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The year in medical research

2021 has been an eventful year, particularly in medical research. Medical News Today’s editors reflect on some of the year’s highlights.

In 2021 we reached the 1-year mark since World Health Organization (WHO) declared the start of the COVID-19 pandemic, and the world of medical research continues to grapple with this public health crisis.

Throughout this year, researchers, healthcare workers, and public health experts have been working tirelessly to find the best ways of limiting the impact of SARS-CoV-2, the virus that causes COVID-19.

According to WHO data, over 8 billion COVID-19 vaccinations have taken place globally, using 29 approved vaccines. Little wonder then that one of the top Google searches of 2021 has been “COVID vaccine.”

However, pandemic-related news has been just part of this year’s global storyline.

Research into the unknowns of the microcosm that is the human body was in the spotlight, as scientists wondered whether the microbiome is, in effect, a kind of organ in its own right.

Research in mouse models may have uncovered the likely cause of Alzheimer’s disease: an overabundance of toxic fat-protein complexes in the blood.

And on December 16, the Democratic Republic of Congo declared its 13th Ebola outbreak — which lasted a little over 2 months — over.

It has also been a busy year for Medical News Today‘s writers and editors, as the ongoing pandemic has impacted health journalism just as much as it has affected other sectors.

In this month’s “In Conversation” podcast, our editorial team discusses the research and topics that stuck with us this year, and we reflect on what we would like to see in medical research going forward.

Previously, we mentioned the fascination that the human microbiome holds over medical researchers. In sum, it is the genome of the microorganisms that inhabit the human body, which includes bacteria, fungi, and viruses.

Most of us are perhaps more familiar with bacteria, especially those present in the gut. Researchers have linked gut bacteria to a wide array of health phenomena, including, most recently, weight loss, heart disease, and inflammation.

Our body’s most surprising permanent lodgers are viruses, which we tend to associate with infections and ill health. However, not all viruses are the same, and scientists believe that many might even play a positive role in health,

Back in February 2021, scientists from the Wellcome Sanger Institute and the European Bioinformatics Institute in Hinxton, United Kingdom, reported that they had established a comprehensive “atlas” of bacteria-eating viruses that inhabit the human gut. These viruses are called bacteriophages or phages for short.

This new database indicates that the human gut contains over 140,000 different phages. While most of these viruses can only infect and attack a single bacterial species, around 36{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809} of phages may have the capability to infect several types of bacteria.

Researchers identify previously unknown phages regularly. One study from October 2021 reported on a newly identified phage that occurs in the human gut. The scientists dubbed it LoVEphage, which stands for “lots of viral elements.”

Currently, it is unclear what role or roles this and other bacteriophages might play in human health. Yet, it is becoming increasingly apparent that they could provide the key to some unanswered questions.

“Everyone knows that gut bacteria are important,” said our Senior News Editor, Tim Newman. “That’s something that has become common knowledge over the last 20-30 years. But these bacteriophages kill bacteria. So if gut bacteria are really important to health, then these phages will be as well.”

One way bacteriophages interest scientists is through their potential for offering an alternative to antibiotics in an era when antibiotic resistance is becoming a widespread problem. Indeed, one study published this autumn suggests that a naturally occurring phage can successfully reduce the spread of the bacterium that causes dysentery.

It is no secret that, like many other fields, medical research and healthcare are gravely affected by structural racism and other forms of discrimination. This impacts who receives healthcare and whether they feel able and confident to seek medical assistance in the first place.

There are many expressions of structural racism in medicine, and one of these is through the visual representation of skin conditions. For years, visual reference material about skin conditions has taken white skin as the standard.

Yet, it stands to reason that signs of dermatological issues will present differently on skins of different tones and colors. So, not including accurate visual representations for the full spectrum of skin colors results in untreated conditions, often leading to fatalities.

For example, around one-quarter of African American people with skin cancer only receive a diagnosis once the cancer has already spread to the lymph nodes. And while white adults in the United States who have received a diagnosis of melanoma have a 5-year survival rate of 92{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809}, African American people with skin cancer have a 5-year survival rate of 67{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809}.

One global initiative — called Project IMPACT, built on the clinical decision support system software VisualDx — is now working to level these disparities by creating and sharing a catalog of images that show how different skin conditions appear on darker skins.

Earlier this year, Ana Sandoiu, News Editor II at MNT, interviewed Dr. Nada Elbuluk about systemic discrimination in healthcare and the development of Project IMPACT, which she helped launch. Dr. Elbuluk is a skin of color expert, practicing dermatologist, and dermatology professor at the Keck School of Medicine at the University of Southern California in Los Angeles.

“[I]n our interview, it quickly became clear that basically worse disease outcomes [for] morbidity and mortality that result from these inequities are the main reason why resources, such as the one that VisualDx created, are so important,” said Ana.

She called the statistics showing the lower survival rates for African Americans with skin cancer “chilling numbers,” pointing out that they mean one thing: Black Americans do not receive timely care for this condition.

“[W]hen Black Americans do reach the doctor’s office, and they get a diagnosis, it’s either already at a late stage, or as Dr. Elbuluk pointed out in her interview with me, these biases in dermatology and medical practice that favor white skin could mean that a lot of these conditions may be missed altogether or misdiagnosed,” Ana noted.

Dr. Elbuluk and her colleagues also found a shockingly low number of published research articles looking at how skin discoloration, acne, and eczema affect People of Color.

According to her, such articles are “in the single digits,” and this situation will likely impact outcomes for People of Color who, as the expert’s research shows, often seek dermatological care for these same conditions.

“Having that cultural competence, or cultural humility, which is a more recent term, is really important. When patients feel that they’re seen and they’re heard and they’re acknowledged, it makes a difference,” Dr. Elbuluk told Ana.

“[T]hose things carry a lot of weight for patients, and if I’m a patient of color and my physician understands what’s pertinent to me, to my background, [and] to how I take care of my hair or my skin, all of that is so important in making a connection with the patient.”

– Dr. Nada Elbuluk

Racism is not the only issue that medical research and healthcare have had to face in 2021. They have also had to contend with the gender data gap, as evidenced by reports that some people who menstruate experienced unusual periods following a COVID-19 vaccine.

The gender data gap refers to the phenomenon that, historically, researchers have taken men’s lives and the male body as the standard of health and well-being and then applied them to female bodies.

However, it has become increasingly evident that females experience many conditions, such as coronary heart disease and ADHD, differently. The gender data gap means that many females with these conditions do not receive an accurate diagnosis.

Earlier this year, a study looking at sex bias in clinical trials concluded that females were most underrepresented in the area of oncology, which is the study of cancer. Other neglected areas include neurology, immunology, cardiology, and genitourinary disease.

Little wonder then that reports of the COVID-19 vaccines potentially disturbing menstrual cycles caused confusion: Do the vaccines really cause these disturbances, and if so, what might the mechanisms be, and who is most at risk of experiencing them?

There is currently only one study that gathered data about COVID-19 vaccines and menstrual changes. Dr. Katharine Lee, a postdoctoral research fellow in the Division of Public Health Sciences at the Washington University School of Medicine in St. Louis, MO, and Dr. Kathryn Clancy, an associate professor in the Department of Anthropology at the University of Illinois at Urbana-Champaign conducted the study. I interviewed them in July 2021.

They set up a survey — now closed, with data analysis pending — asking people who menstruate about their experiences back in spring, after Dr. Clancy and then Dr. Lee experienced changes to their periods following vaccination.

The study, however, only looks at the prevalence of such menstrual changes and not at the potential mechanisms, which, hopefully, future studies will cover.

Understanding how often such changes might occur post-vaccination is only the first step in a long process.

Researchers are yet to determine whether these disturbances to menstrual cycles are due to COVID-19 vaccines since many independent factors can affect periods, including chronic stress — and an ongoing pandemic, as well as vaccine hesitancy, can be prominent stress factors.

Looking out for how new vaccines might impact menstrual cycles at the clinical trial stage could go a long way towards clarifying the presence — or absence — of causal links.

Yet when I interviewed Dr. Lee, she expressed some surprise and disappointment that the researchers behind COVID-19 vaccine development and testing do not seem to have given much thought to how these vaccines might affect periods.

“I think just remembering to ask about differences in the menstrual cycle as part of standard clinical testing of vaccines might be nice, given that we expect a huge immune response, and we know that huge immune response[s] can disrupt lots of other inflammatory pathways in people. Menstrual cycles tend to be something that people who have periods pay attention to, and [they] notice when things get a little bit wonky […].”

– Dr. Katharine Lee

In the meantime, an editorial that appeared in The BMJ also called for more investigation into the potential link between COVID-19 vaccines and changes to periods.

Data cited in the editorial at the time of publication indicate that over 30,000 people in the United Kingdom alone had reported disturbances to menstrual cycles following vaccination.

Our News Editor, Yasemin Nicola Sakay, was most struck by the debates around the so-called Freedom Day in the United Kindom, home to the MNT offices.

On July 19, 2021, British authorities announced Freedom Day when they lifted almost all previous pandemic restrictions — including requiring people to wear masks indoors and on most means of public transport.

While some members of the public, tired of the sense of isolation that obligatory mask-wearing and physical distancing can give, rejoiced at this decision, some public health experts criticized it as unwise, suggesting that it might lead to surges in SARS-CoV-2 infections.

At the time, a study conducted by Imperial College London found that new infections with the Delta variant were on the rise in unvaccinated 5-12-year-olds and in 18-24-year-olds who had only just become eligible to receive a COVID-19 vaccine.

In an open letter published in The Lancet at the end of July, several signatories warned about lifting the restrictions too soon.

“My epidemiology colleagues are concerned that this virus has a high propensity to mutate, and the ‘survival of the fittest’ principle will ensure that new variants are adapted to their environment better than the ones they replace,” one of the signatories, Prof. Trish Greenhalgh, told Yasemin.

In hindsight, her prediction appears to have come true. At present, the U.K. is facing an alarming rise in cases of COVID-19, mainly attributed to the spread of the new Omicron variant of SARS-CoV-2.

Keeping one key restriction in place could have made a significant difference, Yasemin explained: “[A]lmost all of the scientists [I interviewed] converged on one point, and that was that some restrictions, namely mask-wearing, should remain in place. And that decision was science-based because COVID-19, as we know, is an airborne disease and SARS-CoV-2 particles spread through the air.”

Yet there has been and continues to be widespread resistance to mask-wearing. The concept of psychological reactance, which refers to the phenomenon whereby people react adversely to messages concerning public health, may help explain it.

A study that appeared in PLOS ONE in February suggests that to address psychological reactance and improve adherence to mask-wearing, those generating the public health messages should focus more on highlighting personal choice and its impact on the individual and on those around them.

“[D]o it for yourself or someone you love,” said Yasemin when asked what she would tell people who are unsure about using face masks. She and our other editors encourage all of our readers to reflect on how small choices — such as wearing a mask or not — could alter the lives of those at high risk of developing severe COVID-19.

Looking to 2022, MNT‘s editors would like to see more exciting research on the intriguing, mysterious inhabitants of the human body, such as phages.

We also hope there will be an increased focus on health equity in research and healthcare and that health workers and public health experts will continue to empower those who seek medical advice by listening closely to all their concerns.

Finally, we hope to see more research into how emerging COVID-19 vaccines and therapies affect people who are immunocompromised and into ways of offering more protection to those at risk of becoming seriously ill.

In the meantime, may we all stay healthy and safe!

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Interdisciplinarity and COVID-19: Progress and challenges

The COVID-19 pandemic has caused millions of people to be ill and led to millions of deaths worldwide. This public health emergency has affected everyone’s life and well-being. Through the suffering, however, there is one silver lining: The pandemic has also provided motivation for different disciplines to come together and put up a united front against this crisis.

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How has the COVID-19 pandemic changed interdisciplinarity? VICTOR TORRES/Stocksy

Interdisciplinary and interprofessional collaboration are crucial to both research and care settings. When experts with different specialisms are able to come together and help each other, better outcomes are guaranteed for all.

As early as 2010, the World Health Organization (WHO) was stating the importance of interprofessional education — that is, mutual teaching and learning exchanges between healthcare professionals with different specialisms — for the future of public health.

“Interprofessional education is a necessary step in preparing a ‘collaborative practice-ready’ health workforce that is better prepared to respond to local health needs,” the WHO then stated.

“Collaborative practice strengthens health systems and improves health outcomes.”

– WHO Framework for Action on Interprofessional Education & Collaborative Practice, 2010

However, there are myriad obstacles in the way of interdisciplinary and interprofessional collaboration. These include a lack of targeted funding and rigid, incompatible frameworks.

Perhaps for the first time in many decades, the COVID-19 pandemic has provided the motivation necessary for specialists from varied disciplines and professions to come together and overcome existing differences and difficulties.

The public health crisis has also meant that researchers have had more access to national and international funding, as they strove to develop effective vaccines to prevent infection and severe disease and drugs that could help fight COVID-19.

When the rollout of COVID-19 vaccines started across the world, many people expressed hesitancy about receiving them, as they were used to a much longer timeline of vaccine development.

More often than not, in the past, the process of developing a vaccine and confirming its safety and effectiveness could take up to 10–15 years.

So, how was it possible to develop, test, and roll out several new vaccines — some of which use novel mRNA technology — in under a year from the start of the pandemic? The answer: interprofessional collaboration and generous funding.

In a talk they gave at the WIRED Health:Tech conference in 2020, both Tal Zaks, then the chief medical officer of Moderna Therapeutics, and Prof. Uğur Şahin, co-founder and CEO of BioNTech, strongly emphasized the importance of interdisciplinary, interprofessional, and interinstitutional collaboration in the fast development and testing of their new vaccines, which were then still at the stage of vaccine candidates.

“The way [in which] the whole industry developed vaccines against COVID-19 […] is the best performance of collaboration,” said Prof. Şahin.

“Moderna teamed up with the NIH [National Institutes of Health], we teamed up with Pfizer, [and] AstraZeneca teamed up with Oxford University. So, there are several models of collaboration, and we have the strongest transparency in the development of a vaccine,” he explained.

This strong collaboration was crucial to being able to develop new candidate vaccines within a matter of months, as a sense of urgency stemmed from the ever-rising number of COVID-19 cases in countries all around the world.

Funding was also key. Although funding bodies usually tend to split their funds a lot more between disciplines and projects, the pandemic made it necessary for more funds to go toward the development of vaccines and drugs that could tackle SARS-CoV-2, which is the virus that causes COVID-19, efficiently.

In the United States, Operation Warp Speed went full steam ahead to support the development, manufacture, and distribution of COVID-19 vaccines in as little time as possible. In Europe, the European Commission pledged $8 billion to COVID-19 research.

In a guest editorial that appeared in the Journal of Interprofessional Care in August 2020, a team of 11 health experts wrote about how and why interprofessional education and collaborative practice research are especially important during the pandemic.

They also outlined some of the steps and considerations that would be necessary to ensuring constructive interdisciplinary collaboration in a medical research setting.

These include not only combining different types of expertise but also combining methodologies and building teams that are racially, socially, and professionally diverse.

“Inclusive [interprofessional education and collaborative practice] research teams would envision practitioners/clinicians from an array of experiential/applied settings, learners, service users, community members, various academic disciplines, and civil society as partners in all phases of research,” the authors wrote.

Collaboration between different experts and institutions has become more important than ever, not just in research but also in clinical settings and in ensuring effective communication between health experts and the general public during what has become a distressing time for all.

In a statement from May 2020, Dr. Hans Henri P. Kluge, the WHO regional director for Europe, emphasized the importance of “[c]ollaboration, coordination, and communication across the public health community.”

He noted that:

“Strong and integrated management of public health services, primary care services, and […] hospitals and long-term care facilities is critical to [navigating] this delicate phase.”

Although healthcare systems everywhere have been under great strain due to the high number of COVID-19 patients requiring urgent hospital care, this has not negatively impacted healthcare professionals’ collaborative efforts, according to some recent studies.

Medical News Today spoke with Dr. David Cutler, a family medicine physician at Providence Saint John’s Health Center in Santa Monica, CA, about the ways in which interprofessional collaboration in a clinical setting has changed since the start of the COVID-19 pandemic.

Interprofessional and interdisciplinary collaboration has been important to clinicians for decades, he told us, as health workers aim for stronger communication between specialists to ensure holistic care for their patients.

“Several forces are at play [that] foster greater interprofessional cooperation. First, there is the hospitalist movement,” he explained.

“Over the past decade, inpatient hospital care has transitioned from being mostly provided by physicians with practice outside the hospital who would see their few patients in the hospital daily to one where full-time, hospital-based physicians provide the primary care for inpatients.”

“Since hospitalists will generally have no prior knowledge of these patients or follow them subsequent to their hospitalization, there needs to be close collaboration between inpatient and outpatient physicians during the course of the hospitalization to optimize care,” Dr. Cutler noted.

During the pandemic, this spirit of open collaboration in the healthcare system has become all the more present, he went on to say. According to Dr. Cutler, that is because:

“[COVID-19] is treated very differently when it is mild/moderate/outpatient than when it is severe/inpatient. […] [R]ecognizing early on when hospitalization may improve outcomes requires effective and timely communication between primary care, urgent care, ER, specialists, and inpatient physicians. Getting patients to the right level of care can be a matter of life and death. Decisions regarding monoclonal antibody infusions, steroids, remdesivir, intubation, and ECMO [extracorporeal membrane oxygenation] therapy involve multiple physician specialties.”

Technological advances, such as having greater access to e-medical records, are also helping strengthen interprofessional collaboration in a clinical setting, added Dr. Cutler.

“The electronic medical record is perhaps the greatest force improving physician collaboration during the pandemic,” he told MNT. “Physicians who may even be in different healthcare systems can see prior testing and treatment done elsewhere, which promotes improved interdisciplinary care.”

“Electronic records also allow patients access to records generated by geographically diverse providers, which is a great boon to the quality of care,” he added.

Inevitably, the public health crisis that led to numerous lockdowns and travel restrictions across the world has also had a severe impact on the mental health of people around the globe.

This means that mental health care has also had to step up to the challenge. One key way of doing this has, once again, been pushing for more interdisciplinary and interprofessional collaboration.

MNT spoke with Lea Milligan. He is the CEO of MQ Mental Health Research, which is a United Kingdom-based charity funding mental health research. Milligan told us more about the challenges and successes of collaboration across fields and specialisms during the pandemic.

“On the eve of the pandemic, the mental health research community had performed the great task of agreeing [on] a set of ambitious 10-year goals for 2020–2030,” he told us. “They derive from recommendations in the ‘Framework for Mental Health Research’ published in [December] 2017, and [they] also build on previous research priority exercises.”

Milligan explained that the agreed-upon goals for mental health research and care require cross-disciplinary collaboration from the get-go: “Research to support the targets under each goal should be undertaken in partnership with the life sciences industries, charities, the NHS [National Health Service], voluntary, social and independent healthcare sectors, together with patients/ service users, their families/carers and clinicians.”

This need for collaborative mental health research and care has increased exponentially due to the COVID-19 pandemic, he went on to point out:

“Coordination across the [mental health research] sector is essential for the tide to be turned and for mental health science to become the super discipline it has the potential to be. Substantial investment is needed in both human capacity and infrastructural capacity. The emergent umbrella discipline of mental health science needs [an] opportunity to convene, develop a common language, and explore opportunities for collaboration between different approaches.”

The good news is that collaboration is already happening. According to Milligan, “Over the [past] year, in response to the pandemic, we have seen many groundbreaking projects with experts from psychiatry, data science, [and] neuroscience and people with lived experience coming together to tackle some of the biggest challenges faced within mental health care.”

As an example, he mentioned DATAMIND. This is a U.K.-based “hub for mental health informatics research development,” which makes new tools and mental health-related data available to researchers from all disciplines who may benefit from using them.

He also mentioned the Post-hospitalisation COVID-19 Study, which aims to look at the long-term effects of COVID-19 — including those on mental health.

“This holistic approach has resulted in a far more in-depth understanding of the virus’s impact and has opened the door to further areas of research into the long-term cognitive effects [that] many [people] are reporting,” said Milligan.

What remains to be seen is whether or not the progress in establishing and fostering interdisciplinary approaches that researchers and healthcare workers have made throughout the pandemic will persist beyond this public health crisis.

Some challenges remain. For example, although collaborative research has been intensifying during the pandemic — particularly in terms of vaccine development and distribution — there is still a sense that equitable collaboration, wherein all research partners are actively listened to and receive due credit, is often lacking.

A comment feature that appeared in Nature Human Behaviour in March 2021 emphasized the continued inequitability in research settings, noting that it hampers progress and ultimately harms global collaboration.

The authors write that although “[n]umerous academic organizations and departments of anthropology, psychology, and related fields reliant on cross-cultural data production have now declared commitments to combat racism […] and improve [the] representation of minoritized groups among their faculty and student body,” these commitments are often shallow, failing to address deep-rooted systemic inequities.

“Often missing from this discussion among high income country-based researchers, however, is the promotion of equitable collaboration in cross-cultural research with national universities and research [centers] in low and middle income countries,” they go on to note.

In terms of collaborations regarding clinical and mental health care, Milligan told MNT that future improvements should focus more on holistic approaches to treatment.

He also suggested that tackling structural racism and ingrained biases in healthcare remains crucial to building a true spirit of collaboration and to providing adequate care.

“Three areas we would like to see [a] more explicit focus on are: the need for truly interdisciplinary approaches, [the] requisite of seeing the whole person (not an isolated diagnosis), and [a] more explicit focus on addressing inequalities across all targets.”

Yet Milligan was hopeful. “Interdisciplinary working is here to stay, as it should be,” he told us. “When experts from across the spectrum of experience share views and knowledge, it gives us a more rounded approach to research.”

To achieve this “rounded approach,” he explained, it is important to include not just scientists and clinicians in the conversation about health research.

Those on the receiving end of care are also experts, thanks to their lived experience of ill health. Their unique expertise, Milligan added, can transform research and care for the better.

“The next step is to ensure that experts by lived experience are involved in the co-production of research so that their vital contributions are not missed out on.”

For live updates on the latest developments regarding the novel coronavirus and COVID-19, click here.

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Pfizer Covid pill: FDA authorizes first oral antiviral Paxlovid to treat coronavirus infection

This is the 1st antiviral Covid-19 tablet approved for sick persons to just take at property, ahead of they get sick sufficient to be hospitalized.

High-hazard persons age 12 and more mature who weigh at minimum 88 lbs . and have a positive SARS-CoV-2 test are suitable for this treatment and will want to have it approved by a doctor.

The pill “should really be initiated as soon as doable right after analysis of Covid-19 and within just five times of symptom onset,” in accordance to an Food and drug administration statement.

Paxlovid combines a new antiviral drug named nirmatrelvir and an older just one known as ritonavir and is administered as three tablets specified 2 times a working day for five days.

Last week, Pfizer launched updated final results that confirmed the cure slice the chance of hospitalization or dying by 89{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809} if provided to high-chance adults in a couple days of their very first signs. If presented within just the initial five days of signs, the efficacy was comparable: 88{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809}.

Finding a Covid-19 test is a struggle right now in the US as Omicron and holiday plans collide

“Modern authorization of PAXLOVID represents an additional incredible case in point of how science will enable us finally defeat this pandemic, which, even two a long time in, carries on to disrupt and devastate life throughout the planet. This breakthrough treatment, which has been demonstrated to considerably lessen hospitalizations and fatalities and can be taken at home, will alter the way we treat COVID-19, and hopefully support lessen some of the important pressures facing our health care and hospital techniques,” Pfizer Chairman and CEO Albert Bourla explained in a statement. “Pfizer stands ready to start out shipping and delivery in the U.S. instantly to assistance get PAXLOVID into the arms of correct sufferers as immediately as doable.”

In November, the Biden administration announced that it would order 10 million treatment method programs for $5.295 billion. President Biden stated he was inspired by the “promising info” from Pfizer and reported the drug would “mark a considerable move forward in our route out of the pandemic.”

He called Paxlovid a “potentially impressive instrument in our combat in opposition to the virus, which includes the Omicron variant,” but pressured that acquiring vaccinated and getting a booster shot remained “the most significant resources we have to conserve lives.”

The Fda emphasized in a statement that Paxlovid is not for pre- or post-exposure avoidance of Covid-19 and “is not a substitute for vaccination in men and women for whom COVID-19 vaccination and a booster dose are proposed.”

Separately, Merck has asked for crisis use authorization for its antiviral capsule, molnupiravir. It was narrowly advisable by FDA’s advisers in a 13-10 vote at the end of November following details showed it reduce the risk of hospitalization or demise by 30{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809} amid high-hazard grownups. This was lessen than an previously investigation suggesting that selection could be about 50{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809}. The Food and drug administration has not introduced irrespective of whether it will authorize the treatment.

Remdesivir, offered beneath the manufacturer name Veklury, is the only antiviral accredited by Fda for treatment of Covid-19. It really is specified intravenously, not as a pill that can be taken at house.

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Moderna booster shot increases antibody levels against Omicron, company says

At this time, Moderna’s booster is administered as a 50-microgram dose. The business announcement noted that this dose elevated antibody concentrations 37-fold, as opposed with the amounts seen when a fully vaccinated particular person does not get a booster, and a 100-microgram dose greater antibody amounts 83-fold.

It remains unclear what these boosts imply as far as how well the booster doses clinically do the job towards Omicron.

“The remarkable raise in COVID-19 conditions from the Omicron variant is about to all. Nonetheless, these knowledge demonstrating that the currently licensed Moderna COVID-19 booster can strengthen neutralizing antibody ranges 37-fold higher than pre-boost amounts are reassuring,” Bancel mentioned.

'Boost everybody.' CEOs should mandate boosters before returning office workers, Andy Slavitt says

“To react to this remarkably transmissible variant, Moderna will keep on to rapidly progress an Omicron-specific booster applicant into medical tests in scenario it becomes necessary in the long run. We will also continue to produce and share data throughout our booster tactics with community health and fitness authorities to help them make evidence-based mostly conclusions on the very best vaccination procedures versus SARS-CoV-2.”

SARS-CoV-2 is the title of the coronavirus that triggers Covid-19.

It’s now up to US general public overall health authorities to contemplate no matter if Moderna’s coronavirus vaccine booster should really be specified at a larger dose, Dr. Stephen Hoge, president of the corporation, reported Monday.

“The selection of no matter if to deploy 100 micrograms or a better dose is seriously just one for public overall health organizations at this issue. We are just offering the information, and naturally we will share it with all people so that they can make that resolve,” Hoge stated through a enterprise meeting connect with.

Moderna spokesperson Colleen Hussey confirmed to CNN in an emailed assertion Monday that the firm is “sharing the data with regulators as they get started to evaluate if any adjustments to the authorized boosters will need to be created.”

Moderna’s present-day coronavirus vaccine booster is approved for emergency use for people today 18 and more mature in the United States and supplied as a fifty percent-dose at 50 micrograms, and it’s licensed at the 100-microgram dose for people today who are seriously immunocompromised, the assertion mentioned.

According to the US Facilities for Ailment Control and Prevention, about 32{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809} of absolutely vaccinated adults — almost 60 million people today — have gotten a booster dose. Additional than 26.7 million of them have received a Moderna booster, in accordance to CDC details.

Separately, “we’re going to carry on to progress an Omicron-certain booster into medical trials in early 2022,” Hoge said Monday.

Covid-19 booster pictures can assist improve protection towards the Omicron coronavirus variant, and there is no will need for a variant-unique booster dose at this time, Dr. Anthony Fauci, director of the Nationwide Institute of Allergy and Infectious Ailments, said previous 7 days.

“A amount of experiments have been accomplished during the state and the world to take a glimpse at how we may get ready in the context of vaccinations,” Fauci claimed.

“The information remains crystal clear: If you are unvaccinated, get vaccinated,” included Fauci, the chief healthcare adviser to President Biden. “And especially in the arena of Omicron, if you are fully vaccinated, get your booster shot.”

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Coronavirus Today – Dec 20


By Anne Blythe

The message was dire from Gov. Roy Cooper and Mandy Cohen, secretary of the state Department of Health and Human Services.

“Get boosted,” they repeatedly told North Carolinians on Monday during a briefing with reporters broadcast on PBS North Carolina.

In anticipation of a tremendous surge in COVID-19 cases in early January as the Omicron variant looms large on the horizon, Cohen returned to the Emergency Operations Center podium with a sense of urgency in her last days on the job.

Just a week earlier, Cohen told North Carolinians that she thought her update on the state’s COVID trends, metrics and data would be her final press conference. At the end of the month, she plans to resign from her job and turn over leadership of the state’s pandemic response to Kody Kinsley, the chief deputy secretary at DHHS tapped by Cooper to lead the department as the next secretary of health.

“We thought last week might be your last time at the podium, but this pandemic continues to throw us curveballs,” Cooper told Cohen on Monday after she laid out what she wants North Carolinians to do immediately before Omicron becomes as prevalent here as it is in New York and other parts of the world. 

Cohen issued a secretarial advisory on Monday urging all this winter and holiday season to get vaccinated, boosted and tested, and mask up in public places.

COVID cases are on the rise, and North Carolina health care systems are starting to show strain as influenza circulates and the Delta and Omicron variants pose threats. 

Cohen and Kinsley said they expected to see record numbers of cases in the peak of the expected Omicron surge. Though Cohen was reluctant to put a specific number on what that record might be, she estimated that it could be as high as 10,000 cases a day. She also declined to speculate what peak hospitalization might look like as a result of the Omicron wave. 

North Carolina reported 10,541 new lab-confirmed cases of COVID since Friday, Cooper said. There were 1,630 people hospitalized with severe illness related to COVID, 437 of whom were in intensive care unit beds.

Three days ago, New York reported its highest number of daily COVID cases since the start of the pandemic. North Carolina public health officials are preparing for a similar trend to take hold here in the weeks ahead.

“I have two messages for North Carolinians today,” Cohen said with a more urgent tone in her voice than typical at press briefings. “First, the newest variant of COVID-19, Omicron, is the most contagious we’ve seen yet and will likely set record-high, daily case numbers in the coming weeks. Second, and most importantly. You can act now to best protect yourself and family and friends.”

People who received a Pfizer or Moderna vaccine at least six months ago are eligible for a booster and should get one as soon as possible. Those who received a Johnson & Johnson vaccine are eligible for a booster two months after receiving their shot. They can also get a Pfizer or Moderna shot to boost their immunity.

‘Do not wait’

The Omicron variant, which has been detected in “most” hospital labs across the state, according to Cohen, is two to three times as contagious as the Delta variant, currently the dominant variant in North Carolina.

“Fortunately, early evidence suggests that illness from the Omicron variant may be less severe,” Cohen said. “However, it still can pose a danger for people who are not vaccinated, and particularly those who are at higher risk of severe disease.”

During the week ending Dec. 11, Omicron accounted for 12.9 percent of all cases in the U.S. and 37 percent of cases in the Southeast. By the conclusion of the week ending Dec. 18, updated data from the Centers for Disease Control and Prevention shows that Omicron was accounting for 73.2 percent of all cases in the U.S. and 95.2 percent of all cases in the Southeast (Alabama, Florida, Georgia, Kentucky, Mississippi, North Carolina, South Carolina, Tennessee).

Instead of throwing hands up in the air, frustrated that the Omicron variant has shown the strength and adaptability of the coronavirus that has disrupted life for 22 months during the pandemic, Cohen urged North Carolinians to take action.

“Do not wait,” Cohen said, stressing each word.

Researchers from Hong Kong found that Omicron reproduces itself up to 70 times more effectively in the upper airway of an infected person than Delta did, making it spread that much more widely when that person coughs or sneezes. The good news is that Omicron doesn’t reproduce as effectively in the lungs, those researchers found. That could be why Omicron appears to cause less severe disease overall, the researchers speculated.

Public health officials in this country, though, say Omicron is too new to the states to predict whether that will remain the case in the weeks ahead.

As health care systems prepare to treat anyone sickened by the Omicron variant, drugs they’ve used in recent months to help stave off severe illness from the previous variants are not likely to offer much help.

‘Diminished’ COVID therapies

Regeneron, a drug company that created monoclonal antibody therapies that can be used for patients at risk of progressing to severe illness, put out a statement that its current drug has “diminished potency versus Omicron.”

New drugs are being developed, but they might not be readily available if an Omicron surge comes as expected in the weeks ahead.

Cohen was asked whether the record number of cases that she expected in North Carolina starting in early January would also mean a record number of hospitalizations.

“I do not yet know what that will translate into in terms of hospitalizations,” Cohen responded. “What we are seeing with Omicron is, it does seem to be less severe. What we don’t know yet is how it’s going to behave here in the United States. With the level of vaccinations that we’ve had, with the kinds of vaccination that we’ve seen before, I don’t know what that will mean. We are certainly planning to see additional strain on our hospitals. That’s why we are working with our hospitals to be ready, and the more we can act right now, that’s what will protect folks.”

“Right now,” though, is four days before Christmas Eve, when many families plan to gather to celebrate the holiday together after being forced to spend it apart in 2020 because of COVID. Some families are reconsidering how they might celebrate the holidays ahead, while others have opted to gather despite the variant. 

“I know people are frustrated and dismayed by this wave of infection right here at Christmas, but it’s important to remember how far we have come in our fight against this disease,” Cooper said. “We know what works. Vaccines, boosters, testing and masks when needed. With every dose, we’re getting closer to turning the tide on this sickness and death brought on by the pandemic.”

Cooper said his family is vaccinated and boosted. They plan to get tested, “then gather for food, prayer, presents and hugs and time with each other.”

Testing in the spotlight again

Kinsley outlined what the state has done in anticipation of Omicron. They have gotten boosters to state-run nursing homes and worked with hospitals to build systems to support them as weary workers and understaffed nursing teams add an even thornier layer for health care systems.

At-home COVID-19 tests. Photo credit: Rose Hoban

Kinsley also said the state is looking ahead to make sure that enough testing supplies are available during the expected surge. Testing for COVID will be a crucial element in schools, businesses and other places.

During the high-water mark of the Delta surge, which occurred in the late summer, North Carolina saw as many as 86,000 tests administered some days.

With public health leaders advising people who plan to gather for the holidays to get tested in advance, a spotlight has been cast again on whether tests are as easy to find as they should be.

Many pharmacies have empty shelves where rapid at-home antigen tests once were stocked. Even if the shelves were stocked, at nearly $25 a box for some brands with only two tests included, the cost of home testing can add up quickly. 

Kinsley stressed that free home-testing is available in North Carolina through DHHS. They’re not the rapid antigen tests, though. The swabs must be sent to a lab to get PCR results, adding a step that could lead to a delay in results.

“Over the last several weeks we’ve pushed out several hundreds of thousands of tests, rapid tests, to our local health departments to make them available in local communities,” Kinsley said. “Of course we have statewide testing vendors that are providing testing in schools.”

Coronavirus by the numbers

According to NCDHHS data, as of Monday afternoon:

  • 19,167 people total in North Carolina have died of coronavirus.
  • 1,599,595 have been diagnosed with the disease. Of those, 1,630 are in the hospital. The hospitalization figure is a snapshot of people hospitalized with COVID-19 infections on a given day and does not represent all of the North Carolinians who may have been in the hospital throughout the course of the epidemic.
  • As of Tuesday, 437 COVID-19 patients were in intensive care units across the state. 
  • North Carolina tracked COVID-19 re-infections in the case counts from March 1, 2021 through Sept. 20, 2021. All told, North Carolina tracked 10,812 reinfections, 200 of those were in people who were previously vaccinated. Ninety-four people who were reinfected with COVID-19 have died. 
  • 1,538,231 people who had COVID-19 are presumed to have recovered. This weekly estimate does not denote how many of the diagnosed cases in the state are still infectious. Nor does it reflect the number of so-called “long-COVID” survivors who continue to feel the effects of the disease beyond the defined “recovery” period.
  • To date, 21,190,766 tests have been completed in North Carolina. As of July 2020, all labs in the state are required to report both their positive and negative test results to the lab, so that figure includes all of the COVID-19 tests performed in the state. Most recently, 9.3 percent of those testing were testing positive. 
  • People ages 25-49 make up the largest group of cases (39 percent). While 12 percent of the positive diagnoses were in people ages 65 and older, seniors make up 74 percent of coronavirus deaths in the state. 
  • 263 outbreaks are ongoing in group facilities across the state, including nursing homes and correctional and residential care facilities.
  • As of Dec. 20, 6,539,752 North Carolinians have received at least one dose of a coronavirus vaccine. Ninety-one percent of people over the age of 65 have been completely vaccinated, while 58 percent of the total population is fully vaccinated. 2,184,783 boosters have been administered.
  • Children between the ages of 5 and 11 became eligible for vaccination during November. A total of 161,410 first doses have been given to those children, a total of 18 percent of that population.

This story has been updated with new data from the Centers for Disease Control and Prevention.

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by Anne Blythe, North Carolina Health News
December 20, 2021

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Public health emergency end could cause millions to lose Medicaid coverage

Each individual early morning when Christina Preston enters the West Local community Chance Heart, which serves Ohio’s Franklin County, she is familiar with she and her team are going to be flooded with phone calls and purposes from persons in determined need to have of support.

Their despair could turn out to be even additional acute up coming month as the countrywide community health emergency comes to an conclusion. That could lead to thousands and thousands of people’s dropping obtain to Medicaid and other rewards.

“We’re preparing for it as most effective we can, but the way we’re searching at it proper now is triage,” reported Preston, the director of the area employment and household products and services branch in Columbus. “I do not even definitely want to visualize it suitable now. It is going to be huge.”

Across the nation, area companies like Preston’s are making ready for the unraveling of the expanded social safety web that was produced in response to the coronavirus pandemic — and, most considerably, the finish of steady Medicaid protection, which expires Jan. 15, at the finish of the public wellness emergency, unless the Biden administration extends it. 

The provision, a prerequisite beneath the Households Very first Coronavirus Reaction Act, which passed in March 2020, prevented states from removing Medicaid recipients from the program’s rolls. At minimum 11 million individuals have enrolled in Medicaid given that February 2020.   

Up to 15 million men and women, which include practically 6 million children, could be at chance of getting rid of their Medicaid eligibility when the defense expires, according to the City Institute, an financial and policy investigate consider tank. The adjust could have an outsize influence on communities of coloration, the Urban Institute concluded.

Quite a few are probably to be suitable for other types of sponsored coverage, the analysis discovered, but there is a problem that couple people will know that they are in risk of losing Medicaid and are suitable for other varieties of wellbeing insurance policy. There have been few tries to converse this to all those who are impacted, they stated, and not each condition is approaching the dilemma the identical way.

“The time to commence setting up for this was yesterday,” said Cindy Mann, a partner at Manatt Health and fitness who was director of the Center for Medicaid and CHIP Products and services through the Obama administration. “We seriously don’t have far more time.”

In some circumstances, individuals who will be scrambling to evaluate their eligibility and likely striving to find new well being treatment designs could be fulfilled by states hunting for ways to tighten their fiscal belts by aggressively getting rid of individuals from the Medicaid rolls. 

Contending with Medicaid disenrollment following yr is “the looming monster,” reported Preston, who in comparison it to the overwhelming variety of calls and conditions around the country when a record amount of individuals built unemployment requests. 

The issues is that enrollees in disaster might also run into nearby organizations struggling through staffing shortages and morale challenges.

“Everything piling up has prompted a whole lot of burnout, a great deal of disappointment and a ton of people to regretably leave their positions,” explained Preston, who reported it takes 12 months to practice a new caseworker.

Ongoing coverage vs. state budgets

As of now, states are required to continue to keep people on the Medicaid rolls for the duration of the community well being emergency unless of course they move out of the point out or talk to to be taken out. When the general public health and fitness emergency ends, states will have 12 months to go as a result of enrollment and ascertain everyone’s eligibility standing. 

The Centers for Medicare and Medicaid Services documented that from February 2020 to May 2021, enrollment in Medicaid and the Children’s Health and fitness Insurance plan Method, or CHIP, grew by 11 million people today, or a lot more than 17 per cent, the most significant enhance around 18 months in the program’s background. Federal paying out on the system grew by 9.2 {cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809} to $671.2 billion in 2020 for the reason that of the expansion in enrollment.

But when the unexpected emergency expires, Medicaid recipients could be disenrolled from the method for an infraction as seemingly minor as not updating their particular data — some thing they haven’t experienced to do due to the fact March 2020 — or lacking a letter in the mail about their shifting position. 

This is of certain issue simply because quite a few individuals moved during the pandemic, and a significant number of these who obtain Medicaid were being also caught up in the eviction disaster, reported Stan Dorn, director of the Countrywide Heart for Protection Innovation at Family members Usa, a remaining-leaning shopper wellbeing advocacy group. 

“Lots of people who are in tricky conditions are not likely to get these notices,” Dorn explained. “If English is not your most important language, if you have to upload paperwork and never have superior online accessibility, if you are doing the job multiple jobs, this isn’t going to be an uncomplicated nut to crack.” 

Federal government officials and overall health treatment advocates emphasized how massive a shift in American overall health care coverage this would be and noted that this would occur when the nation is still battling with the unfold of the coronavirus.

“This could be the greatest health and fitness treatment transition considering the fact that the Very affordable Care Act handed,” Dorn reported. “But this would be in a destructive path for protection, as an alternative of a good 1.”

With the federal funding to point out Medicaid plans envisioned to draw down speedily in the months right after the community well being emergency ends, some states are debating at what speed to go as a result of the system of trimming the rolls.

In Ohio, the Republican-managed Legislature incorporated in the spending budget it passed earlier this calendar year that the condition would require to comprehensive individuals redeterminations in 90 days, which advocates say is not just about more than enough time to achieve out to Ohio’s 3.2 million Medicaid recipients and guarantee that men and women who remain qualified aren’t disenrolled. 

Erica Crawley, a Franklin County commissioner who now oversees the employment and spouse and children companies system and fought towards the 90-working day provision in the spending plan when she served in the Legislature, stated about 460,000 folks would have to be processed in just 90 days in her county, which involves Columbus. 

With about 300 case supervisors, it would sum to more than 1,500 programs for just about every of them to method in 90 days.

“That’s just for Medicaid. We’re not speaking about SNAP. We’re not talking about cash assistance, and there are new applications that have to be processed, as nicely,” Crawley mentioned. “We’re talking about possibly upwards of 15,000 hrs of time beyond regulation that would need to have to be approved for these to be processed.”

The Ohio Department of Medicaid declined to comment. The Ohio governor’s place of work did not react to a ask for for remark. Ohio state Sen. Tim Schaffer, a Republican and architect of the 90-working day program, did not respond to a request for comment. 

There is a concern among the Republican states that a longer and more methodical redetermination process with a drawdown in federal funding could be extremely costly for states. 

Ohio has long gone so significantly as to suitable $35 million for an exterior seller named Community Consulting Team. The enterprise suggests it can automate eligibility redeterminations by examining 3rd-bash sources and finish the do the job in just times. Of these that General public Consulting Team flags, the point out would shell out 10 to 20 {cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809} of its discounts to the business, according to the November e-newsletter released by the Ohio Basic Assembly Joint Medicaid Oversight Committee.

The Boston-dependent business did not respond to a ask for for remark. 

It’s just one system that some look at controversial for its velocity and payment method that some overall health advocates claimed was akin to spending a bounty for having away residents’ accessibility to wellbeing treatment.

Throughout the region, on the other hand, federal and state officials are getting ready for and debating means to address a herculean administrative undertaking that could have a enormous bearing on states’ budgets and the quantity of folks in their point out with wellness care coverage. 

The Centers for Medicare and Medicaid Companies has achieved out to states and tried to function out a strategy of best tactics. Most essential, officials said, was to unfold the term about the upcoming disenrollment time period and to guarantee that state Medicaid workplaces and area agencies had been informing men and women of their other health and fitness treatment alternatives.

Daniel Tsai, the director of the Heart for Medicaid and CHIP Companies who was appointed in June, claimed his business has developed a performing group with about 25 condition Medicaid companies to go over best tactics on how to strategy a trouble that he termed “unprecedented.” They then satisfy with the remaining states on phone calls that contain much more than 700 folks to relay their results.

The concentrate for Tsai and Chiquita Brooks-LaSure, administrator of the Facilities for Medicare and Medicaid Companies, has been to make sure that those people who continue to be suitable sustain coverage and people who really don’t changeover to other sorts of protection, but there are worries there, as effectively.

The company organized a checklist for states to encourage them to commence speaking the improvements and to get the job done carefully with well being treatment navigators, neighborhood teams and some others to ensure as clean a changeover as possible. 

The challenge is large, Tsai stated, but it has led to some innovation as they perform to join point out Medicaid companies with health and fitness treatment marketplaces. 

“We test to be really cognizant of the realities on the ground, and also producing guaranteed we are utilizing — I virtually mean — each and every lever doable to support protect protection and obtain for individuals,” Tsai explained. 

Build Back Much better: A guardrail and a wrinkle?

The Build Back again Much better Act, the Biden administration’s landmark protection web monthly bill, supplies some guardrails to further secure Medicaid recipients and prolongs the federal funding offered to states, but it could prove to be an additional administrative wrinkle. 

The bill, which is not likely to move ahead of the new yr, would extend the federal funding by means of the stop of September, however it would go down by about half at the conclude of March and lessen further at the end of June.

It would make it possible for states to terminate coverage only for persons who had been enrolled in Medicaid for 12 consecutive months, limit the amount of enrollees a condition could drop from the method for each thirty day period, require states to try to make get in touch with by way of techniques other than mail and call for enhanced oversight and reporting to the federal government.

States, these kinds of as all those that declined Medicaid expansion, could all over again choose to forgo the more federal funds and avoid all of those people guardrails and administrative burdens. 

“States are absolutely undertaking these calculations to determine no matter if it’s truly worth it to adhere to the prerequisites in exchange for the improved [federal funding], or no matter if it can make much more feeling to attempt and perform the redeterminations at a speedier rate,” explained Jennifer Tolbert, associate director of the Kaiser Relatives Basis Plan on Medicaid and the Uninsured. 

No matter if or not states decide to take part, it seems Tsai and other individuals at the Centers for Medicare and Medicaid Companies are getting ready to preserve a close eye on what states are executing and no matter whether they are dropping people today devoid of necessary abide by-by.

In the meantime, Tsai stated it was “unprecedented” the amount of money of work the centers and states have carried out with each other to test to stymie the flood of alter in Medicaid protection and make sure that persons are related to other types of health and fitness treatment protection.

“It’s kind of a no-brainer when you assume of how wellbeing care must get the job done, and it is never been much more crucial than in this context,” Tsai mentioned. “I seriously believe we feel we will need to even more really encourage all of us and our state counterparts to be functioning in this way, not just now, but also in the long run.”