162b5 in our clinical trials; the risk that more widespread use of the vaccine will lead to new information about efficacy, safety, or other developments, including the risk of additional adverse reactions, some of which may be serious; the nature of the clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; whether and when submissions to request emergency use or any marketing approval for BNT162b5, BNT162b2 in additional populations, for a potential booster dose for BNT162b2, any monovalent, bivalent or variant-adapted vaccine candidates or any potential future vaccines (including potential future annual boosters or re-vaccination), and/or other biologics license and/or emergency use authorization applications or amendments to any such applications may be filed in particular jurisdictions for BNT162b5, BNT162b2, any monovalent or bivalent vaccine candidates or any other potential vaccines that may arise from the BNT162 program, including a potential variant-based, higher dose, or bivalent vaccine, and if obtained, whether or when such emergency use authorizations or licenses will expire or terminate; whether and when any applications that may be pending or filed for BNT162b2, BNT162b5, any monovalent, bivalent or variant-adapted vaccine candidates, or other vaccines that may result from the BNT162 program may be approved by particular regulatory authorities, which will depend on myriad factors, including making a determination as to whether the vaccines benefits outweigh its known risks and determination of the vaccines efficacy and, if approved, whether it will be commercially successful; our contemplated shipping and storage plan, including our estimated product shelf life at various temperatures; the ability of BioNTech to supply the quantities of BNT162, BNT162b5, any monovalent or bivalent vaccine candidates or any future vaccine, to support clinical development and market demand, including our production estimates for 2022; that demand for any products may be reduced or no longer exist which may lead to reduced revenues or excess inventory; the availability of raw materials to manufacture a vaccine; our vaccines formulation, dosing schedule and attendant storage, distribution and administration requirements, including risks related to storage and handling after delivery by Pfizer; the ability to successfully develop other vaccine formulations, booster doses or potential future annual boosters or re-vaccinations or new variant-based vaccines; the ability to maintain or scale up manufacturing capacity on a timely basis or maintain access to logistics or supply channels commensurate with global demand for our vaccine, which would negatively impact our ability to supply the estimated numbers of doses of our vaccine within the projected time periods as previously indicated; whether and when additional supply agreements will be reached; the ability to obtain recommendations from vaccine advisory or technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; challenges related to public vaccine confidence or awareness; and uncertainties regarding the impact of COVID-19 on BioNTechs trials, business and general operations. Any forward-looking statements in this press release are based on BioNTech current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the ability to meet the pre-defined endpoints in clinical trials; competition to create a vaccine for COVID-19; the ability to produce comparable clinical or other results, including our stated rate of vaccine effectiveness and safety and tolerability profile observed to date, in the remainder of the trial or in larger, more diverse populations upon commercialization; the ability to effectively scale our productions capabilities; and other potential difficulties.For a discussion of these and other risks and uncertainties, see BioNTechs Annual Report as Form 20-F for the Year Ended December 31, 2021, filed with the SEC on March 30, 2022, which is available on the SECs website at http://www.sec.gov. All information in this press release is as of the date of the release, and BioNTech undertakes no duty to update this information unless required by law.

CONTACTS

Pfizer:Media Relations+1 (212) 733-7410[emailprotected].com

Investor Relations+1 (212) 733-4848[emailprotected]

BioNTech:Media RelationsJasmina Alatovic+49 (0)6131 9084 1513[emailprotected]

Investor RelationsSylke Maas, Ph.D.+49 (0)6131 9084 1074[emailprotected]

Original post:

Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design -...

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