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In our ‘Hope behind the headlines’ series, we continue to round up the most encouraging results in COVID-19 research. But, as the pandemic continues to unfold with many countries embracing a second lockdown, a critical approach to these hopeful results is more necessary than ever.

In a live social media chat, Dr. Anthony Fauci announced a few days ago that the first doses of a safe coronavirus vaccine are set to become available in late December this year or early January 2021. This is, of course, if everything continues to go smoothly.

Dr. Fauci, the director of the National Institute of Allergy and Infectious Diseases (NIAID), was referring to two candidate vaccines currently underway: one in development by Moderna Therapeutics in collaboration with NIAID, and the other in development by Pfizer in partnership with BioNTech.

Since then, Pfizer announced a 90% effectiveness rate for its candidate vaccine. In this article, we track the progress of these therapeutics and offer a critical — yet hopeful — perspective.

Why mRNA vaccines are speedier

MNT recently covered what Tal Zaks, Chief Medical Officer of Moderna Therapeutics, and Prof. Uğur Şahin, co-founder and CEO of BioNTech, had to say about their candidate vaccine at the recent Wired Health:Tech event.

Both the Moderna-NIAID and Pfizer-BioNTech vaccines use mRNA — that is, they use genetic information rather than a viral base to “train” the immune system to respond to SARS-CoV-2, the new coronavirus that causes COVID-19.

The speakers explained how an mRNA-based vaccine could be made available faster and is generally superior to other types of vaccines that use a viral base.

They cited “the infrastructure required” as being “relatively small and quick.” They also mentioned that, because the starting point is genetic information rather than the virus itself, “there is a component of speed that allows you to get into the clinic and then […] scale-up manufacturing.”

However, it is worth noting that while both of these candidate mRNA vaccines for COVID-19 show promise in early-stage clinical trials, there is no data available yet to confirm that they can prevent people from developing the disease.

It is also important to note that there are no human-licensed mRNA vaccines for other diseases. If the Food and Drug Administration (FDA) approve these vaccines, it will be groundbreaking, not just in the fight against COVID-19, but for mRNA vaccines in general.

By December we should know if we have a safe, effective vaccine

Both candidate vaccines are currently in stage 3 of clinical trials, to test their efficacy in large-scale studies comprising tens of thousands of people.

Moderna expects to release its trial stage results later in November. By December, we should know “whether or not we have a safe and effective vaccine,” Dr. Fauci said in the live session.

Pfizer announced the results of its late-stage clinical trials this week. In a move that boosted stock markets across the globe, the company said their candidate vaccine is 90% effective. Dr. Albert Bourla, Pfizer’s CEO, hailed the results as a “great day for humanity.”

“Today is a great day for science and humanity. The first set of results from our phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent COVID-19.” – Dr. Albert Bourla

However, it is worth noting that, at the time of publication, Pfizer have not yet released their data. It is likely their 90% effectiveness rate derives from a small number of participants. Therefore, questions remain about whether the candidate vaccine is safe and effective in older adults and vulnerable populations, who are likely to receive it first.

As soon as the data are released, MNT will cover the ins and outs of the trial and offer a critical perspective.

However, as Dr. Fauci said in his live session, if everything goes well, the first vaccine doses will become available to high-risk people and groups considered most vulnerable and most in need “by the end of December or the beginning of January.”

However, it is unlikely that life will return to normal “until the end of 2021 at least,” he continued. This is because it will take a while before a vaccine is mass-distributed, and even after it is, vaccine-induced immunity takes some time to build up on a national and then global level.

While the end of 2021 feels like a long while ahead, there are other reasons to keep our hopes up in the meantime. Here are other immunity-related scientific findings that we can add to our arsenal in the fight against the new coronavirus.

More proof of long-lasting immunity

Scientists have shown that those who have had the virus may have at least some level of lasting immunity. This is helpful not just for those who have had the infection, but also for using their plasma and possibly T cells to treat others.

For instance, researchers at the University of Arizona College of Medicine in Tucson have found that people who have had COVID-19 develop long-lasting immunity. Their study appears in the journal Immunity.

The Tucson scientists tested for SARS-CoV-2 antibodies in almost 6,000 people right after the infection and again several months later. Co-lead researcher Prof. Deepta Bhattacharya says, “We clearly see high-quality antibodies still being produced 5–7 months after SARS-CoV-2 infection.”

“Many concerns have been expressed about immunity against COVID-19 not lasting. We used this study to investigate that question and found immunity is stable for at least 5 months.” – Prof. Deepta Bhattacharya

The researcher is likely referring to a few studies that point to declining antibodies over time, such as the study conducted at Imperial College London in the United Kingdom. However, the results obtained by Prof. Bhattacharya’s team counter these findings.

Even more hopeful is the parallel that Prof. Bhattacharya draws with SARS-CoV-2’s cousin, SARS-CoV, where evidence suggests immunity could last 12–17 years.

“If SARS-CoV-2 is anything like the first one, we expect antibodies to last at least 2 years, and it would be unlikely for anything much shorter,” he says.

Over 90% of COVID-19 patients had antibodies for 5 months

Another study that appears in the journal Science also adds credence to this notion of long-lasting antibody immunity.

This large-scale analysis summed up over 30,000 people and found that most of those who had the virus and experienced mild-to-moderate disease “experience robust […] antibody responses” lasting up to 5 months.

Florian Krammer, Ph.D., from the Department of Microbiology at the Icahn School of Medicine at Mount Sinai, New York, NY, is the study’s senior author. He says:

“While some reports have come out saying antibodies to this virus go away quickly, we have found just the opposite — that more than 90% of people who were mildly or moderately ill produce an antibody response strong enough to neutralize the virus, and the response is maintained for many months.”

However, the scientists note that their study is not proof that these antibodies protect against reinfection. But, they say, it is also unlikely that they wouldn’t offer protection. More studies are needed to prove this with certainty.

“Although this cannot provide conclusive evidence that these antibody responses protect from reinfection, we believe it is very likely that they will decrease the odds ratio of reinfection, and may attenuate disease in the case of breakthrough infection.” – Florian Krammer et al.

“We believe it is imperative to swiftly perform studies to investigate and establish a correlation of protection from infection with SARS-CoV-2,” conclude Krammer and colleagues.

Antibodies from older males may be most helpful

These antibodies have the potential to protect people from severe cases of COVID-19, while some people’s antibodies may be stronger and more helpful than others.

A new study — led by Prof. Sabra Klein, of the Johns Hopkins Bloomberg School’s Department of Molecular Microbiology and Immunology in Baltimore, MD — tested the ability of antibody-rich blood plasma to inactivate the new coronavirus in cells containing the virus.

The researchers used widely available tests to determine the level of antibodies in 126 adults who had recovered from mild or moderate, lab-confirmed COVID-19. They wanted to see which donors provided the strongest antibodies.

The team found that a strong antibody response correlated with being hospitalized for the disease, being male, and being older.

“We propose that sex, age, and severity of disease should be used to guide the selection of donors for convalescent plasma transfer studies because we found that these were significant patient characteristics that not only predicted the amount of antibody but the quality of that antibody.” – Prof. Sabra Klein

T cells may succeed if antibodies fail

It is worth noting that some studies question the “lifespan” of antibodies, such as the recently published Imperial College London study. But even if antibodies may decline shortly after infection — a hypothesis that is still contentious — there are other aspects of immunity that may help protect against COVID-19, for example, T cells.

A new study that used cell cultures suggests that adoptive immunotherapy — a technique where specialists take the cells that target the virus from the blood of someone who has had the virus and inject them in people with compromised immunity — could protect those with weakened immunity from severe COVID-19.

Dr. Michael Keller, a pediatric immunology specialist who led the study, comments on his team’s findings, saying, “We found that many people who recover from COVID-19 have T cells that recognize and target viral proteins of SARS-CoV-2, giving them immunity from the virus because those T cells are primed to fight it.”

“This suggests that adoptive immunotherapy using convalescent T cells to target these regions of the virus may be an effective way to protect vulnerable people, especially those with compromised immune systems due to cancer therapy or transplantation.”

However, it is important to note that this study was preclinical, used cell cultures, and even in those cells, it did not directly test T cells’ ability to destroy the new coronavirus.

Instead, the researchers found that the T cells stimulated an immune response to a small segment of the new coronavirus — a part of its membrane. Namely, they released interferon, which is crucial in the response to SARS-CoV-2 infection. Most other vaccines target the virus’ spike protein, but targeting the membrane could provide a new avenue for vaccine development.

Furthermore, the number of participants used for the study was relatively small, while many of the donors only had mild COVID-19 symptoms. Finally, not every participant had a positive COVID-19 or antibody test.

In our next installment of Hope behind the headlines, we will take a closer look at the role of T cells in offering immunity, as well as tracking the progress of the Pfizer-BioNTech vaccine.

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A trial suggests that in patients who are no longer responding to metformin, taking a combination of two newer drugs is safe and yields clinical benefits for at least 2 years.

Insulin helps regulate the amount of glucose circulating in the blood. In type 2 diabetes, the body does not produce enough insulin, its cells no longer respond effectively to the hormone, or both.

In the long term, high blood glucose levels can cause a wide range of debilitating and potentially life threatening complications. These include high blood pressure, damage to organs such as the heart and kidneys, nerve damage, and blindness.

According to the Centers for Disease Control and Prevention (CDC), type 2 diabetes affects more than 30 million individuals in the United States and accounts for 90–95% of all cases of diabetes.

Type 2 diabetes used to be called adult-onset diabetes because it mostly affects people over the age of 45. But in recent decades, rates of type 2 diabetes in children, teenagers, and young adults have increased in the U.S.

Lifestyle changes can control or even reverse the condition. Doctors also prescribe drugs to stabilize patients’ blood glucose levels.

The first-line treatment is metformin, but in some patients, the drug’s efficacy can decline over time, necessitating alternative treatments.

Drug combination

A clinical trial called DURATION-8 investigated a combination of two newer drugs — exenatide and dapagliflozin — in patients whose blood glucose levels did not respond to metformin.

Initially, the trial lasted 28 weeks, but it was later extended to 52 weeks. The results suggest that the combination was safe and continued to be more effective than either drug alone.

In addition to stabilizing blood glucose levels, the drug combination was associated with lower blood pressure and body weight.

The researchers report in the journal Diabetes Care that the drug duo remained safe and effective 2 years (104 weeks) after treatment began, following a second extension of the trial.

“Many therapies in diabetes management are short-lived, which is why it is useful to test for long-term effect,” says first author Dr. Serge Jabbour, director of the division of endocrinology and the Diabetes Center at Thomas Jefferson University in Philadelphia, PA.

Exenatide belongs to a class of drugs called glucagon-like peptide-1 receptor agonists, which work by promoting insulin secretion, reducing the release of glucose from the liver, and increasing the feeling of fullness after a meal.

Dapagliflozin belongs to a class called sodium-glucose cotransporter-2 inhibitors, which boost the amount of glucose that is excreted in urine.

“These two classes work synergistically to help control a type 2 diabetes patient’s glucose levels and other measures associated with diabetes,” says Dr. Jabbour. “We can now feel more confident about prescribing these medications long term.”

AstraZeneca, which makes branded versions of both drugs, funded the study. The company also played a role in designing the study, gathering the data, and evaluating it.

Study design

The researchers randomly assigned 695 adults with type 2 diabetes whose blood glucose was not adequately controlled by metformin to three treatment groups:

  • a weekly injection of exenatide and a daily oral dose of dapagliflozin
  • weekly exenatide and daily oral placebo
  • a weekly placebo injection and daily oral dapagliflozin

After 2 years, 431 patients remained in the trial. Most of the participants who dropped out did so because they did not want to sign up to an extension of the trial.

After adjustments for other possible contributing factors, those who received both drugs saw the greatest average reduction in their glycated hemoglobin (HbA1c) levels — a measure of the stability of blood glucose levels — compared with the start of the trial.

In patients who took both drugs, there were also improvements in blood glucose levels after fasting and 2 hours after eating, and reductions in body weight and systolic blood pressure.

The researchers report that patients tolerated well the combination of exenatide and dapagliflozin.

While patients experienced no episodes of major hypoglycemia (dangerously low levels of blood glucose), there were more episodes of minor hypoglycemia in patients who took both drugs compared with the other two experimental groups.

Conclusions

The authors conclude that the clinical benefits of taking both drugs were maintained for 2 years, with “no unexpected safety findings.” They continue:

“Further studies are needed to investigate whether the combination treatment effects observed in DURATION-8 could potentially extend to a reduced incidence of [cardiovascular] and renal events in patients with type 2 diabetes.”

The authors acknowledge that the relatively high proportion of patients who withdrew from the study after 1 year limits the “robustness” of its findings after 2 years.

Finally, they note that their findings may not apply to all patients. Treatment should be tailored to individuals and modified according to how well they progress.

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A new study has highlighted the prevalence of gastrointestinal symptoms in people with COVID-19 and what signs abdominal radiologists should look out for.

In a new study, researchers have synthesized evidence from 36 scientific articles to highlight the prevalence of gastrointestinal symptoms in people with COVID-19.

The study, appearing in the journal Abdominal Radiology, also identifies some of the signs abdominal radiologists should look out for when imaging people.

COVID-19 unknowns

One of the challenges of the COVID-19 pandemic has been the fact that SARS-CoV-2 is a novel coronavirus. While sharing some similarities with the previous severe acute respiratory syndrome coronavirus (SARS-CoV) and Middle East respiratory syndrome coronavirus (MERS-CoV), SARS-CoV-2 also has many differences.

As time progresses, scientists can conduct research on the virus to discover some of these unknowns and therefore help inform effective policy decisions and clinical practices. This has been the case with the symptoms of COVID-19.

While scientists have been aware of the most common symptoms — fever, coughing, loss of smell or taste, and shortness of breath — for some time, they have only recently identified other less common but significant symptoms.

As Dr. Mitch Wilson, a radiologist and clinical lecturer at the University of Alberta’s Faculty of Medicine & Dentistry and co-author of the study points out, “[t]here’s a growing amount of literature showing that abdominal symptomatology is a common presentation for COVID-19.”

The study

In the present article, a team of researchers focused on the growing evidence of people presenting with gastrointestinal issues linked to COVID-19.

To do this, the researchers conducted a study to highlight trends, issues, or areas that require more research.

The team searched through popular scientific databases using variations of the keywords “COVID-19,” “gastrointestinal,” and “imaging.” This resulted in 614 potentially relevant articles. The team identified a further 21 articles from other sources.

The researchers then removed duplicate articles and began screening the articles’ abstracts and titles for relevance, identifying 137 articles.

The researchers then conducted a full-text screening, limiting the studies to those that included findings related to abdominal imaging in people who had received a diagnosis of COVID-19.

The team included 36 articles in their study.

Gastrointestinal COVID-19 signs

After synthesizing the evidence from these 36 studies, the researchers identified two key findings.

First, gastrointestinal symptoms are a significant aspect of COVID-19 and may be present in the absence of other more well-known symptoms.

The researchers highlighted a meta-analysis covering more than 4,200 people that found 17.6% had gastrointestinal symptoms. In another study of 1,141 people, 16% presented with only gastrointestinal symptoms.

Second, the researchers identified a series of signs that an abdominal radiologist should look out for when imaging people — particularly because doctors have reported the incidental identification of COVID-19 in a substantial proportion of individuals with gastrointestinal symptoms.

The signs that the researchers suggest abdominal radiologists should look out for include:

  • bowel inflammation,
  • air within the bowel wall,
  • bowel perforation.

However, these signs are relatively rare in people with COVID-19. As Dr. Wilson points out, “[s]eeing these things is not necessarily telling us a patient has COVID-19. It could be from a variety of potential causes.”

“But one of those potential causes is infection from the virus, and in an environment where COVID-19 is very prevalent, it’s something to consider and potentially raise as a possibility to the referring physician.”

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With 47 COVID-19 vaccine candidates in testing, it is no wonder that there are myths and misconceptions about when a vaccine will actually be available to the public, and how safe it will be. Pan American Health Organization (PAHO) experts have recently addressed the media to clarify some of these issues.

The latest data from the World Health Organization (WHO) indicate that, as of November 3, 2020, there are 47 COVID-19 vaccine candidates in clinical trial phases around the world. There are also as many as 155 in preclinical testing.

Given the sheer number of vaccine candidates that researchers have developed within months of the start of the pandemic, it is only natural that questions and doubts have arisen about this process.

Traditionally, it can take years for a vaccine candidate to undergo testing for safety and efficacy and to gain official approval for distribution to the public.

However, scientists have been ramping up their efforts with the aim of bringing a COVID-19 vaccine to the public in record time.

At this year’s WIRED Health:Tech conference, Prof. Uğur Şahin, the co-developer of one of the most promising vaccine candidates so far — the “Pfizer vaccine” — explained that speeding up does not mean that scientists are rushing the process.

Rather, researchers have been optimizing the vaccine development process by sharing more data across research teams and conducting some of the tests in parallel, rather than consecutively, Prof. Şahin explained.

Still, many people continue to have questions and doubts regarding the safety and efficacy of future COVID-19 vaccines, as well as the development process for vaccine candidates.

To address some of these questions, specialists affiliated with or collaborating with the PAHO held a dedicated webinar on October 23, 2020.

The speakers included:

  • Dr. Cuahtémoc Ruiz-Matuz, chief of the Comprehensive Family Immunization unit at the PAHO
  • Dr. Jarbas Barbosa, PAHO assistant director
  • Dr. Alba María Ropero Álvarez, PAHO regional advisor on immunization
  • Dr. Lucia Helena de Oliveira, PAHO regional advisor on new vaccines

The context of immunization

During the webinar, Dr. Ruiz-Matuz suggested that the issues regarding an upcoming COVID-19 vaccine did not emerge in a vacuum.

For decades, healthcare policymakers have striven to make immunization against common pathogens available worldwide, particularly to prevent potentially dangerous childhood diseases.

Dr. Ruiz-Matuz spoke of the recent situation of worldwide immunization programs, noting that global coverage of vaccines for 1-year-olds is increasing, leading to a lower number of deaths due to preventable illness in infancy.

In the Americas, he said, cases of childhood diseases that countries have been vaccinating against over the past few decades have lowered drastically. This is the case with rubella, diphtheria, pertussis, neonatal tetanus, and measles.

Some diseases, he added, have disappeared altogether — as is the case with polio and congenital rubella syndrome.

However, data from last year indicate that childhood immunization programs may be losing ground. “Of 25 children, three are completely left behind, while one starts the three-dose scheme and does not finish it,” Dr. Ruiz-Matuz pointed out.

Measles, mumps, and rubella vaccinations, in particular, have been on the decline in the past year. According to the PAHO specialist, “This is obviously the impact of the pandemic.”

Dr. Ruiz-Matuz also argued that, sometimes, the challenges that experts face at a local and global level when it comes to immunization are not intrinsic to health services.

Urbanization trends, natural disasters, local political contexts, the lack of social equity, the movement of populations between regions and countries, and country-wide financial crises are all added obstacles standing in the way of adequate vaccination.

Challenges for COVID-19 immunization

Dr. Barbosa noted that once a COVID-19 vaccine is finally available to the public, there will still be many challenges when it comes to distributing it across different populations.

According to him, these challenges include:

  • “ensuring equitable, timely, and sufficient access to the vaccine”
  • “addressing technical and logistic aspects” regarding vaccine development and production
  • “defining the priority groups to receive the first vaccine doses”
  • “determining the appropriate number of doses for adequate protection”

Widespread misinformation may further affect people’s trust in the COVID-19 vaccine and prevent them from getting inoculated against the new coronavirus, Dr. Barbosa also warned.

Mistrust in vaccines could also render the population more vulnerable to other preventable diseases, such as pertussis or measles.

Dr. Barbosa urged media representatives to provide information to the public based on hard scientific evidence, and to present it in a very transparent way, in order to fight current trends of misinformation.

Fighting vaccine hesitancy

Dr. de Oliveira spoke of the dangers of vaccine hesitancy, which, she argued, it is possible to reduce by increasing the public’s understanding of what vaccines are and how they work.

“Vaccines prevent diseases that can be dangerous, or even deadly. They greatly reduce the risk of infection by working with the body’s natural defenses to safely develop immunity to disease,” she explained.

“A vaccine is a part of a germ that is exposed to your immune system in a safe way, so that [the immune system] can learn how to fight off that harmful pathogen and protect your body from it in the future when this pathogen enters [the] body.” – Dr. Lucia Helena de Oliveira

The expert went on to cite WHO data that indicate that vaccines prevented at least 10 million deaths in 2010–2015.

She also noted that many fears around vaccines originate from the belief that, in some cases, they may cause rather than prevent infection. This is not true, she emphasized — but to understand why it is not true, it is necessary to have a clear understanding of how vaccines work.

“Vaccines help develop immunity by imitating an infection,” explained Dr. de Oliveira. “Once the imitation infection goes away, the body is left with a supply memory, and this memory will be activated when the germ — the virus or the bacteria, for example — enters […] your body.”

The imitation infection the vaccine triggers may cause minor symptoms similar to those a person might experience during illness, such as a fever. This is normal, the expert noted. It is a sign that the body is working and learning how to fight the pathogen. This is not the illness itself.

However, following vaccination, “it takes a few weeks for the body to produce antibodies” that can identify and help fight the pathogen.

In the meantime, she cautioned, exposure to an active virus just before or just after vaccination may still lead to disease, given that the vaccine has not yet had a chance to do its work.

Developing a COVID-19 vaccine

Vaccine development “is [a] very large and complex [process], often lasting 10–15 years,” Dr. de Oliveira added.

So, what about the fast work on the COVID-19 vaccine? Will it mean that the end result will not be as safe and effective as other vaccines? Not so, said the PAHO expert.

“It doesn’t mean that the vaccine is not going to be safe and [effective], because there are a lot of protocols [at] this moment — protocols from WHO, protocols from FDA [the Food and Drug Administration], protocols from EMA [the European Medicines Agency] — that [have] established rules for this vaccine, which is going to be produced in a much shorter time.”– Dr. Lucia Helena de Oliveira

Finding a safe and effective COVID-19 vaccine will also be possible because many research teams around the globe are looking at both old and new vaccine platforms. These include:

  • vaccines using a live virus with reduced infectivity
  • vaccines using an inactivated virus
  • vaccines using genetic information
  • viral vector vaccines
  • protein-based vaccines

Moreover, for a vaccine to become licensed for public distribution, it has to successfully pass through three clinical trial phases, Dr. de Oliveira explained.

Phase 1 is a small-scale safety study, phase 2 is an extended safety trial in hundreds of volunteers, and phase 3 is a large-scale trial in thousands of volunteers.

Phase 3 trials test for safety, dosage, and efficacy, as well as possible side effects across various demographics, she noted.

If phase 3 trials are successful, national healthcare decision makers will likely approve the vaccine’s release to the public.

However, the work does not stop there. Dr. de Oliveira said that there is also a phase 4, during which experts distribute the vaccine through immunization programs and the researchers continue to monitor its safety and effectiveness.

Challenges when a vaccine is ready

There are some real challenges ahead once a vaccine is ready and declared safe and effective. The PAHO experts noted that people should not forget these challenges or take them lightly; rather, they should try to understand them for what they are.

Dr. Ropero Álvarez said that the current working scenario is that there will be limited doses of the COVID-19 vaccine available for distribution, meaning that decision makers will have to prioritize their distribution to specific groups.

The WHO co-lead COVAX, which is an international program wherein experts and institutions from 172 countries are collaborating to ensure that a safe, effective COVID-19 vaccine will be available to all.

Dr. Ropero Álvarez cites data that indicate that, to begin with, countries participating in the COVAX program will receive doses that will likely be enough to cover 20% of their population.

Around 3% of doses will likely go to health and social care workers, and around 17% will likely go to high risk adults, such as those with chronic conditions and older adults. It is also possible that some doses may go to additional high priority groups, depending on each country’s situation.

Participating countries will have to conduct very clear communication campaigns, explaining why these groups will take priority in COVID-19 immunization programs, the PAHO expert noted.

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As some scientists work on potential COVID-19 vaccines, others are looking to existing products to slow the rate of coronavirus infection, including mouthwashes and oral rinses.

Alcohol-based hand sanitizers and wipes play an important part in reducing infection rates. However, other products might also have a role to play. Scientists at the Penn State College of Medicine in Hershey, PA, are looking at oral rinses and mouthwashes.

In a recent study, which appears in the Journal of Medical Virology, researchers determined that several oral and nasal solutions might lower the risk of viral transmission when used by those with a coronavirus infection.

Craig Meyers, professor of microbiology and immunology and obstetrics and gynecology, led the study. “While we wait for a vaccine to be developed, methods to reduce transmission are needed,” Meyers says. “The products we tested are readily available and often already part of people’s daily routines.”

Testing existing products

To investigate, Meyers and his team used a human respiratory virus called HCoV-229E, which is in the same virus family as SARS-CoV-2. In a laboratory, they introduced various products to the virus to assess whether they could successfully reduce viral activity.

The selected nasal products included a diluted Johnson’s Baby Shampoo nasal rinse and a CVS Health Neti Pot. The mouthwash gargling products tested were CVS Health Peroxide Sore Mouth Cleanser, 1.5% Hydrogen Peroxide solution (Cumberland Swan Inc.), Orajel Antiseptic Rinse (Church & Dwight Co. Inc.), Betadine 5% (Alcon Laboratories Inc.), Crest Pro-Health (Procter & Gamble), Listerine Antiseptic (Johnson & Johnson Consumer Inc.), Listerine Ultra (Johnson & Johnson Consumer Inc.), Equate (Walmart), and Antiseptic Mouthwash (CVS Health).

Researchers exposed the human coronaviruses to each solution in three separate tests lasting 30 seconds, 1 minute, and up to 2 minutes. While most of the selected products showed some level of impact, the neti pot had no measurable effect across any of the tests.

The Johnson’s Baby Shampoo nasal rinse solution killed 99% of the coronaviruses within 1 minute and 99.9% within 2 minutes. Crest Pro-Health reduced the coronaviruses from 99.9% to greater than 99.99%.

The most impactful product was Listerine Antiseptic, which managed to reduce the virus by greater than 99.99% after 2 minutes. Overall, the Listerine and Listerine-like mouthwashes produced the best results.

The findings further validated similar results published in the Journal of Infectious Diseases in July 2020. In this earlier study, the authors determined that routine oral rinsing by those with a coronavirus infection might reduce the viral load in their mouths, throat, and nose. This could potentially reduce the amount they could transmit to others with a cough or sneeze.

Additionally, the research team found it interesting that the three products with hydrogen peroxide as the main ingredient inactivated the virus at a rate between 90 and 99%. This result supports previous research that also found hydrogen peroxide solutions to be effective against SARS-CoV-2.

Taken together, there is enough research available to strongly suggest that these products could help reduce the transmission of SARS-CoV-2 between someone with an infection and someone without an infection.

Meyers explains: “People who test positive for COVID-19 and return home to quarantine may possibly transmit the virus to those they live with. Certain professions, including dentists and other healthcare workers, are at a constant risk of exposure.”

Study limitations

Use of these over-the-counter solutions, when combined with other preventive methods, could offer an even greater level of protection among the general public.

That said, there are some important aspects of the study to consider that might impact the overall accuracy of the outcome expected against SARS-CoV-2.

For instance, as the authors explain, “We did not use SARS-CoV-2 in this study as the virus, as it was more expensive, less available, and would have required biosafety level-3 laboratory conditions.”

Also, the tests were conducted in laboratory conditions rather than in human participants. As the authors explain, “[T]his does not represent the true nature of the nasopharyngeal endothelial ecosystem.”

Meyers and his team strongly advocate for future trials. With more accurate testing, it might be possible to eventually create a comprehensive prevention strategy that is easy, widely available, and affordable.

It is also important to note that, even if further research confirms the antiviral benefits of mouthwash use, these products cannot replace face coverings, social distancing, and other methods. They will be an additional tool.

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Doctors have warned that people in the United States may be drinking excessively as a way to cope with the COVID-19 pandemic.

In a new viewpoint article, two doctors have warned that more people in the U.S. may be turning to alcohol as a way of coping with the “myriad stressors” of the COVID-19 pandemic.

The article, published in the Journal of General Internal Medicine, proposes a series of interventions to try to minimize this behavior and better support people with alcohol use disorder.

Coping strategy

It is well documented that drinking alcohol is one way that people cope with stressful situations. For example, research has shown that in the U.S., people tend to drink more alcohol following terrorist attacks.

Furthermore, if a person has alcohol use disorder, they are more likely to use alcohol to cope with the stress of a traumatic event.

In this context, the current COVID-19 pandemic is a particular cause for concern. The authors of the current article point out that rather than being a single event, the effects of the COVID-19 pandemic are prolonged over time, potentially exposing people to ongoing trauma.

Further, the pandemic has caused various potential stressors that a person may cope with by drinking alcohol.

As well as the catastrophic effect on people’s health and the loss and grief experienced by many, the pandemic has also disrupted economies and social and cultural life, threatening people’s jobs, disrupting their interpersonal support structures, increasing barriers to health care, and forcing many people into isolation.

Before the pandemic, researchers had noted that people in the U.S. were tending to drink more. This was particularly the case for females.

Recent research suggests that people in the U.S. increased their alcohol consumption in the early phase of the pandemic. This is in line with similar findings from studies in the United Kingdom and Australia.

Alcohol health effects

This matters because well-documented links exist between increased alcohol consumption and adverse health outcomes.

As the National Institute on Alcohol Abuse and Alcoholism point out, alcohol consumption can change mood and behavior, damage a person’s heart, liver, and pancreas, increase the risk of several types of cancer, and weaken a person’s immune system.

Research has also linked excessive alcohol consumption to mental health disorders, such as anxiety and depression, which may worsen during the pandemic.

Consequently, it is important to encourage people to find alternative coping strategies in response to the stressors of the pandemic. Effective support should also be available for people experiencing the effects of increased alcohol consumption or people with alcohol use disorder.

Interventions

The authors of the present study offer various suggestions for interventions that may help reduce people’s dependence on alcohol during the pandemic. Other suggestions focus on better preparing clinical services to support people with substance abuse issues.

According to Dr. Shelly F. Greenfield, director of the Alcohol, Drug, and Addiction Clinical and Health Services Research Program at McLean Hospital in Belmont, MA, “[i]ncreasing identification of harmful alcohol use in patients and intervening early are key components of addressing this problem.”

“In addition, recognition of the problem from policymakers could lead to changes in federal regulations — such as we have seen with telehealth — and improvements in access to healthcare,” she notes.

The authors suggest that public health messaging should raise awareness of the potential for increased drinking during the pandemic, as well as giving advice on alternative coping strategies for the stressors of the pandemic.

They also suggest that primary care practitioners should offer increased screening for alcohol use disorder when people contact primary care services.

Technologies, such as telehealth — that enable clinical information to pass between doctors and individuals at a distance — may also be valuable for people who are isolating or where the pandemic has forced a reduction in the enrolment for some face-to-face clinical services.

Finally, the authors highlight that ensuring people have access to health insurance to cover medical treatment costs is crucial. This is particularly important given the number of people who depend on work-place health insurance and the significant number of people who have lost their jobs during the pandemic.

Co-author Dr. Dawn E. Sugarman, a research psychologist in the Center of Excellence in Alcohol, Drugs, and Addiction at McLean Hospital, notes that:

“We hope this article will call attention to the pandemic’s effects on alcohol use and offer mitigating approaches to this under-recognized public health concern.”

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Nerve damage from neurodegenerative conditions, traumatic injuries, and certain eye conditions leads to disability and death for millions of people in the United States. Currently, doctors consider such damage irreversible.

However, researchers at The Ohio State University Wexner Medical Center have discovered a new type of human immune cell that appears to prevent and reverse nerve damage in the optic nerve and spinal cord.

This finding could allow researchers to create more advanced neurodegenerative immunotherapies.

These therapies might offer fresh hope to people with currently incurable neurological conditions, including Alzheimer’s disease, multiple sclerosis, stroke, and Parkinson’s disease. They might also help treat central nervous system (CNS) damage from injury or infection.

“I treat patients who have permanent neurological deficits, and they have to deal with debilitating symptoms every day, “says Dr. Benjamin Segal, professor and chair of the Department of Neurology at The Ohio State College of Medicine and co-director of the Ohio State Wexner Medical Center’s Neurological Institute.

“So the idea of being able to restore neurological function and take that burden away from my patients is really amazing.”

Funded by the National Eye Institute (NEI), the National Institutes of Health (NIH), the Wings of Life Foundation (C.Y.), and the Dr. Miriam and Sheldon G. Adelson Research Foundation, the study appears in the journal Nature Immunology.

The emerging field of immunotherapy

Immunotherapy therapies alter the immune response by stimulating it or using the body’s own immune cells to treat disease. Over the past few decades, scientists have begun developing them to tackle a wide range of medical conditions.

Doctors already use immunotherapies to treat certain types of cancer. They help the immune system to recognize and destroy cancer cells.

Other researchers are investigating whether immunotherapy could help prevent or treat neurological disease.

Researchers have been extensively testing immunotherapies that increase the clearance rate of certain proteins whose accumulation has links with neurological diseases, such as Alzheimer’s disease, Parkinson’s disease, frontotemporal dementia, and dementia with Lewy bodies.

Scientists have already created T-cell mediated immunotherapy approaches that target proteins linked with these neurological diseases, such as amyloid-beta, tau, and alpha-synuclein proteins.

Immunotherapy may also present opportunities to prevent and treat nerve damage by activating alternative immune pathways in response to CNS damage.

A 2014 study found that anti-inflammatory or immunoregulating (M2) macrophages are critical for remyelination, which is a form of nerve repair.

The study

The researchers examined immune cells in fluids and spinal cord tissues collected from mice with optic and spinal nerve damage.

Within these fluids and tissues, the team found a unique type of granulocyte. Granulocytes are a category of white blood cells. Neutrophils are the most common kind of granulocytes.

Neutrophils are scavengers that help destroy pathogens or other unwanted particles in the body. The new type of granulocyte that the scientists identified behaved like an immature neutrophil.

This newly discovered granulocyte helped protect neural cells and tissues from damage in the mice. It also encouraged nerve cell regeneration by secreting a mix of beneficial growth compounds. The team also found a human cell line with similar neuroprotective properties.

“This type of cell actually secretes growth factors to rescue dying nerve cells. It can also stimulate the surviving nerve cells to grow new fibers once they’re severed or damaged in the [CNS], which is really unprecedented,” says Dr. Segal. “This can potentially lead to therapeutic breakthroughs for a wide range of conditions by repairing these nerve pathways.”

However, researchers have a long way to go before doctors can use immune cells, such as this newly discovered granulocyte, to treat humans.

The team’s first major hurdle will be figuring out how to harness the power of this new immune cell and enhance its natural healing effects by growing it in a laboratory setting. Next, they’ll have to prove their newly proposed therapy is both effective and safe in humans.

In the future, the team hopes that doctors can inject these novel cells into people with chronic cognitive deficits to slow down or halt degenerative decline.

Dr. Segal concludes that they have got a lot of work left to do to make their laboratory findings relevant in a clinical setting, but says he is optimistic about the road ahead:

“There’s so much that we’re learning at the bench that has yet to be translated to the clinic, but I think there’s huge potential for the future.”

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A small observational study has found no evidence that osteoporosis drugs increase the risk of getting COVID-19. The research hints that some of the drugs may even reduce the risk.

In people with osteoporosis, progressive reductions in bone density increase the risk of fractures. The condition tends to affect older people, and its incidence among females increases following menopause.

Researchers have yet to directly test the possible effect of drug treatments for osteoporosis on a person’s risk of developing COVID-19. Influential health organizations, such as the American College of Rheumatology, recommend that people continue taking their medications as usual.

Now, researchers led by a team from the Hospital del Mar Medical Research Institute, in Barcelona, Spain, have analyzed data from 2,102 patients who received treatments for osteoporosis, osteoarthritis, and fibromyalgia at the hospital.

The mean age of the patients was 66.4 years, and 80.5% were female. Around 64% had osteoarthritis, 44% had osteoporosis, and 27% had fibromyalgia.

The researchers compared the incidence of COVID-19 in these patients between March 1 and May 3, 2020, with the incidence in Barcelona as a whole over the same period, during the first wave of infections in Spain.

The age-adjusted incidence rate for COVID-19 was 3.7% in the general population of Barcelona, compared with 4.7% for this group of patients. However, when the researchers focused on the subset of 914 patients with osteoporosis, they found a lower rate of infection: around 3%.

The data appeared to show that some drugs increased COVID-19 risk, some decreased it, and others had no effect. However, this was an observational study, rather than a clinical trial, and the group sizes were too small to draw any definitive conclusions.

The researchers report their findings in the journal Aging.

Statistical models

The physicians and scientists used a statistical modeling technique called Poisson regression to estimate the relative risk of COVID-19 associated with particular treatments.

After adjusting for factors already known to affect the risk, including age, sex, and health conditions such as diabetes and cardiovascular disease, their models suggested that most of the treatments had no influence on the incidence of infection.

These included drugs that directly target osteoporosis, such as oral bisphosphonates or vitamin D, as well as nonsteroidal anti-inflammatory drugs that target chronic pain caused either by fractures from weakened bones or coexisting musculoskeletal conditions.

Antihypertensive drugs, used to treat the common comorbidity of high blood pressure, also showed no influence on COVID-19 infection rates.

According to the models, three osteoporosis treatments were potentially associated with a reduced risk of COVID-19.

Denosumab, a monoclonal antibody treatment, was associated with a 42% reduced risk. There was a considerable degree of uncertainty about this value — it could range from a 72% reduced risk to a 22% increased risk.

Intravenous zoledronate was associated with a 38% reduced risk, with a range of 73% reduction to 41% increase. Meanwhile, calcium showed a 36% reduced risk, with a range of 63% reduction to 12% increase.

“The study suggests that some of these treatments may protect patients against infection by [SARS-CoV-2, the virus that causes] COVID-19, although further studies still need to be conducted on more patients to prove it,” says the study’s first author, Dr. Josep Blanch-Rubió.

Both denosumab and zoledronate are known to modify the immune system, and they do so in different ways.

Denosumab decreases the activity of immune signalling molecules called cytokines, which are involved in the excessive immune reaction that characterizes severe COVID-19.

The authors speculate that zoledronate, meanwhile, may protect the lungs from the infection by stimulating T cells and natural killer cells.

Musculoskeletal conditions such as osteoarthritis and fibromyalgia can cause chronic pain, and fractures resulting from osteoporosis can also be painful. Some pain medications commonly prescribed to people with these health issues appeared to increase the risk of COVID-19.

This was particularly true for pregabalin, which was associated with a 55% increased risk of COVID-19, with a range of estimates of 14% reduced pain to 280% increased pain.

People with these conditions also frequently experience mood disorders, such as depression. Most of the antidepressants in the analysis were associated with an increased risk, apart from duloxetine, which was associated with a 32% reduced risk, with a range of 66% decrease to 34% increase.

Dr. Alba Gurt, a study author and primary care physician at the Pere Virgili Hospital Center, in Barcelona, concludes:

“The data from the study would indicate that the [osteoporosis] treatments and duloxetine administered to our primary care patients are safe against infection by [the virus that causes] COVID-19 and could even reduce its incidence. However, studies with a higher number of patients are required to verify this.”

Important limitations

The analysis had some important limitations that are common to all observational studies. The associations identified may result from hidden “confounders” — other influences on the risk of developing COVID-19 that the researchers did not take into account.

The statistical power of the study was limited due to the relatively small numbers of patients with osteoporosis taking each medication and the possibility of complex drug interactions.

Also, the estimates of relative risk have wide confidence intervals — a term that describes the level of certainty about the risk. As a result, it is possible that denosumab, zoledronate, and calcium could all increase the risk of COVID-19, though the estimates veered more toward the drugs having a protective effect.

Overall, the actual risks or benefits of these osteoporosis treatments with regard to COVID-19 may be very different from what the team has found.

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A preclinical study has tested a new vaccine for Alzheimer’s disease. The researchers found that the vaccine, which targets the beta-amyloid protein, was safe and effective in mice.

Alzheimer’s disease is a progressive neurological condition and the most common cause of dementia.

According to the latest estimates from the Alzheimer’s Association, 1 in 10 people over the age of 65 years in the U.S. have Alzheimer’s disease, and experts expect the number of people with the condition to increase as the population ages. By 2050, projections show that 13.8 million people aged 65 years and over will have Alzheimer’s disease in the U.S.

While groups around the world are working to find an effective treatment for the condition, an alternative approach is to develop a vaccine. Although they are more commonly associated with infectious diseases, vaccines can also prime the body to defend itself against other, noninfectious molecules.

In Alzheimer’s disease, scientists believe that two processes drive the progression of the disease: the buildup of plaques comprising beta-amyloid proteins between neurons in the brain and tangled knots of the tau protein within neurons.

Since the general understanding is that beta-amyloid initiates the disease process, scientists have tried to develop a vaccine against it. The hope is that the immune system recognizes and destroys the beta-amyloid before it can aggravate the cell damage that the tau protein causes.

Although scientists have developed several vaccines, translating the findings from murine models into humans while ensuring safety is notoriously challenging, and the authorities have not yet approved any vaccines for use.

Researchers need to overcome the fact that as people age, their immune system becomes less responsive. As a result, without help, they will have a lower response to a vaccine.

Scientists usually overcome this problem by adding adjuvants that kickstart and enhance the immune response. However, a potential problem is that the adjuvants overstimulate the immune system, leading to inflammation.

A new study that the University of South Florida Health (USF Health) led describes a novel therapeutic vaccine for Alzheimer’s disease, which uses the body’s own immune cells to target beta-amyloid. The study found that this approach avoided the overstimulation of the immune system that can occur due to chemical adjuvants.

The study showed effective antibody production and memory improvements in vaccinated mice, and the findings appear in the Journal of Alzheimer’s Disease.

Harnessing dendritic cells

The new vaccine uses dendritic cells, which communicate with other immune cells, such as B cells and T cells, to guide the immune response.

“This therapeutic vaccine uses the body’s own immune cells to target the toxic [beta-amyloid] molecules that accumulate harmfully in the brain,” explains the senior author of the paper, Dr. Chuanhai Cao.

The dendritic cells are loaded with a modified version of beta-amyloid so that the body can detect and destroy the real thing.

“Because we use dendritic cells to generate antibodies, this vaccine can coordinate both innate and acquired immunity to potentially overcome age-related impairments of the immune system,” adds Dr. Cao.

In the new study, the researchers tested the vaccine in mouse models of Alzheimer’s disease. The mice were genetically modified to produce high levels of beta-amyloid and show cognitive difficulties similar to those that occur in humans with Alzheimer’s disease.

Memory improvements

The team gave some of the mice the vaccine, while others received the dendritic cells only (containing no beta-amyloid).

The mice that received the vaccine produced antibodies against beta-amyloid in their brains and blood. They also showed symptom improvements — for example, in memory tests, the vaccinated mice performed similarly to healthy mice.

The vaccinated mice also showed significantly improved working memory compared with mice that received only the dendritic cells. Working memory involves holding and manipulating information for a short time, and deficits in this form of memory are a common feature of Alzheimer’s disease.

Importantly, the vaccine did not cause an inflammatory response in the mice — a major concern when developing a vaccine and the main reason why researchers had to stop using a previous vaccine.

“Inflammation is a primary symptom of Alzheimer’s disease, so any possible treatment with neural inflammation as a side effect essentially pours gas on the fire,” explains Dr. Cao.

This study found no evidence of an inflammatory reaction. There were no significant differences in the amounts of inflammatory molecules called cytokines in the vaccinated mice compared with the nonvaccinated mice.

What next?

The strength of the new vaccine lies in its specificity, says Dr. Cao. The antigen on the vaccine stimulates a very specific response from T cells, which enables the destruction of beta-amyloid but prevents activity that could cause autoimmunity. “[…] it provides strong immunomodulatory effects without inducing an unwanted, vaccine-associated autoimmune reaction in the aging mice,” he says.

Going forward, the team hopes that the vaccine could serve to stop the progression of Alzheimer’s disease in humans, although further studies will be necessary to confirm that the vaccine can produce long lasting antibodies and is safe to use in people.

It is important to note that this study used a mouse model of Alzheimer’s disease. There is a sharp fall-off in translation from animal models to human treatments from many promising preclinical studies, ranging from 0% to 100% failure.

Also, there has been some debate about the effectiveness of targeting beta-amyloid rather than either focusing on the tau protein, launching a combined attack on both proteins, or dampening the inflammation that results in cellular damage.

Beyond Alzheimer’s disease, the researchers suggest that the vaccine type could help improve the immune system of people with other age-related disorders. The vaccine may “lay the foundation for future immunotherapies for aging-related disorders,” the authors conclude.

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A study suggests an intensive exercise program boosts cognitive performance and physical fitness in United States Air Force personnel. A nutritional supplement may also have some additional benefits.

While exercise is known to improve health and cognition, combining it with a nutritional supplement that mimics a Mediterranean diet may provide further advantages.

Scientists at the University of Illinois in Urbana-Champaign, Abbott Nutrition, and the U.S. Air Force Research Lab found that volunteers who consumed the supplement before and after training sessions had an edge in some measures of fitness and cognition 3 months later.

However, intensive exercise alone improved strength and endurance more than intensive training with the supplement.

On two cognitive performance measures, both the placebo group and the supplement group showed a slight reduction in performance, while other measures improved.

“The physical and mental health benefits of exercise are well known, but this study demonstrates how optimal nutrition can help boost brain function as well,” says study leader Chris Zwilling, a postdoctoral researcher at the University of Illinois.

“We are excited by the results because they provide critical insights into how simple dietary changes can make a big difference in helping people be as efficient and productive as possible in today’s world,” he adds.

The research appears in the journal Scientific Reports.

Strength and fitness training

The scientists recruited 148 active-duty male and female Air Force personnel from Wright Patterson Air Force Base in Dayton, OH, and randomly assigned them to two groups.

Both groups underwent a 12-week exercise program involving five daily sessions of 45 minutes, including rotating sessions of high-intensity interval training, aerobic fitness, and strength training each week.

One group drank the specially formulated nutritional supplement 30 minutes before and 1 hour after each session, while the second group consumed a placebo drink that looked and tasted the same. The supplement contained 267 calories of energy, while the placebo contained 100 calories.

Neither the researchers nor the participants knew who drank the special supplement and who drank the placebo.

The high-protein supplement contained a wide range of nutrients, including:

  • lutein, a carotenoid vitamin related to beta-carotene and vitamin A found in kale, spinach, avocados, and eggs
  • omega-3 fatty acids, found in oily fish such as mackerel and sardines
  • phospholipids, an essential component of cell membranes
  • beta-hydroxy beta-methylbutyrate, a supplement that helps increase muscle mass and aids recovery after exercise
  • folic acid
  • B vitamins
  • vitamin D

Participants took a series of cognitive and physical fitness tests before and after the exercise program. The cognitive tests assessed their memory, fluid intelligence — the ability to solve novel reasoning problems, executive function, and reaction time.

The exercise-only group had positive improvements in 5 out of 6 physical fitness measures and 4 out of 8 cognitive functioning measures. The research team recorded cognitive functioning increases in:

  • short-term memory
  • episodic memory
  • executive function reaction time
  • fluid intelligence and processing efficiency

The group who also took the supplement had improvements in all six fitness measures and 6 out of 8 cognitive measures. Compared with exercise alone, taking the supplement was associated with significant additional enhancements:

  • working memory increased
  • fluid intelligence reaction time decreased
  • lean muscle mass increased
  • resting heart rate, a measure of physical fitness, decreased

However, some of the figures in the study abstract were inaccurate. The authors have provided updated figures to Medical News Today and the journal.

Furthermore, the figures in the abstract were determined using raw data, which the paper did not provide. There were also some errors in rounding. Therefore, MNT is cautious about the study’s findings while the authors and the journal update the figures.

Working memory

Matt Kuchan, a research fellow and brain health scientist at Abbott and a co-author of the study, was impressed by the improvement in working memory among participants who took the supplement.

Working memory is a finite, temporary information store that predicts an individual’s ability to multitask and is often impaired in stressful situations. For example, it allows a person to remember a telephone number long enough to dial it or write it down.

“This is a really big deal,” says Kuchan. “First, because working memory is hard to improve. And secondly, because it is relevant to everybody.”

Strangely, two measures of cognitive function were slightly worse after the intervention for both the supplement and the placebo group: short-term memory and executive function accuracy.

It could be that these small performance decreases were due to test anxiety or chance.

The investigators say they did not design the study to determine which nutrients improved physical and cognitive performance. They also remain unsure if the enhanced cognition was due to the supplement, improvements in physical fitness, or a combination of both.

The study also took just 3 months, and therefore, it is not certain that real-life health programs could maintain these enhancements.

The research team discovered a link between the supplements and improvements that could not be explained by exercise in only 5 out of the 23 analyzed measures of cognitive health.

In addition, they made no adjustments in the statistical analysis to assess many variables in a single and relatively small study.

They also believe there may have been further benefits by using whole foods to deliver the nutrients, rather than supplements.

However, this would have presented several challenges in designing the study, for example, how to deliver exact quantities of several different nutrients.

The study provides evidence that intensive cardiovascular and resistance training offer rapid improvement in fitness, and in line with previous research, is associated with improvements in some measures of cognition.

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