26 September 2023 Blog: On Whole Body MRI Scans

26 September 2023 Blog:  On Whole Body MRI Scans

 

A patient asked me my thoughts on a recent New York Times post on Prenuvo, a whole body MRI.  Here is the post:

“For $2,499, Prenuvo will try to predict your future. The celebrity-endorsed company offers a roughly hour-long session of magnetic resonance imaging, or MRI, that scans your entire body, searching for early signs of cancer, aneurysms, liver diseases and even multiple sclerosis. It’s part of a crop of companies that claim they can revolutionize preventive health care with full-body scans — but experts warn this might not be the right approach.

In recent months, images of celebrities and influencers posing in branded scrubs in front of a glossy, cylindrical MRI machine have popped up on social media. Kim Kardashian wrote in the caption of a post she shared last month that Prenuvo “has really saved some of my friends’ lives.” In May, the television host Maria Menounos said that a Prenuvo scan had alerted her to a mass that turned out to be Stage 2 pancreatic cancer.

Many celebrities talk about their health on social media. But the ones that are documenting their body scans — complete with nearly identical photo ops — have taken the celebrity health endorsement to new heights in terms of cost. And considerable harm can come from screening, experts said.

What do experts say about the scans? Read more at the link in our bio.”

 

INTRODUCTION and GENERAL CONCEPTS of SCREENING

There is so much to unpack here that it is hard to know where to begin. But let’s start at the beginning “Prenuvo will try to predict your future.” It’s never a good sign when the first sentence is factually incorrect. What a whole body MRI is trying to do is illustrate your present. There have been no studies showing that whole body scanning can materially impact one’s health. In fact, MRI and CT scanning were developed for diagnostic purposes for patients with either known disease, serious complaints or trauma (the so-called ‘pan-scan’ is a mainstay of Emergency Medicine and Trauma Surgery). Only low-dose CT scans for lung cancer screening among at risk patients (i.e. prior or current smokers with at least 20 pack years of smoking – or 1 pack per day for 20 years) have undergone careful evaluation and study with two large randomized controlled trials showing that CT screening reduces lung cancer mortality rates in these at risk patients.

Moving along, the suggestion that the Prenuvo MRI will detect early signs of cancer, aneurysms, liver disease and even multiple sclerosis is a curious constellation of outcomes. Multiple sclerosis has typical clinical signs but is best confirmed using an MRI protocol both with and without contrast.  Prenuvo does not use contrast stating ‘we believe the combination of sequences that we take performs as well as contrast-enhanced MRI for tumor detection’ but no mention of MS detection. Similarly, aneurysms are best detected with magnetic resonance angiography (MRA) which is similar to an MRI but focuses on vessels, rather than organs. So oddly, 4 of the conditions they choose to highlight as detectable are not best identified using Prenuvo.

Pancreatic cancer (to which I would add ovarian cancer and kidney cancer) is really an outcome where Prenuvo could make a difference. Typically diagnosed at later stages, the annual incidence rate of pancreatic cancer is 12.9 cases per 100,000 person-years with a death rate of 11.0 per 100,000 person-years. Compare that to colon cancer which has an annual incidence rate of 36.6 cases per 100,000 person-years and a death rate of 13.1 per 100,000 person-years.  I did find it odd that they used the experience of “television host Maria Menounos” to highlight early detection at Stage 2 of disease. Diagnosing pancreatic cancer at Stage 2 only has a 5 year survival rate ranging from 13-39% as opposed to 84% for Stage 1A. A far better example would have been finding localized pancreatic cancer at Stage 1. Once again, an MRI is not the imaging modality of choice for pancreatic cancer detection in a high risk population – endoscopic ultrasound or a magnetic resonance cholangiopancreatography is preferred. 

 

LEAD TIME BIAS

Those who follow my posts know that I won’t let a chance to introduce an epidemiologic concept go to waste – and this blog post is no different. One critique of Prenuvo comes from  lead time bias. Lead time is the period of time between the detection of a medical condition by screening and when it ordinarily would have been diagnosed because a patient experiences symptoms and seeks medical care. A disease for which early treatment is no more effective than late treatment can make early detection look more ‘effective’, when in fact all the patient experiences is more disease time.  This is illustrated in the figure below:


Specific screening for breast (mammography), lung (low dose CT scan among appropriate risk patients, detailed above) and colorectal cancers (colonoscopy) are known to be effective because randomized controlled trials have shown that the mortality rates of those screened are lower than a comparable group of unscreened individuals.

 

LENGTH TIME BIAS

A second epidemiologic Achilles heel of Prenuvo comes from  length time bias. Screening works best when a medical condition develops slowly (this is part of the reason that colonoscopy is such a good screening tool and can be done once every 10 years for an average risk patient with no polyps).  Screening tests like Prenuvo are more likely to find slow-growing tumors because they are present for a longer period of time before they cause symptoms.  This is illustrated in the figure below:

Because screening tends to find tumors with an inherently better prognosis, mortality rates may appear to be better but this has nothing to do with the screening process itself. It simply reflects what the Prenuvo is good at detecting.

 

FALSE POSITIVE RATE

One of the critiques I have specifically left out (until now) are concerns about false positive results arising from the Prenuvo screening. This actually may be one aspect where Prenuvo performs fairly well as it is an expected cost of any screening test.  In short, a false-positive screening test results in an abnormal result in a person without disease. These can then lead to the inconvenience, expense and potential risks associated with obtaining follow-up procedures. About 10% of mammograms lead to a false positive result, and in a study of ovarian cancer screening (CA-125 lab testing and ultrasound) returned an 8.4% false positive rate and one third of those cases underwent surgery. In that study, five times more women without ovarian cancer underwent surgery than did women with ovarian cancer.

My assumption would be that the Prenuvo screening would have a similar false positive rate of between 8-10%. But where clinicians get into trouble with higher false positive rates is when multiple tests are run (the so-called ‘covering all the bases’ phenomenon) occur at once wherein among several dozen tests, it is not unusual to have one or more return as ‘abnormal.’ So having the Prenuvo testing by itself could be a reasonable approach to reduce a cumulative false positive rate.  It is important to note, however, that practice variation can contribute to the false-positive rate.  This is a phenomenon we see with mammography wherein similar large screening programs in the US returned false positive rates nearly twice as high as in the UK – but with similar cancer detection rates. I would not imagine that the true false positive rate of Prenuvo screening will ever be known or publicized but an 8-10% rate remains a fair assumption.

 

SUMMARY: IS IT WORTH IT?

I suppose that the real question is for $2499, is it worth it? I’m not really sure how to answer that, because there are no guidelines on how often the Prenuvo should be performed. Is it annual?  Every five years?  Every ten? But to provide some framework, we know that colonoscopies ($1500, done every 5 to 10 years), mammograms ($200 performed annually), and Low Dose CTs of the Lungs among smokers ($500, done annually) do reduce mortality rate. Prenuvo has placed itself strategically with newer detection technologies such a Galleri which is a blood-based test seeking to detect early stage cancers ($1000, recommended annually). A vigorous evaluation of its efficacy would be reasonable, but as a cash-pay service there is little likelihood that Prenuvo will invest in research when they can put those dollars into marketing and endorsements.

 

September 2023 Newsletter

Welcome to the September 2023 Newsletter for

Santa Monica Primary Care.

In this issue, we cover seasonal vaccines coming due this Fall  (Flu, COVID booster and RSV) with some detail on how they are formulated and deemed effective. We borrow heavily from analysis performed by the UK’s Joint Committee on Vaccination and Immunization (or “Immunisation”).

Flu Shots are “IN”: On Seasonal Influenza Vaccine

Doses of the 2023/2024 seasonal flu shot are stocked in our office and can be given any time as the best time to receive the vaccine is during the months of September and October.

The rationale for such timing is that annual local epidemics follow a fairly predictable
seasonal pattern with outbreaks in North America occurring between November and March. These begin abruptly, peaking in 3 weeks, and then end about 8 weeks later. Viral spread during winter months is presumed to be favored by improved virus survival in lower temperature environments and, indoor crowding due to cold weather. These annual epidemics can affect 10% to 30% of the world population.

Each year in January, a review of circulating influenza viruses is undertaken by the World Health Organization (WHO) and the most likely epidemic strains from two main categories – Influenza A and Influenza B – are selected. For Influenza A this year’s shot contains the ‘swine flu’ familiar H1N1 as well as H3N2 subtypes (H and N are specific surface proteins termed hemagglutinin and neuraminidase). The Influenza B lineages generally cause less severe disease and are called Yamagata and Victoria. So there are 4 components which is why you will hear the shot referred to as ‘quadrivalent’.

The decision on which strains to include in the vaccine formulation is based on global
surveillance data but, in the end, it is a prediction and not always correct. As such, the
effectiveness of the seasonal flu shot can vary from year to year. Even if the vaccine doesn’t completely prevent the flu, it can still reduce the severity and complications of the illness should you become infected.

Vaccination is associated with a reduced incidence of influenza from 2.3% among adults who were unvaccinated as compared to 0.9% among vaccinated. This effect is even stronger among those 65 years and older, wherein vaccination reduced the incidence from 6% to 2.4%.

Side effects to the flu vaccine are generally mild, most common being local injection site reaction (soreness), headache, muscle aches or low grade fever – all resolving within a day or so. About 15% of flu vaccine recipients experience a side effect.

COVID-19 Boosters Will Be “IN”: On the 2023 Booster

For the first time ever, our office will be stocking a COVID vaccine, in this case the 2023
booster. We have been able to bypass the LA County Health Department who had been unwilling to supply us with vaccines and instead are receiving them directly frow the manufacturers. Unlike the influenza vaccine which has population-wide applicability, I am favoring a narrow scope of vaccine efforts for COVID-19. Some of this recommendation is based on bivalent booster experience of 2022 wherein only 17% of the total US population ever received a booster dose. That percentage was a bit better for those over the age of 65 years at 43.3%.

Similar to influenza, COVID historically (until 2023 that is) has had a strong Winter surge beginning right after Thanksgiving (not a big surprise why an airborne virus would spike after such). The Fall 2023 COVID booster, which should gained FDA approval this week, targets the XBB.1.5 a coronavirus subvariant that emerged in late 2022. While XBB.1.5 only makes up 3.1% of the currently circulating variants in the US, basic science data has indicated that its offshoots (EG.5, FL.1.5.1, KBB.1.16.1 and KBB.1.16) share a close relationship with KBB.1.5. As such, it is expected that the updated booster will provide protection against these related variants

The UK’s Joint Commission on Vaccination and Immunization (JCVI) has offered some of the most coherent advice on boosters, recommending them for those at high risk of serious disease and therefore most likely to benefit from vaccination. These include:

  • Residents in a care home for older adults.
  • All adults aged 65 years and over.
  • Persons aged 6 months to 64 years in a clinical risk group.
  • Frontline health and social care workers.
  • Persons aged 12 to 64 years who are household contacts of people with immunosuppression.
  • Persons aged 16 to 64 years who are carers and staff working in care homes for older adults

Similarly, we will advise patients over 65 and those in higher risk groups to strongly consider having the booster by the end of October in time for an expected late November to January surge in cases (this differs from the UK recommendation to have the booster by the end of December). The crux of the JCVI’s advice is based on a coherent analysis of the number needed to vaccinate to prevent a hospitalization or death due to COVID-19. Based on the 2022 booster experience, it would require giving a booster to 240 high risk >90 year olds to prevent one COVID death but over 2 million booster doses to prevent one death amongst healthy 15-19 year olds.

Vaccine efficacy of the 2022 booster dropped rapidly from 53% 2-4 weeks after vaccination to 28% at greater than 15 weeks. Protection against hospitalization after an mRNA booster increases in the two weeks after vaccination and then declines towards a stable plateau of around 50-60% by six months.

While you can have both the flu vaccine and COVID booster at the same time, it may be more prudent to separate the two. That way in the case of an unlikely, but possible, vaccine reaction -the cause will be apparent. A recent study from Sheba Medical Center in Israel showed that systemic reactions among those who received a flu+COVID co-administration was 27.6% as compared to 27.4% for COVID only and 12.7% in flu only. However, COVID spike protein antibody levels were 19% higher amongst those who received the COVID booster separately as compared to those who received COVID and flu vaccines together (link:https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2809119

RSV Vaccine is OUT there: On the New RSV Vaccine

This Fall will be the first time that an RSV (Respiratory Syncytial Virus) vaccine becomes available but is not a vaccine we will stock in the office. It will be available, however, at local pharmacies. Approved in May 2023, two RSV vaccines are available in the prevention of respiratory tract disease – Arevxy (82% effective) and Abrysvo (67% effective)

RSV is a common respiratory illness that infects up to 90% of children in their first two years of life and frequently reinfects both older children and adults. In most cases, RSV infection is mild and may even go unnoticed – with infants under the age of one year and the elderly at greatest risk. For infants, RSV can cause such severe inflammation of the small airways in the lungs that significant breathing difficulties can occur. There is no pharmacotherapy other than supportive care with fluid and respiratory support. RSV is a leading cause of infant mortality globally and, in
some developing countries, is second only to malaria as a cause of death among infants.

The burden of RSV disease in adults is less well understood but undoubtedly
underestimated given that it is most typically (and correctly) associated with respiratory illness in infancy. The same JCVI grappled with a population-wide rollout of RSV vaccine in the UK where the annual number of deaths was estimated to be somewhere between 741 and 6472. The US has about 5 times the population of the UK so that would translate to between 3700 and 32000 deaths here. They also considered the burden of RSV on the health system in general and concluded that a programme for those 75 years and older would be the most ‘efficient’ but one directed at 65 years and older would provide the most benefit. Note: they only considered the Arevxy, noting that these data provided the most ‘comprehensive read out’ and is also more effective. The committee was hopeful that Arevxy would provide multi-year protection, as RSV does not have the same mutation frequency as COVID-19 and influenza. At $336 a dose, one would certainly hope for longer lasting protection.

Side effects seem to be generally mild but common. 34% of recipients reported fatigue, 29% muscle aches and 27% a headache. These typically resolved in 24 to 48 hours.The current RSV vaccine is recommended only as a single dose for individuals 60 years and older in the United States. I would revise that upwards to 65 years of age. Those most likely to benefit would be those with pulmonary disease (such as COPD or asthma), cardiovascular disease, moderate to severe immune compromise, and diabetes. The CDC does not recommend against co-administration with seasonal flu shot or other vaccines although antibody titers for both influenza and RSV were lower when given together. So my recommendation would be to separate RSV vaccination out from other shots by two weeks.

 

Vaccine Recap

Seasonal Flu: An unqualified, yes
COVID Booster: Everybody 65 and older, patients with an immunosuppressed household member, those under age 64 with a risk factor for severe disease
RSV Vaccine: Everybody over the age of 65, those 60-64 with asthma, COPD, diabetes or immune compromise

.

What’s Happening with COVID?

In August, the Los Angeles County Health Department reported a “concerning increase” in reported COVID-19 cases and indeed cases in our clinic showed a notable uptick as compared to much of the Spring of 2023. We had a total of 13 cases, of which 10 were first time infections (Figure 1 below).

Total COVID-19 Cases(Blue) and Repeat Infections (Red) by Month in 2022/2023: Santa Monica Primary Care

Smoothed Daily incident Case Rate (per 100,000 population) of SARS-CoV2: Los Angeles Country, California

While this did represent a significant increase, it is important to contextualize the magnitude of such against the historic low rates of this Spring. Historically, a mid to late summer surge has been seen in every year since the pandemic began, but rates this summer (Green Line in Figure 3 below) were the lowest we have ever seen, including the Summer of 2020 (Blue Line). We were all under shelter-in-place orders during the Summer of 2020 as well.

Smoothed Daily incident Case Rate (per 100,000 population) of SARS-CoV2: Los Angeles Country, California for 2020(Blue), 2021(Red), 2022(Yellow), and 2023 (Green)

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10 August 2023 Blog Post: Surge, What Surge?

The growing consensus I have heard from patients is that we are having a COVID-19 surge in Los Angeles and, given such, they are wondering what additional precautions need to be taken. I was somewhat surprised to hear that we were experiencing an increase in cases in the County, as this has not been seen in our practice case numbers.

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10 August 2023 Blog Post: Surge, What Surge?

Surge, What Surge?

The growing consensus I have heard from patients is that we are having a COVID-19 surge in Los Angeles and, given such, they are wondering what additional precautions need to be taken. I was somewhat surprised to hear that we were experiencing an increase in cases in the County, as this has not been seen in our practice case numbers. Whereas November 2022 we say 29 cases, case rates here at Santa Monica Primary Care have been a slow drumbeat since March. 6 cases in March, 7 in April, 4 in May, 5 in June, 6 in June and only 2 thus far in the first 10 days of August.

But turning to headlines, I can see why a surge is of concern.  Yesterday the Los Angeles Times headline blared “COVID-19 is heating up all around’ this summer. Should we be wearing masks again?” (link: https://www.latimes.com/california/story/2023-08-09/covid-19-is-heating-up-this-summer-should-we-wear-masks-again).  According to Dr. Peter Chin-Hong, a UC San Francisco infectious diseases expert, said transmission is increasing and “we haven’t seen the crest yet” of the wave.

Now I understand that my small slice of the medical universe is not necessarily generalizable, but generally with a communicative patient population I’m aware when case burdens increase – whether it be flu, RSV, or COVID.  

Reading further into the Los Angeles Time’s coverage, state Epidemiologist Dr. Erica Pan noted that California’s test positivity rates have gone up in the last two to three weeks, “and I’m sure many of you are anecdotally both hearing about friends and family and colleagues … about some more circulating COVID,” Pan said. “Thankfully, our hospitalizations are looking very reassuring so far.”

Those who have followed my blog posts in the past will remember that test positivity rates are an inaccurate and problematic metric as it depends on the denominator of who is being tested. Few go to public health labs or obtain reportable PCR tests any more; rather most COVID cases are identified through home testing which are not reportable to public health agencies.

When diving into Los Angeles County Data, Dr. Pan is indeed correct that test positivity rates have increased, but not just over the past 2 to 3 weeks but rather over the past 2 to 3 months. Test positivity rates were as low as 2.9% in early May and have climbed to 7.9% in the last week in July (Figure 1 below).

Left unmentioned by the Los Angeles Times and Dr. Pan is the sharp decrease in testing itself (the denominator of test positivity). Only 45 Daily tests per 100,000 population are currently being reported to the County (Figure 2 below). For reference, at the height of the January 2022 surge there were 2,744 reportable tests being performed daily per 100,000 population. As numbers become smaller, the accuracy of a reported metric becomes less accurate.

To account for this statistical noise, we turn to prevalence rate which is the estimated number of active (not necessarily infectious) cases per 100 individuals. Currently, the County’s prevalence rate stands at 0.22 or, expressed differently, 22 cases per 10000 individuals. While this is an uptick compared to the rate seen in early May (9 cases per 10000 individuals), it is far lower than the late February rate of 60 cases per 10000 individuals (Figure 3 below).

It is important to note that mid to late summer surges have been a feature of COVID-19 in years past, most notably in 2022 when prevalence rates indeed surged to an estimated 9.7% of the population having the infection.  Placing this summer in perspective – the green line in Figure 4 below suggests that we are having an unexpected lull in cases, certainly when compared to prior years.

This is not to suggest that cases will not increase moving forward. In 2021 (red line), cases increased significantly through late July and peaked mid-August. However, at this point in time, there does not seem to be evidence of increased community transmission nor a particularly significant population burden of disease, particularly when compared to prior years.

Aug 2023 Newsletter

Welcome to the August 2023 Newsletter for

Santa Monica Primary Care.

In this issue, “Vaccine-palooza” we are going to cover all the vaccines that have been recommended this Fall and the rationale for each. This season we will have a new RSV vaccine as well as reformulated seasonal Influenza and a COVID booster. With so many, planning is necessary!

Seasonal Influenza Vaccine

Doses of the 2023/2024 seasonal flu shot have already begun to ship and typically vaccination efforts begin in late August or early September each year. Influenza has a seasonal pattern with outbreaks occurring in the winter months primarily (in tropical regions, it may be more year round). But this is why vaccination efforts begin in the Fall, in preparation for such. This season’s vaccine will have either three components (trivalent) or four (quadrivalent) with the latter being recommended for those over the age of 65 or with chronic conditions.

The decision on which strains to include in the vaccine formulation is based on global
surveillance data but, in the end, is a prediction and not always correct. As such, the
effectiveness of the seasonal flu shot can vary from year to year. It is important to note that even if the vaccine doesn’t completely prevent the flu, it can still reduce the severity and complications of the illness should one become infected.

One of my favorite online resources for influenza is Columbia University’s Flu Forecasting System (link: https://cpid.iri.columbia.edu/) which provides geographic spread predictions by US city. Influenza travels east to west so we will see case spikes along the eastern seaboard before we have a surge of cases in Los Angeles. But, for those who travel for business or leisure, this web resource is helpful to see if you are heading into an area with either a high current case load or a predicted increase. Historically, the peak of influenza cases in Los Angeles has occurred in the last week of December and first week of January, coinciding with holiday travel. My general recommendation is that patients have the flu vaccine by Halloween, although those
who have travel to the east coast or Europe may want to have it sooner.

COVID-19 Booster

Last year at this time, the FDA authorized the use of Moderna and Pfizer Bivalent Vaccines for a single additional booster dose at the end of August 2022. This updated booster was to be given at least 2 months after completion of a primary series or the most recent booster dose of a monovalent (original) COVID-19 vaccine.

Population uptake of the bivalent booster was abysmal – only 17% of the total US population received a booster dose. That percentage is a bit better for those over the age of 65 years at
43.3%.

Similar to influenza, COVID historically (until 2023 that is) has had a Winter surge although there has been historically a mid-summer increase in cases as well (Figure below).

Smoothed Daily Incidence Case Rate (Per 100,000 population) of SARS-CoV2: Los Angeles Country, California for 2020 (Blue), 2021 (Red), 2022(Yellow), and 2023(Green)

Both the CDC and vaccine manufacturers have indicated that COVID booster shots will move closer to an influenza like pattern with the goal to ‘keep up’ with COVID variants. But this isn’t really a true or fair parallel because the seasonal influenza shot is planned and predicted whereas the COVID booster is reactionary. For instance, the Fall 2023 COVID booster, which should gain FDA approval this month, targets XBB.1.5 a coronavirus subvariant that emerged in late 2022. Unfortunately, XBB.1.5 is no longer the primary circulating variant in the US. In fact, it isn’t the second most common, nor the third. It’s the fourth at 12.3%  (link:https://covid.cdc.gov/covid-data-tracker/#variant-summary). 

While the expectation is that the updated booster will provide protection against subsequent variants, I think this is going to be a difficult gap to bridge for the US public and uptake will again be low. The CDC would be better served by making a strong case for those over the age of 65 or those with chronic medical conditions to have the shot rather than an across the boards recommendation for everybody to have it.

Most likely, I will advise patients over 65 and those in higher risk groups to strongly consider having the booster by the end of October in time for an expected late November to January surge in cases (although this never fully materialized in 2022 -2023). I have not seen compelling data to support its use in those that are younger and without risk factors for developing severe disease.

While you can have both the flu vaccine and COVID booster at the same time, it may be more
prudent to separate the two. That way in the case of an unlikely, but possible, vaccine reaction -the cause will be apparent.

RSV Vaccine

This Fall will be the first time that an RSV (Respiratory Syncytial Virus) vaccine becomes available. Approved earlier this year, this vaccine has been recommended for adults 60 years and older based on clinical trial data showing that one dose of the vaccine was ‘moderately effective’ in preventing respiratory tract disease from RSV.

Epidemiologically, RSV affects children more severely than adults and also displays a seasonal pattern with outbreaks more common during the winter months. Infection in healthy adults typically results in mild cold-like symptoms but can lead to more severe respiratory infections inhigher risk groups (infants, young children, older adults and those with a weakened immune system).

Developing a vaccine has been complicated due to the complexity of the virus, the fact that prior infection does not protect against re-infection (even amongst those with high specific antibody titers), and the potential for vaccine-enhanced disease in certain populations. Vaccine-enhanced disease occurs when vaccinated individuals experience more severe symptoms upon subsequent exposure to the virus.

The current RSV vaccine is recommended only as a single dose for individuals 60 years and older. Those most likely to benefit would be those with pulmonary disease (such as COPD or asthma), cardiovascular disease, moderate to severe immune compromise, and diabetes. The CDC does not recommend against co-administration with seasonal flu shot or other vaccines although antibody titers for both influenza and RSV were lower when given together. So my recommendation would be to separate RSV vaccination out from other shots by two weeks

Vaccine-palooza Recap

The Fall of 2023 is shaping up to be a busy vaccination season with seasonal flu, the COVID booster and the new RSV vaccination. While the flu shot itself is generally well tolerated without significant side effects, my general recommendation would be to separate out the vaccine shots by about 2 weeks – particularly the RSV which is a completely new vaccine and has not been studied widely. The finding that antibody titers of both flu and RSV are lower when given together is yet another reason to separate them out.

Also – if you can’t remember what you’ve had when – we have good news for you! Our office recently has integrated the California Immunization Registry (CAIR, now version 2.0) directly into our Electronic Medical Record. Not only do we send vaccination data to the registry for those receiving shots in the office, we are able to query the state registry for vaccines our patients may have had previously at an outside location.

What’s Happening with COVID?

Recently, the Los Angeles County Health Department reported a “concerning increase” in reported COVID-19 cases, detailing a 32% rise in cases week over week. This is a very curious assertion given that the data published by the County do not show this rise. Week over week data are below:

Smoothed Daily Incidence Case Rate (Per 100,000 population) of SARS-CoV2: Los Angeles Country, California

Cases have been in a very narrow band of 2.2 to 2.6 new daily cases per 100,000 population since mid May. The largest week over week rise has been 16% when going from 2.2 to 2.4. Most recently we have seen a slow rise in the last three weeks of 2.2 to 2.4 to 2.6 but nowhere is there a 32% increase.

Cases have also been steady within our own practice with only 4 to 7 cases monthly since March of this year. So case rates remain at historic lows.

Total COVID-19 Cases and Repeat Infections by Month in 2022/2023: Santa Monica Primary Care

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April 2023 Newsletter

Welcome to the April and a Half 2023 Newsletter for

Santa Monica Primary Care.

While published later in the month than usual, the information is not any less timely! In this issue we will cover LA County’s COVID-19 Emergency which ended March 31st, 2023. We also cover our clinic’s Spring experience with COVID-19and provide guidance on “new” booster recommendations.

End of LA County’s COVID-19 Emergency

With very little fanfare, Los Angeles County’s COVID-19 Emergency ended on March 31st – withthe major impact being the closure of County-run testing facilities. But beyond that, not muchchanges. An indoor masking mandate was lifted 13 months ago and face coveringrecommendations for the general public ended two months ago. In healthcare settings, maskscontinue to be required for healthcare workers providing direct patient care or working in patientcare cares. This, however, is a Los Angeles County only requirement as at other healthcaresettings in California, no masks are required whatsoever. It was certainly reasonable for the County to close testing sites as weekly testing rates are thelowest they have been (at 148 tests per 100,000 population) since May of 2020 (Figure below).At their maximum, 2745 tests per 100,000 were performed the week ending 1/11/2022.

Smoothed SARS-CoV2 Daily Testing rate (per 100,000 population): Los Angeles Country

Free testing remains available at LA County Public Health clinics.

Current COVID Incidence and Prevalence

The Los Angeles Times offered this outstanding turn of phrase when reflecting on the lifting of the COVID Emergency:

“But just as March 2020 is now indelibly etched in our collective consciousness— a watershed moment when daily life screeched to a — March 2023 may be remembered as when COVID-19 officially went from top of mind to back of mind.”

From my perspective, I was concerned that we would experience another January surge as wehad in 2021 and 2022 but that never materialized (Figure below)

Smoothed Daily Incidence Case Rate (per 100,000 population) of SARS-CoV2: Los Angeles Country, California for 2020 (Blue)

We are now in our current and expected Spring lull in cases, seen in all years of the pandemic -although 2020 should be interpreted cautiously given that we were under shelter-in-place orders.

Current prevalence rates (active cases per 100 population) are the lowest they have been at less than 0.1% – so fewer than 1 case per 1000 individuals – since October of 2022 (Figure below).

Estimated Prevalence Rate (per 100 individuals) of SARS-CoV2: Los Angeles Country, California

Death Rates - At A Historic Low

One common mantra that has been repeated throughout the pandemic is that of “more cases,more hospitalizations, more deaths.” This is a pattern currently holding in the inverse with deathrates also now at historic lows as case rates are at seasonal lows as well. However, in 2023 withearly detection from accurate home testing and widespread availability of Paxlovid, mortalityrates now stand at 0.02 deaths per day per 100,000 population (equivalent to 2 deaths per dayin LA County, with 10 million people). The last time mortality was this low?

The week of March 17th, 2020.

The figure below is a log transformed graph which shows more clearly just how much mortalityrates have dropped/

Smoothed Daily Mortality Rate (per 100,000 population) of SARS-CoV2: Los Angeles Country, California

Santa Monica Primary Care and COVID-19: Paralleling the County’s Experience

Similar to the County’s experience, we too have seen a massive decline in cases sinceNovember 2021 when we had 29 new cases (and 5 repeat infections). Thus far in April we havehad only 3 cases (2 of which were repeat infections)

Total COVID-19 Cases and Repeat Infections by month in 2022/2023: Santa Monica Primary Care

FDA Recommendations for a Repeat (Second) Bivalent Booster

This past week, the FDA amended the terms of its Emergency Use Authorization (EUA) for theModerna and Pfizer bivalent boosters, permitting individuals 65 and older and those withunderlying immunocompromise to have an additional dose (providing that it has been 4 monthsfrom the last).

In conversations with patients about this new recommendation, I’ve found myself clarifying a fewaspects of the FDA’s communication:

  • This is not a “new” booster, it is a new recommendation. The booster is identical to that originally authorized at the end of August of 2022.
  • The Bivalent booster contains mRNA components from the original strain ofSARS-CoV-2 as well as from the BA.4/BA.5 omicron variants. The BA.4 and BA.5variants have not circulated since the Fall of 2022.
  • This recommendation brings the US more in line with the UK and Canada. In the UK, they have referred to the second bivalent booster as a ‘top off’ for vulnerable populations.
  • Fall 2022 bivalent booster uptake was far higher in the UK than the US. In the UK, 65%of those 50 and over received the bivalent booster, and >80% of those over 70 received the booster. In the US, only 42% of the population over 65 had a booster dose. So some of the rationale for recommending a second bivalent booster may, in fact, be to encourage people simply to get their first.
  • The general expectation is that there will be a new booster available in the Fall of 2023which would be updated for circulating variant(s) at that time and also coincide in timing with an annual flu shot.
  • For now there is little compelling reason if one is young and healthy to have another bivalent booster. Individuals that are older (65 and above) with comorbidities or any immunocom promise could think about one at this point, with the context that cases and deaths are currently at historic lows. 

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March 2023 Newsletter

Welcome to the March 2023 Newsletter for

Santa Monica Primary Care.

In this issue we will break down the anticipated end of LA County’s COVID-19Emergency expected March 31st, 2023.We also cover our clinic’s experience with COVID-19 and how that has paralleled that of the County as a whole.

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End of LA County’s COVID-19 Emergency

On the last day of February, the Los Angeles County Board of Supervisors declared unanimously that the last day of March would mark the end of the COVID-19emergency. It seems emblematic of the County’s pandemic response that a political body of 5 individuals representing 10 million County residents would declare it ‘over.’ To date, the County has recorded 3.5 million cases and 33,859 deaths – both no doubt significant underestimates of the virus’ true impact

But looking at the pandemic as a whole (155 weeks of data), the Supervisors do have a point in declaring the emergency phase over. The presumed January peaking of cases seen starkly in the Figure below that occurred in 2021 and 2022never materialized in 2023.

Smoothed Daily Incident Case Rate(per 100,000 population) of SARS-CoV2: Los Angeles Country, California

Estimated Prevalence Rate (per 100 individuals) of SARS-CoV2: Los Angles Country, California

So when looking at incidence and prevalence rates historically and combining such with a lack of an (expected) January surge, it does appear that we are moving away from an emergency state.

Current COVID “Situation

The Los Angeles Times article highlighting the end of the COVID Emergency (link:https://www.latimes.com/california/story/2023-02-28/la-county-to-end-covid-state-of-emergency-in-march) states the following rationale for moving to a less vigilantposture:

“But given the current situation — with vaccines and therapeutics plentiful and hospitalization and death rates having tumbled without the sort of aggressive interventions seen earlier in the COVID-19 era, such as mask mandates and stay-at-home orders — officials said the emergency declaration was no longer necessary.”

To be sure, there is no lack of vaccine availability, both the primary series and the bivalent booster remain available from a variety of sources. Stocks are available because only 17.5% of eligible County residents have received the bivalent booster, although this is slightly better than 16.1% nationally.

“Plentiful” therapeutics, however, this really isn’t the case. Monoclonal antibodies have had their use authorization revoked as they have not demonstrated efficacy against Omicron and subsequent variants. This includes: Bamlanivimab,Estesevimab, Bebtelovimab, Casirivimab, Imdevimab, and Sotrovimab. Even Evusheld, which is a long acting monoclonal antibody used for COVID-19prevention among those who may not have mounted an adequate immune response, has been removed from the market

What is available is Paxlovid which has its clearest benefit among unvaccinated adults who have risk factors for progression to severe disease. Accumulating observational data suggest that high-risk vaccinated individuals also benefit and alarge VA study has shown a 30% risk reduction in long COVID from Paxlovid. Therehas been no difficulty in prescribing or obtaining Paxlovid through local pharmacies.

However, Paxlovid interacts with a variety of medications, most particularly medications for cholesterol, hypertension and migraines as well as blood thinners. For some patients, these medications can be held during the 5 day treatmentwindow but, for others, Paxlovid cannot be given. The only other recommendedCOVID-19 therapeutic in Remdisivir but this is administered intravenously for three consecutive days which each administration taking up to two hours. So, functionally, only one therapeutic is plentiful.

Death Rates - Have They Tumbled?

Hospitalization data are not published in a raw format by Los Angeles County, so we cannot independently evaluate the Board of Supervisors statement about hospitalizations having tumbled. But mortality rates are trending lower after a small rise in November and December 2022. They currently stand at 0.06 daily deaths per100,000 individuals. They peaked at 2.8 daily deaths per 100,000 in mid-January2021 and rose as high as 0.87 in February 2022. The lowest rates (0.03) have been seen in a couple of instances: June 2021 and May 2022.

A factor of 100 makes the County-wide mathematics easy when considering the totals. Currently, 6 County residents (0.06*100) die from COVID daily. At the peak that number was 280 and at the lowest, that total was 3. Extrapolating this out further, COVID at its lowest observed rate (10.95 deaths annually per 100,000population) would place it as the 11th leading cause of death in the County above motor vehicle accidents (8.6) and below colorectal cancer (14.2). Since we wear seatbelts and have colonoscopies, it would seem prudent from a public health perspective that we do something about COVID moving forward.

Smoothed Daily Incident Case Rate(per 100,000 population) of SARS-CoV2: Los Angeles Country, California

Santa Monica Primary Care and COVID-19: Paralleling the County’sExperience

Similar to the County’s experience, we too have seen a steady decline in casessince November 2021 when we had 29 new cases ( and 5 repeat infections). InFebruary 2023 we had only 9 cases, all of which were first infections. Totals fromJanuary 2022 until the end of February 2023 by month are outlined in the Figurebelow

Total COVID-19 Cases and Repeat Infections by month in 2022/2023: Santa Monica Primary Care

Paxlovid Prescribing Patterns and Rebound

Given the significant benefits of Paxlovid in reducing severe disease and hospitalization as well as in reducing the risk of long COVID, I have been a proponent of early use of this medication. Of the 260 COVID cases we have had in the practice since Paxlovid came on the market, 96 (36.9%) received Paxlovid. This is significantly higher than the national rate where only about 20% of those eligible for Paxlovid have received the treatment.

The biggest downside of Paxlovid continues to be rebound which can occur about10 to 14 days after beginning treatment. It is typically characterized by a day or two of very mild symptoms but a positive rapid antigen test. I have advised patients to assume they are infectious and able to transmit the virus during these rebounds, although I have not seen any instances of such.

While Pfizer (who manufactures Paxlovid) reported a 2.3% rebound rate in their studies, a more recent Oxford study suggested that this rate was significantly higher at 14.2% (link: https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciad102/7049992?login=false)

Our observed rate in clinic is higher still at 24% (23 rebound cases among 96treated).

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February 2023 Newsletter

Welcome to the February 2023 Newsletter for

Santa Monica Primary Care.

COVID At A Crossroads
In this issue we will focus exclusively on COVID-19 as 2023 has seen a fundamental(although not necessarily correct) shift in how we are approaching SARS-CoV-2 andthe clinical consequences of infection.
As always, we will start with fundamentals and along the way answer the commonquestions we are hearing in the clinic.

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Is It Still A Pandemic?

This is an interesting question and critical question – one which was posed to me just last week by a patient. Rephrasing the question in epidemiologic terms gives the following, “is COVID-19 an epidemic still or is it endemic.” So are there new case sex ceeding what we expect (epidemic) or is it now a constant presence (endemic)? Case rates in Los Angeles County have declined substantially since our 2022 mid-summer peak. In fact, even the case surge we experienced in November was only half the magnitude (34.8 new daily cases per 100,000 population) of that seen at the summer maximum (64.7).

Smoothed Daily Incident Case Rate(per 100,000 population) of SARS-CoV2: Los Angeles Country, California

This significant decline is more readily apparent when we look at prevalence(number of active cases per 100 County residents). In mid to late July 9.7% of the population had an active COVID infection, and now it is 0.4%.

Estimated Prevalence Rate (per 100 individuals) of SARS-CoV2: Los Angles Country, California

So to answer the epidemic versus endemic question, it looks like we are approaching endemicity with a base expected incidence rate of 8-10 new daily cases per 100,000 population and a prevalence rate of 0.3-0.4%. For large portions of the year we experience this low, steady rate of community transmission but at other times we are having significant surges in activity. The question being – can we predict when those surges might occur? More below..

Is It Seasonal?

If you had asked me this question the last week of December 2022 I would have said‘ absolutely’ but this past January did not follow the trend we had seen in prior years. The figure below shows weekly incident case rate data for every year of the pandemic (2020 Blue, 2021 Red, 2022 Yellow, and 2023 Green). In both 2021 and2022 we had a distinct (and massive to the point that the axis is changed in the figure to accommodate the Omicron outbreak visually) increase in cases beginning in mid November and extending until mid February. That is, until 2023. We had an increase in cases beginning mid-November (yellow line, far right) but then cases plateaued in December and collapsed in January (green line, far right).

Smoothed Daily Incidence Case Rate (Per 100,000 population) of SARS-CoV2: Los Angeles Country, California 2020 (Blue)

Evusheld - Where Have You Gone?

As of January 26th, 2023 Evusheld is no longer authorized by the FDA and will be unavailable to patients. This is a significant and alarming development for immunocompromised individuals as well as those who did not tolerate vaccinations /boosters and relied on Evusheld’s protection. The FDA estimated that “fever than10% of circulating variants in the US causing infection are susceptible to the product.”

This decision was based not on epidemiologic data but instead on laboratory experiments (nevertheless valid) which showed as early as May of 2022 that theBA.4 and BA.5 Omicron subvariants had “escaped or reduced the activity of monoclonal antibodies developed for clinical use” but that Evusheld and Sotrovimab still showed activity (Tuekprakhon et al. link:https://www.biorxiv.org/content/10.1101/2022.05.21.492554v1.full.pdf). In July, Boschi et al. reported that Evusheld’s neutralization was 233 times less active on Omicron than the Delta variant, suggesting of “limited efficacy” (link:https://academic.oup.com/cid/article/75/1/e534/6529556).

Fortunately, there is accruing evidence that polyclonal antibody preparations – suchas plasma from vaccinated and previously infected individuals (terms: convalescent plasma) – would restore protection amongst immunocompromised patients. For amore detailed discussion, readers can refer to this excellent STAT News article – link:https://www.statnews.com/2023/02/06/covid-convalescent-plasma-antibody-therapy/

Blog This Month

Our blog posts this and previous months can be found archived on our website at www.drbretsky.com/blog. Our blog post this month covered booster vaccinations
https://drbretsky.com/12-january-2023-blog-post-on-covid-boosters/

Variants, Variants and more Variants

Both BA.4 and BA.5 (included in the currently available bivalent booster) have now essentially vanished according to CDC data. For Region 9 (which includes Arizona, California, Hawaii and Pacific Territories), BA.4 and BA.5 make up only 0.2% of the currently circulating variants, as compared to 3.9% in January and 90.1% in early August 2022.

KBB.1.5 which was 7.0% of the total variant population in early January 2022 is now the most common at 45.8% with BQ.1.1 and BQ.1 at 31.0% and 13.6% respectively. Initial concerns for an increased transmissibility of this variant were based on observations in China which, until recently, had held to a zero COVID policy and has a largely immunologically naive population. As noted above, cases in our region have decreased in January 2023 during the time period when KBB.1.5 increased infrequency. The general consensus had been that KBB.1.5 does not cause any more severe disease than Omicron or its subvariants.

Link: https://covid.cdc.gov/covid-data-tracker/#variant-proportions).

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12 January 2023 Blog Post: On COVID Boosters

12 January 2023 Blog Post: On COVID Boosters

It is a question I get a lot these days – “How is the bivalent booster working?”

Not well is the answer.

Without even delving into the immunogenicity and efficacy data, the booster isn’t working well simply when its most important metric – uptake.  To date, an abysmal 15.4% of the population eligible for the bivalent booster have received it (link: https://covid.cdc.gov/covid-data-tracker/#datatracker-home).

A critical fraction of individuals must be vaccinated in order to either control or eradicate an infection with a specific base reproductive ratio (remember in 2020 when we were talking about R-naught / R0?). For disease with high transmission potential, the vaccination fraction would be higher than for those diseases with lower transmission potential.  Generally the R0 of COVID is felt to be between 1.8  and 2.5 which would mean that about 40-50% of the population would need to be vaccinated to make an appreciable difference in transmission rates.

In a concise and readable format, Dr. Paul Offit from the Vaccine Education Center at UPenn, details the “underwhelming” immunity response derived from the bivalent boosters (link: https://www.nejm.org/doi/full/10.1056/NEJMp2215780) suggesting that booster dosing is ‘probably best reserved for the people most likely to need protection against severe disease.” He argues against boosting healthy young people with “vaccines containing mRNA from strains that might disappear a few months later.”

And, in fact, the public would agree – even Maine which has amongst the highest booster vaccination rates in the US.  By age group (link:https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-people-booster-percent-pop65):

Age Group             Percentage of Population with Updated Booster Dose

5+:                          28.5%

12+:                        30.2%

18+:                        31.7%

65+:                        63.6%

But, with all due respect to Dr. Offit, this isn’t really public health policy – all he has done is held up a reflective glass to the actual population trend (and supported such with immunologic data). But kudos for dealing with reality.

A more effective public health strategy, I would argue, would be to boost the population (with priority to those most susceptible to severe disease) with vaccines containing mRNA from strains that will appear. We already do this for influenza wherein the components of the annual flu shot are based upon data from 144 national influenza centers in over 114 countries that conduct year-round surveillance for flu viruses. Vaccine components are selected based upon which viruses are making individuals sick, the extent to which those viruses are spreading prior to the upcoming season and how well the previous year’s vaccine might protect against such. A combination of active surveillance and retrospective analysis of the variants that have emerged (alpha, delta, BA.1, BA.4, BA.5) would be our best chance of developing a more effective, longer lasting booster. 

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January 2023 Newsletter

January 2023 Newsletter

Welcome to the January 2023 Newsletter for Santa Monica Primary Care – our first newsletter of the New Year!

In this issue, we are going to cover the current state COVID cases and will share our practice experience with COVID plus trends in LA County at large. 

We will also highlight a couple of initiatives that we have planned for 2023.

COVID-19 at Santa Monica Primary Care and in LA County

Readers may find it surprising that we actually saw less COVID in December than we did in November. COVID-19 cases in our practice decreased by more than 50% month over month (Graph below). After managing 27 cases in November (one of which required hospital level care), December brought 13 cases.  Of these 3 (23%) were repeat infections.

As I collated Los Angeles County numbers I noticed that we are on row 1035 of the spreadsheet. Little did I imagine in March of 2020 when I began collating the case counts that we would find ourselves in Year 3 of the pandemic.

Cases in Los Angeles County show essentially the same trend, although press reports relying heavily on guidance from County officials would lead one to believe otherwise (link: https://abc7.com/coronavirus-los-angeles-la-covid-cases-new-years-eve/12629266/).  Cases in the County also dropped nearly 50% from 34.5 to 19.8 new daily cases per 100,000 population between from the start until the end of December. 

What County officials are not talking about, however, are persistently elevated COVID mortality rates, despite a decline in cases (Figure below).

In 2020, the average mortality rate was 0.37 deaths per 100,000 population per day.  In 2021 this rose to 0.41 daily deaths per 100,000 population (largely driven by rates >2 in January and early February before vaccines were widely available).

So where would you expect mortality rates to be in 2022 given widespread vaccination, boosters and effective treatments such as Paxlovid.  Much lower, right?  Would 90% be a reasonable assumption – I would think so given that clinical trials have shown up to a 94% reduction in mortality risk with 3 mRNA vaccine doses during Omicron (link: https://www.cdc.gov/mmwr/volumes/71/wr/mm7112e1.htm?s_cid=mm7112e1_w)

Instead we are really only seeing about a 50% reduction in mortality, as at the end of 2022 the mean number of daily deaths stood at 0.18 daily deaths per 100,000 population. Yet I’ve seen little substantive discussion from the County attempting to understand who is dying of COVID and why that is occuring, but instead a dogged / singular focus on reducing cases (which is sound public health policy as reducing cases reduces mortality but there seems to be some subtlety that they are missing). 

One question which I would like to put to Dr. Ferrar is as follows:  Why in July of 2022 was the mortality rate 0.16 with a case rate of 61.8 but in December there was a mortality rate of 0.12 with a case rate of 19.8?

Paxlovid Prescription Trends and “Rebound”

Given the strong clinical data on the significant reduction in long COVID among those treated with Paxlovid (covered in December’s newsletter), utilization rates of this medication have gone up in our practice . Of the 13 individuals who tested positive for COVID-19 in December, 7 elected to begin Paxlovid (53%). Similarly, in November 17 of 27 (63%) took Paxlovid. In October only 3 of 13 cases (23%) chose to begin the antiviral.

The biggest downside of Paxlovid is the “rebound” phenomenon with a return of symptoms and again testing positive, usually about two weeks after the initial positive test. Overall about 25% of the patients for whom we have prescribed Paxlovid experience clinical and testing rebound of the disease but in December only 1 of 7 treated rebounded.

The biggest upsides of Paxlovid include a rapid clinical response where those treated are feeling better, faster – usually in 1-2 days after starting the medication. There is also strong clinical evidence of an up to 30% reduction in the risk of long COVID symptoms as well.

Two New Initiatives in 2023

Each year I try to do “one new thing” in the practice, although it always seems to be more than one. So in the spirit of realism, I will highlight the two new things we will introduce in 2023.

Get DNAbled Program

In 2022 we took our first foray into formal genetic risk analysis with the Galleri cancer screen, based on DNA methylation patterns. While this remains a viable next step (but not a replacement for) routine cancer screening (e.g. mammography, prostate examinations / PSA, and colonoscopy) this year we will also offer a comprehensive pathway for full genome scanning via a partnership with DNAbled – https://getdnabled.com/our-program.html .

For additional detail,see also: https://drbretsky.com/genomic-analysis/

Aledade

In 2023 our Medicare Shared Savings Program will begin formally as part of our ongoing collaboration with Aledade to improve both quality of care and value of care. The lynchpin for this effort will be the annual wellness examination – software developed by Aledade integrates to our Electronic Medical Record platform and identifies patients that are due for such as well as any gaps in their care. Specific emphasis will be on hypertension, diabetes and women’s health initially. Further, with their support, we will seek to manage transitions of care – such as from the hospital to skilled nursing facility and back home. Or, even better, find opportunities to keep patients out of the hospital entirely.

 

We have spent much of 2022 in a slow ramp up position for this effort which will be considerable as Medicare-age patients are a much higher proportion of our practice at Santa Monica Primary Care than most general scope practices – reflecting the age structure of the geographic area.  We have a parallel program already with Anthem Blue Cross that has been running in 2022 and will continue into 2023.  For more information on the transformative work that Aledade is doing with practices across the country, check them out at https://www.aledade.com/our-solutions

Blogs This Month

Our blog posts this and previous months can be found archived on our website at www.drbretsky.com/blog. Our blog post this month covered a couple of COVID topics.

In the first, “Observed Over Expected” we attempted to quantify the true population rates of COVID infection given that the overwhelming majority of cases are now diagnosed by home antigen testing – something that is no longer reportable to the Country Health Department.  The link for this blog is: https://drbretsky.com/13-december-2022-blog-post-observed-over-expected/ 

In our second effort, we covered yet again another Board of Supervisors foray into COVID policy, something I always find interesting because the Health Department falls under the governing scope of the LA Board of Supervisors. Nevertheless, Supervisor Hahn chose to give her thoughts to Fox 11 News.  That link: https://drbretsky.com/15-december-2022-on-protecting-yourself/ 

Variants, Variants and more Variants

Both BA.4 and BA.5 (included in the currently available bivalent booster which has been administered to a whopping 15% of the eligible population over the age of 5) are occupying a smaller and smaller proportion of currently circulating and forecasted variants.  

For Region 9 (which includes Arizona, California, Hawaii and Pacific Territories), BA.5 makes up only 3.9% of currently circulating variants as compared to 90.1% in early August. BQ.1 and BQ.1.1 are estimated to comprise 31.1% (holding steady, was 31.5% in early December) and 40.6 (rising from 31.1% in early December) respectively of the total population of variants (link: https://covid.cdc.gov/covid-data-tracker/#variant-proportions). KBB and KBB.1.5 comprise 7.6% and 7.0% of the total.

A late November CDC study suggests that the bivalent booster provided additional (but not great) protection against symptomatic SARS-CoV2 infection, even in time periods where BA.4/BA.5 sublineages (including BQ1 and BQ1.1) predominated. In this study including over 350,000 (of whom a shocking 25% were unvaccinated) the bivalent vaccine efficacy topped out at 56% (for reference, seasonal influenza vaccine is about 50% effective) amongst those 18-49 who were more than 8 months out from their prior booster. For the highest risk group (those 65+), the bivalent booster was only 43% effective when given 8 months or more after the prior booster. If given within 2-3 months, it was 28% effective. Link: https://www.cdc.gov/mmwr/volumes/71/wr/mm7148e1.htm?s (Note that Table 3 is the most useful representation of their data).

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