Making Sense of the New CDC Guidelines Here in Florida

There were almost 6,000 new cases of Coronavirus illness in Florida yesterday with the positivity rate of those tested being well above 5%. Fewer and fewer people are showing up for testing or to receive vaccine here in the Sunshine State.

The Center for Disease Control (CDC) has issued new less restrictive activity guidelines last week which suggest outdoor activities in low population densities do not require a mask. This makes great sense and I am in complete agreement. They go further and say small indoor gatherings with vaccinated individuals do not require a mask. This makes great scientific sense as well. What they do not want is thousands of individuals, whose vaccination or immunity status is unknown to be packed into a venue indoors or out without being masked. They additionally don’t recommend large private gatherings indoors of individuals whose immune status is unknown. This makes sense to me as well in Florida where the infectious positivity rate remains greater than 5%.

We know vaccinated individuals have a low probability of catching COVID if exposed. If they are unlucky enough to catch it (about 6,000 breakthrough cases are known in the USA with about 150 million already receiving vaccine) there is an even smaller chance of getting sick enough to require hospitalization or dying. They still are not sure if those infected can transmit it to those unvaccinated or those frail, immunosuppressed and vulnerable.

The Governor of Florida and his Attorney General have sued the CDC, NIH and Federal government demanding that they allow cruise ships to begin sailing again from Florida ports. My daughter and grandchildren depend on cruise industry revenue to pay their mortgage, feed and clothe the family and live. The cruise industry has gone to great expense to vaccinate its crews and restrict passenger access to those who can prove they have been vaccinated or prove they are not COVID Positive. They wanted a “vaccine passport” for passengers.

Florida responds by having its Surgeon General, pediatrician friend and political ally of the Governor with zero public health or infectious disease background declare if you are vaccinated you are not required to wear a mask anywhere anytime. The legislature, composed primarily of members of the Governors party, passes legislation forbidding businesses from barring individuals from their business based on their vaccine status. This comes well after they supported the Governor with legislation forbidding local municipalities from enforcing local ordinances requiring masks.

I want the ships to sail so my son-in-law keeps his job! The last thing we need is for Florida politics to permit a ship to go out to sea and become a center of infection, illness and death because Florida elected officials watered down the sensible guidelines the cruise industry developed to begin sailing again safely.

Florida is a gateway state encouraging visitors from Latin and Central America as well as US tourists. Brazil is embroiled in a COVID surge of infection and death . The poverty in Central America and the islands prevent knowing exactly what their status is. I am more concerned about the disease entering and leaving Florida via visitors and no rules than I am concerned with illegal immigrants bringing it in at the Texas and Arizona borders as the media and certain elements of the U S seem to be.

Vaccines have brought us so close to controlling the Pandemic. Why can’t we mask up and be patient for a few weeks more?

In my office we will continue to follow the CDC guidelines. We will wait to see if the relaxed mask recommendations of the CDC, plus the vaccine program, keep the infection rate down. Florida Surgeon General Scott Rivkes’ no mask for the vaccinated anywhere may be interpreted as no masks anywhere for everyone. It will take three to four weeks for the consequences of these announcements to make an impact. If the number of infected decreases, my physician associate and I will sit down and alter our approach based on the science. Until that time, we will require masks in our office!

Will I Be Able to Choose My COVID-19 Vaccine?

There are currently four vaccines to prevent COVID-19 in the pipeline. I have been asked numerous times when am I going to have the vaccine in my office and which vaccine should individuals take? This question was addressed by MedPage Today, an online health care periodical on 11/27/2020. The same question was asked of National Institute of Health “chief” Francis Collins, MD, PhD last week at a press briefing. Dr Collins responded there will not be enough vaccine available in December for the whole country and “people who get offered one should feel quite happy about that.” Leana Wen, MD, of George Washington University responded to the same question saying, “Initially there won’t be nearly enough vaccines for hundreds of millions of Americans. We will probably take whatever we are able to get access to.”

If you are a healthcare worker, or in the more vulnerable groups, you are most likely to be offered one of the nRNA vaccines from Pfizer/BioNtech or Moderna because they are further along in completing the FDA required trials and application process for approval. Younger healthier individuals having less priority may get to choose.

Larry Corey, MD, a viral expert at Fred Hutchinson Cancer Institute in Seattle and a leader of the COVID-19 Prevention Network Vaccine Program broke down the numbers at a November 18, 2020 meeting of the American Public Health Association and National Academy of Medicine:

  1. The US Government has contracts for 100 million doses of the Pfizer/BioNTech and Moderna vaccines with production producing the 200 million doses by the spring of 2021. That should cover the highest risk groups including healthcare personnel, nursing home residents, essential workers and the medically vulnerable per the CDC Advisory Committee on Immunization Practices (ACIP) guidelines. The vaccine will be shipped to 50 states, the District of Columbia, 8 territories and five large urban health departments including NYC and Chicago. Who receives it first, and where they receive, it will be decided by the local jurisdictions. This process should take until the end of March 2021 leaving some 200 million Americans waiting for a vaccine. Dr. Corey was clear that “We need other vaccines for the rest of the population.”
  2. In addition to the Moderna and Pfizer/BioNTech mRNA vaccines, there are products from Oxford/AstraZeneca, Janssen/Johnson &Johnson, Merck, Sanofli/Glaxo SmithKline and Novavax. Jay Butler, MD, deputy director for infectious disease at the CDC expects there to be mass vaccinations run by public health agencies and possibly some vaccination programs at community pharmacies. No mention was made of supplying physician offices or clinics.
  3. If there are no major delays, seven different vaccines should be available by the spring of 2021. Naor Bar-Zeev, PhD, of the International Vaccine Access Center at Johns Hopkins University in Baltimore said it is too soon to compare the products because there are no studies comparing them head-to-head. He reminded us that different vaccines might be better suited for different patient populations with pediatric patients, the elderly, the immunocompromised likely to do better with some and not others.

Despite the lack of detail to date, Moncef Slaoui, MD, head of the federal Operation Warp Speed, told CNN that he expects 70% of the US population to be vaccinated by May 2021.

Volunteering for the COVID-19 Vaccine Trials

My civic-minded daughter in California asked me what I thought about her volunteering for one of the drug trials or vaccine trials involving COVID-19. She asked me if I knew how they found volunteers for these research studies. I told her I had no idea, but I would investigate it.

The Center for Disease Control and Prevention (CDC) and the National Institute of Health (NIH) websites directed me to a volunteer network formed to find volunteers to test treatments for HIV disease. I was directed to a website being run by the Fred Hutchinson Cancer Institute in the Midwest.

Mr. Hutchinson was a former major league baseball player and the manager of the great Cincinnati Reds baseball team that lost to my beloved New York Yankees in a World Series in the 1960’s. Fred had contracted cancer and been involved in philanthropic works in cancer research. After his death, the center took on his name. It is a first-class extraordinary cancer research and care facility. They are supervising the COVID-19 Trials Prevention Network.

If you access the site at http://www.coronaviruspreventionnetwork.org you have an opportunity to volunteer for prevention and treatment studies. There is a short questionnaire to fill out asking you about your health, height, weight, exposure to COVID-19 and contact information. If you are selected for a trial, you will be contacted and at that point have a chance to review what is being studied and what the risks and benefits are for your participation.

Filling out the form does not obligate you to participate but does put you in the pool of individuals willing to consider participating in a prevention or treatment trial.

Tdap Booster Vaccinations

Several years ago an epidemic of whooping cough (pertussis) was ongoing in affluent areas of California and Arizona. Epidemiologists from the Center for Disease Control (CDC) and National Institute of Health (NIH) descended on those areas to determine the cause of the life threatening illness to very young children.

Much to their surprise, grandparents were inadvertently transmitting it to their new and not completely vaccinated grandchildren. As youngsters, these grandparents took the suggested DPT series of shots believing they were resistant to diphtheria, pertussis and tetanus for life.

Like most things, as we get older, the immune system just doesn’t work as well. The immunity to pertussis waned and adults were catching the adult version of whooping cough in the form of an upper respiratory tract infection with bronchitis. The adult version resembled a run of the mill viral upper respiratory tract infection with a prolonged barking cough. This was just the type of infection which infectious disease experts were suggesting we do not treat with antibiotics and instead let our immune systems fight off independently. Unknown to us was the fact that even after we stopped coughing, if this was in fact adult whooping cough, we could transmit the pertussis bacteria for well over a year after we stopped coughing.

The solution to the problem was to give these adults a booster shot against pertussis when they received their tetanus shot booster. It is recommended that we get a tetanus booster every seven to ten years.

Tdap, produced by Sanofli Pasteur, was the solution and an international campaign of vaccination was begun. The campaign was successful but what do you do seven to ten years later when the next tetanus shot is due? In a study sponsored by the manufacturer, adults 18- 64, were given a second dosage 8-10 years after the first Tdap shot and tolerated it very well. Blood levels for immunogenicity taken 28 days later showed the benefit of the second shot.

The data has been submitted to the CDC and its vaccination Prevention Advisory Panel for consideration for a change in the recommendations on vaccinating adults.

Does Tdap Protect You From Whooping Cough?

Within the past few years an epidemic of whooping cough swept through and injured youngsters in California and Arizona. There were tragic childhood mortalities in the frail not yet vaccinated pediatric population. The researchers from the Center for Disease Control and National Institute of Health swooped in and concluded that adults, primarily grandparents, were transmitting the disease to their newly arrived and not yet immunized grandchildren. They reasoned that the adults’ immunity from their childhood vaccinations with DPT had worn off and they were unknowingly transmitting it to the youngsters after a mild adult upper respiratory tract infection with bronchitis.  We were told that in adults, Bordetella pertussis produced bronchitis indistinguishable from a viral bronchitis. This was just the type of illness health care leaders were telling physicians not to prescribe an antibiotic for in their international campaign for the prevention of antibiotic resistance developing.  Little did they know at first that in adults, the bronchitis is a mild illness but in children it is aggressive and is often lethal.  They were not originally aware that long after our adult mild bronchitis resolved we could still transmit the bordetella pertussis to our grandchildren.

Their solution was to re-immunize adults with a pertussis booster in combination with your next tetanus shot. The combination was called Tdap.  A national information campaign was undertaken to get primary care physicians to spread the word to their adult patients.  The question is does it really work? In a recently published study led by Dr. Nicola P. Klein of the Kaiser Permanente Vaccine Study Center in Northern California which appeared in the Journal Pediatrics, it seems that the vaccine is only effective for a short time in the very healthy and robust 11 and 12 year children.  Their study showed that Tdap protected young adolescents 69% of the time in the first year, 57% in the second year, 25% in the third year and only 9% in the fourth year.  The vaccine was given during an epidemic in California in whooping cough in the hopes of averting a greater infection rate.

 

The failure of the vaccine to provide long term benefits in adolescents and teenagers will lead to different immunization strategies. Tdap is already a milder form of a former vaccine, scaled down to prevent some of the rare side effects seen when it was administered.  A possible return to that previous vaccine or whole cell preparation may be needed. Another proposal calls for vaccinating pregnant women hoping that their maternal antibodies will pass to the fetus and provide long term protection.

The real question with no answer is what about the millions of adults who received Tdap with immune systems far less robust and protective than adolescents?  Are they immune and for how long?  No one knows because the research has not been done or published yet.  Still the CDC and the NIH and the American College of Physicians call for adult immunization with Tdap.  The Kaiser Permanente Study will surely establish the need for an adult efficacy investigation. Until then we will give the Tdap while we wait for answers. It does raise the question of whether our approach to adult bronchitis should include an antibiotic that treats Bordetella pertussis until a quick test is developed to distinguish it from run of the mill viral pneumonias.

FDA Approves Coronary Artery Disease Screening Test

FDA - Steven Reznick, MDMedPage Today, the online medical journal of the University of Pennsylvania School of Medicine, announced that the FDA has ” cleared a blood test ” to screen for heart disease known as Lp-PLA2 or lipoprotein associated phospholipase A2. This test is an individual marker of vascular inflammation produced within atherosclerotic plaques. Its use was cleared for screening in all adults with no history of coronary artery disease.

In a National Institute of Health study, known as Reasons for Geographic and Racial Differences in Stroke, it was shown in a review of 4,598 people, aged 45 – 92, that individuals above the threshold level for Lp-PLA2 were more than twice as likely as others to have an event, heart attack or stroke, 7% versus 3.3 %. The study was particularly helpful when looking at black women as a group. An Lp-PLA2 level > 225nmol/min/mL is considered elevated.

This test has been available to patients in our practice through the Cleveland Heart Labs screening panel. It plus the myeloperoxidase level, CRP and other markers have been felt by the Cleveland Clinic cardiology division to have predictive value. These tests are currently available but in many cases require private pay because Medicare and private insurers do not yet cover them all.

Drinking Coffee, Lower Mortality

Over the years, the consumption of coffee and its relationship to your health has been controversial.  In my medical school, internship, and training years in the late 1970‘s, it was thought that consuming more than five caffeinated beverages per day was associated with an increased risk of pancreatic cancer. That relationship has since been disproved.

The May 17th issue of the New England Journal of Medicine published a study on coffee drinking that will certainly make coffee drinkers more comfortable with a consuming a “cup of Joe.” They looked at a National Institute of Health – AARP study that began 1995 and includes almost 230,000 men and 173,000 women. They found that coffee drinking was associated with many negative behaviors including cigarette smoking, less exercise, eating more red meat, and eating less fresh fruits and vegetables.  Upon initially looking at the data, coffee drinking was associated with an increased mortality. However, when researches removed the negative behaviors from the data, and looked at the people who drank coffee but didn’t smoke and exercised; they found a significant drop in the mortality of coffee drinkers. Over 13 years, men who drank 4-5 cups of coffee per day had a risk reduction of 12% while women had a risk reduction of 16%.

The risk reduction was considered “modest” by Neal Freedman, PhD of the National Cancer Institute.  Lona Sandon, RD (registered dietitian) of the UT Southwestern Medical Center in Dallas said, “Based on this study alone I would not tell people to start drinking more coffee to lower their risk of death.”   She felt individuals should “stop smoking, be more physically active, and eat fruits, veggies, whole grains and healthy fats…. A little coffee doesn’t appear to hurt.”  Cheryl Williams, RD, of Emory Heart and Vascular Center in Atlanta commented that “if you are not a coffee drinker, this study is not a good enough reason to start.”

The study seemed to show that with consumption of 4-5 cups of coffee per day your risk of death due to cardiovascular disease, respiratory disease, injuries and accidents, diabetes and infections decreased. Coffee consumption did not appear to protect against cancer-related deaths. The design of the study does not allow us the luxury of saying drinking coffee is the “cause” of an “effect” of lowered overall mortality, but does certainly hint at it.

What is clear is that coffee drinking does not appear to have an adverse effect on already healthy lifestyles, but will not protect an individual from the detrimental effects of smoking, poor dietary choices and inactivity.