Category Archives: Immunology

Immunology

Pfizer Augments Inflammation and Immunology Business with $6.7 Billion Buy – BioSpace

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The share price of Arena Pharmaceuticalsnearly doubled in premarket trading after pharma giant Pfizer announced it was acquiring the company and its diverse portfolio of developmental and clinical assets, including a late-stage ulcerative colitis treatment, in an all-cash deal valued at approximately $6.7 billion.

Pfizer will acquireoutstanding shares of the company for $100 per share. Arenas stock closed at $49.94 on Friday, and the share price has soared to $95.95 in premarket trading after the announcement was made.

Mike Gladstone, president and general manager of Pfizers Inflammation and Immunology division, said the acquisition of Arena would complement the companys inflammation and immunology business. He said the Arena assets would provide hope for a better and more effective treatment for patients with debilitating immuno-inflammatory diseases.

Specifically, Pfizer is eying Utah-based Arenas experimental Crohns treatment etrasimod, a highly selective, once-daily, oral sphingosine 1-phosphate (S1P) receptor modulator. Not only doesetrasimod showpotential in Crohnsbecause of its design to provide systemic and local effects on specific immune cell types, but the experimental drug can also potentiallytreat multiple immune-mediated inflammatory diseases, including ulcerative colitis, eosinophilic esophagitis, atopic dermatitis, and alopecia areata.

Currently, etrasimod is in two Phase III studies in ulcerative colitis, a Crohns disease study, and is moving into a late-stage program in atopic dermatitis.

In Phase II studies in ulcerative colitis, etrasimod showed promise. After 12 weeks, many patients showedpositive clinical responses, clinical remission, or endoscopic improvement. Additionally, data showed that patients in the study experienced sustained or improved effects up to week 46 an open-label extension. Etrasimod also demonstrated a favorable benefit/risk profile. Data from the Phase III studies are expected in 2022.

Last month, Arena announced it achieved target enrollment in its Phase II/III CULTIVATE Study A, designed to assess the efficacy, safety, and tolerability of oral etrasimod as a potential therapy for adult participants who have moderate to severe Crohns disease and are refractory or intolerant to at least one of the currently available therapies. Etrasimod is also in two Phase II programs in eosinophilic esophagitis and alopecia areata.

Utilizing Pfizers leading research and global development capabilities, we plan to accelerate the clinical development of etrasimod for patients with immuno-inflammatory diseases, Gladstone said in a statement.

In addition to etrasimod, Arenas pipeline includes two development-stage cardiovascular assets, temanogrel and APD418. Temanogrel is currently in Phase II development to treat microvascular obstruction and Raynauds phenomenon secondary to systemic sclerosis. APD418 is currently in a Phase II clinical trial for acute heart failure.

Arena President and Chief Executive Officer Amit D. Munshi expressed excitement regarding the planned acquisition. Munshi said the proposal recognizes Arenas potentially best-in-class S1P molecule and contribution to addressing unmet needs in immune-mediated inflammatory diseases. When the merger goes through, Munshi said Pfizers capabilities will accelerate the companys mission to bring those medications through the regulatory paths and to patients who need new options.

We believe this transaction represents the best next step for both patients and shareholders, Munshi said in a statement.

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Pfizer Augments Inflammation and Immunology Business with $6.7 Billion Buy - BioSpace

Immunology

Luke O’Neill says booster helped to ensure he only got ‘mild’ Covid – The Irish Times

Immunology professor Luke ONeill has encouraged people to get vaccinated, saying he is only experiencing mild symptoms of Covid-19 as a result of having beenjabbed.

Speaking to The Irish Times on Monday evening, Prof ONeill said that he was deemed a close contact of a confirmed case, and the second HSE antigen test he took on Friday was positive.

On Saturday, he got a PCR test to confirm the result, which came back positive on Sunday.

Im pretty healthy because of the vaccine... vaccines prevent severe disease, and Ive got very mild symptoms, thank God, he said.

People who are fully-vaccinated should not be too worried about Covid, according to Prof ONeill. The virus might grow in your nose... The vaccine is really working to protect your lungs, not so good at your nose, because the immune system cant get there. Thats whats happened to me, its stayed in my nose, and its like a cold.

However, he said people who are immunocompromised are most at risk at the moment, and he was glad to see the National Immunisation Advisory Committee (Niac) recommending a fourth dose to people in this category.

We worry about the immunocompromised. These are people who are on chemotherapy, or some other reason their immune system isnt working properly. They need the best possible chance at protection.

He said that now that we know the vaccines are safe, we should utilise them as much as possible. Niac have said immunocompromised people should get a forth dose three months after their third.

Prof ONeill added that children should hopefully get vaccinated soon, with the first shipment of childrens vaccines arriving into Ireland this week.

It was especially important to vaccinate children who were immunocompromised as they had no protection yet, he said.

He also thought that offering a booster dose to everyone three months after their second dose, regardless of what vaccine they received, was a wise move ahead of the increased socialisation around Christmas. Minister for Health Stephen Donnelly announced this change on Monday evening on foot of Niacs recommendation.

There was good evidence published that three months works basically, you get a good response... theres no need to wait for five months.

Omicron has changed the situation, he added, and the Government and Niac had responded to it appropriately.

He doesnt think that everyone will need a forth dose, but added that it was hard to know yet. It might be offered to older people... younger people usually have a stronger immune system.

Earlier, Prof ONeill said he would be quadruply vaccinated, having had the booster on Thursday after his two-shot vaccine, and then testing positive for Covid at the weekend.

Now is the time to boost as many as possible, he told RT Radio Ones Today with Claire Byrne show.

He said that, even if symptoms from the Omicron variant were milder, as research had indicated, there could still be a number of people who ended up in hospital and that would put pressure on the health system.

However, it was still uncertain how strong the level of infection was , he said, which was why it was important for everyone to be boosted.

This article was amended on December 14th, 2021

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Luke O'Neill says booster helped to ensure he only got 'mild' Covid - The Irish Times

Immunology

Corbett Named One of Time’s Heroes of the Year | Newsroom – UNC Health and UNC School of Medicine

Kizzmekia Corbett, PhD, a vaccine scientist at the National Institutes of Health and UNC School of Medicine Alumna, was named one of Time magazines Heroes of the Year for her work on developing a COVID-19 vaccine.

Kizzmekia Corbett, a 2014 graduate of the UNC School of Medicine Microbiology and Immunology PhD Program, has been named among Time Magazines 2021 Heroes of the Year.

Times 2021 Heroes of the Year recognition honors the scientists whose work produced COVID-19 vaccines, including Corbett; Barney Graham, MD, PhD, former deputy director of the NIH Vaccine Research Center; Katalin Kariko, PhD, biochemist and adjunct professor of neurosurgery at the University of Pennsylvania Perelman School of Medicine; and Drew Weissman, MD, PhD, Roberts Family Professor in Vaccine Research in the Perelman School of Medicine.

As a student in the UNC School of Medicine, Corbetts mentor was Aravinda de Silva, PhD, professor in the UNC Department of Microbiology and Immunology. Corbett focused on vaccine development and studied dengue virus at UNC. She won an off-campus dissertation fellowship from the UNC Graduate School and conducted research in Sri Lanka, and she was involved in extracurricular activities, including serving as a representative on the UNC Student Congress, a delegate to the UNC System Association of Student Governments, a staff member in the Honor System Attorney Generals office, and as a member of the science policy advisory group.

In 2014, Corbett was appointed to serve as the team lead for coronavirus research within the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Centers Viral Pathogenesis Laboratory. Corbetts team partnered with Moderna to create a vaccine using state of the art mRNA technology in. The FDA cleared Modernas vaccine for emergency use in December 2020.

Today, Corbett is an assistant professor of immunology and infectious diseases at the Harvard T.H. Chan School of Public Health.

Her work has garnered several prestigious awards, including the Benjamin Franklin Next Gen Award and the Salzman Memorial Award in Virology. Additionally, the Board of Commissioners in Corbetts hometown of Hillsborough, North Carolina, declared Jan. 12, 2021, as Kizzmekia Kizzy Corbett Day.

In February 2021, Corbett was named to Time Magazines 2021 TIME100 Next List, and in May 2021, Corbett and Anthony Fauci, MD, director of the NIAID, delivered UNC-Chapel Hills Spring Commencement Address.

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Corbett Named One of Time's Heroes of the Year | Newsroom - UNC Health and UNC School of Medicine

Immunology

US FDA Approves Pfizer’s XELJANZ (tofacitinib) for the Treatment of Active Ankylosing Spondylitis | Small Molecules | News Channels -…

DetailsCategory: Small MoleculesPublished on Wednesday, 15 December 2021 10:02Hits: 300

NEW YORK, NY, USA I December 14, 2021 I Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for XELJANZ / XELJANZ XR (tofacitinib) for the treatment of adults with active ankylosing spondylitis (AS) who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers.

We are proud to offer XELJANZ, a treatment option for ankylosing spondylitis that does not require an injection or an infusion, to treat this debilitating and chronic immuno-inflammatory disease, said Mike Gladstone, Global President, Inflammation & Immunology, Pfizer. This regulatory approval affirms the clinical value and versatility of XELJANZ, the first and only Janus kinase (JAK) inhibitor approved for five indications in the United States for the treatment of patients with certain immuno-inflammatory conditions.

The approval of XELJANZ for AS is based on data from a Phase 3, multicenter, randomized, double-blind, placebo-controlled study that evaluated the efficacy and safety of tofacitinib 5 mg twice daily versus placebo in 269 adult patients living with active AS. The study met its primary endpoint showing that at week 16, the percentage of patients achieving an Assessment in SpondyloArthritis international Society (ASAS)20 response was significantly greater with tofacitinib (56.4%, n= 75) versus placebo (29.4%, n=40) (p<0.0001). In addition, the percentage of patients achieving an ASAS40 response was significantly greater with tofacitinib (40.6%, n=54) versus placebo (12.5%, n=17) (p<0.0001), a key secondary endpoint of the study.1 ASAS20/40 are used for defining improvement or response to treatment.2 The safety profile observed in patients with AS treated with XELJANZ was consistent with the safety profile observed in rheumatoid arthritis (RA) and psoriatic arthritis (PsA) patients.

Ankylosing spondylitis, a type of arthritis that causes inflammation in certain parts of the spine, affects more than 350,000 people in the U.S.3 This disease often occurs in early adulthood and causes pain, swelling and possibly restricted mobility,4 said Steven Taylor, Executive Vice President, Mission and Strategic Initiatives of the Arthritis Foundation. With this approval, physicians and patients now have an additional oral treatment option that can help address this chronic and often progressive disease.

About XELJANZ (tofacitinib)

XELJANZ is the first and only oral JAK inhibitor approved in the United States in five indications. XELJANZ is indicated in patients who have had an inadequate response or intolerance to one or more TNF blockers: in adults with active AS, adults with moderately to severely active RA, active PsA, moderately to severe active ulcerative colitis (UC) and in children two and older with active polyarticular course juvenile idiopathic arthritis (pcJIA).

XELJANZ has been studied in more than 50 clinical trials worldwide, including more than 20 trials in RA patients, and prescribed to over 300,000 adult patients (the majority of whom were RA patients) worldwide since 2012.5,6,7 As the developer of XELJANZ, Pfizer is committed to advancing the science of JAK inhibition and enhancing understanding of this medicine through robust clinical development programs in the treatment of immuno-inflammatory conditions.

Earlier this month, the FDA updated the prescribing information for XELJANZ and included a new boxed warning for major adverse cardiovascular events and updated boxed warnings regarding mortality, malignancies and thrombosis (with corresponding updates to applicable warnings and precautions). In addition, indications for the treatment of adults with moderately to severely active RA or active PsA, and patients who are two years of age and older with active pcJIA were revised to require inadequate response or intolerance to one or more TNF blockers.

About Ankylosing Spondylitis

Ankylosing Spondylitis is a chronic, inflammatory disease that affects men and women in early adulthood. The onset of symptoms usually occurs before the age of 30 and seldom occur after the age of 45. Symptoms of AS include chronic pain and stiffness in the back and hips for those living with the disease and can negatively impact health-related quality of life. Over time, some patients may experience fusion of the vertebrae in the spinal column.8 According to studies, more than 350,000 people live with AS in the United States.3

INDICATIONS

Rheumatoid Arthritis

Psoriatic Arthritis

Ankylosing Spondylitis

Ulcerative Colitis

Polyarticular Course Juvenile Idiopathic Arthritis

Please see full Prescribing Information, including BOXED WARNING for XELJANZ available at: http://www.xeljanzpi.com.

About Pfizer Inflammation & Immunology

At Pfizer Inflammation & Immunology, we strive to deliver breakthroughs that enable freedom from day-to-day suffering for people living with autoimmune and chronic inflammatory diseases, which can be debilitating, disfiguring and distressing, dramatically affecting what they can do. With a focus on Rheumatology, Gastroenterology and Medical Dermatology, our current portfolio of approved medicines and investigational molecules spans multiple action and delivery mechanisms, from topicals to small molecules, biologics and biosimilars. Our differentiated R&D approach resulted in one of the broadest pipelines in the industry, where we purposefully match molecules to diseases where we believe they can make the biggest difference. Building on our decades-long commitment and pioneering science, we continue to advance the standard of care for patients with these debilitating diseases and are working hand-in-hand with patients, caregivers and the broader healthcare community on healthcare solutions for the many challenges of managing chronic inflammatory diseases, allowing patients to live their best lives.

To learn more, visit http://www.pfizer.com/science/immunology-inflammation.

Pfizer Inc.: Breakthroughs that change patients lives

At 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 Facebook.com/Pfizer.

1 Deodhar A, Sliwinska-Stanczyk P, Xu H, Baraliakos X, Gensler LS, Fleishaker D, Wang L, Wu J, Menon S, Wang C, Dina O, Fallon L, Kanik KS, van der Heijde D. Tofacitinib for the treatment of ankylosing spondylitis: a phase III, randomised, double-blind, placebo-controlled study. Ann Rheum Dis. 2021 Apr 27;80(8):100413. doi: 10.1136/annrheumdis-2020-219601. Epub ahead of print. PMID: 33906853; PMCID: PMC8292568. 2 Landew R, van Tubergen A. Clinical Tools to Assess and Monitor Spondyloarthritis. Curr Rheumatol Rep. 2015;17(7):47. doi:10.1007/s11926-015-0522-3 3 Strand V, et al. Prevalence of axial spondyloarthritis in United States rheumatology practices: Assessment of SpondyloArthritis International Society criteria versus rheumatology expert clinical diagnosis. Arthritis Care Res (Hoboken ). 2013;65:1299-1306. doi:10.1002/acr.21994 4 Johns Hopkins Arthritis Center. Ankylosing Spondylitis. Accessed December 1, 2021. https://www.hopkinsarthritis.org/arthritis-info/ankylosing-spondylitis 5 Pfizer Data on File. XELJANZ Worldwide Registration Status. 6 ClinicalTrials.gov. Tofacitinib RA Studies. Accessed June 25, 2020. 7 Pfizer. Data on File. Tofa Counts. April 2019 8 University of Maryland Medical Center. A Patients Guide to AS. Accessed August 2021. Available at: https://www.umms.org/ummc/health-services/orthopedics/services/spine/patient-guides/ankylosing-spondylitis

SOURCE: Pfizer

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US FDA Approves Pfizer's XELJANZ (tofacitinib) for the Treatment of Active Ankylosing Spondylitis | Small Molecules | News Channels -...

Immunology

Cellworks Personalized Therapy Biosimulation Study Identifies Novel Biomarkers Predictive of Response in AML Patients – BioSpace

AML Biomarker Identification Can Improve Clinical Trials for New Drugs and Accelerate Drug Approvals

ATLANTA--(BUSINESS WIRE)-- Cellworks Group, Inc., a world leader in Personalized Medicine in the key therapeutic areas of Oncology and Immunology, today announced results from a clinical study using the Cellworks Biosimulation Platform and Computational Omics Biology Model (CBM) to predict therapy response for individual Acute Myeloid Leukemia (AML) patients were featured in a poster presentation at the 63rd American Society of Hematology (ASH) Annual Meeting and Exposition held December 11-14, 2021 in Atlanta, Georgia. The complete results from this study are available online in the ASH Meeting Library as Abstract 1299.

In the study, the Cellworks Biosimulation Platform and CBM was used to assess cytarabine (ARA-C) and anthracycline response and novel biomarker response criteria for the addition of etoposide (VP16) in AML. The study found that Cellworks biosimulation identifies novel biomarkers that predict therapy response in AML patients, which offers the opportunity to tailor FDA-approved chemotherapy regimens to each patient to improve disease control and minimize toxicity. In addition, biosimulation is emerging as an essential tool to improve the success rate of clinical trials and speed the development of lifesaving medicines for the patients that need them.

From comprehensive genomic inputs, the Cellworks Biosimulation Platform identifies pathway based polygenic biomarkers that predict the efficacy of novel drug combinations and new drugs for AML patients, said Dr. Michael Castro, MD, Chief Medical Officer at Cellworks. Cellworks AML biomarker identification and therapy response prediction capabilities should accelerate clinical trials for new therapies and improve trial success rates by predicting if a patients genomic profile will respond to specific regimens. Biosimulation has the ability to improve outcomes for patients, avoid drugs that produce only toxicity and extend the reach of precision medicine in the clinic.

The Cellworks Biosimulation Platform simulates how a patient's personalized genomic disease model will respond to therapies prior to treatment and identifies novel drug combinations for treatment-refractory patients. The platform is powered by the groundbreaking Cellworks Computational Omics Biology Model (CBM), a network of 4,000+ human genes, 30,000+ molecular species and 100+ signaling pathways. By reliably predicting an individual patients therapy response prior to receiving the treatment, the Cellworks Platform can guide the selection of the optimal treatment, help patients avoid ineffective therapies and improve patient outcomes.

Clinical Study: ASH Abstract 1299

Biosimulation using Cellworks Computational Omics Biology Model (CBM)-based assessment of cytarabine (ARA-C) and anthracycline response and novel biomarker response criteria for the addition of etoposide (VP16) in AML.

Background

Genomic heterogeneity in leukemic blasts characterizes AML patients and is associated with variable drug responses. In this study, 539 AML patients were selected based largely on genomic data published in TCGA and PubMed. The Cellworks Biosimulation Platform and Computational Omics Biology Model (CBM) was used to identify novel genomic biomarkers associated with response among AML patients treated with cytarabine (ARA-C) + idarubicin or daunorubicin (anthracycline) with or without etoposide (VP16).

Results

Cellworks biosimulation of ARA-C + anthracycline with and without VP16 identified biomarkers responsible for therapy responses. Additionally, the biosimulation identified novel drug combinations for non-response to these standard combinations. Altogether, 89 of the 539 patients (16.5%) could have been managed with a potentially superior treatment approach based on the biosimulation by either adding or omitting VP16 or being treated with an alternative therapy.

Conclusion

This study highlights patients for whom triplet therapy promises potential superior benefit, others who would benefit equally from doublet therapy without VP16 and others unlikely to respond to standard or triplet therapy for whom an alternative personalized approach might offer better outcomes. In AML, Cellworks biosimulation offers the possibility to tailor the chemotherapy regimen to each patient to improve disease control and minimize toxicity.

About Cellworks Group

Cellworks Group, Inc. is a world leader in Personalized Medicine in the key therapeutic areas of Oncology and Immunology. Using innovative multiomics modeling, computational biosimulation and Artificial Intelligence heuristics, Cellworks predicts personalized therapy responses for patients. The Cellworks Therapy Biosimulation Platform optimizes the uniqueness of each patients cancer by utilizing their multiomic data to create a personalized disease model using Cellworks proprietary Computational Omics Biology Model (CBM). The Cellworks Platform uses the personalized disease model to identify disease-biomarkers unique to each patient and biosimulate the patients responses to drugs and therapy regimens. Backed by UnitedHealth Group, Sequoia Capital, Agilent and Artiman, Cellworks has the worlds strongest trans-disciplinary team of molecular biologists, cellular pathway modelers and software technologists working toward a common goal attacking serious diseases to improve the lives of patients. The company is based in South San Francisco, California and has a research and development facility in Bangalore, India. For more information, visit http://www.cellworks.life and follow us on Twitter @cellworkslife.

All trademarks and registered trademarks in this document are the properties of their respective owners.

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Cellworks Personalized Therapy Biosimulation Study Identifies Novel Biomarkers Predictive of Response in AML Patients - BioSpace

Immunology

First cases of the omicron variant of coronavirus confirmed in Slovenia | GOV.SI – Gov.si

Marta Grgi Vitek presented the updated vaccination recommendations. She said on the subject of the vaccination of children up to 12 years of age that vaccination is recommended for children with chronic diseases and those living with people having such diseases. The recommendations will also be modified to cover the booster dose. The booster dose is recommended after six months, with a minimum interval of three months between the primary dose vaccination and the booster dose. As Grgi Vitek added, the consultation group that met yesterday also agreed with the European Commission's proposal to limit the validity of the Digital COVID Certificate. For those vaccinated with the primary dose of COVID-19 vaccine, the validity of the Digital COVID Certificate will thus be limited to 270 days. After this period the certificate will expire and a booster dose will be required to renew the certificate.

According to Dr Miroslav Petrovec, four samples of the omicron variant were detected in the last screening tests carried out at the Institute of Microbiology and Immunology. The persons infected come from the Ljubljana area and were tested in the period from 29 November to 6 December. The epidemiological data are still being investigated. One of the infected persons contracted COVID-19 last year. Dr Petrovec therefore urged everyone to get vaccinated and invited those who received two doses of the vaccine at least six months ago to get vaccinated with a third dose.

In his introduction, Minister Poklukar presented the epidemiological indicators measuring the burden of the disease in hospitals. As he pointed out, 83 % of the 235 COVID-19 patients that are in intensive care have not been vaccinated. According to the Minister, there are a total of 817 coronavirus patients in hospital, of whom 71 % have not been vaccinated.

The Minister believes that the discovery of omicron may cause another COVID-19 wave. The decline in the daily number of infections in recent days is also slowing down and the Minister renewed his call to the people to get vaccinated.

Poklukar noted that 90% of the patients admitted to the COVID-19 wards are over 45 years of age. In COVID-19 intensive care units the situation is the same. He also pointed out that approximately 190,000 people aged over 50 years have not yet been vaccinated. In this age group, the rate of hospitalisation is about 10 %, while the rate of admissions to intensive care units amounts to 3 %. In the light of the rapid transmissibility of the omicron variant, between 15,000 and 20,000 hospital admissions can be expected. The virus will continue to burden hospitals until summer, which will be difficult for the health sector to sustain.

The Minister added that from 19 to 23 December 2021 a vaccination campaign will take place across Slovenia. Vaccination centres will be open from 8 am to 8 pm at all current locations. In each statistical region there will also be a vaccination centre or a location where vaccination will take place form 8 pm to 8 am. Mobile units will also be set up, in larger numbers than in the past, concluded Minister Poklukar.

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First cases of the omicron variant of coronavirus confirmed in Slovenia | GOV.SI - Gov.si

Immunology

Cuba: results of new Alzheimers drug revealed – OnCubaNews

Cuban scientists revealed the results of the phase II-III clinical trial of the Cuban product NeuroEpo in patients with mild/moderate Alzheimers disease, and they are encouraging, according to the information published on the Cubadebate website.

The drug is the result of studies carried out by the Center for Molecular Immunology (CIM) in collaboration with other BioCubaFarma institutions to achieve a nasal formulation of recombinant EPO with a low content of sialic acid, an isoform with a composition similar to natural EPO produced in the central nervous system.

The principal researcher of the clinical trial, Dr. Saily Sosa Prez, pointed out that we are in the presence of an achievement of Cuban science that will allow the treatment, with our product, of a traumatic disease, both for patients and their families, especially those who must take care of them, who are usually one or two members of the family.

Dr. Sosa Prez, who leads a service for attention to memory disorders, explained that in the world there are only six medications to alleviate the effects of the disease, and all are extremely expensive (treatment for a year can exceed up to $80,000).

The researchers, cited by the media, pointed out that the application of isoforms of this erythropoietin (EPO) could restore cerebral homeostasis, acting on neurons and astrocytes; and that novel EPO formulations, with great selectivity on the brain, could be used to treat neurodegenerative diseases and slow their progression.

On the data collected during clinical trial II-III during intranasal administration of the product, the experts established that treatment with NeuroEPO for 48 weeks was safe and well tolerated (there were no serious adverse events), that many of the patients showed a reduction in the progression of cognitive impairment and secondary variables also improved.

The study randomized, double-blind, placebo-controlled and adaptive design also showed signs of improvement in cerebral perfusion in the parietal-temporal region, and that 72% of the treated patients stabilized the global values of the electroencephalogram (EEG), among other results.

Population aging, an urgent matter

It also emerged that the application of the product is being evaluated for the treatment of other diseases, such as ataxia, Parkinsons, ischemic brain accidents, and the sequelae of COVID-19.

Alzheimers disease is considered the leading cause of disability in the elderly in Cuba, whose population is currently experiencing accelerated aging (at the end of 2020, 21.3% were 60 years old and over).

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Cuba: results of new Alzheimers drug revealed - OnCubaNews

Immunology

Will we always need Covid-19 boosters? Experts have theories – STAT – STAT

With the world facing the latest in a seemingly endless stream of coronavirus variants and with bullish talk from manufacturers about a need for even more vaccine shots you wouldnt be alone if you were wondering: Are Covid boosters always going to be a fixture in our future?

The simple truth is that, at this point, theres no definitive answer to that question.

But virologists, immunologists, and vaccinologists have opinions that are anchored in an understanding of how the immune system works and in emerging data on how Covid vaccines engage with this complicated enterprise that has evolved to help humans fend off disease threats.

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STAT asked a number of these experts whether they think we face a future of endless Covid boosting. In the main, their answers were more reassuring than we expected.

Some said they think three doses of vaccine may protect many people for some time against the worst of Covids potential ravages. Many said they think the benefit of the third shot, given after a six-month interval, will turbocharge immune responses.

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Interestingly, a number said they think that even if we end up needing more boosters down the line, the messenger RNA vaccines the Pfizer and Moderna vaccines that have been the cornerstone of the U.S. vaccine effort to date may not be the vaccines we use for that purpose. Vaccines that cause fewer side effects may be needed if public health authorities want to persuade people to get regular or even sporadic boosters.

Here are some observations and informed theories from nine leading experts in this field.

Ali Ellebedy, an associate professor of pathology and immunology at Washington University School of Medicine in St. Louis, studies what happens in the lymph nodes and bone marrow of people who have been vaccinated against Covid-19. Hes been amazed at how long the first two doses of mRNA vaccine act on the immune system; half a year after the second shot, the response is still maturing. He wouldnt have predicted that, Ellebedy admitted.

There is an ongoing reaction in our lymph nodes thats going for six months. And that reaction, we are showing, that it is actually enhancing the potency of the antibodies, he said. Even before the third dose.

The maturation of the immune response which would be accelerated by a third dose, given after a longer interval brings big benefits. The antibodies we make improve in quality through a process called affinity maturation. They become more capable of recognizing their viral target, even if that target has made changes to its appearance, in the way variants have done.

If you wait six months or more between a priming and boost, what you see is not just a boosting of the immunity that you got from the first vaccine, but you see a broadening of the immune response so that it recognizes other viruses or other variants. Your immune response becomes much more cross-protective, said David Topham, an immunologist at the University of Rochester Medical Center and director of the New York Influenza Center of Excellence.

Florian Krammer, a professor of vaccinology at the Icahn School of Medicine at Mount Sinai Hospital in New York, had been reluctant to get a booster shot, figuring he had solid protection from the two doses of Pfizer he received earlier this year. Better to allocate scarce doses to low-income countries that have had limited access to date to vaccine, he thought.

The emergence of the highly mutated Omicron variant has changed his thinking on the advisability of giving booster shots. But Krammer is not sure what the long-term impact of the third dose will be. We see that you get your booster and you get up to two times, three times the [antibody] level that you had after the second dose. But the question is: How long does it last? How far will it fall? Will the set point be the same? he asked.

Even with booster doses there might be breakthrough infections at some point, said Krammer. And I think the real goal is to get so much immunity in the population that the virus is annoying but not problematic.

Barney Graham has long thought that a delayed third dose would be needed to complete a Covid vaccine series.

An immunologist who was deputy director of the National Institutes of Healths Vaccine Research Center until his retirement at the end of August, Graham led the NIH team that worked on the prototype of the Covid spike protein that many vaccine manufacturers used in their vaccines.

The antibodies induced by delayed third doses will be of higher quality, generating a broader immune response that can more reliably recognize even mutated viruses, such as new variants, he said.

Once you give the [antibody-producing] B cells a chance to mature and then boost them later that type of response tends to make immunity across all these different variants more similar, he said.

Graham also believes as we go forward, our immunity against SARS-CoV-2 may be naturally topped up by occasional exposures to the virus; thats called anamnestic boosting. Neutralizing antibodies will probably decline after the third dose, as they did after the second, so we may get infected by SARS-2 from time to time. But the other facets of the immune response will kick in to stop the virus from descending into the lungs, where it can do serious damage.

So I think that the whole question about durability of immunity is going to have to be determined by three years from now, are people still getting sick or are they relatively well-protected against severe disease regardless of whatever their antibody level is in serum. Because that may wane, but you still have a lot of memory B cells that can rapidly respond, Graham said.

Anthony Fauci, Grahams former boss, agreed, though he didnt rule out the possibility of another booster down the road.

What I think could ultimately happen is that by a prime, second, and then a third boost and who knows, maybe a fourth boost, you get a level of protection that would sort of transform all of this to overwhelmingly an asymptomatic or mildly symptomatic infection. So that it starts to drift much, much more towards the common cold coronaviruses, said Fauci, director of the National Institute of Allergy and Infectious Disease.

Marion Pepper and her laboratory at the University of Washington have been working to come up with real world evidence on how well the immunity weve been acquiring protects against SARS-2. They have been following a cohort of people who were vaccinated or who were infected and in some cases were both infected and then vaccinated. Among those vaccinated, some have received two shots; some have received a third. It is an observational study; they did not randomly assign the people they are following to these groups.

Pepper said from what her group is seeing, she expects boosters to give an important window of enhanced protection. But she doesnt think there is limitless benefit from boosting again and again, using the same vaccine strain. She and her team saw, for instance, that people who had been infected, vaccinated, and then boosted did not get much additional benefit from the third dose of vaccine.I think there is a misconception that the immune system can constantly be repetitively elevated such that you dont go back to that same starting point, she said. And in some people, maybe if they didnt have a good first immune response, it will enhance their cell numbers. But for the large majority you end up hitting a set point of memory that doesnt just keep getting bigger every single time you get the same boost.

She suggested vaccinating with another strain of the virus something like the Omicron version, for example might draw new immune cells into the fray and broaden the scope of the protection the vaccine offers. There are, however, many weighty factors to consider in making a decision to change the Covid vaccine.

Other experts have concerns about whether were as far along as Graham and some others hope. Paul Bieniasz, head of the laboratory of retrovirology at Rockefeller University, said the work he and his team have done suggests there is still room to top up immunity in vaccinated people and unfortunately plenty of unvaccinated people who still need protection.Bieniasz had thought, like some of the others cited here, that with booster doses people would start to get the upper hand on the virus. But the emergence of Omicron has shaken his faith that our immune systems are going to take the lead in what he called a genetic arms race.

I was much more confident a couple of weeks ago that the antibodies would have the edge in being able to outstrip the evolutionary capacity of SARS-CoV-2. But I dont think thats completely clear now, he said.

Topham too thinks viral evolution may dictate whether we have future dates with booster shots.

If next week we see the emergence of a variant that can escape the current vaccine, then yes, were going to have to get another shot of an improved vaccine as soon as they can make it, he said.

People likely wont agree to take mRNA vaccines indefinitely

The Pfizer-BioNTech and Moderna vaccines have been game-changers in this pandemic, proving that new vaccines can be designed, tested, and mass-produced within a hitherto unthinkable time. The first syringes containing the Pfizer vaccine began to slide into arms in the United Kingdom and the U.S. about 11 months to the day from when a Chinese scientist posted the genetic sequence of the SARS-CoV-2 virus on internationally accessible databases.

The vaccines are extraordinarily protective. Theyre also reactogenic; they can come with a real kick. Some people experience no side effects of note while others have only a sore arm. But a significant portion of people experience headache, fatigue, and malaise; others spike fevers, experience muscle aches, and are wracked with chills. And of course, there is an elevated rate of myocarditis and pericarditis inflammation of heart muscle or tissue around the heart, respectively in some males in their teens and early 20s who get vaccinated with these shots.

In the throes of the pandemic, people have seen these vaccines as the best hedge against a potentially fatal encounter with Covid-19. But as our immunity against the new virus rises, experts like Ellebedy dont think folks will be willing to put up with potentially feeling lousy for a day or two after getting a booster.

People in a pandemic can accept things, but I think if youre talking about a regular vaccine thats not really needed because of a pandemic, Im not sure if people would be more accepting of that, he said.

John Wherry, director of the Institute for Immunology at the University of Pennsylvania, agreed. I dont think were going to see just a yearly wild-type spike mRNA vaccine every year ad infinitum, he said, suggesting people will likely be drawn to other types of vaccines as boosters down the road, if we need them.

Currently in the U.S. the only other vaccine option is the one manufactured by Johnson and Johnson, which has not been a popular draw. Less than 4% of vaccine doses administered in the country have been J&Js vaccine. But it is conceivable other vaccines with fewer side effects will become available here.

Novavax and the partnership of Sanofi and GSK are both producing recombinant protein vaccines that are thought to be highly promising. Novavax, which has struggled to produce vaccine at commercial scale, has been given an emergency use authorization by Indonesia and other countries are expected to follow suit. Novavax has filed with regulatory authorities in Canada and the European Union, among others, and has said it expects to file for an EUA from the Food and Drug Administration. The Sanofi-GSK vaccine is still in Phase 3 testing.

Recombinant protein vaccines are generally not as reactogenic as mRNA vaccines.

If you get two vaccines and both work and one you know makes you feel sick for a day, and the other one doesnt, you know who wins, right? Krammer said of the prospects for another type of vaccine to make inroads in the U.S. booster shot market.Akiko Iwasaki, an immunologist at Yale University, thinks we will likely need vaccines that are administered differently if we want to prevent Covid infections. She and colleagues last week published a paper in Science on pre-clinical study of an intranasally administered vaccine. Early data from Israel is showing that the third dose, even though it provides a very effective protection, it also does wane, Iwasaki said. So its not like the third dose will fix antibody response forever. Thats kind of hard to ask any vaccine to do that.Developing a vaccine that aims to arm the mucosal tissues of the upper respiratory tract with immune protection would stop SARS-2 at its point of entry, not after it is rampaging through our cells. Its really like putting the guard outside the door as opposed to inside the door, she said.

The early estimates of the efficacy of the mRNA vaccines to prevent infections in the 95% range created unrealistic expectations about what Covid vaccines would be able to do over the long-term in blocking all infections. As months pass from vaccination, weve seen declines in neutralizing antibody levels and an increase in breakthrough infections among the vaccinated a phenomenon that seems to be accelerating with the spread of the Omicron variant.

But make no mistake. The vaccines are working. In the vaccinated, hospitalizations and deaths triggered by Covid infections have plummeted. Those are the performance metrics we need to be keeping our eyes on, said Wherry.

We are currently hyper-aware hyper-aware of infections. And the reaction to these infections in at least vaccinated people is disproportionate with their consequences right now, he told STAT. To me, its the wrong mindset.

Wherry said he knows people who have been vaccinated and have later become infected. Im walking the dogs and they complain to me, Great vaccine. And I just turn and say When did you have Covid? And they said Two days ago.

His response? Really? Yeah, its a great vaccine.

See the article here:
Will we always need Covid-19 boosters? Experts have theories - STAT - STAT

Immunology

Tonix Pharmaceuticals : Added to the Nasdaq Biotechnology Index – Form 8-K – marketscreener.com

Tonix Pharmaceuticals Added to the Nasdaq Biotechnology Index

CHATHAM, N.J., December 15, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that it has been added to the Nasdaq Biotechnology Index (Nasdaq: NBI) as part of the Nasdaq's annual reconstitution process. The addition will become effective prior to market open on Monday, December 20, 2021.

The Index is designed to track the performance of a set of securities listed on The Nasdaq Stock Market (Nasdaq) that are classified as either Biotechnology or Pharmaceutical according to the Industry Classification Benchmark (ICB). For more information about the Nasdaq Biotechnology Index visit https://indexes.nasdaqomx.com/Index/Overview/NBI.

About Tonix Pharmaceuticals Holding Corp.

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics and diagnostics to treat and prevent human disease and alleviate suffering. Tonix's portfolio is primarily composed of immunology and central nervous system (CNS) product candidates. Tonix's immunology portfolio includes COVID-19-related product candidates to prevent and treat COVID-19, to treat Long COVID as well as to detect functional T cell immunity to SARS-CoV-2. The Company's CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix's lead CNS candidate, TNX-102 SL1 (cyclobenzaprine HCl sublingual tablets), is in mid-Phase 3 development for the management of fibromyalgia. TNX-13002 is a biologic designed to treat cocaine intoxication that is expected to start a Phase 2 trial before year end. Tonix's lead vaccine candidate for COVID-19, TNX-18003, is a live replicating vaccine based on Tonix's recombinant pox vaccine (RPV) platform to protect against COVID-19, primarily by eliciting a T cell response. Tonix expects to start a Phase 1 study in humans in the second half of 2022. Tonix is also developing TNX-21004, an in vivo diagnostic to measure the presence of functional T cell immunity to SARS-CoV-2 and intends to initiate a first-in-human clinical study in the first quarter of 2022. TNX-35005 (sangivamycin, i.v. solution) is a small molecule antiviral drug to treat acute COVID-19 and is in the pre-IND stage of development. Finally, TNX-102 SL is a small molecule drug being developed to treat Long COVID, a chronic post-COVID condition, and is also in the pre-IND stage. Tonix expects to conduct a Phase 2 study in Long COVID in the first half of 2022. Tonix's immunology portfolio also includes biologics to address immunosuppression, cancer, and autoimmune diseases.

1TNX-102 SL is an investigational new drug and has not been approved for any indication.

2TNX-1300 is an investigational new biologic at the pre-IND stage of development and has not been approved for any indication.

3TNX-1800 is an investigational new biologic and has not been approved for any indication. TNX-1800 is based on TNX-801, live horsepox virus vaccine for percutaneous administration, which is in development to protect against smallpox and monkeypox. TNX-801 is an investigational new biologic and has not been approved for any indication.

4TNX-2100 is an investigational new biologic and has not been approved for any indication.

5TNX-3500 is an investigational new drug at the pre-IND stage of development and has not been approved for any indication.

This press release and further information about Tonix can be found at http://www.tonixpharma.com.

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate," "expect," and "intend," among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval, and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2020, as filed with the Securities and Exchange Commission (the "SEC") on March 15, 2021, and periodic reports filed with the SEC on or after the date thereof. All Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

CONTACTS

Jessica Morris (corporate)

Tonix Pharmaceuticals

investor.relations@tonixpharma.com

(862) 904-8182

Olipriya Das, Ph.D. (media)

Russo Partners

Olipriya.Das@russopartnersllc.com

(646) 942-5588

Peter Vozzo (investors)

Westwicke, an ICR Company

peter.vozzo@westwicke.com

(443) 213-0505

See more here:
Tonix Pharmaceuticals : Added to the Nasdaq Biotechnology Index - Form 8-K - marketscreener.com

Immunology

Omicron is making the holidays complicated. 50 COVID experts weigh in with their advice – Toronto Star

50 COVID experts weigh in with their advice for the holidays | The Star

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Omicron is poised to overtake Delta in Ontario: What you need to know

Kingstons Omicron-fuelled surge leads to strict measures and offers a preview

Millions of Ontarians will need a third COVID vaccine this month. Can we ramp up capacity like in the summer?

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Wed., Dec. 15, 2021timer5 min. read

updateArticle was updated 8 hrs ago

A dinner of chicken with stuffing, mixed in with some Indian food. A Secret Santa gift exchange. Everyone gathered around the TV to watch Home Alone.

These are the simple holiday pleasures Dr. Nitin Mohan, assistant professor of microbiology and immunology at Western University, is looking forward to sharing with a couple of extended family members, after COVID essentially cancelled the season last year.

While Im frustrated that we wont be having the Christmas we thought we would be having a month ago, when I look at where we were last year, I still think were in a better position than where we were back then, said Mohan, who is being extra cautious as he and his wife have a five-month-old son.

The Star reached out to COVID-19 experts, including Mohan, to ask how they were marking the 2021 holidays, whether that involved celebrating Christmas, Kwanzaa, New Years Eve, or just enjoying some time off work.

Fifty epidemiologists, infectious disease experts, health analysts, virologists, immunologists, biostatisticians, a few PhD students and others from coast to coast, responded.

The upshot? Vaccines have opened up the possibility for gathering with loved ones, something many missed out on last year. But the pandemic is not over, and the quickly evolving situation with the new Omicron variant has made decisions even more complicated. The experts stressed that the situation is changing fast; theyre watching closely and are prepared to scale down, or even cancel plans, if needed. Thirty-nine experts who answered the Stars survey plan on having a small dinner or gathering with people outside of their household this holiday season.

Dr. Kieran Moore, Ontarios chief medical officer of health, told reporters Tuesday that people should keep things small and limit contacts as the risk goes up, hinting that more guidance will be coming soon. It also depends on your own individual health, and the situation in your family and community. If youre very vulnerable to COVID, than you should avoid contact with others altogether, he said.

Last year, when the Star conducted a similar survey, most Canadians were forced inside by government restrictions and only able to socialize within their households or outside in small groups.

This Christmas, Canadians are freer to gather (albeit with some restrictions), dine in a restaurant, and partake in some of the usual, pre-pandemic festive activities. Experts holiday plans reflect that range of choices.

Decisions on attending gatherings or holiday parties are largely influenced by peoples unique situations, like the prevalence of COVID in their area, the vaccination status of their friends and family, and their own personal risk tolerances.

As a result, feelings about socializing outside of the household vary significantly.

Dr. Martha Fulford, infectious-disease specialist at McMaster Childrens Hospital in Hamilton, said she has no concerns at all, adding, It is time to move on and learn to coexist with COVID.

Laura Cowen, professor of statistics at the University of Victoria, said: We just had an outbreak at UVic and we are now pivoting online. It would be reckless to have a gathering outside of my household at this time.

Its just not worth it, wrote Ananya Banerjee, assistant professor of epidemiology at McGill University, whose mom is immunocompromised and a cancer survivor. Instead of seeing people outside of her household, Banerjee plans to spend the holidays learning the amazing traditional Indian dishes her mom cooks. Shell visit with friends and family outdoors (weather permitting of course!) enjoying the wondrous beauty of nature.

Despite some risks, most experts feel its possible to gather safely in small groups. Many are taking precautions like using rapid tests beforehand, opening windows to increase airflow and ensuring everyone eligible is vaccinated.

After a holiday season in lockdown last year, most are just thankful to celebrate with loved ones at all.

Last year was very lonely for many of us. I was alone with my daughter, our first Christmas without her brother or grandparents, wrote Cynthia Carr, an epidemiologist in Winnipeg, adding that she picked up Christmas dinner from her parents. (They cooked, because I cannot.)

This year, shes excited to be able to celebrate with both of her kids, and to enjoy her parents amazing meal in person again.

Twelve experts are planning on attending a larger gathering of more than 10 people, though most are keeping it under 15, with just extended family or close friends. Some plan to take the bigger parties outside, to skating rinks and bonfires.

In Ontario, private indoor gatherings are still capped at 25. Kingston, Frontenac, and Lennox & Addington health unit is asking that people keep them at five people or less, amid an Omicron surge.

While most experts will see friends and family, the majority will do so close to home. Just 11 are planning on travelling.

(As of press time Tuesday night, the federal government was poised to warn against non-essential travel over the holidays.)

Over the course of the five days we gave experts to answer the survey, at least three went back to change their answers as the situation became more dire.

I was feeling much better about my familys Christmas plans a few weeks ago. Now, less so, wrote Toronto-based science communicator Samantha Yammine in an updated response to the survey.

She says her family is planning to protect her small Christmas gathering by being mindful of their risk budget in the week leading up to the holiday, postponing other social plans and limiting close contacts. Yammine posted tips for holiday gatherings on Instagram, including making it easy for guests to bail if they have symptoms, rapid testing between events and opening windows/having HEPA filters around (since COVID is airborne).

Mohan, like many, is taking precautions. Everyone at his gathering who is eligible will be vaccinated a few people work in health care and they will have three doses and they will all isolate for three to five days beforehand. Hes watching the Omicron numbers closely, in case they need to cancel.

But he also thinks its important to factor in mental health, and be empathetic with one another because this isnt easy for anyone.

For Banerjee, its also a time to reflect on how much we have, as Canadians.

We should be grateful we are at the stage of getting access to booster shots while so many low-middle-income countries are still waiting for their first dose of vaccination, she said.

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Omicron is making the holidays complicated. 50 COVID experts weigh in with their advice - Toronto Star