CMO Update November 24, 2021 Given the upcoming holiday, I would personally like to thank each of our QualDerm teammates for your continued efforts to embrace the “QualDerm Way”, our mission, vision and values to provide high quality care for our patients and to support one another, particularly during the chaos of the last 20 months.   I know everyone is eager to move past this pandemic and enjoy the holidays with our families and friends. There is certainly some reason for optimism, but I want to also inform you about mounting concerns that we cannot ignore.

The Good News

Vaccination continues to show excellent effectiveness and safety in all age groups and for Delta strain. For most people, the vaccines remain remarkably effective at turning Covid into a manageable illness that’s less dangerous than some everyday activities. The main dividing line is age. In Minnesota, which publishes detailed Covid data, the death rate for fully vaccinated people under 50 during the Delta surge this year was 0.0 per 100,000 — meaning, so few people died that the rate rounds to zero. >2 million children have already received 1st vaccine dose.

Pfizer announced Monday that their vaccine was 100 percent effective in protecting 12- to 15-year-olds from coronavirus infection in a Phase 3 trial involving 2,228 participants. The data showed no serious long-term safety concerns in follow-ups six months or longer after the second dose. This is especially important as we see rates of COVID-19 climbing in this age group in some regions, while vaccine uptake has slowed.

Any adult who received a Pfizer or Moderna COVID-19 vaccine series at least six months ago is eligible for a booster, as is any adult who received the single-shot J&J vaccine at least two months ago; adults age 50+ and with high risk factors are strongly encouraged. 36% of US adults have already received booster. Boosters provide 96% effectiveness against infection compared to no booster (see Figure showing benefit after only 7 days in booster vs. placebo). Immune protection from prior COVID infection (natural) and from full vaccination regimen decreases significantly over time, esp. for Delta.

‘Mix and Match’ is best strategy to expose your immune system to a different vaccine so booster should be with Pfizer or Moderna, opposite of initial dose. Study published in Open Forum Infectious Diseases shows vaccinated health care workers with breakthrough COVID-19 infections shed less virus than those who are unvaccinated and infected. More treatments available to reduce hospitalizations and death for those infected. Antivirals Remdesivir – reduces severity and death in hospitalized patient. Molnupiravir - reduces hospitalization and death when given in first 5 days of confirmed C-19 symptoms in high risk adults. Monoclonal Antibodies Regeneron monoclonal antibody treatment, a combination of two antibodies called casirivimab and imdevimab, reduces COVID-19-related hospitalization or deaths in high-risk patients by about 70%. When given to an exposed person -- like someone living with an infected person -- monoclonal antibodies reduced their risk of developing an infection with symptoms by 80%. High risk = high blood pressure, heart disease, a body mass index (BMI) higher than 30, an autoimmune disorder, people taking immunosuppressant drugs, and pregnant women. AstroZenica recently showed that patients given a single injection of monoclonal antibody Evusheld were 83% less likely to develop symptomatic cases of the coronavirus than participants given a placebo. In a separate trial, patients with mild-to-moderate Covid-19 who were given one dose of Evusheld within three days of developing symptoms had their risk of developing severe disease reduced by 88%.                  Not yet FDA approved Countries like Israel and Japan have overcome the Delta surge through successful vaccination programs (>90%) and mitigation strategies like masking and distancing. A review of eight studies in the British Medical Journal shows face masks more than halve the risk of getting Covid; physical distancing cuts the risk by a quarter.

The Bad News

Delta variant is so contagious that “Herd Immunity” requires very high vaccination rates plus natural immunity, and both benefit from a booster for longer protection from Delta. COVID-19 has become Endemic, in Japan and Israel with a low baseline level of infection, like influenza, and their people are enjoying normal living again. Europe and United States remain in Pandemic state, with high case counts and widespread community transmission: vax rate <60% adults; <20% boosted. Covid-19 cases in children are up 32% from two weeks ago, according to new numbers published Monday by the American Academy of Pediatrics.

Europe has higher vaccination rates than US and only countries like Spain and Portugal with very high immunity approaching 90% have avoided resurgence of Delta infections; CDC now recommending against travel to Germany and Denmark due to surges there. We heard this summer that the Delta surge was a pandemic of the unvaccinated; with immunity falling from previous early vaccination or prior COVID infection, we are now experiencing a “pandemic of the unboosted”. COVID-19 breakthrough infections are now occurring more among people with underlying health conditions and the elderly, even when fully vaccinated, a worrisome trend as families gather for holiday celebrations; please protect your older relatives and local communities by getting vaccinated or boosted ASAP. This graph shows how the vaccine effectiveness falls over time, and why boosters are necessary. This is common for many viruses and vaccines.

CDC reported pregnant women with COVID-19 had a higher risk for stillbirth, which spiked from double the risk to four times the risk with the emergence of Delta variant. US has recorded more COVID-19 deaths in 2021 than in 2020, despite wide availability of vaccines and new treatments, due to slow vaccine uptake, falling natural immunity and prevalence of more contagious Delta variant. Children and families are severely impacted, and mental health providers are struggling to provide counseling; JAMA published a report last week entitled “Thousands of US Youths Cope With the Trauma of Losing Parents to COVID-19”.

PLEASE read this thoroughly researched article below, written by a leading expert on how the United States and all of us at QualDerm can ‘get it right’ before it’s too late. Have a safe, healthy and happy Thanksgiving! ~ Dr. A

Covid cases are surging in Europe. America is in denial about what lies in store for it. Eric Topol The US thinks it will be ‘immune’ to what is happening in Europe. That’s wishful thinking   ‘Now is the time for the US to heed the European signal for the first time, to pull out all the stops.’   Fri 12 Nov 2021 06.16 EST It’s deja vu, yet again. The pandemic first hit Europe in March 2020, and Americans were in denial, thinking it wouldn’t happen here. Then, later in the year, the Alpha variant wave took hold in the United Kingdom and the United States was unprepared. This recurred with Delta in the summer of 2021. Now, in the fall of 2021, Europe is the outlier continent on the rise with Covid, with approximately 350 cases per 100,000 people and many countries are soaring to new records. This not only involves eastern and central Europe, where there are some countries with low vaccination rates (such as Georgia, only 24% fully vaccinated) and caseloads as high as 160/100,000 (Slovenia), but also western Europe, such as Austria, Belgium, Ireland and several others. Indeed, in Germany, leading virologist Christian Drosten recently warned their death toll could be doubled if more aggressive mitigation and vaccination strategies were not quickly adopted. Why is this happening again in Europe after the Delta wave passed through and high rates of vaccination were achieved? There are a few important reasons. First, there are a large proportion of unvaccinated individuals in each country, and only countries such as Spain at 80% and Portugal at 88% that fully vaccinated their total populations have set a high bar and have thus far withstood the continental trend of rise in cases. Noteworthy is Belgium with 74% fully vaccinated and one of the hardest-hit countries in the world, now at 79/100,000, currently 10th highest caseload globally. That alone tells us 74% isn’t enough, and that prior Covid (without vaccination, what some refer to as “natural immunity”) is unreliable for representing a solid immunity wall against the Delta variant. In fact, it has been projected for Delta that any country needs to achieve 90-95% of its total population fully vaccinated (or with recent Covid) in order to have population-level immunity that covers, providing relative protection, for the others. Key among the unvaccinated are teenagers and children. For European countries, the UK was slower in starting their vaccination program for teens and that has been suggested as one of the reasons their cases started rising again. There is compelling data from both the UK and United States that children and teens have been a key driver of spread in recent months. It is noteworthy that we are not dealing with just cases or a “casedemic”. For example, Greece’s cases have now quickly soared to 650/100,000 people and so has their death rate increased. While many countries have “uncoupled” their rise in cases from hospitalizations and deaths, that is incomplete at best, and many infected individuals are getting seriously ill, no less the risk of long Covid which remains under-recognized as to its importance and potential of durable disabling effects. Second, there is evidence of waning of immunity on top of the hyper-contagious Delta strain. Even though much of Europe got a later start in vaccination, a recent study showed that with the Astra Zeneca vaccine the decline in anti-spike antibody occurred quite early and there was a clear relationship between antibody levels and breakthrough infections. Decline below the anti-spike antibody threshold of 500 U/ml was reached at 96 days for AstraZeneca’s vaccine compared with 257 days for Pfizer’s. The impact of waning, and the opportunity to restore very high (~95%) effectiveness of mRNA vaccines (specifically Pfizer/BioNtech) with booster (third) shots has been unequivocally proven from the Israeli data. Yet the adoption of boosters, even in the highest-risk groups such as age 60 plus, has been very slow. Third, there has been relaxation or abandonment of mitigation measures. Countries such as Denmark and Norway completely reopened and have seen resurgence of cases since that occurred. Throughout the world, the profound pandemic fatigue has led to the irresistible notion that the pandemic end is nigh, that masks, distancing, and other measures have run their course, essentially that enough is enough. It is hard to imagine fighting a foe as formidable as Delta that a vaccine-only strategy can be effective. We’ve seen a dramatic improvement in Japan, with full return to baseline after their worst outbreak, by the combination of high level of vaccination and the continued use of masks and mitigation measures. That brings us to the United States, sitting in the zone of denial for the fourth time during the pandemic, thinking that in some way we will be “immune” to what is happening in Europe. That somehow the magical combination of mRNA vaccines with only 58% of the population fully vaccinated, a relatively low proportion of booster shot uptake, a start to vaccinating teens and children, and a lot of prior Covid, and little in the way of mitigation, will spare us. That’s no magic. Add to that the complete lack of availability of cheap, rapid home tests to screen for infectiousness. Unlike Europe, the US was not capable of uncoupling cases from hospitalizations and deaths during its initial Delta wave – fully 75% of hospitalizations and 66% of deaths occurred compared to its third wave peak before vaccinations were available. We are already seeing signs that the US is destined to succumb to more Covid spread, with more than three weeks sitting at a plateau of ~75,000 new cases per day, now there’s been a 10% rise in the past week. We are miles from any semblance of Covid containment, facing winter and the increased reliance of being indoors with inadequate ventilation and air filtration, along with the imminent holiday gatherings. Now is the time for the US to heed the European signal for the first time, to pull out all the stops. Promote primary vaccination and boosters like there’s no tomorrow. Aggressively counter the pervasive misinformation and disinformation. Accelerate and expand the vaccine mandates that unfortunately became necessary and have been proven effective, and mass distribute medical quality masks and rapid home testing kits at no cost. Soon enough potent pills (Molnupiravar and Paxlovid) that take down the Sars-CoV-2 virus will get authorized and should also be made widely available to help prevent hospitalizations and deaths. Otherwise, we will probably face a fifth wave. Now is not the time for happy talk, but to instead show we can persevere, run this marathon, make it to the finish line. We can acknowledge and accept endemicity – that a low level of Covid will remain in the background, but that is not >75,000 new cases a day. Instead of succumbing to yet another major rise in cases and their sequelae, this is a chance for America to finally rise to the occasion, showing an ability to lead and execute. ---------- Eric Topol is the founder and director of the Scripps Research Translational Institute, professor of molecular medicine, and executive vice-president of Scripps Research

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