21 November 2022 Blog Post : Paxlovid and Long COVID

21 November 2022 Blog Post : Paxlovid and Long COVID

A recent study published through the Department of Veterans Affairs has suggested that Paxlovid treatment within 5 days of COVID-19 symptoms can reduce the risk of long COVID (news story link: https://www.militarytimes.com/news/coronavirus/2022/11/07/va-study-finds-paxlovid-may-help-prevent-long-covid-19-problems/).  Researchers examined a total of 56,340 participants of whom 9,217 were treated with Paxlovid and 47,123 who were treated with supportive care (i.e. no antivirals or monoclonal antibodies within 30 days of infection). Study dates were from March 1st to June 30th 2022 (paper link: https://www.medrxiv.org/content/10.1101/2022.11.03.22281783v1.full.pdf). 

The authors define long COVID as “Post-Acute Sequelae of SARS-CoV-2” or PASC and, in the study, identified those individuals who suffered from at least one extended outcome from a total of 12 pre-specified outcomes beginning 30 days after infection (and, importantly, did not display this outcome prior to COVID-19 infection). The same primary author had characterized PASC to include pulmonary, cardiovascular, hematologic, GI, kidney, mental health, musculoskeletal, and neurologic disorders as well as fatigue (link: https://www.nature.com/articles/s41586-021-03553-9). 

So looking at the study, it was interesting to see that about 16% of the cohort (all outpatient as Paxlovid is approved for non-hospital use) was prescribed Paxlovid. As a comparison, in our practice, 44 of 166 patients diagnosed in 2022 have been prescribed Paxlovid (26.5%). The mean age in the VA study was 65 years (65.06 for those prescribed Paxlovid and 65.07 for those who received supportive care). One limitation of the VA study, however, is that it was predominately (87.6%) male perhaps limiting conclusions about Paxlovid efficacy among women (this is, of course, a reflection of the VA population as a whole and not a specific critique of this study in particular). An additional oddity in the data was that 25% of the VA population studied in this effort was unvaccinated which is slightly higher than the 20% of the US population that has not received any COVID vaccination whatsoever.

Additionally, Paxlovid was given in the majority of occasions (80% of the time) to individuals who had completed a primary series of vaccination or had a primary series plus a booster. Only 16% of the time was the treatment given to an unvaccinated individual which, of interest, is the only cohort in whom Paxlovid has been shown to have significant clinical benefit. As an aside, a relative risk reduction of about 50% was seen in terms of likelihood of hospitalization or death among those who had received the COVID-19 vaccine, but this did not attain statistical significance (link: https://www.pfizer.com/news/press-release/press-release-detail/pfizer-reports-additional-data-paxlovidtm-supporting). This intersection between vaccination and treatment also extended to influenza vaccination where 71% of those treated with Paxlovid had received a seasonal flu vaccination as opposed to 60.2% of those in the control group.

On the other hand, it did appear that Paxlovid was given appropriately to those with more chronic clinical conditions that would leave them at increased risk of poor outcome.  Those in the treatment group were heavier (BMI: 30.94 versus 30.55; as a quick aside the mean BMI of all participants was 30.61 and obesity is defined as a BMI above 30), more frequently had a cancer diagnosis (15.0% versus 12.9%), diabetes (33.9% versus 29.8%; again noting that the prevalence of diabetes was 30.5% in the entire cohort), cardiovascular disease (30.9% versus 29.1%) and elevated cholesterol (80.9% versus 71.4%; noting that 73% of the entire study group had high cholesterol).

In the VA study, Paxlovid treatment was associated with a reduced frequency of long COVID (PASC) with 9.43 per 100 individuals reporting long COVID symptoms at 90 days in the control group as compared to 7.11 among those treated with Paxlovid – a 26% reduction in risk. Despite being less well at baseline, those treated with Paxlovid also had reduced rates of hospitalization (2.57 events per 100 patients as compared to 3.66 in the control group) and fewer deaths (0.30 deaths per 100 patients treated versus 0.58 in the control group), also at 90 days.  As a comparison, mortality rates for those hospitalized with COVID-19 during Delta were 15.1 per 100 and during Omicron, 4.9 per 100. Numbers reported in this VA study were during Omicron as well.

The authors take their analyses a couple of steps further, which is helpful to better elucidate the precise role of Paxlovid beyond a statement that it ‘reduces Long COVID.’  They tested the association between Paxlovid and the risk of PASC according to the number of baseline risk factors for progression to severe acute COVID-19 illness. While Paxlovid was associated with reduced risk of PASC in people across different risk factors strata, no pattern emerged.  Among those with fewer than 2 risk factors, Paxlovid reduced the risk of long COVID by 33%. The same magnitude of effect was seen among patients with 3-4 risk factors but dropped slightly for those with 5 or more to 30%.

We know from Pzifer’s clinical trial studies that the greatest magnitude of protective effect in terms of reduction of hospitalization and death rates was seen among those who were unvaccinated. A similar pattern emerged in this study when it came to long COVID. While Paxlovid reduced the risk of PASC/Long COVID among those vaccinated and boosted by 21%, it lowered the risk by 32% among the unvaccinated.

Lastly, Paxlovid was associated with reduced risk of PASC in people with primary SARS-CoV-2 infection and in people with reinfection to an identical degree, both with a 25% reduction in Long COVID risk.

To date, Paxlovid has been a ‘no brainer’ treatment among those who are unvaccinated, given strong clinical evidence of efficacy in reducing hospitalization and death. Of course, the vaccination and boosters have also shown strong efficacy in reducing COVID-19 hospitalization and death but that is a separate discussion.  This current VA study suggests that among their cohort (average age of 65 years, 75% Caucasian, 20% African American, 87% male and 42% former smokers), there may be an additional benefit – namely in the reduction of Long COVID. As with the general indications for prescribing Paxlovid in general, it seems that among an older, male population with comorbidities including prior tobacco, that Paxlovid is efficacious. It would be helpful to see additional studies in other populations, particularly comprised of a greater proportion of women.

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November 2022 Newsletter

November 2022 Newsletter

Welcome to the November 2022 Newsletter for Santa Monica Primary Care. 

In this issue, we are going to cover the alphabet soup of COVID variants and try to predict what may happen as we enter the Holiday Season. We will share our current practice experience with COVID cases as well as trends we are seeing in LA County at large. Lastly, we cover this month’s Blog posts, including one on the utility of colonoscopies in reducing colon cancer mortality rates.

COVID-19 in the Practice and in LA County 

COVID-19 cases in our practice have shown a slight rebound as compared to the dramatic slowing of September (Figure below).  The month of October left us with 10 cases, one of which was a repeat infection and the remaining 9 all initial infections. Cases were generally mild (5 of the 10 were characterized as such) but one did lead to hospitalization.  Of the three cases treated with Paxlovid, one led to a rebound phenomenon.

Cases in Los Angeles County, on the other hand, continue to be on the decline, and are now the lowest levels since March of this year (Figure below). The most recent daily incidence rate is 7.4 new daily cases per 100,000 population down from 7.9 the week prior.

This trend runs in direct opposition to comments from the LA County Health Department which notes that ‘coronavirus cases are no longer declining at the rate seen over the summer and appear to have plateaued.’ LA County Health Department Director Dr. Ferrer commented, “We’re no longer seeing a steady decline in cases” as LA County’s case rate began showing week-over-week increases just after mid-October (link: https://www.latimes.com/california/story/2022-11-01/new-coronavirus-omicron-subvariants-bq1-bq11-ba5).   

The prevalence rate is also the lowest it has been in many months at 3 active cases per 1000 residents (Figure below).

Lastly, mortality rates have shown a steady decline since mid-summer and are now as low as they have been since April 2022.

BA.4/BA.5 Bivalent Booster Uptake Remains Slow

In August, the FDA authorized the use of Moderna and Pfizer Bivalent Vaccines for a single additional booster dose 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. The Pfizer booster is authorized for individuals 12 years of age and older. The Moderna for those 18 years and older.

According to the latest CDC data (link: https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-people-additional-dose-totalpop), only 22 million – or 7.3% of those eligible – have received a bivalent booster dose.  This has increased from 7.6 million (3.5%) last month at this time.

Blogs This Month

Our blog posts this and previous months can be found archived on our website at www.drbretsky.com/blog. As a bit of a departure, we covered a recent report suggesting that colonoscopies were not as effective in reducing colon cancer mortality. While this generated a fair amount of press coverage, the study itself was actually not all that compelling and certainly was not enough to change clinical recommendations of colonoscopy as a screening tool

On Colonoscopies:  https://drbretsky.com/11-october-2022-blog-post-on-colonoscopies/

We also covered COVID-19 in 2022 as compared to 2020 and 2021 in our second blog:

https://drbretsky.com/13-october-2022-blog-post-a-crazy-covid-year/

The Alphabet Soup of Variants

BA.5, BQ.1, and BQ.1.1 are among the ever growing population of variants of concern. But, in reality, tried and true BA.4.6 and BA.5 make up 84.6% of the variants sequenced across the United States (link: https://covid.cdc.gov/covid-data-tracker/#variant-proportions) and 83.3% of the variants seen in HHS Region 9 which includes California, Arizona, Nevada and Hawaii. While the proportion of BA.4 and BA.5 is decreasing over time (Figure below), they are nevertheless the overwhelming majority of variants seen both regionally and nationally. With booster vaccines that are directly matched to these variants, we should continue to see decreasing case rates and mortality rates.

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13 October 2022 Blog Post: A Crazy COVID Year

13 October 2022 Blog Post: A Crazy COVID Year

Reflecting on this weekend’s LA Times article headlined “With COVID on the retreat, are Halloween, Thanksgiving and winter holiday gatherings safe?” (link: https://www.latimes.com/california/story/2022-10-10/with-covid-on-the-retreat-how-safe-are-holiday-gatherings), my first question was – “is COVID really on the retreat?”

The short answer is, yes. Although what a year we have had!  Things started out with an Omicron bang in January as both incidence and prevalence rates hit dizzying new heights. Test positivity rates were so high in January that it broke our prevalence calculator which estimated that for the week ending 1/11/2022 that 72% of the County residents had the infection. We are much, much, much lower now with a 0.5% (1 in 200 residents) with active infection – down from a midsummer high of 9.8%. Our best week was that ending 3/22/2022 at 0.05% (1 in 2000 residents). So, yes, depending on your perspective COVID is in retreat. Figure 1 below graphs prevalence rate.

A similar trend is seen in incidence rates – readers will know that I have moved away from this metric as it does not include results from home rapid antigen (lateral flow) tests as the County does not tabulate these or permit reporting of these results. But even looking at only PCR results from accredited laboratories, this rate too is in retreat with 9.97 new daily cases per 100,000 for the week ending 10/4/2022 (most recent week for which complete data are available). This rate was 453.19 new daily cases per 100,000 the week ending 1/11/2022.  Figure 2 below graphs incidence rate.

Mortality follows cases and, as expected, current COVID-19 mortality rates are also “retreating”.  There are currently 0.03 daily deaths per 100,000 population in the County, as compared to our peak of 0.82 daily deaths per 100,000 the week ending 2/8/2022 (note the lag time between peak prevalence/incidence and peak mortality of about 3 weeks – again a pattern we’ve seen time and time again during the pandemic).  Figure 3 below graphs mortality rate.

Historically, October has been a time of relative COVID lull. Interestingly, 2022 (Yellow) had the highest historical midsummer prevalence rate (nearly 10% at maximum) as compared to 2020 (Blue) and 2021 (Red).  Prevalence rates for the week ending October 4th were low in all years:

 

2020:  0.4%

2021: 0.1%

2022: 0.5%

Enjoy the lull, because based on our 2020 and 2021 experiences, it isn’t a great secret about what happens next (Figure 5 below).

𝗦𝗶𝗴𝗻 𝗨𝗽 𝗳𝗼𝗿 𝗢𝘂𝗿 𝗡𝗲𝘄𝘀𝗹𝗲𝘁𝘁𝗲𝗿

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11 October 2022 Blog Post: On Colonoscopies

11 October 2022 Blog Post: On Colonoscopies

Interestingly enough, the effectiveness of colonoscopy has never been evaluated using a gold-standard clinical trial wherein one group (treatment) is evaluated for colon cancer with a colonoscopy and a comparison (control) group is not. This week, the New England Journal of Medicine published results from a “pragmatic” clinical trial wherein over 84,000 men and women between the ages of 55 and 64 years of age from Poland, Norway, Sweden and the Netherlands were split (1:2 ratio) between being “invited” to have a colonoscopy versus “usual care” (no colonoscopy or screening offered).  The study recruited patients between 2009 and 2014, and followed them for up to 10 years (Bretthauer et al.  Link: https://www.nejm.org/doi/full/10.1056/NEJMoa2208375). 

The study found a risk of colon cancer at 10 years to be 0.98% in the invited group versus 1.20% in the usual care group. Mortality rates were 0.28% in the invited group versus 0.31% in the usual care group. 

So at face value, colonoscopy seems to be a pretty underwhelming screening tool – but a couple of caveats:

  1. The invited study population was between 55 and 64. Current US recommendations are for colonoscopy to begin at age 45. Earlier screening, in general, has more robust benefits rather than later screening so the older age cohort is a limitation of this study.
  2. Colon cancer itself, generally speaking and exclusive of more aggressive cases, can take many years to progress from polyp to cancer may be greater than the 10 years of follow-up undertaken by this current study. So a longer study period would be preferable.
  3. Of those study participants invited to have a colonoscopy (total of 28,220 individuals) only 42% (11,483) underwent the procedure. This is a significantly lower percentage of colonoscopy uptake than is typically seen in the US where about 70% of those who are offered colonoscopy then have one.

So overall a very interesting study and even when analyzed with ‘intent to treat’ (i.e. considering all 28.220 as having had a colonoscopy even though only 11,483 did), there was an 18% risk reduction effect associated with the procedure. In short:

“I don’t think this should change our practice,” said Dr. Robin Mendelsohn, a gastroenterologist at Memorial Sloan Kettering Cancer Center in New York City. “The bottom line is still get screened, still have the discussions” with your doctor.

𝗦𝗶𝗴𝗻 𝗨𝗽 𝗳𝗼𝗿 𝗢𝘂𝗿 𝗡𝗲𝘄𝘀𝗹𝗲𝘁𝘁𝗲𝗿

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October 2022 Newsletter

October 2022 Newsletter

Welcome to the October 2022 Newsletter for Santa Monica Primary Care. 

In this issue, we are going to try to triangulate the state of COVID-19 in Los Angeles County. We will share the current practice experience with COVID and explain how the bivalent boosters might be so exciting. We will also cover the Blogs posted by Dr. Bretsky this month.

1. COVID-19 in the Practice and in LA County

COVID-19 cases in our practice have slowed dramatically (Figure below) with only 5 cases reported the entire month (2 repeat infections, 3 first time infections).  In August we had 12 cases (3 were 2nd infections).  In July we had 18 cases (3 were  2nd infection), June saw 29 cases (3 were 2nd infections) and in May we managed 33 infections (3 were 2nd infections). I had expected a bit of an uptick in cases with the start of school but this has not occurred, at least in our small sample.

Trying to figure out what is occurring in terms of case rates at the County level is still a bit of a guessing game – most notably hampered by the fact that the overwhelming majority of cases are diagnosed via home testing and, by the County’s case definition, are not reportable. That notwithstanding, incidence case rates have declined steadily since mid July (Figure below).

In previous issues we have discussed how a calculated prevalence rate might be a more accurate representation of the true case frequency. Current prevalence rates are as low as they have been since May at 0.7 active cases per 100 individuals.

2. BA.5 Bivalent Booster Uptake

As most of you likely know, the FDA authorized the use of Moderna and Pfizer Bivalent Vaccines for a single additional booster dose at the end of August. This updated booster is 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. The Pfizer booster is authorized for individuals 12 years of age and older. The Moderna for those 18 years and older.

According to the latest CDC data (link: https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-people-additional-dose-totalpop), only 7.6 million individuals – about 3.5% of those eligible for the updated COVID booster – have received one. Of additional concern is that awareness of the new boosters is “modest” according to a recent survey (link: https://www.kff.org/coronavirus-covid-19/poll-finding/kff-covid-19-vaccine-monitor-september-2022/). One in five people surveyed have heard “nothing at all” about the new booster as compared to 17% who have heard “a lot.”

Personally, I’m pretty pumped (as Parker Schnabel would say – for my fellow Gold Rush fans out there – Discovery Channel Friday nights) about the new booster and am hopeful that it generates more specific and durable immunity than the prior boosters. Why would I feel this way?

Well, firstly, the current booster is matched with the dominant circulating strains as it contains an mRNA component from the BA.4 and BA.5 Omicron variants. The graphic below shows that these account for the overwhelming majority of variants isolated in the United States: BA.5 at 85% and BA.4 at 13%.

Additionally, this is one of the first times that we have not been vaccinating or boosting into the teeth of a case rise. Given such, the relatively slow uptake of the booster dose is less concerning as we do have the luxury of time, for once. With a general rule of thumb being that it takes about two weeks for the booster effect to take hold in our immune system, the continued decline in cases makes it less likely that one will be exposed to the virus soon after the booster dose – perhaps before it takes effect. 

I generally have been advising patients to strongly consider having the booster by the end of October – which is also a guideline for the seasonal influenza vaccine. While you can have both 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.

3. Blogs This Month

Our blog posts this and previous months can be found archived on our website at www.drbretsky.com/blog. This month we had two Blogs covering booster shots. One in the context of the seasonality of COVID (a trend which has clearly emerged) and the other structured as a Q&A session on the boosters itself.

Booster Shots and COVID Seasonality: https://drbretsky.com/9-september-2022-blog-post-new-booster-shot-heralds-covid-seasonality/

Booster Q&A: https://drbretsky.com/13-september-2022-blog-post-fall-2022-covid-boosters/

Our third blog covered more well-trod ground looking at incidence and prevalence rates of COVID-19 in Los Angeles:

https://drbretsky.com/14-september-2022-blog-post-mid-september-covid-case-numbers/ 

And out final monthly blogged looked at the idea that the US ‘follows’ the UK when it comes to COVID case rates (spoiler alert: it sort of does, but not always): https://drbretsky.com/28-september-2022-blog-post-following-the-uks-lead/ 

This final blog garnered some interesting Twitter reactions, namely critiques of the Zoe Health Study which is composed of self-selected participants who record COVID like symptoms into an app along with any COVID testing results.

4. On Patient Reviews

Patients who have seen us in the office recently will know that we have been actively seeking patient feedback about our services on rating sites, including Google, Facebook and Yelp. These have become increasingly important in quality metrics that measure the patient experience. We appreciate the time and effort that you have taken to post your experience.

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28 September 2022 Blog Post: Following the UK’s Lead

28 September 2022 Blog Post: Following the UK's Lead

Recent press reports have suggested that the UK could be heading into a fall COVID-19 wave with the United States not far behind (link: https://www.cnn.com/2022/09/27/health/uk-fall-wave-covid-us). It made me curious that this statement, and subsequent narrative, was accepted as a simple truism – with the first question being, is this in fact the case?

There is some precedent for this East to West movement. Influenza virus in the United States typically begins on the East Coast and moves to the West Coast. Here in Los Angeles, we tend to see a peak in flu cases in the last week of December, although there are certainly cases beforehand and afterwards.

The graph below shows case rates in the UK and the US.  There are clear overlaps corresponding to successive waves fueled by distinct variants.

With the first cases reported in March of 2020 in both countries, mitigation efforts kept cases rates low (relative as compared to the massive Omicron outbreak) until a clear January 2021 peak.  While there was not much genetic epidemiology being done at that time, the alpha variant was seen in March 2021 in 97% of UK cases and 15% of US cases. Although the UK had a more sharp peak than the US, it is clear that case rates in that instance accelerated before the UK.

The next clear rise in cases occurred in the summer of 2021 – fueled by the Delta variant.  In this instance the UK did take the lead with cases peaking the week of July 21st while the US topped out September 5th. Delta also began circulating first in the UK with 53.5% of cases in May being due to the variant as compared to 3.9% in the US.  By August 31st, 99.95% of cases in the UK and 99.44% of cases in the US were due to Delta.

The next big surge was Omicron, with the UK again taking the lead. Cases began to rise in the UK in late October and peaked the week of January 5th. The US had cases rising late November with a peak the week of January 14th. But this isn’t quite as simple (but still follows a pattern of the UK taking the lead) as one might think when considering the genetic epidemiology.  

In the UK in October, 99.97% of cases were Delta. In mid-December, over 60% of the cases were still Delta (40% Omicron, BA.1) and in early January 10% were Delta, 90% Omicron.  

In the US in October, 99.78% of cases were Delta. In mid-December, over 75% of the cases were still Delta (25% Omicron, BA.1) and in early January 16% were Delta, 84% Omicron.  

So what really occurred was a surge fueled by a mix of Delta and Omicron (BA.1) with the latter supplanting Delta as the primary circulating variant. Omicron took hold in the UK before the US, however.

The UK experienced a second Omicron wave in March of this year fueled by the BA.2 variant – something which simply did not occur in the US. In mid-March, 75% of cases in the US were still BA.1, 25% BA.2 as opposed to the UK where the opposite was seen: 20% of cases were BA.1 and 80% BA.2. Cases rose in the US in May, this time due to the BA.4 variant (accounting for 56% of cases and only 4% were BA.4) – a pattern which did not occur in the UK (80% of cases in the UK remained BA.2).

Dr. Tim Spector, professor of genetic epidemiology at Kings College London says, “Generally, what happens in the UK is reflected about a month later in the US.” Is this true?  Well sort of. It was not true for the Alpha variant, was most certainly true for Delta and again for Omicron. Interestingly, the distribution of BA.1, BA.2 and BA.4 has varied significantly during 2022 leading to a more short term trend where the US and UK are quite out of phase (Figure below).

Spector runs a study of about 500,000 individuals which uses an app to let people in the UK and US report their daily symptoms and record results of home antigen testing results. He states: “Our current data is definitely showing this is the beginning of the next wave,” Spector said.

Will the US follow suit? I think that largely depends on the behavior of BA.5 and which, if any, new variant takes hold. Currently the US and UK are aligned both in terms of case burden (US: 157 new daily cases per million, UK: 78) and variant proportion (US: 86% BA.5, UK: 89.4% BA.5).  

𝗦𝗶𝗴𝗻 𝗨𝗽 𝗳𝗼𝗿 𝗢𝘂𝗿 𝗡𝗲𝘄𝘀𝗹𝗲𝘁𝘁𝗲𝗿

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14 September 2022 Blog Post: Mid-September COVID Case Numbers

14 September 2022 Blog Post: Mid-September COVID Case Numbers

A brief look today at the current incidence and prevalence of COVID-19 cases in Los Angeles County.

Incidence is defined as the number of new cases in the population over a specified period of time. In the calculations below we present a daily rate per 100,000 population (averaged over 7 days to smooth out any reporting delays, such as over weekends and holidays). While we generally expect the start of school to carry with it an increase in transmission risk, this is not being seen at the population level. The graph begins in November and clearly shows the Omicron peak of Winter 2021/2022 along with the slow rise of summer cases that can be attributed to BA.5.

Prevalence rates are also declining in the County. Prevalence is defined as the number of active cases (both new and pre-existing) in a population over a defined time period. Here we estimate the proportion of the population with COVID-19 infection over a one week period. This is currently at 1.4% which is the lowest it has been since the week ending May 24th of this year. We calculate prevalence as a function of test positivity.

The current 1.4% prevalence is higher than that seen in prior years. The prevalence rates were lower for the week ending September 6th in both 2020 (0.3%) and 2021 (0.5%).

𝗦𝗶𝗴𝗻 𝗨𝗽 𝗳𝗼𝗿 𝗢𝘂𝗿 𝗡𝗲𝘄𝘀𝗹𝗲𝘁𝘁𝗲𝗿

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13 September 2022 Blog Post: Fall 2022 COVID Boosters

13 September 2022 Blog Post: Fall 2022 COVID Boosters

What is in the new boosters? Is there any difference between the Pfizer and Moderna formulations?

Both new vaccines consist of equal portions of mRNA directed against the ancestral 2020 strain of the virus and mRNA directed against the newer Omicron BA.4 and BA.5 variants. The BA.5 is the primary variant that is circulating currently at 87.5% of samples studied.  BA.4 is far less frequently seen at 2.2% (link: https://covid.cdc.gov/covid-data-tracker/#variant-proportions). The Pfizer product may be used by adolescents (age, ≥12) and adults; the Moderna product may be used only by adults (age, ≥18).

Are there any studies in humans to support the use of this BA.4/BA.5 bivalent booster?

No – there are no clinical studies as yet supporting its use.  Animal and limited human studies have confirmed excellent antibody production against both ancestral virus and variant strains but there is no information regarding its efficacy. Canada, the UK, and the European Union have approved earlier bivalent boosters that target Omicron variant BA.1. Neither the Pfizer nor the Moderna BA.4/BA.5 bivalent booster that was authorized by the U.S. FDA is in use elsewhere in the world.

What happened to the old booster? Do I need to ask specifically for the new booster so I don’t get the old one?

The original Pfizer and Moderna monovalent mRNA COVID-19 vaccines are no longer authorized for use as boosters in the U.S. for adolescents (age, ≥12) and adults. Only children (age, ≤11 years) who received a primary vaccination with a monovalent product can receive a dose of the Pfizer monovalent vaccine as a booster. For everyone else, the new bivalent vaccines are the only boosting options so there is no need to ask for a specific booster.

How long should I wait from my last booster or primary series before getting this new one?

Both new vaccines are intended for use at least 2 months after a previous vaccination (whether a primary series or a first or second booster). As with prior boosters, the general recommendation for those that have had a recent community acquired infection is to wait at least 3 months before boosting after infection.

If I decide to take the new booster, when should I receive it?

This is an individual choice and has a number of factors to consider but waiting is a reasonable choice at this juncture. Firstly, for those concerned about the lack of human safety and efficacy data, it may feel more comfortable to simply wait until those data become available. Secondly, prevalence rates here in Los Angeles have been decreasing steadily since a mid-July peak making coming into contact less likely at the population level (Figure 1 below) so delaying vaccination makes sense from that standpoint as well.

Patients planning to attend a high-risk event or who are traveling in the fall might decide to get a booster a few weeks beforehand (generally two weeks before departure is about the latest one should wait). Others might prefer to wait until early winter in anticipation of the cold-weather surge in respiratory infections including COVID (we covered COVID seasonality in a post earlier this month). This latter approach fits too with the CDC’s seasonal guidance wherein they are recommending COVID booster and flu shots together (link: https://emergency.cdc.gov/coca/calls/2022/callinfo_090822.asp). 

𝗦𝗶𝗴𝗻 𝗨𝗽 𝗳𝗼𝗿 𝗢𝘂𝗿 𝗡𝗲𝘄𝘀𝗹𝗲𝘁𝘁𝗲𝗿

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9 September 2022 Blog Post: New Booster Shot “Heralds” COVID Seasonality

9 September 2022 Blog Post: New Booster Shot "Heralds" COVID Seasonality

The latest bivalent boosters began shipping over the Labor Day weekend and have now become available in local pharmacies. These are termed ‘bivalent’ as they contain two messenger RNA (mRNA) components of the SARS-CoV-2 virus – one from the original (ancestral) strain and the other a common sequence between the BA.4 and BA.5 sublineages of the Omicron variant. The artist formerly known as ‘the booster’ (which was monovalent) containing only the original strain has been taken off the market entirely and is no longer available. In this way, there will be no confusion about which booster to give to a patient, as only one has approval currently.

The timing of the bivalent booster shipping coincides closely and not coincidentally with seasonal influenza shots. We received our annual flu shots in the office about two weeks ago and have been dispensing them to patients already. It is a not so subtle nod to the seasonality of COVID-19. White House COVID-19 Response Coordinator Dr. Ashish Jha suggested that the bivalent booster could be bundled with seasonal flu shots saying (somewhat cumbersomely) “I really believe this is why God gave us two arms – one for the flu shot and the other for the COVID shot.”

Despite Dr. Jha’s clear misconception about the intelligent design of two arms (which were an obvious evolutionary pressure to allow for the  crossover dribble) – his framing is similar to the advice I have been giving patients about the timing of the bivalent booster. The overall goal being established protection by the Thanksgiving holidays, which is when seasonal respiratory viruses begin to spread in earnest – fueled by travel, family gathering and increased time indoors. Typically I recommend that flu shots be delivered by the end of October although we continue to vaccinate patients well into January (particularly if we have a later season surge).

There is clear evidence of a seasonal distribution of COVID-19. Below is a graph of prevalence (percentage rate of cases per 100 population) by week for Los Angeles County. There are three lines: 2020 (Blue), 2021 (Red), 2022 (Yellow)

Looking at the graph it is clear that there are low seasons: March to June (all years although remember in 2020 we were ‘flattening the curve’ and in 2021 we still had Spring mask mandates) and September to November (which is interesting because there is a lot of fretting that goes on with the opening of school in the Fall).

Summer 2022 showed a clear rise in cases but the obvious seasonality begins mid to late November (2020 especially), peaking mid January (Omicron in yellow was indeed everywhere in 2022) before falling rather rapidly by early February.

So the rollout of the updated COVID-19 boosters targeting the BA.4 and BA.5 subvariants are indeed meant to head off a 2022/2023 winter surge but also give us a sense of how the CDC is shifting our pandemic approach to a more predictive rather than reactive response. 

Dr. Fauci echoed this sentiment in classic Fauci speak: “It is becoming increasingly clear that—looking forward with the COVID-19 pandemic, in the absence of a dramatically different variant—we likely are moving towards a path with a vaccination cadence similar to that of the annual influenza vaccine, with annual, updated COVID-19 shots matched to the currently circulating strains for most of the population.”

𝗦𝗶𝗴𝗻 𝗨𝗽 𝗳𝗼𝗿 𝗢𝘂𝗿 𝗡𝗲𝘄𝘀𝗹𝗲𝘁𝘁𝗲𝗿

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September 2022 Newsletter

September 2022 Newsletter

Welcome to the September 2022 Newsletter for Santa Monica Primary Care. In this issue, we are going to discuss COVID-19 prevalence in Los Angeles County and try to predict its future, in the context of the new bivalent booster and an inevitable Winter surge. We will also cover medical records sharing and ‘interoperability’ between electronic systems and healthcare providers.

 

COVID-19 in LA County and the Practice during August 2022

COVID-19 cases in our practice have begun to slow slightly – a trend consistent with that seen nationally and in Los Angeles County. In August we had 12 new cases (3 were 2nd infections)  with clusters at the beginning of the month (8/1-8/3), the middle (8/16-8/16) and the end (8/29-8/31). This is a somewhat different pattern than we had seen in July (18 cases, 3 were  2nd infection), June (29 cases, 3 were 2nd infections) and May (33 infections, 3 were 2nd infections) where cases accumulated at a steady clip of about one new case a day.

Trying to figure out what is occurring in terms of case rates at the County level is a bit more difficult. Firstly, LA County continues to have a significant lag in reporting with case numbers only current to 8/24/2022. Secondly, a significant proportion of positive tests will be from home testing which the County specifically does not include in their tabulations. Despite such, COVID-19 case rates for the month of August 2022 were the highest they have been in any pandemic for the month of August. For the week ending August 24th, 2022 set the high bar at 61.2 new daily cases per 100,000 population compared with 27.4 in 2021 and 18.4 in 2020. Current case rates are about twice as high currently as they were last year.

Given the difficulty in case ascertainment, another metric that can be considered is mortality rate. The mortality rate currently is 3 times what it was at the end of August 2021 (0.04 daily deaths per 100,000 population in 2021 versus 0.12 in 2022). Current mortality rates are about three times as high currently as they were last year.

Nationally, the BA.5 variant remains the overwhelmingly dominant circulating viral strain.. BA.5 now accounts for 88.7% of the variants isolated as opposed to 81.9% in July and 54% in June. Link: https://covid.cdc.gov/covid-data-tracker/#variant-proportions 

 

BA.5 Bivalent Booster and Predicting the Future

On August 31st, the FDA authorized the use of Moderna and Pfizer Bivalent Vaccines for a single additional booster dose, 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. It is important to note that the bivalent booster will contain genetic recipes for both the original COVID strain as well as BA.4 and BA.5. The Moderna bivalent vaccine is authorized as a single booster for those aged 18 years and above, and Pfizer is approved for those 12 and older.

The question moving forward is just how effective the new booster formulation will be – both in terms of boosting neutralizing antibody levels but, more critically, in preventing infection. While there have been no human studies of the bivalent vaccine going to trial, a study of an earlier BA.1 + ancestral strain booster (2nd booster) showed improved neutralizing antibody levels as compared to the monovalent (original). Antibody levels among those with no prior COVID infection were 2372 with the bivalent booster as compared to 1473 with the monovalent booster. It is interesting to see that these levels are quite a bit lower than what we have been seeing in the practice, with most individuals having levels between 3000-6000 after a primary series + one or two boosters. Whether or not these neutralizing antibodies are of sufficient quantity and specificity to prevent infection remains to be seen.

The future is not too difficult to predict, as seen from the prevalence chart below. I think we have every reason to expect another Winter surge – most likely beginning mid December and lasting through January.

Blogs This Month

Our blog posts this month included a two part series on changes at the CDC. There is also a more lengthy essay on Monkeypox (which appears to be decreasing in frequency, at least in Los Angeles).

Structural Changes at the CDC (Parts 1 & 2):

https://drbretsky.com/29-august-2022-blog-post-major-changes-in-cdc-announced-part-1-of-2/

https://drbretsky.com/30-august-2022-blog-post-major-changes-in-cdc-announced-part-2-of-2/ 

 

Monkeypox:

https://drbretsky.com/3-august-2022-essay-everything-you-wanted-to-know-about-monkeypox-but-were-afraid-to-ask/

 

On Medical Record Sharing and Interoperability

One question I have gotten a lot this month has been about medical record sharing and, specifically, if our office receives outside consultation notes, imaging and studies. The short answer is – sometimes (even if you specifically request it from the consulting physician) but it is a process that we are working to improve.

Traditionally, consulting physicians or specialists have communicated directly with a patient’s primary care provider in the form of a consult ‘note’. Many of the more experienced specialists will not only send their clinic / chart note but also a cover letter summarizing their findings and recommendations. Sadly, with the advent of Electronic Medical Records, this tradition has largely been lost. One would think that notes would be automatically routed to the referring or primary care physician but this too does not always happen.

The term ‘interoperability’ is used as a catchall phrase by health insurers and EMR vendors to describe a “system architecture that allows for the electronic sharing of patient information between different EHR systems and healthcare providers.” The idea being that information passes between the doctors providing patient care seamlessly. Responsibility for such was intended to fall to health insurance companies, permitting data exchange should an individual change insurance. However, the current administration has decided to defer enforcement of this responsibility citing the COVID-19 pandemic (link, if you are fascinated by this: https://www.cms.gov/blog/interoperability-and-connected-health-care-system).

What we have done as a practice is begun to set up processes to physically go and look for our patients’ information. One such mechanism comes through our collaboration with Aledade (www.aledade.com) which we have discussed in previous newsletters. In addition to their quality of care metrics tracking, Aledade software includes an interface that alerts us as to any hospitalization or Emergency Department visit, prompting us to follow-up on that event.

One way that patients can further help with interoperability is to ensure that on their CareEverywhere or MyChart account that Dr. Bretsky is listed as their primary care provider. We have started a process in the Cedars / Providence / UCLA systems of adding our office contact information manually so that reports are automatically sent to us. But patients themselves can double check that we are listed as Primary Care Providers (often these listings are outdated or include other providers, such as OB/GYN).

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