25 February 2021 Blog Post: Johnson and Johnson Vaccine

25 February 2021 Blog Post: Johnson and Johnson Vaccine

Tomorrow, the FDA’s Vaccines and Related Biological Products Advisory Committee will meet and is widely expected to approve Johnson and Johnson’s (specifically Janssen Biotech, a subsidiary) single dose COVID-19 vaccine candidate.  This will be the third vaccine available in the US.  The company and the FDA have already released documents which show that the vaccine is safe and effective – although not as effective as the Pfizer/BioNTech and Moderna vaccines already approved.

The J&J vaccine was developed on a “replication-incompetent” (i.e. inactivated) adenovirus (common cold) platform which expresses the much discussed spike protein of the novel coronavirus. This is a well established methodology of vaccine development, unlike the mRNA platforms of Pfizer/BioNTech and Moderna.  The specific adenovirus 26 platform has been used in vaccine trials for Zika, filovirus, HIV, HPV, malaria and RSV.  Nearly 200,000 individuals have received vaccines from this platform. There are two major advantages to the J&J candidate:  1. It only requires standard refrigeration to maintain stability and 2. It is given as a single dose.

Before diving into its efficacy, there is one nuance to review from the clinical trial. For the J&J study, the primary endpoint was moderate and severe/critical COVID-19 illness identified by a patient prompted “illness visit.”  This is slightly different from the Pfizer/BioNTech and Moderna endpoints which included mild illness – although severe illness was considered in a separate sub-analysis. This appears to be an intentional decision for, as I detail below, the J&J vaccine is significantly less effective in preventing symptomatic COVID-19 infection than vaccines currently available – but it is quite effective in preventing hospitalization and death from the disease.

As summed up by Dr. Brandon Dionne, assistant clinical professor in the School of Pharmacy at Northeastern:

“This is the challenge when we talk about efficacy. What endpoint are you using? For Johnson & Johnson, their definition was: How many people are diagnosed with symptomatic COVID-19? So even though the vaccine didn’t prevent symptomatic cases quite as well as the Moderna or Pfizer vaccines, it did a great job preventing hospitalizations and deaths.”

Overall, the J&J vaccine was 66.1% effective against laboratory confirmed, moderate to severe COVID-19 infections occurring two weeks after the first and only dose.  By age, efficacy was essentially equivalent at 66.1% from 18-59 and 66.2% for those 60 and older. It was less effective in women (60.3%) as compared to men (69.8%).  There were also striking regional differences with US showing 74% efficacy but South Africa at 64% and Brazil at 61%.  Much press discussion has focused on the effect of the South African variant but I have seen no coherent discussion of the lowest efficacy in Brazil.

Additionally concerning, is that for those individuals with at least one comorbidity the vaccine efficacy was 58.6% as compared to those with no chronic conditions at 68.8%.  For those with HIV the vaccine was only 47.5% effective, Hypertension 35.7% and Type 2 Diabetes 23.0%.

Similar to the Pfizer/BioNTech and Moderna vaccine, we again see a striking Kaplan-Meier plot showing a clear delineation between the placebo group and vaccinated group beginning between 2 and 3 weeks after inoculation (page 31 of https://www.fda.gov/media/146217/download).

Overall efficacy for severe cases was estimated to be 85% but this protective effect was more pronounced among the 18-59 years age group at 91.7%.  For those 60 and older, the preventive efficacy was quite a bit lower at 70.3%.  For hospitalization, the vaccine exerted a 93.1% efficacy after 2 weeks from inoculation.  There were no deaths reported whatsoever in the vaccination group, all 7 deaths were in the placebo group.

Safety appears to be excellent.  In fact there were fewer “medically attended adverse events” among the vaccination group (1.4%) than placebo (1.9%)

So what’s the bottom line then on this new candidate? 

Clearly there is a much needed role for additional vaccines given the impossibly laborious rollout thus far.  The J&J candidate has less rigorous storage requirements and can be given as a single dose. However, it lacks efficacy at key points – specifically when it comes to the South African variant, perhaps a Brazilian variant, among those that are older and those with key comorbidities (especially diabetes).

But we know from surge after surge that fewer cases in the population leads to fewer hospitalizations and fewer deaths. The J&J vaccine will be an invaluable tool at the population level but, from my perspective, should be directed towards those that are young and healthy, among whom it displays the greatest efficacy.

𝗦𝗶𝗴𝗻 𝗨𝗽 𝗳𝗼𝗿 𝗢𝘂𝗿 𝗡𝗲𝘄𝘀𝗹𝗲𝘁𝘁𝗲𝗿

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24 February 2021 Blog Post: A quick note on antibody testing at Santa Monica Primary Care

24 February 2021 Blog Post: A quick note on antibody testing at Santa Monica Primary Care

I have received several questions about the type of antibody testing we perform at Santa Monica Primary Care.

To date, we have sent samples out to Labcorp to test for antibodies to the nucleocapsid protein. The nucleocapsid is arranged in a helical structure and encapsulates the viral genome, thereby protecting it from the host cell environment.

This antibody test is specifically intended to test prior natural infection – and a positive result will suggest such. We have run this test in those who have reported no prior infection (generally negative, but we have had some surprises!), known prior infection (positive), one vaccine jab (negative), and two vaccine jabs (negative). We have even run it in some patients with a known prior history of natural coronavirus infection who also received the vaccine (positive result).

Vaccines elicit a response to the often mentioned spike protein. We now have the ability through LabCorp to order spike-protein specific antibody tests for those who may be interested to see if their vaccination led to a detectable antibody response. Given the strong efficacy of the Pfizer and Moderna vaccines (95% efficacy), one would expect that all – or nearly all – would generate antibodies.

𝗦𝗶𝗴𝗻 𝗨𝗽 𝗳𝗼𝗿 𝗢𝘂𝗿 𝗡𝗲𝘄𝘀𝗹𝗲𝘁𝘁𝗲𝗿

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23 February 2021 Blog Post: Politics and COVID: An Unhealthy Mix

23 February 2021 Blog Post: Politics and COVID: An Unhealthy Mix

British publisher and writer Ernest Benn wrote that “Politics is the art of looking for trouble; finding it everywhere, diagnosing it wrongly, and applying unsuitable remedies.” Nowhere is this more true that in Los Angeles County’s politically spearheaded COVID-19 vaccine distribution.

Front and center in this process has been Chair of the County Supervisors Hilda Solis who has announced successive expansions of efforts to those 65+ and now to include education and childcare workers saying – “And we’ll still continue to kind of go through a process of making sure that we’re as equitable as possible.”

However, Los Angeles County’s effort has been far from equitable, and in particular African-American populations have been left far behind.  Despite comprising 11% of the County population, they have only received 4.1% of all administered doses (source: https://covid19.ca.gov/vaccines/#California-vaccines-dashboard).  Latinx who comprise 44.6% of the population have only received 23.2% of vaccines.  Characterized by Dr. Barbara Ferrer, County Public Health Director, as a “glaring inadequacy.” Supervisor Solis’ comment that we will “kind of go through a process” to ensure equity is hardly reassuring, is not a plan and does not convey the urgency of effort that is needed.

To date, Los Angeles County has relied exclusively on large, county-run centers which have been their “unsuitable remedy” for the challenge of vaccinating the populace. Politicians here, as it is outside of their expertise, see the COVID-19 vaccination effort as a unique event ignoring the fact that there already is an annual mass vaccination campaign – the flu shot. This is in sharp contrast to states such as North Dakota who specifically relied on their flu experience (more specifically lessons learned from H1N1) to guide their rollout process.

So how do we manage the annual flu shot?  Those data are readily accessible from the CDC who reports these data (link: https://www.cdc.gov/flu/fluvaxview/nifs-estimates-nov2018.htm). The most common setting for vaccination among both adults and children was a doctor’s office (children: 67.6%; adults: 34.3%). Other medical settings for flu vaccination included pharmacy (children: 6.0%; adults: 32.2%), clinic/health center (children: 13.5%; adults: 7.9%), hospital/emergency department (children: 4.4%; adults: 5.4%), school (children: 5.4%), and workplace (adults: 14.9%). 

In fact a wider distribution of vaccines beyond County run mass vaccination sites will not only speed delivery but also ensure equitable access. Provision of doses specifically to centers and healthcare providers in those communities thus far left out of the COVID-19 vaccination campaign will narrow gaps. Involvement of pharmacies already in communities (both commercial and independent) will reach people where they live and work rather than having them spend hours traveling to and waiting at mass vaccination sites. Efforts should include vaccinations at Emergency Departments, schools and places of employment. On its current trajectory, the County’s approach when it comes time to vaccinating children will only magnify inequities given the proportion that receive vaccination with their own physicians – a group entirely left out (perhaps deliberately) from the County’s approach.

We are indeed in trouble – with the rising tide of variants, an incomplete and inequitable vaccination pattern has the potential to select out these or other more virulent strains of coronavirus. Our troubles have been misdiagnosed and misappropriated by politicians who lack the training, expertise or historical perspective to manage such a program. After the debacle that has been the last two months of vaccine distribution, it is time for a suitable remedy to be applied.

𝗦𝗶𝗴𝗻 𝗨𝗽 𝗳𝗼𝗿 𝗢𝘂𝗿 𝗡𝗲𝘄𝘀𝗹𝗲𝘁𝘁𝗲𝗿

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23 February 2021 Blog Post : As my posts have tended lately towards more general

23 February 2021 Blog Post : As my posts have tended lately towards more general

As my posts have tended lately towards more general observations about the vaccine rollout, I thought it might be helpful to provide some more specific data from our practice’s experience – both with vaccination and with COVID-19 antibody testing.

Currently we have a practice of about 650 individuals of whom about 225 are aged 65 and older. Thus far, we have documentation that 82 (12.6% of the total practice; 36.4% of those over 65) have received at least their first COVID-19 vaccine. As an aside, those receiving their first dose have, without exception, been able to schedule and/or receive their second dose from the County.

Since April of 2020 we have run 411 antibody tests of which 28 have been positive (6.8%)

So within our small microcosm of the population, our effective immunity rate today stands at an estimated 19.4% (it may be higher as we may not have information on all those vaccinated) – far below the 60-70% needed to attain a viable threshold which would meaningfully halt viral spread.

Moving forward it is clear that much more work needs to be done to deliver vaccine more quickly. The good news is that cases are dropping significantly, but it is important to use this lull to establish a significant degree of population (or ‘herd’ immunity). With the majority of individuals remaining susceptible to infection, there is still ample opportunity for spread.

𝗦𝗶𝗴𝗻 𝗨𝗽 𝗳𝗼𝗿 𝗢𝘂𝗿 𝗡𝗲𝘄𝘀𝗹𝗲𝘁𝘁𝗲𝗿

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8 February 2021 Blog Post: COVID-19 Update in Los Angeles County

8 February 2021 Blog Post: COVID-19 Update in Los Angeles County

Having spent the last two months functioning as the country’s COVID-19 epicenter, cases in Los Angeles are declining rapidly (Figure 1). But the difficulty with interpreting this graph is that our maximum case load (which plateaued at the 125-135 new daily cases per 100,000 for 5 weeks!) was so high that it dwarfs the remainder of the graph.

To provide some perspective, our current rate of 39.6 new daily cases per 100,000 population is still above our mid-summer surge. It is 6 times higher than our next risk tier down (need to be below 7 new daily cases per 100,000 to drop a tier). Even 7 cases per 100,000 is considered ‘wide community spread’ and rigorous test, trace and isolate programs should be implemented (LA County Health Department is too overwhelmed to manage such a program).

Deaths too are decreasing (Figure 2) now 50% of the 1/12/2021 peak. This is welcome news.

I was recently asked on Twitter to predict where I thought we would be in a few weeks. I do think that cases will begin to decline to the 7 new cases per 100,000 range. However, we have not been able as a County to decrease below this threshold level. Now with the new circulating variants such as B.1.1.7 and a stalled vaccine program (only 2nd doses are being given this week so no new effective population immunity will be established), I think that we will see a rise in cases again to the 30-40 range. We have now had multiple instances of COVID-19 smoldering at low(ish) community transmission rates which then flare into an outbreak surge. There is no reason to think that this will not happen again.

But hopefully never again above 100.

𝗦𝗶𝗴𝗻 𝗨𝗽 𝗳𝗼𝗿 𝗢𝘂𝗿 𝗡𝗲𝘄𝘀𝗹𝗲𝘁𝘁𝗲𝗿

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4 February 2021 Blog Post: On Vaccinating Teachers

4 February 2021 Blog Post: On Vaccinating Teachers

It is no secret that I believed that the CDC and then Director Dr. Robert Redfield had effectively abdicated their responsibility during the coronavirus pandemic of 2020.  Flash forward to a new administration, a new year and a new director – but strangely the missteps at CDC continue.

In an interview yesterday on MSNBC, new director Dr. Rochelle Walensky (who is a well respected HIV clinician and researcher but has no formal public health experience) doubled down on her opinion that teachers do not necessarily need to be vaccinated should “proper” mitigation efforts be in place.  She cites “the science” that shows that there is “very little” transmission in schools providing adequate ventilation, masking, handwashing, “de-densification” (echos of Alexander Haig – is this even a word?) among other efforts.

https://www.msn.com/en-us/news/politics/mitigating-measures-key-to-opening-schools-without-vaccinating-teachers-cdc-director/vi-BB1dncwG

But let’s look at her argument – starting with ‘the science’. This is often a mistake that physicians (but not researchers) make, trying to sum the totality of evidence with a sweeping generalization or relying on a single seminal paper to support a viewpoint. Point in fact, there have been only a few studies of COVID-19 transmission in schools and early childhood education and these give conflicting results. One study in New South Wales Australia (link: https://doi.org/10.1016/S2352-4642(20)30251-0) showed that the 27 coronavirus cases identified in schools spread to only 18 of 1448 close contacts (1.2%).  But these very low rates of infection need to be interpreted with caution, because most educational facilities were closed after case identification, and close contacts were expected to home quarantine for 14 days.  A similar phenomenon was seen in Ireland (Heavey et al., Euro Surveill. 2020; 252000903) where 6 school-based cases led to zero secondary cases. So these studies do lend support to Dr. Wallesky’s argument.

On the other hand, an outbreak centred in a high school in northern France (link: https://doi.org/10.1101/2020.04.18.20071134) showed high secondary infection attack rates were high in students (aged 14–18 years) at 38% and staff 49%.  Rates were much lower among parents and siblings (11% and 10%, respectively) suggesting that infection was concentrated within the school environment.

Dr. Walensky notes that schools should be “the first things to open and last things to close” but we all know that such a belief is pure fantasy.  Opening of schools goes hand in hand with reopening of restaurants, bars, retail and workplaces in general. Surely a year into the pandemic we don’t seriously believe that we would open schools to the exclusion of other venues, do we?

And this is the fatal flaw in Dr. Wallensky’s argument – and the reason why teachers most certainly do need to be vaccinated before returning to school (and “the science” supports the counterargument).  

Reopening of schools will, of course, increase work-related contacts among teachers.  In addition, it is accompanied by an increase in other contacts because of the wider lifting of restrictions. In fact, Panovska-Griffiths and colleagues (link: https://doi.org/10.1016/S2352-4642(20)30250-9) found that reopening schools (even partially) and the accompanying return to more normal contacts is likely to lead to a second wave of infections, unless testing is scaled up significantly. Unfortunately, it is not clear from their analysis whether the increase in cases that occurs when schools are reopened in the model is due to increased contact between children or increased contact between adults who can now return to work and leisure activities.

Besides, isn’t $60 in vaccination costs per teacher a far better investment than the billions upon billions that it would take to “de-densify” classrooms? It is strange that the CDC would argue otherwise.

𝗦𝗶𝗴𝗻 𝗨𝗽 𝗳𝗼𝗿 𝗢𝘂𝗿 𝗡𝗲𝘄𝘀𝗹𝗲𝘁𝘁𝗲𝗿

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3 February 2021 Post: Seniors Are Among The 1st To Get Vaccines But The Process Has Glitches

3 February 2021 Post: Seniors Are Among The 1st To Get Vaccines But The Process Has Glitches

People 65 and older are priortized for vaccinations, but it’s not always obvious how they should find a place to actually get a site. Efforts to help them are a hodgepodge nationwide.

STEVE INSKEEP, HOST:

Millions of Americans over the age of 65 qualify for a COVID vaccine, but the process of signing up has been an ordeal. Will Stone has more.

WILL STONE, BYLINE: Many seniors are finding the road to a vaccine shot is littered with dead ends, wrong turns and frustration. Eighty-five-year-old Colleen Brooks lives on an island near Seattle.

COLLEEN BROOKS: I mean, I knew it was here someplace. It wasn’t easy to find out.

STONE: Brooks had gone online, but it was overwhelming. Then she got a tip from a friend.

BROOKS: Our pharmacy’s right in the middle of town, and she saw them unloading boxes of it.

STONE: Unsure of what to do. She showed up at the clinic on a whim. She just happened to score a shot.

BROOKS: I actually personally know several seniors who just kind of gave up.

STONE: In Washington, D.C., Helen Franckie, who’s 92, did find the online portal to sign up, only to discover…

HELEN FRANCKIE: It was evident that I was much too slow.

STONE: Spots filled up in no time.

FRANCKIE: It’s terribly competitive, clearly favors those with advanced computer skills.

STONE: The next week, she tried calling at the designated time. The lines were jammed. A neighbor got online to help – same story. Franckie ended up finally getting a shot after her neighborhood listserv directed her to a hospital.

FRANCKIE: But if I had had to depend on the D.C. vaccination website and telephone, I’d still be anxious and unsuccessful.

STONE: And in Arizona, Miguel Lerma is trying to help his 69-year-old mother, who doesn’t speak much English.

MIGUEL LERMA: My mom does not know how to use email. She barely got iPhone this year.

STONE: No one reached out to her about the vaccine. And Lerma says by the time she learned to go online, slots were booked through February. Her husband, Lerma’s father, died from COVID last year.

LERMA: So she’s mourning not only, like, for my dad, but she’s also suffering as an adult now because she depended on certain tasks for him. He would handle all this.

STONE: Who, when and how to get a shot depends on where you live. This patchwork and shortage of supply means widespread chaos in many places.

BILL WALSH: You know, it’s unconscionable that we can’t do better.

STONE: That’s Bill Walsh with AARP. He thinks public health outreach should include flyers, mail, phone calls and physical locations, like senior centers.

WALSH: Who am I trying to reach here? Because just posting a website and urging people go there is not a recipe for success.

STONE: Philip Bretsky, a primary care doctor in Southern California, says his older patients are struggling with the digital scheduling system there.

PHILIP BRETSKY: That’s not how 85-year-olds have interacted with the health care system. So it’s a complete disconnect.

STONE: Many are calling Bretsky for help, except he doesn’t know what to tell them. He’s approved to give the shot but has no clue when that will be possible.

BRETSKY: These folks are basically just investing a lot of time and not getting anything out of it.

STONE: Some states are moving slower in order to focus on the very oldest residents. But the majority have now opened it up to anyone over 65. In New York City, Jeremy Novich, a psychologist, started an informal help service for seniors. It began with a few synagogues, a Facebook post.

JEREMY NOVICH: We have a huge number of requests that are just piling up of people who are, like, really desperate.

STONE: His voicemail is filled with messages from people who are blind, handicapped, terrified they’ll miss their chance.

NOVICH: You can’t have the vaccine distribution be a race between elderly people typing and younger people typing. That’s not a race. That’s just cruel.

STONE: Novich says they’ve assisted more than 100 people but had to stop for now. It was impossible to keep up.

For NPR News, I’m Will Stone.

INSKEEP: That story is from NPR’s partnership with Kaiser Health News.

(SOUNDBITE OF NIKLAS PASCHBURG’S “FRAGMENTATION”)

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𝗦𝗶𝗴𝗻 𝗨𝗽 𝗳𝗼𝗿 𝗢𝘂𝗿 𝗡𝗲𝘄𝘀𝗹𝗲𝘁𝘁𝗲𝗿

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