Challenges Ahead with the Next Phase of COVID Vaccination

By Robert L. Moore, MD, MPH, MBA, Chief Medical Officer

“Wishful thinking is no substitute for careful planning.”

-Steve McConnell

As you are no doubt aware, starting on March 15, adults aged 18-64 with certain medical conditions will qualify for COVID vaccination, based on the clinical judgement of their medical providers. See below for the full list.

Operationalizing this process, coordinating the judgement of the clinician with the actual vaccinators will be challenging if the provider making the judgement is not also doing the vaccination. Even if the provider is doing both, the sheer volume of patients who qualify is daunting and raises many questions:

Do you treat all the groups below equally, or do you prioritize subsets for your first outreach efforts? How exactly does this fit into the patients who sign up through the centralized myturn.ca.gov site? How can myturn.ca.gov possibly know who meets the medical criteria based on their physician judgement? What role will Blue Shield play? The three final options in the list are vague and allow clinician judgement that may not be uniform. How do you interpret that language for your patient population?

While we may wish that these questions will be answered by March 15, it is probable that they won’t be. Each of your health centers, offices and organizations will be expected to use this general guidance to create their own operational plans. This will likely involve using the registry function of your electronic health records to generate lists of potential patients in each group, sub-prioritizing your own outreach activities, and communicating this clearly to your patients. It will also involve ramping up and streamlining your vaccination process, from taking sign-ups, verifying eligibility, checking identity, and auditing for misapplication of the criteria.

These next few months will be even more challenging for primary care. Hope for the best, but plan for the worst. Keep your plans flexible and adaptable to most likely challenges: variable vaccine supply and disconnected communication between the different systems that will need to work together.

Provider Bulletin from the California Department of Public Health:
Beginning March 15, healthcare providers may use their clinical judgement to vaccinate individuals aged 16-64 who are deemed to be at the very highest risk to get very sick from COVID-19 because they have the following severe health conditions:

  • Cancer, current with debilitated or immunocompromised state
  • Chronic kidney disease, stage 4 or above
  • Chronic pulmonary disease, oxygen dependent
  • Down syndrome
  • Immunocompromised state (weakened immune system) from solid organ transplant
  • Pregnancy
  • Sickle cell disease
  • Heart conditions, such as heart failure, coronary artery disease, or cardiomyopathies (excludes hypertension)
  • Severe obesity (Body Mass Index ≥ 40 kg/m2)
  • Type 2 diabetes mellitus with hemoglobin A1c level greater than 7.5%

OR

If as a result of a developmental or other severe high-risk disability, one or more of the following applies:

  • The individual is likely to develop severe life-threatening illness or death from COVID-19 infection
  • Acquiring COVID-19 will limit the individual’s ability to receive ongoing care or services vital to their well-being and survival
  • Providing adequate and timely COVID care will be particularly challenging as a result of the individual’s disability

Focusing Leadership Energy

By Robert L. Moore, MD, MPH, MBA, Chief Medical Officer

“The tragedy of life is not in failure, but complacency.”

-Benjamin Mays

The “Rule of Three” is a principle in writing and public speaking that states that ideas presented in threes are inherently more interesting, more enjoyable and more memorable for your audience. Information grouped into threes will stick in our heads better than other sized groups.

For lexophiles, there are two single words for the Rule of Three.

The first is tricolon, derived from the Greek tria (three) and kolon (clause or member). The idea is old; Aristotle described it in his book Rhetoric. The three words or phrases have different meanings but are grouped together for a common purpose.

Some medical examples:
Airway, breathing, circulation
Oriented to person, place and time.

The second word is hendiatris, derived from the Greek hen dia treis (one through three), in which three words are used to convey a single concept. For example, Shakespeare’s Julius Caesar says:

Friends, Romans, Countrymen, lend me your ears.

Why does this rule work so well? One theory is that our minds naturally organize information into patterns so that they can process and retain information. The smallest number in a pattern is three, hence the Rule of Three.

Leaders throughout history have used the tricolon to communicate, inspire and motivate those around them. There is another variation on the Rule of Three used by leaders to focus their strategic energy and achieve success on what matters most. To be effective, we need to regularly decide what our top three priorities are for focusing our discretionary energy. Write them down, talk about them, and remember them when you can take a break from the myriad of busy tasks (email, meetings, patient care) that take up so many hours each day.

Focusing on your top three priorities requires discipline to defer lower priorities to later, or perhaps delegate them to someone else. This discipline also forces us to be clear on the criteria for prioritizing the highest priorities, a process sometimes called “remembering our north star,” the guiding light in the darkness which is steadfast, and present, night after night.

So take a moment to remember the principles that guide you, and set your top three priorities for the next week/month/year. Then, as you seek to inspire others to work on these priorities, consider how rules of three can help you.

Effective Promotion of COVID Vaccination

By Robert L. Moore, MD, MPH, MBA, Chief Medical Officer

“For he who has health has hope; and he who has hope has everything.”
-Owen Arthur

The first step to encouraging our patients to take advantage of the opportunity and privilege of being vaccinated against COVID-19 is to understand and communicate some core facts on vaccine development, efficacy, and safety. Here are some examples that may be helpful.

Have you ever seen a home makeover TV show, where they build a sturdy beautiful home in a week? New homes typically take months to build. How is this possible?

  1. By having prefabricated parts ready to assemble rapidly. Don’t build everything from scratch.
  2. By pouring resources (workers and money) into the building process, and working long hours.
  3. Wherever possible, by doing different parts of the project simultaneously, instead of sequentially.

These same three steps have been the key to developing highly effective COVID vaccines with thorough safety testing:

  1. Re-purposing a vaccine platform that has been proven effective and safe on other similar infections, adapted to the specific genetic code of the COVID-19 virus.
  2. Getting up-front funding for the final product, allowing people and facilities to be re-purposed to produce the vaccine on a large scale, quickly.
  3. Do all the usual steps in testing a vaccine for effectiveness and safety without unnecessary delay between steps, WHILE large scale production is already going on, in case it works well.

Efficiency, while assuring quality. No corners were cut!

I heard you can still catch COVID after being vaccinated. If that’s the case, why should I get vaccinated? Do COVID vaccines protect against COVID infection?

The COVID-19 vaccines are amazingly effective against both serious COVID-19 infection (close to 100%) and symptomatic COVID infection (95% for two doses of the two mRNA vaccines, 72% for a single dose of the Johnson and Johnson vaccine, when available in the US).

Importantly, protection against asymptomatic infection is probably in the ballpark of 50%, so vaccinated individuals can still carry infection home to their family and friends who are not vaccinated. Because of this, it is very important to continue to diligently use masks, physically distance and avoid indoor gatherings with individuals outside of your COVID bubble. This won’t last forever. We need many people to be vaccinated AND little COVID to be circulating in the community before we consider easing up on other protective measures.

I’m worried about the side effects of the vaccine. Could I catch COVID from the vaccine? Can’t the RNA in the vaccine become a part of my own DNA, causing problems down the road? What about long-term side effects?

First and foremost, COVID vaccination cannot cause COVID-19 (about 30% of Americans believe this, so it is important to address this up front). No COVID virus was used in production of the vaccine. The messenger RNA in the vaccine codes for just one protein of the virus. This messenger RNA was manufactured from chemical building blocks in vaccine production facilities.

The messenger RNA is quickly digested by our bodies back into these building blocks, just after it instructs the protein factories within cells to produce the COVID spike protein in large amounts, so your body can learn to react against it in the future. Messenger RNA does not become part of your body’s DNA. Your DNA is safely located in the nucleus of the cell, away from the protein factories where the messenger RNA does its work.

In the past year, about 1 in 700 Americans have died of COVID. In comparison, the major risks of the vaccines are exceedingly rare: 4 hospitalizations per million doses of the current vaccine for either anaphylaxis or low platelet count (immune thrombocytopenia). Longer term side effects affect about 5-10% of those infected with COVID-19 (sometimes called “long haulers”), while no long-term side effects have yet been described for the vaccine (at least 42 million doses given so far, in just the United States).
Short term side effects of the vaccine include arm pain, muscle aches, headache, fever, and fatigue. These minor side effects are quite common, and usually last no more than 24 hours.

Framing the Conversation
Frame COVID-19 vaccination conversations with messages that resonate. Here are three ways of framing recommended by the Ad Council COVID Collaborative:

  1. Moments Missed. Reference things your patients miss the most. With many feeling COVID-19 fatigue, missed moments (especially human connections that we took for granted like visiting family and friends) serve as a powerful reminder of the ultimate end goal: vaccination as a pathway to the possibility of regaining these moments (don’t use the term “return to normal” though as this overpromises and may lead to unsafe behavior after vaccination).
  2. Protection. Emphasize a shared goal of “protecting yourself, loved ones and those in your community” (rather than “coming together as a nation”).
  3. Positive tone. Be inviting and respectful as opposed to demanding. Start with the assumption that the person would want to be vaccinated. If they say they don’t want the vaccine, then acknowledge “the choice is yours to make” which connects with the deeply rooted American value of liberty. Trying to harness fear of COVID can backfire, leading to fear of the vaccine.

In this pandemic, all of us in the health care community have the privilege and the responsibility to be public health ambassadors, for our patients, our families and our communities. As ambassadors, to be most effective we must be energetic, committed and diplomatic.

New Information on Highly Infectious COVID-19 Strains

By Robert L. Moore, MD, MPH, MBA, Chief Medical Officer

“The tragedy of life is not in failure, but complacency.”

-Benjamin Mays

In the past week, there has been a flurry of new information about different COVID-19 strains. With large-scale community transmission, new strains can spread widely, and the most infectious strains will become more prevalent than less infectious strains over time. New information will continue to become available in the days and weeks ahead. Here is a summary of highlights:

CAL.20C: California has its own highly infectious strain of COVID-19, called CAL.20C which first appeared last summer in Los Angeles, but spread steadily since November, accounting for 30% of cases three weeks ago, and 50% of COVID-19 isolates two weeks ago in Los Angeles. This strain has now been found throughout California, including the Bay Area. Kaiser has identified it at all of their hospitals in Northern California.
This strain was incidentally discovered when California scientists began looking for the highly infectious British strain.

A laboratory director in Napa noted last week isolates of COVID-19 from community testing have much higher load of viruses in the samples than seen before in Napa. This is consistent with the mechanism for higher infectivity of these strains, which is that more virus is shed when people are infectious. Sequencing confirmation is pending, but this suggests that a more infectious strain is rapidly spreading in Northern California in larger numbers. This means that we may be looking at accelerated spread in our region in the month to come.

In the next few weeks, we will learn steadily more about this CAL.20C strain and its role in the notable big surge in COVID-19 cases in California, Arizona, and Nevada, starting in November. Specifically, we need data on mortality rates, effectiveness of vaccines, degree of increased infectiousness, and pattern of spread through the state.

B.1.1.7: On Friday, the UK government announced that early data suggests that the British variant (B.1.1.7), already known to be about 50% more infectious, may have a 30% higher mortality rate than the previous COVID-19 circulating in the UK. In the UK, this means an increase in overall mortality rate from about 1.0% to about 1.3%, still far below the mortality of coronaviruses that caused SARS in 2003 or MERS in 2012.
Early studies have confirmed Moderna vaccine effectiveness against the B.1.1.7 variant.

501Y.V2: This strain, circulating widely in South Africa, has decreased cross-reactivity to convalescent plasma and monoclonal antibodies. Today, Moderna announced that the immune response to their vaccine was somewhat less strong against 501Y.V2 than the original Wuhan strain that their vaccine is based on. We don’t know how much less clinical effectiveness (in terms of actual prevention of infection) that this translates to, but Moderna has developed a new version of their vaccine targeting this strain that it is planning on testing as a booster dose, after the original 2 dose series is completed.

P1: A new strain with over 20 mutations has been identified in Manaus, Brazil has exploded in December, 2020, even in a community which was devastated by a 60-70% infection rate in April, 2020, enough that should have generated herd immunity of the original COVID-19 strain. This raises concerns of widespread re-infection when strains of COVID-19 are sufficiently different, and makes it more likely that vaccines will be less effective against this strain. It will be weeks before we know more details.

Implications of Increased Infectiousness of COVID-19: France and Germany decided that cloth masks are not sufficient to counter spread of more infectious strains. Germany is now requiring N95, KN95, FFP2, or surgical masks, and specifically not cloth masks, for people interacting in public (like grocery stores and public transit). The original push for homemade cloth masks came from a desire to save scarce N95 masks and other masks for doctors, nurses, paramedics, doctor’s offices, etc. It is doubtful that the global supply chain for N95 masks can meet the demand to have the entire population wear them, but KN95 masks are more readily available. Absent these medical grade masks, some are calling for wearing two cloth masks, one on top of the other, to decrease risk of infection.

To increase protection against these more infectious strains, in addition to possible future changes in mask recommendations, the CDC may alter their recommendations around physical distancing. In the meantime, it might be prudent to consider a higher standard (such as 9 feet and 5 minutes instead of 6 feet and 15 minutes), in your health care settings.

Scaling Up COVID Vaccinations: Reflections on the Science of Implementation and Spread

By Robert L. Moore, MD, MPH, MBA, Chief Medical Officer

“Nearly every problem has been solved by someone, somewhere. The challenge is to find out what works and scale it up.”

-Bill Clinton, former U.S. President

In spite of several months of planning, the scaling up of the COVID vaccine has been challenging. Often, the scaling up of successful pilot programs and improvement projects encounter problems. Successful large scale implementation is a skill set not necessarily associated with good intentions, innovative thinking, or the size of the organization.

Stephen Dubner offers a nice introduction to this challenge in a Freakonomics Radio podcast, from early 2020.

In the last 10-15 years, a new social science concept called “Implementation Science” seeks to explain the factors leading to implementation challenges and how to overcome them. Several of these frameworks on how to increase the success of large scale implementation were combined into a Consolidated Framework for Implementation.

Here are a few major reasons that scaling up of successful pilots may fail:

  1. The pilot did not actually work (look at the actual data, not the hype).
  2. The people studied in the pilot are not representative of the general population.
  3. Efforts to scale up implementations cut corners and no longer follow key aspects of the pilot program.
  4. Scaling up does not account for limited supply of qualified staff and other inputs.
  5. Scaling up assumes the “build it and they will come” theory; that demand for the intervention will spontaneously be high. An insufficient marketing plan is included.

Over the course of our careers, as we experience or witness failed implementations, it is too easy to develop a sense of fatalism about many proposed expansions. In the case of mass COVID vaccination, our society, health care delivery system, and economy, demand that we have a different mindset. Successful implementation is hard, it is a skill-set, but it importantly reflects a “can do” mindset, not a “can’t do” mindset. It means tackling challenges head on, seeking new solutions to problems encountered, including the key challenge of vaccine hesitancy.

We at PHC thank you, and your staff, for your work on promoting COVID vaccination among your staff and in your community, in the weeks ahead.

More Infectious COVID Strain Will Require Higher Vaccination Rates

By Robert L. Moore, MD, MPH, MBA, Chief Medical Officer

“One of the biggest myths in medicine is the idea that all we need are more medical breakthroughs and then all our problems will be solved.”

-Dr. Quyen Nguyen, Pioneer in Fluorescence-Guided Surgery

Most recent estimates from Great Britain are that the SARS-CoV2 VOC 202012/1, also known as COVID-19 variant (B.1.1.7) is 50% more infectious than the previously dominant COVID strain. DNA sequencing of samples of SARS-CoV2 has been at very low rates in the United States, so we don’t know how quickly this strain is spreading. On Wednesday, San Diego County announced that they had detected 34 cases in the previous few days.

Fortunately, this strain is no more deadly or likely to cause serious illness than other COVID strains. It appears to be more infectious due to a higher number of particles being shed in the early pre-symptomatic or asymptomatic phase.

Unfortunately, a higher rate of infectiousness means that we will need higher rates of vaccination to achieve herd immunity and stop the spread of COVID. Some estimate that a vaccination rate of 90% will be needed to achieve herd immunity to this new strain, instead of the 70% we were counting on since March 2020. In addition, the current distance and time standards (6 feet and 15 minutes) that define high risk exposures may need to be changed as this more infectious strain spreads.

Even when we get past the current major logistical challenges involved in vaccine prioritization and distribution, given high rates of vaccine hesitancy, we have a major public health challenge ahead, which will require consistent strong communication from you, your clinicians and your staff.

By all accounts, much of 2021 is shaping up to look like 2020, from a COVID perspective.

The January 6 edition of the New England Journal of Medicine included a comprehensive overview of the many strategies that can be used to increase vaccination rates. Here is their list of recommendations for primary care clinicians:

  1. Prepare a list of common vaccine questions
  2. Investigate specific concerns of your various segments of patients
  3. Develop a list of effective responses
  4. Practice and train staff for responses
  5. Add incentives (free sports exams, prizes).
  6. Develop prompts to persuade vaccine-hesitant patients and offer compromises.
  7. Make vaccination status observable in your community

In addition, they describe how to vary the message, depending on the level of vaccine hesitancy.

The article describes the targeted strategies in more detail.

For the good of our communities, our health, and our economy, thank you for training and mobilizing your staff to rise to this public health challenge!

Our Role in Addressing Fear of COVID Vaccination

By Robert L. Moore, MD, MPH, MBA, Chief Medical Officer

“Nothing in life is to be feared, it is only to be understood. Now is the time to understand more, so that we may fear less.”

-Marie Curie

Recent surveys have found that physicians are largely inclined to use the new COVID-19 vaccinations (80-90%), while nurses are much less inclined (30-50%), which is lower than the rate in the general public (about 60%). What is the cause of such hesitancy?

The quote above from Marie Curie, two-time Nobel Prize winner for her discovery of radioactivity and radioisotopes, is apropos to answering this question.

On the surface, the appeal to use understanding to overcome fear would seem to invoke using vaccine study data to overcome vaccine hesitancy. There is also an element of idealistic recklessness (or courage?) in this quote, since Marie Curie died of aplastic anemia, likely brought on by the radiation that she first described as a scientist. Given how little was known about radiation at the time, much less its effect on humans (DNA was identified as the basis of genetics decades later) it is perhaps not surprising that she was unafraid of radiation. In the end, her drive to generate new knowledge and understanding of the subatomic world was stronger than her fear of potential risks that would not be defined until the future.

Rosalind Franklin was another physicist to die of radiation exposure, in the pursuit of understanding. Her exquisite X-rays of crystalized DNA were the basis of determining that DNA formed a double helix, which allowed Watson and Crick to theorize on its structure. If she hadn’t died, she would have likely been a co-winner of the Nobel Prize for this work. But if she hadn’t persisted in doing radiograph after radiograph (and getting exposed), Watson and Crick would not have had the key information needed to sort it all out.

If Marie Curie had been as afraid of radioactivity as she probably (in retrospect) should have been, the nature of radiation would not have been understood for many years later. She may have lived some years longer, but her important contributions to physics would have had to wait for others to work out. I think her statement above was a reflection of courage, with some subconscious knowledge of the unknown risks, but she felt the work was so important that it outweighed these unknown risks.

The decision to use a new vaccine carries a similar balance of hopefulness and caution: vaccinate sooner to help break the cycle of infection, but potentially be exposed to a risk that is not known at this early time.

New vaccines have a long history of being treated with suspicion at first, so there is an evidence base on what helps increase vaccination rates in this setting. Interestingly, long explanations of all the ways the vaccine has been studied and found to have side effects less severe than the risk of natural infection is NOT very effective. This approach is still important, but we must realize it will not lead to mass acceptance of the vaccine.

So what does work?

Having famous, well-liked or well-respected people publicly get vaccinated and speaking up about why they are doing so is very effective. In 1956, Elvis Presley rolled up his sleeve on national television to receive the new polio vaccine. Historians say this helped increase the acceptance of this vaccine and the rate of adoption.

Making vaccination easy and matter-of-fact is another helpful tactic. Allowing social communities (like schools, churches, hospitals, and health centers) to be vaccinated as a group also increases overall vaccination rates. The combination of convenience and subtle social pressure helps overcome ambivalence.

As leaders, we can use both these strategies in our communities. Find trusted opinion-leaders (including you, the medical leaders in your community) to publicly get vaccinated and speak about it. Make it easy, make it social.

Never in human history has a vaccine been introduced so quickly nor in the face of such a raging pandemic. There may be more risk than we are aware of now, but there are compelling benefits to balance this, as a society, as healthcare leaders and as individuals.

The Origin of the N95 Mask

By Robert L. Moore, MD, MPH, MBA, Chief Medical Officer

“This dramatic escalation of global travel highlighted the perils of emerging infectious diseases.”

–Dr. Wu Lien-teh, talking about the role of railroads on the spread of the Manchurian pneumonic plague of 1910

Born in Malaysia and trained at Cambridge, London, and Paris, Dr. Wu Lien-teh was sent by the Chinese government to control an outbreak of almost universally-fatal pneumonic plague in Manchuria in 1910. He determined that this form of plague was transmitted from person to person by respiratory droplets and developed cloth masks to protect health care workers. European infectious disease physicians initially did not believe Dr. Lien-teh’s findings, partly due to bias against him for being ethnic Chinese. French physician Dr. Gerard Mesny and Scottish physician Arthur Jackson both refused to wear a mask in the hospital treating patients with pneumonic plague, to demonstrate their disagreement with Dr. Lien-teh’s hypotheses. Both contracted pneumonic plague and died.

Refusal to wear masks as a statement of what the person believes, with deadly consequences, is not new to COVID-19. Sadly it has a long history. Luckily, the masks initially used in Manchuria were adapted over the years into the N95 mask and associated personal protective equipment (PPE) we use today.

Dr. Wu Lien-Teh eventually traced the source of the pneumonic plague to trappers of the Mongolian Marmot, which was an endemic carrier of plague. He used a number of measures to study and control the outbreak, including mass cremation of individuals who died, which were unpopular among local officials and the local population. He had to appeal directly to the Chinese emperor for support. Like COVID-19 today, the support of the most senior leader ultimately determined if public health measures would be embraced or not, against resistance of the population.

After COVID-19 is under control, we need to think about how we train not only public health experts, but also non-scientists who may be future political leaders, about the leadership lessons and ethical tradeoffs of past epidemics to try to prevent repeating deadly mistakes of the past in the next pandemic.

Courage to Heal: A short historical novel on the life of Dr. Sidney Garfield

By Robert L. Moore, MD, MPH, MBA, Chief Medical Officer

“Peak performers see the ability to manage change as a necessity in fulfilling their missions”

–Dr. Sidney Garfield, Founder, Permanente Medical Group

Surgeon Sidney Garfield partnered with industrialist Henry Kaiser to create what was to become the largest integrated health care delivery system in the United States, known for its high quality, its labor-management partnership, and its cost effectiveness.

In the early years, the American Medical Association and the California Medical Association sought to destroy the model and to drive Dr. Garfield out of business; Kaiser Permanente only survived due to the influence of Henry Kaiser.

Courage to Heal, written by journalist Paul Bernstein, gives a good sense of the political and personal forces that came together in the 1930s and 1940s to start the Kaiser health system, while providing a glimpse of the state of medical practice at the time.  The book highlights the skill and courage of Dr. Garfield and others who believed that everyone deserved access to preventive and curative care regardless of their ability to pay, a radical idea at the time.

This is an inspiring tribute to the ideals of medicine as a profession and a system of care.

Bringing the Patient Story Back to the Medical Record

By Robert L. Moore, MD, MPH, MBA, Chief Medical Officer

“A story can put your whole brain to work.”

–Leo Widrich, co-founder, Buffer

Linguists have shown that humans that do not store their thoughts or memories in written form have a remarkable ability to remember and relate long stories orally, from generation to generation.  Even with written language and now audio-visual capture of information, stories are easier to remember than a stream of facts, events or even a theoretical framework.  (The early chapters of Sapiens: A Brief History of Humankind offers a good summary.)

There is a neurologic basis for this.  Streams of facts or ideas mainly stimulate the auditory processing portion of the brain, while stories activate the deep brain structures associated with emotions and long-term memory, as well as various portions of the cortex.  A story puts our whole brain to work.

This may explain why studies of Electronic Health Records that segregate clinical tidbits into different discrete parts of the medical record decrease the ability of a subsequent reader to really understand what was going on with a patient.  The patient story is lost, making the medical record a poor communication tool.

A well written opinion article in the September 1, 2020 Annals of Internal Medicine calls on clinicians to “Restore the Story” in clinical notes.  The American College of Physicians created a “Restoring the Story Task Force” to promote this effort.  The article summarizes the attributes of an ideal clinical note:

“The ideal clinical note is more than a verbatim transcript.  It is a coherent representation of relevant data that have been sifted through and examined in the context of the patient’s life and priorities, yielding an assessment of the situation and rationale for recommended next steps.”

In the electronic health record, the two most important places for telling the story are the history of present illness and the assessment.  Utilizing the free text option in these two locations is essential to achieve this.