Pfizer scientist: Seniors, people with underlying conditions to be 1st to get Covid vax booster

 High-risk groups such as the elderly and people with underlying medical conditions are expected to be the first in line to get booster shots of the Pfizer-BioNTech Covid-19 vaccine, Pfizer’s chief scientific officer told investors Tuesday.

The two-dose vaccine has been shown to be about 95% effective against Covid two weeks after the second dose, though researchers who helped develop the shot now say they are beginning to see that strong protection wane over time.

Executives at Pfizer and BioNTech previously told CNBC that people will likely need a booster shot, or third dose, of the Covid-19 vaccine within 12 months of getting fully vaccinated. They also said it’s likely people will need to get additional shots each year.

During an earnings call Tuesday, Mikael Dolsten, Pfizer’s chief scientific officer, said it makes sense to start with those most susceptible, such as older adults and those with chronic diseases that make them more vulnerable to severe illness and hospitalization, such as cardiovascular disease or asthma.

The Centers for Disease Control and Prevention makes recommendations to states on who should get the shots first.

“We cannot predict” what the CDC will do, Dolsten said.

Dolsten’s comment comes after the company reported that sales of its Covid-19 vaccine boosted its first-quarter financial results.

The company now expects full-year sales of $26 billion from the vaccine, up from its previous forecast of about $15 billion. It expects an adjusted pretax profit in the high 20% range of revenue for the vaccine.

“Based on what we’ve seen, we believe that a durable demand for our Covid-19 vaccine, similar to that of the flu vaccines, is a likely outcome,” Pfizer CEO Albert Bourla told investors on the earnings call.

Should Americans require booster shots, the U.S. government would likely need to make arrangements with the drugmakers to supply additional doses and make plans for vaccine distribution.

Last month, Andy Slavitt, senior advisor to President Joe Biden’s Covid response team, said the White House is preparing for the potential need for Covid-19 vaccine booster shots. He said the Biden administration has thought about the need to secure additional doses.

https://www.cnbc.com/2021/05/04/covid-booster-shot-pfizer-expects-older-adults-those-with-underlying-conditions-to-be-first-in-line.html

Target Offers Coupon to Customers, Employees Who Get COVID Vax at Stores

 Target stores are rolling out a new program to help encourage customers to get the coronavirus vaccine, giving a coupon to customers who get their shots at in-store CVS pharmacies.

The announcement coincides with the chain’s announcement that all of its locations with CVS pharmacies will now offer coronavirus vaccine doses to associates and customers.

Guests can register for appointments through CVS’ website, according to Target officials.

When guests or employees get their vaccine doses, the company will provide a $5 coupon for use on in-store purchases of $5 or more, according to an email sent out this week.

“Since the onset of the pandemic, the safety of Target team members and guests is our top priority,” the company said in a statement.

For more information, customers can visit Target’s website, or the “A Bullseye View” newsletter site.

https://www.nbcchicago.com/news/local/target-offers-coupon-to-customers-employees-who-get-covid-vaccinations-at-stores/2502140/

BioNTech near request for approval of longer-lasting version of COVID vaccine

 BioNTech is working on getting approval for a version of its COVID-19 vaccine which can be stored in fridges of 2 to 8 degree celsius for up to 6 months, Chief Executive Ugur Sahin said on Tuesday.

"Our first formulation had to be stored and shipped at minus 80 degrees. We have now, in the meantime, a formulation which is not yet approved... which can be stored at two to eight degrees," Sahin told a Financial Times conference panel, adding that data packages were being prepared for regulators.

"We will most likely reach six months stability at two to eight degrees," he said of the vaccine, which is being made with Pfizer (PFE.N).

https://www.reuters.com/business/healthcare-pharmaceuticals/biontech-nearing-request-approval-longer-lasting-version-covid-vaccine-2021-05-04/

Psaki defends emails between CDC, teachers union as ‘best practice’

 Who put them in charge?

After critics ripped the Centers for Disease Control and Prevention (CDC) for caving to the powerful American Federation of Teachers (AFT) union over school reopening guidance in February, White House press secretary Jen Psaki claimed Tuesday the agency was following a “longstanding best practice.”

Emails obtained by the conservative watchdog group Americans for Public Trust and provided to the Post last week show that a top AFT official described the union as the CDC’s “thought partner” in planning the return of in-person classes.

In a Feb. 1 email, AFT senior director for health issues Kelly Trautner lavished praise on the CDC, thanking officials for what she called a “rich discussion about forthcoming CDC guidance and for your openness to the suggestions made by our president, Randi Weingarten, and the AFT.”

In the same message, Trautner noted that union officials “were able to review a copy of the draft guidance document over the weekend and were able to provide some initial feedback to several staff this morning about possible ways to strengthen the document”.

That email was forwarded to CDC Director Dr. Rochelle Walensky by White House coronavirus testing coordinator Carole Johnson. Another email indicated a call between Walensky and Weingarten was set for Feb. 7.

The CDC school-reopening guidelines issued Feb. 12 included at least two carveouts insisted upon by the union. One of those was the statement that while schools can be open regardless of community spread of coronavirus, “[i]n the event of high community-transmission results from a new variant of SARS-CoV-2, a new update of these guidelines may be necessary.”

The AFT also demanded, and got, guidance permitting teachers “who have documented high-risk conditions or who are at increased risk for … COVID-19” or “staff who have a household member” with similar conditions to continue working from home.

The emails caused an uproar among Republicans, with Sen. Tom Cotton (R-Ark.) accusing the CDC Monday of being “a thoroughly politicized agency, bending to the call of teachers unions.”

Psaki described Cotton’s criticism as “false” and argued that “it’s actually longstanding best practice for the CDC to engage with organizations, groups that are going to be impacted by guidance and recommendations issued by the agency.

American Federation of Teachers senior director for health issues Kelly Trautner described the union as the CDC’s “thought partner,” emails show.

Getty Images for MoveOn.org

“It doesn’t mean they are taking everything they want, or even a percentage of what they want, but it’s important to understand the implementation components. They do so to ensure that recommendations are feasible and that they adequately address the safety and well-being of the individuals the guidance is aimed to protect,” Psaki continued. “So, the CDC engaged with around 50 stakeholders that are on the front lines in this pandemic and have requisite perspective for the guidance.”

Psaki did not elaborate on which other “stakeholders” were consulted.

Even as the emails flew in from AFT, Walensky initially appeared bullish on the reopening guidance. During a White House coronavirus briefing on Feb. 3, the CDC head indicated that “safe reopening does not suggest that teachers need to be vaccinated in order to reopen safely.”

The following day, Psaki claimed that Walensky had merely spoken “in her personal capacity.”

https://nypost.com/2021/05/04/psaki-says-emails-between-cdc-teachers-union-best-practice/

Gene mutation linked to exfoliation syndrome, most common cause of glaucoma

 Researchers from the Agency for Science, Technology and Research's (A*STAR) Genome Institute of Singapore (GIS) and Bioprocessing Technology Institute (BTI), as well as Singapore Eye Research Institute (SERI), have identified a genetic mutation (functionally defective CYP39A1 gene) associated with exfoliation syndrome, the most common cause of glaucoma. The findings could pave the way for future research on the cause of exfoliation syndrome and potential cures. Their research was published in Journal of the American Medical Association (JAMA) on 24 February 2021.

Exfoliation syndrome is a systemic disorder characterised by abnormal protein material that progressively accumulates in the front of the eye. This disorder is the most common cause of glaucoma, and a major cause of irreversible blindness.

In this study, the scientists sequenced all protein encoding genes of more than 20,000 participants from 14 countries across Asia, Europe, and Africa, including more than 1,200 Singaporeans. They observed that people with exfoliation syndrome are twice as likely to carry damaging mutations in the gene encoding for the CYP39A1 protein, an enzyme which plays an important role in the processing of cholesterol. Further extended analyses suggest that defective CYP39A1 function is strongly associated with increased risk of exfoliation syndrome.

Although exfoliation syndrome is the most common cause of glaucoma, its origin is shrouded in mystery because it is not known where the abnormal protein deposits (exfoliative material) originate, and how the disease comes about. Answers to these questions could provide approaches to design and develop an effective treatment. The current findings point to the important role of cholesterol processing in the exfoliation syndrome disease process. As cholesterol is found abundantly in all cells, disruption to how cholesterol is processed due to defective CYP39A1 activity could adversely impact their normal functions. In particular, this study discovered that epithelial cells in the front of the eye responsible for filtering the blood supply to produce the clear fluid known as aqueous humour that bathes and nourishes other cells in the eye, were most affected by the CYP39A1 gene mutation. Disruption to the gene function can compromise the filtering function of epithelial cells and lead to leakage of exfoliative material from the blood into the eye.

Prof Patrick Tan, Executive Director of GIS, said, "This is a ground-breaking study that could facilitate future research efforts aimed at restoring defective CYP39A1 function and inhibiting the formation of exfoliation material in the eye as treatments for exfoliation syndrome and glaucoma."

Prof Aung Tin, Director of SERI and Deputy Medical Director of SNEC, said, "This is a major eye disease, affecting over 70 million people worldwide, which causes a lot of visual morbidity and blindness, not only from glaucoma but also due to complications related to cataract surgery. This study was notable for involving many centres from many different countries around the world, but led from Singapore. The study findings are very exciting as we found a new pathway for the disease which opens up possibilities for new treatments."

Prof David Friedman, the Albert and Diane Kaneb Chair in Ophthalmology at Harvard University and Director of the Glaucoma Service at the Massachusetts Eye and Ear Infirmary, Boston, commented, "Very exciting work. The researchers have identified rare gene variants that results in disrupted cholesterol homeostasis and transport that will open the door to novel therapeutics. Having studied over 20,000 individuals, the study demonstrates the power of studying rare variants to detect disease-causing genes in complex conditions." Prof Friedman was not involved in the study.

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Story Source:

Materials provided by Agency for Science, Technology and Research (A*STAR), Singapore. Note: Content may be edited for style and length.

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Journal Reference:

1. Zheng Li, Zhenxun Wang, Mei Chin Lee, Matthias Zenkel, Esther Peh, Mineo Ozaki, Fotis Topouzis, Satoko Nakano, Anita Chan, Shuwen Chen, Susan E. I. Williams, Andrew Orr, Masakazu Nakano, Nino Kobakhidze, Tomasz Zarnowski, Alina Popa-Cherecheanu, Takanori Mizoguchi, Shin-ichi Manabe, Ken Hayashi, Shigeyasu Kazama, Kenji Inoue, Yosai Mori, Kazunori Miyata, Kazuhisa Sugiyama, Tomomi Higashide, Etsuo Chihara, Ryuichi Ideta, Satoshi Ishiko, Akitoshi Yoshida, Kana Tokumo, Yoshiaki Kiuchi, Tsutomu Ohashi, Toshiya Sakurai, Takako Sugimoto, Hideki Chuman, Makoto Aihara, Masaru Inatani, Kazuhiko Mori, Yoko Ikeda, Morio Ueno, Daniel Gaston, Paul Rafuse, Lesya Shuba, Joseph Saunders, Marcelo Nicolela, George Chichua, Sergo Tabagari, Panayiota Founti, Kar Seng Sim, Wee Yang Meah, Hui Meng Soo, Xiao Yin Chen, Anthi Chatzikyriakidou, Christina Keskini, Theofanis Pappas, Eleftherios Anastasopoulos, Alexandros Lambropoulos, Evangelia S. Panagiotou, Dimitrios G. Mikropoulos, Ewa Kosior-Jarecka, Augustine Cheong, Yuanhan Li, Urszula Lukasik, Monisha E. Nongpiur, Rahat Husain, Shamira A. Perera, Lydia Álvarez, Montserrat García, Héctor González-Iglesias, Andrés Fernández-Vega Cueto, Luis Fernández-Vega Cueto, Federico Martinón-Torres, Antonio Salas, Çilingir Oguz, Nevbahar Tamcelik, Eray Atalay, Bilge Batu, Murat Irkec, Dilek Aktas, Burcu Kasim, Yury S. Astakhov, Sergei Y. Astakhov, Eugeny L. Akopov, Andreas Giessl, Christian Mardin, Claus Hellerbrand, Jessica N. Cooke Bailey, Robert P. Igo, Jonathan L. Haines, Deepak P. Edward, Steffen Heegaard, Sonia Davila, Patrick Tan, Jae H. Kang, Louis R. Pasquale, Friedrich E. Kruse, André Reis, Trevor R. Carmichael, Michael Hauser, Michele Ramsay, Georg Mossböck, Nilgun Yildirim, Kei Tashiro, Anastasios G. P. Konstas, Miguel Coca-Prados, Jia Nee Foo, Shigeru Kinoshita, Chie Sotozono, Toshiaki Kubota, Michael Dubina, Robert Ritch, Janey L. Wiggs, Francesca Pasutto, Ursula Schlötzer-Schrehardt, Ying Swan Ho, Tin Aung, Wai Leong Tam, Chiea Chuen Khor. Association of Rare CYP39A1 Variants With Exfoliation Syndrome Involving the Anterior Chamber of the Eye. JAMA, 2021; 325 (8): 753 DOI: 10.1001/jama.2021.0507

https://www.sciencedaily.com/releases/2021/05/210504112512.htm

Enzyme may help curb chronic kidney disease

 University of South Australia researchers have identified an enzyme that may help to curb chronic kidney disease, which affects approximately 700 million people worldwide.

This enzyme, NEDD4-2, is critical for kidney health, says UniSA Centre for Cancer Biology scientist Dr Jantina Manning in a new paper published this month in Cell Death & Disease.

The early career researcher and her colleagues, including 2020 SA Scientist of the Year Professor Sharad Kumar, have shown in an animal study the correlation between a high salt diet, low levels of NEDD4-2 and advanced kidney disease.

While a high salt diet can exacerbate some forms of kidney disease, until now, researchers did not realise that NEDD4-2 plays a role in promoting this salt-induced kidney damage.

"We now know that both a high sodium diet and low NEDD4-2 levels promote renal disease progression, even in the absence of high blood pressure, which normally goes hand in hand with increased sodium," says Dr Manning.

NEDD4-2 regulates the pathway required for sodium reabsorption in the kidneys to ensure correct levels of salt are maintained. If the NEDD4-2 protein is reduced or inhibited, increased salt absorption can result in kidney damage.

Even people on a low salt diet can get kidney damage if they have low levels of NEDD4-2 due to genetic variations or mutations in the gene.

Prof Kumar says the long-term goal is to develop a drug that can increase NEDD4-2 levels in people with chronic kidney disease (CKD).

"We are now testing different strategies to make sure this protein is maintained at a normal level all the time for overall kidney health," Prof Kumar says.

"In diabetic nephropathy -- a common cause of kidney disease -- levels of NEDD4-2 are severely reduced. This is the case even when salt is not a factor."

The study also revealed a surprising finding: that the high salt diet induced kidney disease is not always due to high blood pressure.

"In a lot of cases, kidney disease is exacerbated by hypertension, so we wanted to investigate that link in our study. In fact, we found the complete opposite -- that a high salt diet caused excessive water loss and low blood pressure. This is significant because it means that kidney disease can also happen in people who don't have high blood pressure," Dr Manning says.

A 2020 Lancet paper estimated that about 700 million people -- or 10 per cent of the world's population -- suffer from chronic kidney disease, which represents a 29 per cent increase in the past 30 years.

The huge spike in CKD is mainly attributed to a global obesity epidemic in recent decades, leading to diabetes, one of the leading causes of chronic kidney disease along with high blood pressure.

World Health Organization statistics reveal a 300 per cent increase in diabetes between 1980 and 2014, making it one of the top 10 causes of death worldwide and showing the gravity of the problem facing scientists trying to tackle kidney disease.

"Obesity and lifestyle are two main factors driving chronic kidney disease but there are other things at play as well," says Dr Manning. "Acute kidney injuries, drugs taken for other conditions, high blood pressure and a genetic predisposition can also cause it."

The UniSA scientists are collaborating with clinicians from the Royal Adelaide Hospital and Flinders Medical Centre and hope to secure funding to take their research to the next stage -- to find a way to regulate NEDD4-2 and protect against kidney disease.

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Story Source:

Materials provided by University of South Australia. Note: Content may be edited for style and length.

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Journal Reference:

1. Jantina A. Manning, Sonia S. Shah, Andrej Nikolic, Tanya L. Henshall, Yeesim Khew-Goodall, Sharad Kumar. The ubiquitin ligase NEDD4-2/NEDD4L regulates both sodium homeostasis and fibrotic signaling to prevent end-stage renal disease. Cell Death & Disease, 2021; 12 (4) DOI: 10.1038/s41419-021-03688-7

https://www.sciencedaily.com/releases/2021/05/210504112610.htm

Treating Mental Illness Won't Prevent Mass Shootings

 As the coronavirus pandemic begins to wane in the U.S., a number of public mass shootings have once again reminded us of the epidemic of gun violence in our country. The FedEx shooting in Indianapolis, the massage parlor shooting in Atlanta, and the Boulder supermarket shooting were only a few of the 160 mass shootings (defined as four or more people killed) in the first four months of 2021. Each of these horrific incidents leaves us wondering what could possibly motivate someone to walk into a public space and open fire on a group of strangers. Perhaps because of the scale of such violence, the indifference to human life, and of the lack of obvious gain for the perpetrator, many assume that there must be some sort of defect in the mind of the shooter -- and thus that they must be mentally ill.

While there is an association between mass shootings and mental illness, it is a weak one. There are examples of mass shootings perpetrated by people who are driven by delusions or hallucinations that alter their perception of reality, but these are few and far between. More often, the shooters are driven by a grudge against an employer, a family member, or a peer.

Though they may have mental health problems, few mass shooters have been formally diagnosed with a serious mental illness. Most lack overt signs of hallucinations or delusions that would affect their ability to understand what they were doing, or to recognize that it was wrong. Instead, many have traits of narcissism, depression, inability to empathize, and entitlement -- indicators of poor coping mechanisms, but not necessarily treatable mental illnesses. And though in retrospect it seems like these traits could help identify potential mass shooters, these traits are common and therefore lack predictive value.

Each time a mass shooting happens, we ask what we could have done to stop it. If one assumes that the shooters are driven by mental illness, it follows that fixing our mental health system is a reasonable solution. And our mental health system is certainly broken: there is a dire provider shortage, too few inpatient beds, a lack of intensive outpatient services, too little supported housing, too few ways to intervene when a person is too sick to accept help.

But the mental health system is a blunt instrument to prevent mass shootings at best. While a minority of these shooters might have benefitted from treatment to reduce psychotic symptoms, the majority appeared to be driven more by entitlement, misogyny, white supremacy, or a desire for revenge -- conditions that are notoriously difficult to treat. Not to mention, it's difficult to get people into treatment if they are not willing to go voluntarily. Few recent perpetrators rose to the attention of the authorities in a manner that would have qualified them for involuntary psychiatric services.

Even if mental health treatment doesn't ameliorate the risk of violence, there are mental health associated firearm prohibitions that could prevent would-be mass shooters from having access to guns. However, these prohibitions don't apply until a person is formally committed by a judge during a psychiatric hospitalization, or otherwise found to lack the capacity to manage their affairs. This process can happen days or even weeks into their hospitalization and treatment, and many people who are brought in involuntarily don't make it to that checkpoint. They are discharged home to their guns, with their rights to own them and to buy more still intact.

So, what can healthcare providers do in the event they become concerned that one of their patients might perpetrate a mass shooting?

Healthcare providers working in primary care, emergency, pediatric, and psychiatric settings may face situations where a patient makes concerning statements, or a family member or friend expresses concern. A recent report from the FBI showed that over half of mass shooters make internet posts or other communications to people that publicly hint at their plans prior to acting -- a phenomenon called leakage. This leakage may be brought to the attention of their healthcare provider.

Providers have options in these situations. Because of the diverse motivations behind mass violence, one of the best preventative strategies is to immediately remove the person's access to firearms. This means getting guns out of the home and prohibiting them from purchasing more. In many states, law enforcement or family, and in some cases, healthcare providers or employers, can petition a judge for an Extreme Risk Protection Order (also known as "red flag laws") that will allow for removal of currently owned firearms and place a temporary prohibition on buying more. These orders are based on threats and risk, and in most states, don't require a diagnosis of a mental illness. While research has shown they can be a portal into mental health services for those who need it, they can also prevent violent fantasies from becoming a reality by removing weapons regardless of motive. Some states also have specific workplace or school protective orders that provide additional protection for potential targets in addition to firearm restrictions.

Psychiatric hospitalization may be warranted if it appears that a patient is a danger to others because of a mental illness. While treatment may decrease some contributing symptoms, providers should familiarize themselves with state and federal firearm prohibitions based on mental health interventions so they are aware of how the person's firearm rights may be affected. Even if the person does merit inpatient treatment, ancillary steps should be taken to ensure prompt removal of their access to weapons rather than relying on mental health-related prohibitions.

If the person of concern is a minor, it is crucial to engage parents, caregivers, and other family members. Many states have child access prevention laws that make it illegal for adults to store firearms in a way that minors could access them. Preventing access by removing guns from the home or locking them up is vital, as the majority of school shooters get their firearms from home or from a family member.

Healthcare providers should also engage and collaborate with any law enforcement teams who may be involved in threat mitigation. HIPAA allows for disclosure of protected health information in cases where there is an imminent or serious threat of harm, as long as that disclosure is made to someone who can lessen the threat. Law enforcement may have helpful collateral about criminal charges, protective orders, and firearm access.

Many firearm violence prevention organizations, healthcare systems, and healthcare providers have become interested in supporting programs for clinicians to become more knowledgeable about preventing firearm injury and death. And in 2019, California became the first state to fund such an initiative, giving $3.84 million to the development of the BulletPoints Project. Addressing the issue of gun violence will take significant reform across our society, but clinicians can play an important role in preventing this type of injury and death in their own patients.

Amy Barnhorst, MD, is the Vice Chair for Community Mental Health at the UC Davis Department of Psychiatry and the director of the BulletPoints Project, a state-funded effort to develop and disseminate a curriculum to teach healthcare providers across California how to counsel at-risk patients about firearms.

https://www.medpagetoday.com/psychiatry/generalpsychiatry/92412