Will Humble Uncategorized, Wills Blog

Arizona Continues Our Hospital Capacity and Capability Crisis March

Dr. Joe Gerald just finished his weekly COVID epidemiology and hospital capability report.  As always, there are many informative charts and graphs that depict the profound trajectory of COVID-19 cases and the resulting hospital capacity and capability crisis. It’s now clear that as a system, our hospitals are operating under Contingency Standards of Care approaching the “Crisis Standards of Care” threshold.

I probably sound like a broken record- but I feel compelled to say again that the situation we now find ourselves in is not because of fate as the Governor and state health director suggest. It is largely because they have been unwilling to implement evidence-based interventions this fall including authentic enforcement of the existing “required” mitigation measures for bars, restaurants and nightclubs. A requirement without enforcement is merely a suggestion.

Below are some excerpts from this week’s report from Dr. Gerald:

Arizona hospitals’ safety margin continues to erode in the ward and ICU. Most hospitals have cancelled scheduled procedures to ensure adequate capacity for patients with Covid-19 care. We are now undergoing the great “displacement” such that hospital services are now being rationed so that patients with severe Covid-19 illness are displacing others who have slightly less severe non-Covid medical conditions.

Hospital Covid-19 occupancy continues to increase with each day setting new records for ward and ICU occupancy. By early-to-mid January hospital capacity could be overwhelmed by new Covid-19 cases. Hospitals continue to postpone scheduled procedures to create additional capacity for Covid-19 patients at the expense of others with serious medical conditions. This coping mechanism could be exhausted soon if admissions continue to increase.

Health professionals are being asked to work additional hours and assume new duties. Shortages and burn-out will degrade our capacity to provide critical care services over the coming weeks.

The test positivity rate for traditional PCR testing remains at record levels, 26% this week. The mismatch between testing capacity and demand indicates viral transmission is growing faster than estimated.

As Covid-19 illness continues to increase, delaying others’ care will become ever more difficult. At some point, hospitals will have to expand their physical capacity. Make no mistake, the Covid-19 crisis is now placing a greater share of Arizonans’ at-risk, not just those unfortunate enough to contract Covid-19.

It is also important to recognize that hospital admission and discharge practices are changing in concert with management of nonCovid-19 patients. Covid-19 patients are likely being discharged home sooner and must have higher average severity to be admitted to the hospital and ICU. Furthermore, many who would have been transferred to a tertiary care facility are being managed at smaller, more rural hospitals.

The week ending December 13th has now seen 525 recorded deaths (Figure 7). This number will rise further over the coming weeks as more deaths are made known. Covid-19 deaths are expected to exceed 500 per week for the foreseeable future and may reach a new record by late December. Recall that deaths lag new cases by 14-days and are often only known weeks later. As a rule of thumb, multiplying the number of weekly cases by 1.5%, the case fatality rate, will approximate the number of Covid-19 deaths in 2 – 3 weeks’ time.

Will Humble Disease Control, Vaccination, Wills Blog

UK Temporarily Authorizes Use of the Oxford/AstraZeneca Vaccine

The UK’s Department of Health & Social Care and their Medicines and Healthcare Products Regulatory Agency (MHRA) temporarily authorized the AstraZeneca/Oxford vaccine for use in the UK. This is a “temporary authorization” which is somewhat like our Emergency Use Authorization .

Here’s their clinician information packet with some of the particulars about the vaccine. The MHRA doesn’t appear to post as much of the Phase III data as the FDA does.

Here’s the short summary of the safety profile from the clinical information packet:

“The most frequently reported adverse reactions were injection site tenderness (>60%); injection site pain, headache, fatigue (>50%); myalgia, malaise (>40%); pyrexia, chills (>30%); and arthralgia, nausea (>20%). The majority of adverse reactions were mild to moderate in severity and usually resolved within a few days of vaccination. By day 7 the incidence of subjects with at least one local or systemic reaction was 4% and 13% respectively. When compared with the first dose, adverse reactions reported after the second dose were milder and reported less frequently.  Adverse reactions were generally milder and reported less frequently in older adults (≥65 years old).”

Here’s the short summary of the efficacy profile from the packet:

“In this population, vaccine efficacy from 22 days post dose 1 was 73.00% (95% CI: 48.79; 85.76 [COVID-19 Vaccine AstraZeneca 12/7,998 vs control 44/7,982]).  Following vaccination with COVID-19 Vaccine AstraZeneca, in participants who were seronegative at baseline, seroconversion (as measured by a ≥4 fold increase from baseline in S binding antibodies) was demonstrated in ≥98% of participants at 28 days after the first dose and >99% at 28 days after the second.” 

This is a more traditional vaccine when compared to the Pfizer and Moderna vaccines. AstraZeneca uses an adenovirus vector to develop the immune response, while Pfizer and Moderna use a new mRNA technology.

Importantly, this vaccine is supposed to be stored at regular refrigerator temperatures, has a 6-month shelf-life, and can be stored between 2°C and 25°C during the in-use period. These characteristics make the vaccine far more flexible and easier to use in a much wider range of settings.  It will be particularly valuable for developing nations with limited infrastructure.

Back in May,  HHS announced that they had contracted with AstraZeneca, providing $1.2B to support the development of their candidate vaccine (which has been developed in conjunction with the University of Oxford). The agreement is to make available at least 300 million doses of the vaccine for the United States. 

I couldn’t find info on how many doses have already been manufactured that may be available in the U.S. when the vaccine is ultimately given Emergency Use Authorization (most likely in January).

Will Humble Disease Control, Vaccination, Wills Blog

ACIP Issues Second Set of Recommendations for Vaccine Priority Allocation Categories – Adding Folks 75+ to Category 1b

Arizona Vaccine Prioritization Advisory Committee Approves the New ACIP Recommendations

Last week the Advisory Committee on Immunization Practices (ACIP) voted 13 to 1 to flesh out the priority population recommendations a bit more.  This article provides additional details. The new recommendations make the following changes:

Phase 1b: persons aged ≥75 years are moved to category 1b (previously 1c)

Phase 1c: persons aged 65–74 years, persons aged 16–64 years with high-risk medical conditions

Elevating folks 75+ to AZ’s next (1b) vaccination phase is meaningful and ethical. Thanks to AZ’s independent Vaccine Prioritization Committee for this evidence-based decision. Here’s the updated decision by the AZ Committee: https://bit.ly/38IJnlZ

There are more than 1M persons in 1b now, so outreach to seniors will be key. Because the decision to add 75+ to 1b was made yesterday (and there are 500K + people in that category) the county health departments are still working out the details. There aren’t anywhere close to 500K doses available in AZ right now. Could they focus on 85+ first? We’ll see. That would be an evidence-based decision.

Will Humble Disease Control, Wills Blog

New SARS CoV2 Variant Emerges in England

Last week we heard a lot in the media about a new genetic variant of the SARS CoV2 virus in southern England. Several countries have imposed travel limitations in response to the reports. Here’s some background about what’s going on.

Public Health England wrote last week about a cluster of genetically similar cases in mid-November. They found that the cluster is genetically distinct from the rest of cases in the UK.

An investigation of the cluster found that the virus causing the cluster appears to be transmitted more easily than other variants (the reproduction rate is higher). The virus doesn’t appear to be more lethal.

The variant has mutations in the genetic code that effect the receptor binding site on the viral coat. The authors hypothesize that the changes in the receptor binding affinity of the spike protein enhances the transmissibility of the virus.  They think it’s possible that the changes in this strain make antibodies less effective at neutralizing the virus.

So far, there’s no evidence that this particular variant (and there are thousands of variants) poses a risk to vaccine effectiveness. Vaccines are made such that they can accommodate genetic changes. The influenza virus is completely different in that it’s prone to major antigenic shifts- which is a big reason why we have new influenza vaccines each year.

Also, this virus was identified in mid-November, more than a month ago. That means it has been circulating far more widely in Europe than is currently known and possibly in the US as well.  Implementing travel restrictions as is happening in Europe is unlikely to make a meaningful difference and diverts attention from the core public health measures that we do know slow the spread of the virus. Here’s CDC’s brief and factsheet about the emerging variant.

Will Humble Disease Control, Vaccination, Wills Blog

Moderna Vaccine Receives Emergency Authorization Use from FDA and Approved Use Recommendations from CDC

Last week the current CDC Director signed the Advisory Committee on Immunization Practices’ recommendation for using Moderna’s COVID-19 vaccine in people ages 18 and older. That official CDC recommendation followed FDA’s decision to authorize the emergency use of Moderna’s vaccine. The recommendation is published in CDC’s Morbidity and Mortality Weekly Report.

Other CDC resources on the Moderna vaccine include: Evidence to Recommendations;  Interim Clinical Considerations; and  Local Reactions, Systemic Reactions, Adverse Events, and Serious Adverse Events.

Will Humble Disease Control, Prevention, Wills Blog

ADHS Director Scraps COVID-19 Spread Metrics for Business Operations

Substantial Spread No Longer Exists as a Category in Arizona

Over the summer, a host of stakeholders including the business community developed COVID-19 metrics to inform policy decisions like when it’s time to pause the operation of bars and have restaurants go to take out and outdoor dining.  Shortly after the ideas were presented to the Governor’s Office, the ADHS quickly adopted the metrics and highlighted them as a key tool for driving future intervention decisions. Those metrics were then used when the state decided to lift the limitations put on bars, restaurants and gyms during the summer “pause”.

Under the former criteria bars and in-person dining are not allowed to operate when a county is in the Substantial category (based on more than 100 cases per 100,000 residents, more than 10% of people testing coming back positive, and more than 10% of people showing up at hospitals having COVID-like illness). We supported those metrics (although we pointed out that COVID-Like Illness is a very poor metric for decision-making).

As community spread began to increase in late October and into November & December, county after county moved into the Substantial spread category. When asked why the ADHS was not advocating for enhanced interventions because of the substantial spread, Dr. Christ (the agency director) said that while the metrics were valuable for deciding when to open businesses, they were irrelevant for deciding when to close them.

As that argument became increasingly untenable, Dr. Christ late last week quietly changed the standards governing business operations such that it is impossible to reach a threshold in which community spread is high enough to warrant enhanced interventions on bars and restaurants, no matter how serious the infection rate gets.  Basically, Substantial Spread has been eliminated as a category.

If you don’t believe me, you can check it out for yourself. Go to the ADHS Business Dashboard. You can see that the state as a whole and all the counties are well into the Substantial Spread range in terms of cases per 100,000, percent positivity, and even COVID Like Illness. 

Yet, the business reopening status is Moderate…  meaning steady as she goes.

Astonishing.

Will Humble Disease Control, Prevention, Vaccination, Wills Blog

Pre-screening Being Used to Prioritize Vaccine Recipients in Tier 1A

Pre-screening is open for all Phase 1A healthcare workers interested in being vaccinated for COVID-19. Because supplies are limited it will be available by appointment only and pre-screening is required to determine eligibility in most counties. For example, in Maricopa County you can go to their Phase 1A prescreening worksheet to check you or your family member’s eligibility. That site also lays out the various eligibility categories.

The first allocation of vaccine doses will be prioritized to individuals that ACIP has recommended to be in Phase 1A: those working in a healthcare setting, especially those with the most potential exposure to COVID-19, as well as residents and staff of long-term care facilities.

To determine your eligibility, please complete this pre-screen survey as the first step to scheduling an appointment. Your response will help MCDPH determine your eligibility and connect you with your assigned regional vaccine provider, based on the location of your primary worksite.

I tested the system out so I could write about how it works, but I was (appropriately) screened out at Step 1.

Note: Through the Pharmacy Partnership for Long-term Care Program, CDC has engaged retail pharmacy partners (CVS and Walgreens) to secure vaccine and provide on-site vaccination of residents, at no cost to the facility. Skilled Nursing Facilities residents and staff will receive the vaccine first followed by Assisted Living and other adult congregate settings. 

Will Humble Disease Control, Vaccination, Wills Blog

FDA Authorizes Moderna’s Vaccine for Emergency Use

FDA’s Vaccines and Related Biological Products Advisory Committee met last Thursday to discuss the request for emergency use authorization for a COVID-19 vaccine from Moderna. They recommended Emergency Use Authorization of the Vaccine and the FDA commissioner promptly approved their recommendation.

See: FDA Authorizes Pfizer Vaccine for Emergency Use & ACIP Recommends Administration Schedules. Meeting information on the Moderna meeting this week can be found here.

The CDC’s Advisory Committee on Immunization Practices met yesterday and are meeting today to make their administration recommendations to the CDC director.

Today’s ACIP meeting is from 9am to 2:30pm.  Here’s the ACIP Final Agenda for today and yesterday & here is the Webcast Link. Here are the Presentation slides from this weekend’s ACIP meetings.

Data released by Moderna in their application for EUA stated the following:

“The EUA request includes safety and efficacy data from an ongoing Phase 3 randomized, double-blinded and placebo-controlled trial of mRNA-1273 in approximately 30,400 participants. Efficacy in preventing confirmed COVID-19 occurring at least 14 days after the second dose of vaccine was 94.5% (95% CI 86.5%, 97.8%) with 5 COVID-19 cases in the vaccine group and 90 COVID-19 cases in the placebo group. Subgroup analyses of the primary efficacy endpoint showed similar efficacy point estimates across age groups, genders, racial and ethnic groups, and participants with medical comorbidities associated with high risk of severe COVID-19.”

Analysis of approximately 30,350 participants ≥18 years of age randomized 1:1 to vaccine or placebo with a median of 7 weeks of follow-up after the second dose supported a favorable safety profile, with no specific safety concerns. The most common solicited adverse reactions associated with mRNA-1273 were injection site pain (91%), fatigue (68%), headache (63%), muscle pain (59%), joint pain (44%), and chills (43%). Severe adverse reactions occurred in 0.2% to 9.7% of participants, were more frequent after dose 2 than after dose 1, and were generally less frequent in participants ≥65 years of age as compared to younger participants.

See these documents for the particulars: Vaccines and Related Biological Products Advisory Committee December 17, 2020 Meeting Briefing Document – FDA and Vaccines and Related Biological Products Advisory Committee December 17, 2020 Meeting Briefing Document Addendum- Sponsor

Will Humble Disease Control, Vaccination, Wills Blog

Dr. Gerald’s Weekly COVID Report: The March to Crisis Standards of Care Continues Unabated

Dr. Gerald’s weekly epidemiology and hospital capacity is hot off the presses. No surprises in this week’s report. No good news again, as expected, given the dearth of policy and operational interventions under the governor and health director’s leadership. As always, several good Figures in this week’s report document the severity of this unmitigated crisis.

Arizona is now experiencing a public health crisis where access to critical care services is limited due to shortages of space, personnel, and critical supplies. We are undergoing a great “displacement”. Hospital services are being rationed so that patients with severe Covid-19 illness are displacing others who have slightly less severe non-Covid medical conditions.

As Covid-19 illness continues to increase, delaying others’ care will become ever more difficult. At some point, hospitals will have to expand their physical capacity and implement Crisis Standards of Care. The Covid-19 crisis is now placing a greater share of Arizonans’ at-risk, not just those unfortunate enough to contract Covid-19.

With 617 deaths, the week ending July 19th is still Arizona’s deadliest week, but not for long. Because cases have been increasing, deaths are also increasing. Sharper rises are expected over the coming weeks as deaths lag new cases by 14- days and are often only made known weeks later.

By Christmas, Arizona will be experiencing >500 deaths per week. However, this toll will not be apparent until mid-January once all deaths are accounted for. As a rule of thumb, multiply the number of weekly deaths by 1.5% (approximate case fatality rate) to estimate the number of expected deaths in 2–3 weeks time.

It is now clear that there will be no interventions from the governor or health director to mitigate this crisis. Their plan appears to be to slowly vaccinate persons with the highest risk of hospitalization and death. Such a strategy will be quite slow owing to: 1) the slow pace of vaccinations given the totality of the population at highest risk; and 2) the lag time between vaccination and the development of protective neutralizing antibodies and T cells.

Will Humble Disease Control, Public Health Law, Wills Blog

AzPHA Joins a Host of Healthcare Heavy Hitters to Urge the Governor and Health Director to Act

Today the Arizona Public Health Association joins with the Arizona Hospital and Healthcare Association (AzHHA), Arizona Medical Association (ArMA), Arizona Osteopathic Association (AOMA), Maricopa County Medical Society (MCMS), and the Arizona Organization of Nurse Leaders (AAONL) to urge the governor to issue executive orders to temporarily pause the operation of certain types of businesses or further limit their operations, to temporarily limit gatherings, and to additionally mandate statewide mask wearing.

We know there is deep-seated opposition to some of these recommendations. And there are negative economic consequences to others, which have a down-stream impact on public health. However, we believe urgent action is needed on a temporary basis to protect the immediate fragility of the healthcare delivery system.

In our letter, we urge the governor and health director to take the following steps for the next six to eight weeks—while vaccines are being administered to healthcare workers and long-term care residents under Phase 1a of the state’s COVID-19 Vaccine Plan:

  • Close bars and nightclubs. These could be reopened earlier if the state returns to moderate community spread.

  • Limit restaurant operations to outside dining and take-out service. These restrictions could be lifted earlier if the state returns to moderate community spread.

  • Except for essential services, limit public gatherings to no more than 25 people. Encourage people to only socialize with members of the same household. With holiday celebrations continuing through the New Year, we are incredibly concerned about multi-household gatherings which will become super spreader events.

  • Implement a statewide and enforceable face covering mandate that focuses on business compliance rather than individuals.

Arizona finds itself in a potentially catastrophic situation. The healthcare system is overwhelmed and on the brink of considering the need to implement crisis standards of care. We also face the reality that our hospital systems will likely run out of available staff to care for patients who need our help.

Editorial Note: Sadly, the recommendations above to close bars and have restaurants go back to take out service could have been avoided if mitigation measures like a statewide, uniform, and enforceable face covering mandate (placing the responsibility for compliance on businesses and organizations) and far better enforcement of mitigation measures in bars and restaurants had been implemented weeks ago.

If those less dramatic interventions been implemented in October when the case rate and trajectory began to increase, those interventions would have been able to slow down the spread enough to decrease the imminent hospital capacity crisis.

Many weeks of opportunities to benefit from better enforcement in bars and restaurants and a uniform and enforceable statewide mask mandate (with enforcement focused on businesses and organizations rather than individuals) have now been missed, necessitating the recommendations above.

Editorial Note II Regarding Bars & Restaurants:  For the last many months I have been in favor of much better enforcement of the existing required mitigation measures. Sadly, the opportunities to put together an efficient compliance system (and benefit from it) have been lost.

We’ve learned a lot about this virus and we now know that the virus thrives in closed indoor environments where people typically don’t wear masks.

When these businesses started back up a couple of months ago, they were required to sign attestations that they’d follow required mitigation measures (restaurants at 50% capacity and bars operating like restaurants and also using capacity limits). While there is a complaint hotline and some follow up of those complaints (I’ve heard that many are simply phone calls) there is little if any proactive compliance checks and sporadic enforcement.

Any effective regulatory program requires routine proactive compliance checks that include enforcement when necessary. Had we been doing better proactive compliance checks, there would be far fewer bars, restaurants and nightclubs ignoring the existing mitigation requirements. Businesses that are complying are frustrated that their competitors are cheating and getting away with it. That causes more businesses to cheat.

But how could such a system have worked? There were at least 2 possibilities. The existing food safety workforce in AZ (called Sanitarians) could have been reassigned to COVID mitigation detail for the next few months. Alternatively, the National Guard (who is currently helping with the response on other areas like food banks and shelf stocking among other things) could have been put on mitigation compliance check detail at bars restaurants and nightclubs. An Executive Order could have given authority to nullify the Attestations made by those businesses that are not complying, suspending their individual operation.

If better compliance and enforcement had been in place several weeks ago, we would be in a different place. As it stands, we are now in exponential growth of the virus and at the brink of a hospital capacity crisis.

My point has been that shutting the bars again could have been avoidable if better compliance and enforcement of the existing required mitigation measures had been in place many weeks ago.

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