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COVID-19 and The Road Ahead

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.

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Healthier Eating

How to Pare Down Protein & Cut Back Carbs

Inspired by a belief that our diets can be redefined to integrate both healthier eatting 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
“Carbohydrate Flip.”

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.

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Pandemic Inspires and Challenges Medical Innovation

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.

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New Lung Cancer Screening Recommendations

Spotlighting Both Challenges and Progress

This winter the U.S. Preventive Services Task Force (USPSTF) released its new Lung Cancer screening recommendations, lowering both the starting age and pack-year criteria. Previously, low-dose computed tomography screening was advised for adults age 55 to 80 years with a 30 pack-year history of smoking who are current smokers or have quit within the past 15 years; now the USPSTF recommends extending the screening to adults starting at age 50 who have a 20 pack-year smoking history.

For most, the announcement may have gone under the radar due to the intense focus on the COVID-19 vaccine rollout in early 2021. But as the first change in lung cancer screening eligibility criteria since 2013, its significance was quickly recognized and is still being broadly debated across the medical community.

Notably, previous recommendations missed female patients who tended to be lighter smokers than men, and despite Black smokers’ higher risk of developing lung cancer, included only 17% of Black people who smoke compared to 31% of White smokers. The question is, by doubling the number of people eligible for screening, do the guidelines indicate a significant shift that will improve gender and racial disparities in testing and outcomes, or are they simply a small, overdue step in the right direction?

“It’s excellent news because expanded screening eligibility can reduce lung cancer mortality and may reduce all-cause mortality,” acknowledges Ella Kazerooni, MD, professor of radiology and internal medicine at the University of Michigan Medical School, who’s devoted much of her career to creating lung cancer survivors through her work as chair of the National Lung Cancer Roundtable.

The downside: “This may also cause false-positive results, leading to unnecessary tests and invasive procedures, because we’re still not incorporating other known risk factors. These encompass more than just smoking, but include air pollution, exposure to radon and other carcinogens, family history and social determinants of health,” says Dr. Kazerooni.

In March 2021, the American Academy of Family Physicians (AAFP) weighed in with support for the measure while also noting the need for additional research to determine potential harms from annual screening.

“More studies are needed to achieve our goal of increasing survivorship and lowering mortality without enhancing risk along the way,” agrees Dr. Kazerooni. “Compared to cardiac disease, research for lung cancer screening and risk assessment is relatively new and evolving. Tools, like an individualized lung cancer risk calculator, will take time to develop because of the complexity of the disease.”

Lung cancer survivor Jill Feldman views the new recommendations with the same unflinching honesty that’s fueled her remarkable 20-year crusade for others with the disease. She is the former president of LUNGevity and a founding member of the EGFR Resisters, both leading nonprofit patient support and advocacy organizations.

“We took too long to get here,” she says, “and it’s still not being viewed with a nearly wide enough lens. By focusing solely on age and smoking habits, we’re not considering the critical intersection of environmental factors and personal and family history that impact an individual’s risk of lung cancer.”
Having lost two grandparents, an aunt and both her parents to lung cancer before being diagnosed in 2009 with non-small cell lung cancer at age 39, Jill is painfully aware of the barriers that still surround screening and treatment.

“Despite its prevalence, lung cancer carries a real stigma,” says Jill. “The unintended consequence of successfully educating the public about the heightened risk of lung cancer among people who smoke, is that it’s considered preventable, making people reluctant to seek screening, and if diagnosed, ashamed to admit they have it.”

“It’s a significant problem that impacts people along the entire cancer care continuum,” says Dr. Kazerooni. “And it affects funding and research dollars as well. Although lung cancer is the leading cause of cancer death in the U.S., only 6% of federal dollars dedicated to cancer research are allocated to lung cancer.”

The stigma issue is particularly harmful for the rising numbers of younger women in their 20s to 40s with no smoking history who are diagnosed with lung cancer. “When someone is forced to
emphasize that they never smoked, the message being sent to the 85% of patients with lung cancer who have a smoking history is ‘you are the ones who deserve this.’ No one deserves lung cancer,” says Jill.

Epidemiology studies centered on nonsmokers with lung cancer have begun, but actionable findings may not be reported for at least another decade or two, according to Dr. Kazerooni. The GO2 Foundation for Lung Cancer is currently studying genomic, environmental and behavioral risk factors to identify the common link among nonsmokers in order to run trials.

“We know the disease seems to be increasing among nonsmokers, especially younger women, but we don’t know enough to effectively screen for it now,” says Dr. Kazerooni.

While screening challenges remain, advances in treatment show incredible promise, especially targeted biomarker therapy, which is allowing Jill to treat her incurable lung cancer as a chronic condition.

“I never used to use the word ‘hope’ in the same sentence with lung cancer. But there is real hope now,” she says.

The following are traditional signs of non-small cell and small cell lung cancer, which can also be present as a result of many other conditions. Keep in mind, however, that the hope of expanded lung cancer screening is to find the disease before these symptoms appear.

A cough that gets worse or does not go away
Coughing up blood
Breathing trouble, such as shortness of breath
New wheezing when you breathe
Ache or pain in your chest, upper back or shoulder that doesn’t go away and may get worse with deep breathing
Hoarseness
Frequent respiratory tract infections, such as pneumonia or bronchitis
Feeling unusually tired all the time
Weight loss with no known cause
Trouble swallowing
Swelling in the face and/or veins in the neck

Source: LUNGevity Foundation

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A Quick Guide to Seasonal Allergies

Pollen, Grass, Ragweed and Mold spores

For more than 24 million Americans, the flowering trees and mild weather of spring and summer, signals another allergy season in full bloom. The cause: substances such as pollen, grass, ragweed and mold spores enter the body and are mistakenly identified as a threat by the immune system, triggering a variety of symptoms. We hope you find some comfort in this quick guide to seasonal allergies.

Reduce the effects of seasonal allergies

Pollen and spores can be carried into the home on your clothes or enter through windows during allergy season.
Know which pollens you are sensitive to and then check pollen counts. Weather reports often include this information during allergy seasons. In spring and summer, during tree and grass pollen season, levels are highest in the evening. In late summer and early fall, during ragweed pollen season, levels are highest in the morning. For an interactive map to view allergy levels and pollen count forecasts, visit pollen.com.
If your allergy symptoms are very bothersome:
- Take a shower, wash your hair and change your clothes after you’ve been working or playing outdoors, and keep windows and doors shut at home and in your car.
- Wear sunglasses and a hat outside to keep pollen out of eyes and hair. Your COVID-19 mask could provide a protective barrier against pollen.
- Indoors, get an air purifier with a HEPA filter, and vacuum regularly.

Treatment

Seasonal allergies are often treated with over-the-counter or prescription antihistamines (non-drowsy types are available), nasal steroid sprays, decongestants and immunotherapy (allergy shots that expose you over time to gradual increments of the allergen), as well as alternative methods. Please check with your healthcare provider to discuss what’s right for you.

Symptom Checker: Is It Allergies, a Cold or COVID-19?

	Allergies	Colds	Covid-19
Duration of symptoms	Allergy season	4-10 days	Varies
Mucus	Thin, watery and clear	Thick and yellow/green	—
New loss of taste or smell	Uncommon	Uncommon	Often (early)
Itchy or watery eyes	Usually	Rarely	Rarely
Sneezing	Usually	Sometimes	Rarely
Cough	Frequent	Usually	Usually
Shortness of breath	Sometimes allergens can exacerbate a respiratory condition	Sometimes	Usually
Sore throat	Frequent	Usually	Usually
Fever	Never	Sometimes	Usually
Diarrhea	Never	Uncommon	Sometimes
Contagious	Never	Yes	Yes
Body aches	Never	Sometimes	Usually
Fatigue	Sometimes	Sometimes	Usually

Not Your Imagination: Pollen Season May Be Getting Worse

According to the American College of Allergy, Asthma and Immunology (ACAAI), climate change has made pollen season longer and more severe throughout North America. A recent study showed that pollen seasons for plants like trees, grasses, and weeds showed a 20-day increase in length and a 21% increase in pollen concentration from 1990 to 2018. Notably the researchers also found that the pollen produced is more allergenic – more likely to trigger an allergic reaction with fewer grains of pollen in the air.
Sources: Mayo Clinic, ACAAI

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The Art of Cooking Without Sugar

A Chef’s Tasteful Look at Taking Sugar Off the Table

In part two of our series with professional chef Stan Hodes, he shares some artful substitutes, both natural and man-made, to sweeten up recipes without dipping into the sugar bowl.

“It’s almost impossible to eliminate sugar completely because it appears, sometimes stealthily, in just about all foods,” says Chef Stan, “but there are many alternatives available that won’t substantially raise your blood sugar level and leave you craving even more sweetness.”

Cutting back can produce a number of important benefits, as evidence links added sugar to poor oral health, obesity, diabetes, heart disease and cancer.

“Keep your primary goal in mind – reduced insulin levels, decreased caloric intake, weight loss or disease prevention – when considering substitutions and tailor accordingly,” he urges.

When Cooking, Chef Stan Recommends:

- Minimize use of salt and you’ll bring out the natural sugars in your ingredients by at least half.
- Focus on lower-sugar ingredients that coax out sweetness: dark chocolate, coconut or coconut oil, prunes and berries. Carrots and dates are terrific for sweetening stews.
- Try robust spices that enhance sweetness: cinnamon (whole or powdered), fennel, star anise, licorice root, vanilla.
- Make dehydrated fruit: Thinly slice fruit, cook in a convection oven at 160º to 180º for 2 to 4 hours, depending on the firmness and chewiness you prefer. Dehydrated fruit contains more calories than fresh fruit (because the sugar content becomes concentrated) so cut portion size in half.

Choose your Fruits Carefully

Some naturally contain substantially more fruit sugar, or fructose, making it best to limit: mangos (the highest), grapes, cherries, pears, pineapple, watermelon, dried figs, dates and bananas. Lower-sugar choices include: blackberries, cranberries, strawberries, grapefruit, starfruit, rhubarb, casaba melon, cantaloupe, papaya and guava.

Natural Sweeteners

Most natural sweeteners contain more nutrients and antioxidants than refined sugar, but beware, a calorie is still a calorie, and these contain approximately the same amount as sugar. Look for:

Date sugar, a powder made by pulverizing dried dates, is high in potassium.
Maple syrup, in its pure form, is one of the most natural forms of sugar, processed simply by boiling the sap of maple trees.
Honey, one of the oldest replacements for sugar around the world, made by bees from flower nectar and then mechanically filtered and strained. The complex range of flavors is ideal for baked goods and easily incorporated into desserts requiring a smooth texture such as custards and puddings.
Blackstrap molasses, made by boiling down sugar cane or sugar beet juice for a syrup-like consistency, is high in iron, potassium and calcium.
Organic coconut sugar, naturally processed from coconut palm sap, offers a rich brown sugar-like flavor, nutrients such as zinc and iron, and some inulin (fiber), but has a high fructose content.

Sugar Substitutes Offer Reduced or No-calorie Alternatives to Table Sugar:

Monk fruit, extracted from the Asian luo hang guo fruit, has been used for centuries in Chinese medicine. It contains no carbohydrates or calories, drawing its sweetness (up to 200 times sweeter than table sugar) from antioxidants called mogrosides.
Sugar alcohols such as xylitol and erythritol, processed from plant fibers like birch and cornhusks, have a sweetness similar to sugar. Most of it is not broken down by enzymes in the body, but excreted in urine. In large doses, these sweeteners can cause digestive issues such as gas and diarrhea in some people.
Stevia, made from the leaves of a South American shrub, has been considered by some as the most natural sugar substitute, but it is highly refined and often blended with additives.

Avoid completely:

Agave Syrup contains 75-90% fructose, which rapidly raises blood sugar levels.
High Fructose Corn Syrup contributes to diabetes, inflammation, high triglycerides and non-alcoholic fatty liver disease. It’s not typically used as an individual ingredient at home, but is commonly found in store-bought sauces, salad dressings and other condiments – check the labels before you buy.

Stan Hodes served as Executive Chef and Manager of Dining Services Operations at Baptist Hospital of Miami for 27 years, and worked as chef for the Marriott Hotels, Cancun’s Casa Magna Resort, and Royal Caribbean and Norwegian cruise lines. He was recognized by HealthLeaders Magazine as one of the top 20 Most Innovative Foodservice Executives in America.

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J&J Vaccine Update: CDC and FDA Recommend Use of J&J’s Janssen COVID-19 Vaccine Resume

On April 23rd, the pause on using J&J’s COVID-19 vaccine in the U.S. was lifted. Visit the CDC website to see the CDC/FDA official statement. For more information, download a copy of the CDC recommendations.

Please continue to check the CDC website for the latest vaccine information.

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4.13.21 J&J Vaccine Update

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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COVID-19 Vaccine Update

Experts Weigh In With Reassuring Outlook

The COVID-19 vaccine rollout is in full swing around the country but many questions remain. We reveal the latest answers (as of February 2021) from nationally recognized vaccine experts Dr. Paul Sax, Professor of Medicine, Harvard Medical School and Clinical Director of Infectious Disease, Brigham and Women’s Hospital; and Michael Kinch, PhD, Director of Washington University’s Center for Drug Discovery.

How will the new variants impact the effectiveness of the vaccines?

Sax: Data is emerging daily. The UK variant has a higher level of contagiousness but is mediated just as well with the vaccine; other variants’ stories are still unfolding. Vaccine manufacturers are retooling the antigens to make them effective against a broader group of viruses. Boosters may be provided in the future.

Kinch: The variants show us that the coronavirus is very efficient at mutation, and we’ll likely need to adapt our vaccines every two to five years to provide the right protection.

Is it safe to get vaccinated at large outdoor stadiums?

Sax: Yes, absolutely. People are not being crowded into poorly ventilated indoor spaces at these events.

Which vaccine is best?

Sax: The one that’s offered to you! Don’t wait for a specific vaccine because in the interim, you’re at higher risk for getting a more severe case of COVID-19. Pfizer and Moderna, both mRNA vaccines, are 95% effective after two doses. The J&J vaccine works differently, using a virus that doesn’t reproduce in humans and stimulating an immune response after just one dose. While J&J’s 70-80% rate may not be as high as the others, it’s very effective in preventing severe disease, so you can feel confident about getting it. We are also likely to have a fourth vaccine, Novavax, available soon.

Kinch: We may not have a definitive answer to this question until later this year. But these are incredible vaccine breakthroughs, with exceptionally high rates of effectiveness.

Is delaying the second dose problematic?

Sax: Getting it too early is actually more concerning. The first dose primes the immune system and the second dose gives it a huge boost. Waiting six weeks won’t matter.

Are side effects worse after the second dose?

Sax: Yes, there are more side effects reported but this indicates your body is responding to the vaccine. I experienced headache, fatigue and trouble concentrating immediately afterwards, and then felt totally fine the next day. That’s a trade-off I’d take anytime versus the potentially life-threatening consequences of COVID-19.

What if I don’t experience side effects?

Sax: No need for concern, as the vaccines were shown to be highly effective in trials with thousands of people, including a significant number over age 55. However, older, frailer people weren’t tested, and it’s possible they may not respond as well to the vaccine.

Can I take pain relievers before or after getting the vaccine?

Sax: Don’t take any beforehand as it can blunt the immune response; afterwards, it’s fine.

What is still unknown about COVID-19 and vaccines?

Sax: We don’t know the risk of immunized people transmitting COVID-19, but we’re seeing promising evidence from Israel that vaccinated individuals carry lower amounts of virus. This will significantly reduce but not completely eliminate transmission. Also unknown is whether natural or vaccine-induced immunity is better.

Kinch: The long-term durability of the vaccine’s immune protection isn’t known, but we’ll discover that over time. Preliminary data seems to indicate that recovery from minor cases of coronavirus provides three to nine months of protection.

Is it important to vaccinate younger people?

Sax: Elementary age kids only get mildly sick from COVID-19 and they’re not very contagious, but teenagers are at higher risk for severe disease and are more contagious. The most important group to vaccinate is people in their 20s, who’ve been primary spreaders of the virus.

Should immunosuppressed patients get the vaccine?

Kinch: Yes, and in fact, patients with autoimmune conditions will be prioritized as a higher-risk group. One of the most promising and least discussed aspects of the Moderna and Pfizer trials is that while many patients became infected with the virus, not one was hospitalized, needed intubation or died. This is particularly significant for immunosuppressed patients, because if infection can’t be prevented altogether, the vaccine will lessen disease severity and result in much better outcomes.

Should pregnant women get the vaccine?

Sax: Pregnancy is a severe risk factor for COVID. While theoretically the vaccine is safe, we don’t have all the data yet. I’d recommend it, but also understand if a woman chooses to wait.

What needs to happen to resume normal life?

Sax: We have to be laser focused on mobilizing vaccinations nationally and not expect the states to just figure it out. I feel optimistic that enough vaccine will be available by summer, possibly even by late spring, for everyone to be immunized.

(sidebar)After vaccination, is it safe* to…

Visit family and friends? Wearing masks and social distancing is still necessary in large, public settings, but we can relax a bit in small group settings. Although the risk of interacting without masks is not zero, it is low, so go ahead and hug your grandchildren! And if you’re dining indoors with family, simply open the windows for good ventilation.
Exercise? Yes, and no need to wear a mask if outdoors and you’re a decent distance away from people. At indoor gyms, wear a mask, keep your distance and avoid areas that are not well-ventilated.
Eat at restaurants? Yes, if outdoors; no if indoors.
Travel by air? Yes, with precautions. Surprisingly few transmission events haveoccurred aboard planes; however, the boarding process and airport experience are not well controlled, so stay masked and distanced.

Additional post-vaccination guidelines are available from the CDC.*Dr. Paul Sax, Guest Speaker, Lown Cardiology Group Health & Wellness Webinar (2.16.2021)

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A Guide to the Power Players in Pain Relief

Which Pain Relievers Work Best?

When you reach for a pain reliever, what are you most likely to find in your medicine cabinet? And does it matter? While aspirin, Tylenol and Aleve may appear similar and aim for the same results, their effects can vary. Below is a quick guide to today’s most recognizable over-the-counter (OTC) pain relief products.

The effectiveness of nonsteroidal anti-inflammatory drugs (NSAIDs) in alleviating pain and reducing inflammation is well documented. They work by blocking the effects of specific enzymes to decrease the number of prostaglandins made in the body, which cause tissue to swell and increase the pain you experience. While widely used, it’s important to be aware of the limitations of these medications, most notably that all NSAIDs except aspirin carry an FDA warning for increased risk of heart attack, stroke or high blood pressure when used at high doses for long periods of time. They can also cause stomach upset, heartburn, and ulcers which may bleed; because they are blood thinners, should not be taken with medications such as Coumadin. Additionally, NSAIDs provide rapid pain relief for most, but may require a two-to-three week regimen to realize anti-inflammatory effects.

NSAIDs include:

Acetylsalicylic acid/aspirin (Bayer, Bufferin)
Aspirin, the first OTC pain reliever to be mass produced in the early 1900s, is still the most commonly used for headaches, minor aches and pains and inflammation. Unlike other NSAIDs, it is not associated with a higher risk of heart attack.

Ibuprofen (Advil, Motrin)
Ibuprofen is commonly used to treat pain and bring down fever, and alleviates symptoms of migraine, menstrual cramps, toothache, and inflammation with better results than aspirin. Some studies point to a lower risk of ibuprofen causing ulcers and gastrointestinal bleeding than other NSAIDs.

Naproxen sodium (Aleve, Midol)
This NSAID is most effective for alleviating backaches, arthritis, sprains and other types of inflammatory-based pain. In comparable doses, naproxen has a longer-lasting effect than other pain relievers, lasting 8 to 12 hours versus 4 to 8.

The non-NSAID solution:

Acetaminophen (Tylenol, Anacin)
Tylenol, the most well-known brand of acetaminophen, is used to treat pain and reduce fever and is safe for both heart and gut. However, this non-NSAID can’t be used to relieve inflammation-related conditions. Also different from NSAIDs, acetaminophen is broken down and removed by the liver, and taking too much in a 24-hour period can cause liver damage. Be sure to read product labels carefully because acetaminophen, ibuprofen and aspirin are often combined in products to treat cough, flu or sinus infection.

Which pain reliever should you take? There are no easy answers because individual responses to the same type and dose of medication can be considerably different. It’s sometimes necessary to try one drug and then another to determine optimal treatment; or consider prescription medications. Please call our office to discuss your best options.

New Perspectives on Aspirin

The long-accepted use of a daily low-dose aspirin to treat or prevent heart attacks or strokes was re-examined in light of recent studies showing the therapy’s heightened risk of gastrointestinal bleeding or hemorrhagic stroke outweighed its benefits for people who are healthy with no history of cardiovascular disease. Some experts now recommend daily aspirin therapy only for those who’ve already had a heart attack or stroke, a coronary artery stent or coronary bypass surgery, or are at a higher risk for coronary artery disease.

Always using pain relievers to bring down a fever has been challenged, somewhat controversially, by researchers including Dr. Paul Offit, vaccinologist at the University of Philadelphia and author of Overkill: When Modern Medicine Goes Too Far. “Fever is a symptom that occurs for a reason,” he says. “The immune system actually works better at a high temperature, so treating a fever with aspirin can prolong or worsen illness.”

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