From Boosters & Breakthroughs to Vaccines & Variants: Where Do We Go From Here?
The following reflects an 8/24/2021 discussion; please check the CDC website for real-time updates as the situation continues to evolve.
Their answers may not land lightly, but epidemiologist Jodie Guest, PhD, and drug development expert Michael Kinch, PhD, have been immersed in examining COVID-19 since its first stirrings in early 2020. They share an informed look at the road ahead for us all.
State of Concern
Noting more than 39 million COVID-19 cases nationwide, (as of 9/2/21) Guest projects this will continue to rise rapidly and eclipse one million a week. While “hot spots” for outbreaks clearly correspond to the country’s most lightly vaccinated locales, the impact of the delta variant is being felt in virtually every state. “There’s almost nowhere you can go in the U.S. that you don’t need to be masked indoors, even if vaccinated,” she says. The progressive increase in vaccinated patients with COVID-19 in European hospitals is also troubling, says Kinch, a potential harbinger of what is to come for the U.S.
However, what’s driving the surge is not cases among the vaccinated, known as “breakthroughs.” It’s a term Guest would like to eliminate permanently, given its negative connotation regarding vaccine efficacy. “These type of infections are still rare. More than 90% of those hospitalized with COVID-19 are unvaccinated.” She points out that while viral loads in patients with COVID-19 are the same for vaccinated and unvaccinated patients in the first few days of illness, they drop much faster and further in the vaccinated.
The vaccine, contends Kinch, was never intended to eliminate all possibility of getting COVID-19. “It’s not a suit of armor,” he says, “because no vaccine ever provides 100% protection. But we know they work incredibly well to prevent you from getting very sick or dying.”
The FDA’s recent approval of the Pfizer mRNA vaccine, with Moderna approval expected to follow soon, is pivotal, says Guest, in helping launch vaccination requirements at businesses, schools and other locations. “Don’t underestimate the importance of this approval in providing support for mandates that will protect all of us,” she says. “Recognize that in the entire history of vaccines, there has never been a set more studied than the ones we have now.”
Adds Kinch, “With the enormous amount of data gathered on the vaccines’ efficacy and safety, those who think of themselves as vaccine hesitant may more accurately be described as vaccine resistant.”
Third Doses and Boosters
The recent approval of a third dose of Pfizer or Moderna for immunosuppressed patients who didn’t build sufficient immunity from the first two doses applies to just 3% of the adult population. For everyone else (with the exception of pregnant women), a booster shot six to eight months after the initial series is being considered for approval.
“Right now, that’s how long we believe we can go without significantly diminished immunity,” says Guest. Antibody tests are not proven to be an accurate measure of protection from COVID-19, says Kinch, because the antibody levels vary by individual.
If you received Pfizer or Moderna initially, choose the same for a booster. Notes Kinch: “There’s no difference between these two vaccines—one is not better than the other.” In fact, some studies show no impact on efficacy from switching brands, he says; Johnson & Johnson data is yet to come.
And where does the flu shot fit in this fall? Absolutely essential, both agree, with the only caution that a two-week separation between the two vaccines may be recommended by some healthcare providers to avoid triggering a hyperactive immune response.
Protecting our Children
The best way to keep youngsters under 12 safe is ensuring that everyone around them is vaccinated, says Guest.
“Teachers, caregivers, babysitters and others should be vaccinated, or fully masked whenever they’re with children,” she advises. A different dose is being tested for 5- to 12-year-olds, with approval possible later this year.
The Next Wave of Variants?
While not identified by the Centers for Disease Control (CDC) as a “high concern,” Kinch admits that the lambda variant worries him primarily because not enough is known about its ability to resist vaccines. “One view is that the COVID-19 spike protein can only mutate to a certain point, and if that’s true, lambda could be the end of the virus. The other view is that we don’t know if it stopped mutating,” he says.
“We’re not defenseless, though,” counters Guest, “because we can keep it from getting here by having COVID-19 not circulating in communities. Greater numbers of vaccinated people will prevent us from getting whatever variant might follow delta.”
Stay Safe and Well
One of last year’s most popular signoff lines takes on new resonance as our experts advise on what that now means for the vaccinated in fall 2021.
Mask Up, Indoors and Out.
Masks are increasingly needed outside in crowded areas. Indoors, remember that while a soft, comfortable cloth mask protects others from you, if you need extra protection in certain settings, use a KN95 or N95 mask.
Pass on Indoor Dining, Movies, Concerts and Sporting Events.
Also reconsider full-capacity outdoor events with no masking/distancing/vaccine requirements. (As an alternative, order take-out and support virtual events offered by local venues). And avoid getting together in person with those who are not vaccinated.
Reach out to Every Unvaccinated Person you Know.
“The best action we can take is to keep encouraging every unvaccinated person we know to get the shot, now,” advises Guest. “We’re all in the race against variants and need to work together to defeat them as quickly as possible.” Adds Kinch, “It’s unfortunate that the motivations behind much of the messaging has messed up the message itself. Be completely honest about what is known and not known about the vaccine.”
The Swiss Cheese Respiratory Pandemic Defense.
“Layering prevention messages is crucial because the delta variant has made the holes in the Swiss cheese slice of the vaccine just a bit bigger,” says Guest. “Now masks are more crucial than ever before.”
Dr. Jodie Guest is professor and vice chair of the Department of Epidemiology, Emory University, Atlanta, and award-winning leader of Emory’s Outbreak Response Team for COVID-19.
Dr. Michael Kinch is associate vice chancellor and founder/director of the Center for Research Innovation in Biotechnology and the Center for Drug Discovery at Washington University, St. Louis.
Pandemic Sparks Promising Future for Clinical Trial Speed and Flexibility
Like wartime medicine, the pandemic inspires and challenges medical innovation.
The silver lining of the pandemic is the reinvigorated sense of urgency breaking down
cumbersome and expensive barriers to the FDA’s phased approval process. While the research- lab-to-patient-arm trials for the highly successful COVID-19 vaccines famously moved the traditional pace to warp speed, other critical and life-altering medicines, devices and therapies also broke through during this period.
To be clear, the current surge of medical innovation through clinical trials in immunology, cardiology, multiple sclerosis, oncology and more, is not the result of a rush-to-market panic. All necessary and appropriate testing protocols to ensure quality are still being achieved, but at a more expedient pace in many cases. This is the good news.
“In times of crisis, we can accelerate the development and review process,” explains Andrew Badley, MD, infectious disease specialist, Mayo Clinic. “Throughout the pandemic, many of these steps were accelerated. No steps were skipped. It was just the amount of effort that went into the development and the review that was increased.”
Of course, there is also some not-so-good news about clinical trials today. During the pandemic, the number of new studies launched dropped by as much as 57 percent, according to Trials Journal, and the overall completion rate of clinical trials decreased between 13 and 23 percent globally. Shifting research priorities (11 percent of studies shifted to pandemic-related trials in 2020) and initial challenges in recruiting and following up with volunteer patients during the global lockdown contributed to this decrease. Often, a clinical trial is tethered to an academic medical center with participants centered in one geographical area, limiting volunteer pools and access.
However, the future speed and flexibility of clinical trial protocols is very promising, reflecting the long-term viability of alterations made to the fabric of patient care and research during the pandemic. Some of the new flexibility that is being assessed and considered for permanent use includes:
- Telemedicine. While telemedicine has been available for years, the lockdown most certainly fast-tracked adoption among researchers, regulators, physicians and patients. Clinical trial investigators can now use telemedicine for many patient check-ins, saving time and broadening the geography of volunteer pools. Dr. Ray Dorsey, a neurologist at the University of Rochester, noted in a recent article that his virtual clinical study of
genetic predisposition to Parkinson’s disease moved forward more quickly amid the pandemic, spurred by a rising number of online enrollments.
- Delivery. Like specialty pharmacies and physicians during lockdown, clinical trial investigators are now allowed to deliver trial medicine to volunteers.
- Remote Access. Volunteer participants are able to use online platforms for completing consent forms, and they can often visit their local physician for basic assessments. Some
trials also require less frequent check-ins, which can be important in recruiting volunteer patients. The growing number of smartphone-enabled applications that provide measurement of critical physiologic variables means patients don’t need to continually return to the hospital or clinic for tests during the trial. For instance, an entirely remote study testing vitamin D for treating COVID-19 and preventing transmission is being conducted by Brigham and Women’s Hospital; participants obtain their own blood samples with a finger prick, dot the blood drop onto filter paper supplied to them and mail it back.
The Clinical Trial Explainer
In the United States, the Food and Drug Administration (FDA) directs and approves all prescribed medicines, diets, diagnostics, devices and therapies. Clinical trials are the part of research that determines whether a medical intervention should be moved, or “translated,” from the lab to routine patient care. At each phase along the way, the team must answer different questions about safety, efficacy (whether the intervention works as intended) and whether there might be better options available. The current clinical trial journey to FDA approval, shown below, can take years, a mountain of paperwork and millions of dollars – there is room for improvement.
- Preclinical phase establishes the pharmacological profile and determines toxicity on at least two animal species.
- Phase I, a short study of 20 to 80 healthy people to determine safe treatment and dosing.
- Phase II, a larger-scale study of targeted patients to determine treatment effectiveness and identify side effects; can take months to years to complete.
- Phase III compares the trial intervention with existing therapies; requires several years of multiple data collection check-ins and comparisons. About 1 in 15 won’t make it past phase III.
- FDA Review and Approval
- Phase IV follows patients after therapy approval to ensure the intervention is working and prove the long-term benefits outweigh any risks or side effects.
How to Pare Down Protein & Cut Back Carbs
Inspired by a belief that our diets can be redefined to integrate both healthier eating and environmental responsibility, Menus of Change encourages a meaningful “flip” in the emphasis on animal proteins and highly processed carbohydrates to an emphasis on highly appealing alternatives.
Menus of Change, a collaboration of the Harvard T.H. Chan School of Public Health and the Culinary Institute of America (CIA), authors a creative approach to enjoying delicious, nutritional and sustainable foods: “The Protein Flip” and its companion, the
The Protein Flip, introduced in 2016, laid the groundwork for the Menus of Change health- oriented methodology, stating, “Higher intake of red meat, irrespective of its total fat content, increases risk of heart disease, stroke and diabetes when compared to poultry, fish, eggs, nuts, or legumes.”
The Menus of Change solution was to challenge chefs in every setting to place meat, poultry and seafood in a supporting role or as a side and make vegetables and plant proteins the stars – for example, burger blends composed of primarily mushrooms, other vegetables, grains or legumes; surf and turf reimagined as seafood with bountiful vegetables and only a bite or two of meat; use of tapas, mezze and other plant-forward small plate replacements for entrees. The public response was immensely gratifying, spurring further innovation and the mainstreaming of vegan options, such as lentil, barley and black bean burgers or wild rice polenta burgers made with mushrooms, carrots and leeks.
Building on their successful work with proteins, the collaborative is now developing a complementary program centered on advancing carbohydrate quality on the American plate. “From fluffy pancakes to soft hamburger buns, refined, fast-metabolizing carbohydrates are still found in many a diet and are contributing to the rise in diet-linked chronic conditions such as
diabetes and heart disease,” according to a recent Menus of Change summit panel discussion headed by Sarah Schutzberger, RD, CSO (certified in oncology nutrition). “In large part because of our food choices, scientists project that 75 percent of chronic diseases are attributable to diet and lifestyle.”
A substantial emphasis on whole, minimally processed carbohydrates can help change the trajectory, beginning with these flips described by the panel:
- Take on the Three Pleasures challenge: Create a delicious dessert using dark chocolate, nuts, and fresh-cut or dried fruit. “Instead of forcing a choice between a whole slice of cheesecake with a single strawberry as garnish or a plain bowl of berries, enjoy a dessert made from a healthy market basket that includes dark chocolate, fruit, whole grains, nuts and yogurt,” advised Greg Drescher, Culinary Institute of America.
- Look to world food cultures for inspiration:
- Mediterranean region: “This type of cooking features a healthy fat versus a low fat approach to diet, with olive oil as the foundation of flavor,” said Drescher. Try tabouli, made of cracked bulgur wheat, chopped parsley and olive oil, or a salad made with hydrated, whole-grain barley rusks, topped with chopped tomatoes and fresh feta cheese and tossed with olive oil. Also important: improve the health profile of pasta by using a whole-grain type and cooking al dente to make it a source of slower-releasing carbohydrates.
- France: The niçoise salad suggests ways to include potatoes in limited amounts by pairing with green beans and other vegetables, hard-boiled egg, and a light vinaigrette for a slow-metabolizing lunch.
- Asia and India: Try a salad featuring soba noodles made from buckwheat flour; a Buddha bowl with foundational ingredients that include legumes, fresh vegetables and plant proteins, paired with small amounts of salmon or roasted tofu; and whole-grain flatbreads.
On April 23rd, the pause on using J&J’s COVID-19 vaccine in the U.S. was lifted. Click here to see the CDC/FDA official statement. For more information, click here to view or download a PDF of the CDC recommendations.
Please continue to check the CDC website for the latest vaccine information.
The post J&J Vaccine Update: CDC and FDA Recommend Use of J&J’s Janssen COVID-19 Vaccine Resume appeared first on Specialdocs Consultants.
As news regarding the J&J vaccine has changed significantly since our COVID-19 Vaccine Update posted on 3.24.21, we offer the following link to today’s Joint CDC and FDA Statement on Johnson & Johnson COVID-19 Vaccine.
Please continue to check the CDC website for the latest vaccine information.
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What are your 2021 Anti-Resolutions?
Year after year, the pattern rarely varies. Resolutions made, promptly followed by resolutions broken. The odds of sticking to New Year’s resolutions are, in fact, completely stacked against us, as research shows a paltry success rate of between 10 and 20%. But since the challenges of 2020 have reconfigured every aspect of daily living, 2021 may be the ideal time to reset this ritual as well. Perhaps it’s time we consider this upcoming new year, the year of the anti-resolution for dieting, exercising, eating healthier and managing stress.
We’ve asked therapists steeped in mindful eating, body positivity and resilient thinking to help reframe this perennial wish list. There are no checklists to mark off or milestones to meet, just inspiration to view yourself and the world around you through a new lens.
Instead of Dieting in 2021… Consider being more mindful about what you eat.
Replace the resolve to lose weight on a diet with a shift to mindful eating. “Keep in mind that while all diets work in the short run, there’s not a single plan that has long-term results for the majority of participants, and that’s why people make the same resolution every year,” says Judith Matz, nationally recognized speaker, therapist and co-author of The Diet Survivor’s Handbook and Beyond a Shadow of a Diet. “The deprivation that comes from dieting often leads to overeating or bingeing, setting into motion an endless cycle of frustration.”
Instead, learn to eat when you’re hungry and stop when you’re full, and choose from a wide variety of foods, including healthful ones.
Matz describes the essence of the process. “First, learn to recognize when you are just beginning to feel hungry. If you have a headache, are crabby, irritable, fatigued and low on energy, you’ve waited too long and are much more likely to overeat as a result.”
Next, think about what food would make you feel satisfied. “Sometimes a fresh apple or a raw carrot is exactly what you want, and at other times you might want ice cream or a bowl of pasta. Depriving yourself of foods you love can be counterproductive – there’s room for all types of food,” she says.
For patients with specific medical issues, such as high cholesterol, Matz notes that adjustments can easily be made while still respecting the process: a craving for ice cream can be met with a sorbet instead.
Finally, trust your body to let you know when to stop eating. While that may sound simple, Matz counsels patience, especially for chronic dieters. “It can take time to tune in to your natural cues for both hunger and satiety.”
The key is to stop having rules around food and to really listen to your body. “Ultimately it’s about having a healthy relationship with food rather than focusing solely on eating so-called healthful foods,” she says.
Moving from body image to body appreciation.
An equally important shift is changing the desire for a new body size to a genuine appreciation of the body you have. Matz defines this as “body positivity, relating to your body with acceptance and respect rather than self-criticism and shame.” It means rejecting ingrained cultural messages related to body embarrassment and weight stigma and replacing them with ones that reflect inclusiveness and self-compassion. It encourages taking pleasure in natural body changes throughout your life cycle and not putting off anything you might enjoy doing because you’re not the “perfect” size or shape.
Body positivity also empowers you to view exercise positively rather than as punishment for having the wrong body. “Unhook exercise from weight, and focus on choosing exercise for endurance, strength, flexibility, stress reduction, health, social connection or just the simple pleasure of moving your body,” advises Matz.
Finally, refrain from focusing on weight loss praise, which reinforces the mistaken belief that you can’t be happy, healthy and successful unless you’re a certain body size, says Matz.
“Consider that body positivity is a gift we can give to support family, friends and, most notably, the next generation.”
Find joy in what you do and who you surround yourself with to reduce stress.
Resolving to manage stress effectively is an oft-expressed but infrequently realized New Year’s wish. But it can be triggered by one pivotal question, says influential family therapist Debbie Gross, who asks it at every session with a new client: “What brings you joy?”
She explains, “It’s transformational in terms of moving out of the survival mode many experienced last year, and into thriving mode. When people are in crisis, they become overwhelmed by the thought that no one will meet their needs. Their only goal is to focus on how to get through this moment; their attitude is ‘If I don’t take care of me, who will?’”
To stop the “anxiety spiral” in the brain, Gross recommends the “5, 4, 3” grounding exercise for staying in the present: “Focus on five things you can see, four things you can hear and three things you can feel, either physically or emotionally.”
And while it’s all too easy to devolve into perpetual doom and gloom against a backdrop of unceasing anxiety, Gross says we have a choice – Eeyore or Tigger?
“We can wake up each day just waiting for the next problem to come our way, or we can look at the world with more of a ‘beginner mind’ that recognizes small, everyday miracles,” she says. “It takes real work for some to switch the channel in their brain to that mindset, but the difference it makes is astounding.”
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