Will Humble Disease Control, Wills Blog

ACIP Recommends Vaccine Priority Populations

State Largely Adopts the Recommendations

The CDC’s Advisory Committee on Immunization Practices met last week and recommended that the initial shipments of the vaccine be focused on vaccinating healthcare personnel and residents of long-term care facilities. About 420,000 Arizonans work in the healthcare industry. An estimated 60,000 persons live in AZ long-term care facilities.

Slides from the meeting are available on this CDC website. The committee will meet again following FDA authorization to consider additional recommendations.

Prior to the ACIP meeting, the CDC published this Early Release MMWR describing the proceedings of the meeting and outlining the principles they used to make their decision. They considered data on safety and efficacy and employed the ethical principles of:

  • Maximizing benefits and minimizing harms.

  • Promoting justice.

  • Mitigating health inequities.

  • Promoting transparency in their recommendations.

The state outlined priority populations for Arizona last week. The following represent the priorities that came out of the task force that has been assembled. Keep in mind that the practical logistics of vaccinating large numbers of people will likely mean that there will be some overlap between these phase groups.

Phase 1A

    • Skilled nursing facility residents

    • Assisted living, independent living, HUD senior housing residents

    • DES group homes for individuals with developmental disabilities and intermediate care facilities for individuals with intellectual disabilities, and staff

    • Health care practitioners and technical occupations

    • Health care support occupations

Phase 1B

    • Adults with high-risk medical conditions living in shelters or other congregate living settings

    • Law enforcement, corrections, and other emergency response staff

    • Power and utility workers

    • Food and agriculture related occupations

    • Transportation and material moving occupations

    • State and local government workers who provide critical services for continuity of government

    • Education and childcare providers

    • Other essential workers

Phase 1C 

    • Adults with underlying medical conditions

    • Adults 65 years and older

    • Adults living in congregate settings

Last Friday was the deadline for the ADHS to turn in requests for the first shipment of Pfizer vaccine (including the destination for shipments). Arizona’s allotment for the remainder of 2020 is expected to be about 350,000 doses (it’s unclear whether it’s all Pfizer vaccine or a combo of Pfizer and Moderna).

The first doses of that vaccine could be shipped as early as Monday, December 14 assuming that the FDA Biological Products Advisory Committee and the FDA Commissioner authorize Emergency Use of the vaccine immediately following this Thursday’s VRBPAC meeting.

The FDA’s VRBPAC committee meeting regarding the Moderna vaccine is set for Thursday (December 17). This week Moderna, Inc. announced that their candidate vaccine is 94% effective at preventing COVID19 infections. Their Phase 3 study enrolled more than 30,000 participants in the U.S.  The primary analysis was based on 196 COVID19 cases in the trial. 185 of the cases were observed in the placebo group versus 11 cases in the mRNA vaccine group.

Will Humble Disease Control, Public Health, Wills Blog

Latest Epidemiological Analysis and Hospital Resource Report Paints a Grim Christmas Picture in Arizona

Dr. Joe Gerald just published his weekly epidemiology and hospital resource report. Needless to say, it’s not a pretty picture. Below is a summary of the results, but the full report provides the detail and some very informative graphs and charts.

Viral transmission is increasing throughout Arizona. If not slowed within the next 1 – 2 weeks, new Covid19 cases will overwhelm our capacity to provide hospital care by the end of December. New cases are being diagnosed at a rate of at least 390 cases per 100,000 residents per week. This rate is increasing by approximately 27 cases per 100,000 residents per week.

Transmission rates could be faster than measured owing to limited access to and/or lower uptake of Covid-19 testing during the Thanksgiving week. Holiday travel, commerce, and social gatherings between Thanksgiving and New Years are likely to accelerate transmission rates without additional public health interventions.

Without intervention, we are on track to experience a major humanitarian crisis during the Christmas – New Year holiday season. Hospital Covid-19 occupancy is increasing and is on course to exceed previous peaks by mid-December. It could overwhelm hospital capacity by late-December.

The fall-winter viral respiratory season plus the return of part-time residents who winter in Arizona will continue to strain hospitals capacity through January – February. Hospitals are already postponing scheduled procedures and requiring health professionals to work additional hours and assume new duties. Shortages and burn-out will degrade our capacity to provide critical care services. The test positive rate for traditional PCR testing reached 22% this week.

The growing mismatch between testing capacity and demand indicates viral transmission is growing faster than the estimate here. Covid-19 mortality continues to increase. While rates remain lower than those observed with this summer’s outbreak, cases are rising quickly. It is likely that Arizona will record >500 Covid-19 deaths per week by Christmas.

Will Humble Disease Control, Public Health, Public Health Law, Wills Blog

A Lack of Interventions Led to Our December Hospital Crisis: How Will It Play Out?

As evidenced by several predictive models (which have a good track record) Arizona is now headed head-long into our second COVID-19 hospital overcapacity crisis.

There were several opportunities to implement interventions to prevent the crisis (see this blog post from last week), but those opportunities were passed over by Arizona’s governor and public health director. We can expect to see a pattern of events in the new weeks as we press headlong into the crisis.

First, we will see hospitals restrict visitation. That happened last week as several hospital systems implemented varying types of visitation limits.

Second, we can expect to see increasing numbers of patient transfers between hospitals as they try to level out patient loads when they have periods of time. Some hospital systems like Banner are large enough to do interfacility transfers using their own resources and data. Others will need to contact the ADHS Surge Line, where transfers can be facilitated. I’ve been told that in recent days the Surge Line has been activated to facilitate patient transfers.

Third, we will see hospitals begin to restrict elective procedures. This isn’t something hospitals like to do because patients really need these important procedures and because general surgery and elective procedures contribute much to the financial bottom-line. Nevertheless, these procedures will begin to be postponed or canceled. This is probably already happening.

Fourth, we will see hospitals change their admission decisions. For example, persons presenting in the emergency department may be sent home when, under normal circumstances, they would be admitted. Likewise, a patient that would normally be admitted to an Intensive Care Unit (with robust staffing rations) might instead be placed on a general ward bed.

Fifth, hospitals will change their discharge decisions. People that have been admitted and who would normally stay for a couple more days will be discharged rather than observed. In some cases, persons that are in the ICU may be discharged directly to home rather than admitted to a general ward bed. Others will be discharged to a skilled nursing facility rather than a general ward hospital bed.

Finally, the system will become totally saturated and the hospitals will ask the ADHS to activate the Crisis Standards of Care. “Crisis Standards of Care” is basically a protocol for making healthcare decisions when the system can’t provide all of the care that everybody needs because the needs outstrip the resources. Ethics panel discussions will be held to make very difficult decisions regarding who will get care and who will not.

The Crisis Standards of Care is a protocol to help healthcare providers objectively decide who gets care when resources don’t allow everyone to get treatment. This blog post fleshes it out How Will Patients Be Prioritized Under the New “Crisis Standards of Care”. 

Here’s a link to the ADHS Crisis Standards of Care Planning Document. It’s 141 pages, but the real heady stuff is on pages 29 through 38 where it discusses the scoring system to prioritize which patients will get treatment and which will not and how to ration care to all patients when resources are outstripped by demand.

The ADHS also has an Addendum to the report called Allocation of Scarce Resources in Acute Care Facilities Recommended for Approval by State Disaster Medical Advisory Committee.

That Addendum was the subject of a complaint filed by disability rights advocates for violating the rights of persons with disabilities (on July 17, 2020).  I don’t think the Addendum was modified as a result of that complaint. 

Grim stuff…  but it’s where we’re headed because of the decisions made and not made over the last couple of months by Arizona’s Executive Branch.

Will Humble Disease Control, Prevention, Vaccination, Wills Blog

Prioritizing the Initial Vaccine

Among the most important policy decisions that need to be made in the coming weeks is how to prioritize the allocation of the early doses of vaccine. With the clinical trials showing promising results and manufacturers of several vaccines already in production (even though they are still only in Phase III Trials), it’s time to decide how to distribute the initial vaccines.

Immunizing the U.S. population to prevent COVID will probably be the largest vaccination campaign ever undertaken.  A successful and equitable vaccination plan will require participation by county health departments, community health centers, healthcare providers of all kinds, emergency managers and private & nonprofit sector partners.

How should the early doses of vaccine be allocated? Fortunately, the National Academies of Medicine assembled an all-star group of professionals to come up with a proposed prioritization plan that considers evidence, ethics, and health disparities. It’s called the Committee on Equitable Allocation of Vaccine for the Novel Coronavirus.

They released their final report back in October entitled Framework for Equitable Allocation of COVID-19 Vaccine.  In addition to sharing an updated framework for equitable allocation of a COVID-19 vaccine, the final report includes community engagement strategies, risk communication approaches, methods to promote vaccine acceptance, and global considerations.

National Academy Plan for the equitable allocation of vaccine report was commissioned by the NIH and CDC. It’s a long document, but here’s a snapshot of the recommendations Phase 1 populations include:

  • 1a: Front-line healthcare workers (including care home workers, hospitals, home health)

  • 1a: Emergency services workers

  • 1b: Older adults in crowded settings

  • 1b: Persons of all ages w/co-morbid conditions & significantly increased risk

Chapter 3, Page 20 gives an overview of priority populations in all 4 Phases along with a detailed rational for the various selections.

This is a well thought-through document that is objective and non-partisan. Hopefully the federal, state and county governments will look to this landmark report as they develop the SARS CoV2 vaccination plans.

The CDC’s Advisory Committee on Immunization Practices have presumably closely reviewed the NAESM’s report to inform their recommendations this Tuesday.

UPDATE: Yesterday, CDC’s Advisory Committee on Immunization Practices recommended that during the initial phase of the COVID-19 vaccination program, the vaccine should be offered first to healthcare personnel and residents of long-term care facilities.

Current estimates are that 21 million people work in the healthcare industry and three million live in long-term care facilities. Slides from the meeting are available here. The committee will meet again following FDA authorization to consider additional recommendations

Will Humble Disease Control, Prevention, Vaccination, Wills Blog

FDA Biological Products Advisory Committee Meetings On Deck (VRBPAC)

 Committee Meetings to Be Held December 10 and 17th on Pfizer and Moderna Emergency Use Authorization Requests

The Pfizer and Moderna vaccines (which use a new mRNA vaccine technology) have completed their Phase III clinical trials and are ready for the FDA to review their requests for Emergency Use Authorization of their candidate vaccines. Because this is a public health emergency the FDA can authorize emergency use of the vaccines prior to issuing full approval of the products. You can read more about how that process works in this blog post: How Are New Vaccines and Drugs Approved?

The first step is for the FDA’s Vaccines and Related Biological Products Advisory Committee to review the Phase III trial data and make their recommendation to FDA Commissioner Hahn about whether to authorize emergency use if the vaccines prior to approval.

The VRBPAC meeting for the Pfizer request is Thursday, December 10.  The Moderna meeting will be a week later (on December 17).  The FDA has promised to make background materials available to the public, including the meeting agenda and committee roster by December 8 for the Pfizer meeting and December 15 for Moderna. The current Commissioner (Hahn) issued this statement committing to data  transparency.

The meetings have been set 2 weeks after the EUA applications to allow the committee a couple of weeks to review the data before the meeting. This allows the committee to review the application and data, and it’s possible that they could make a recommendation to the Commissioner shortly after the meetings.

FDA intends to issue a Federal Register notice with details of the meetings, which will include information about a public docket for comments. At that time, public comments can be submitted. These comments will be reviewed by the FDA.

The FDA said that they will be livestreaming the VRBPAC meeting on their YouTube, Facebook and Twitter channels and broadcast from the FDA website. No details are available yet.

If the FDA Commissioner authorizes emergency use of these vaccines, they could potentially become available for distribution in mid to late December. That’s because many months ago the federal government entered into purchasing agreements with Pfizer and Moderna agreeing to pay for vaccine in advance (and even if they turned out to be ineffective).  That allowed the manufacturers to make the vaccine during the Phase III trials.

Will Humble Disease Control, Wills Blog

CDC’s Advisory Committee on Immunization Practices Meeting Tuesday

The CDC’s Advisory Committee on Immunization Practices is meeting on Tuesday, December 1st starting at noon to review, discuss and perhaps make a recommendations about how to prioritize initial supplies of the various SARS CoV2 vaccines.

Here’s the Meeting Agenda which includes: 1) a presentation of the proposed allocation of initial supplies of COVID-19 vaccine; 2) a discussion of clinical considerations for populations included in Tier 1; and 3) a post-authorization safety monitoring update.

A discussion follows those presentations with a vote on the ACIP’s recommendation. Here’s the link to the Webcast, which does not require pre-registration.

ACIP recommendations carry a lot of weight in the medical and public health communities and are often adopted by clinicians and public health as-is.  The recommendations usually include the ages when the vaccine should be given, the number of doses needed, the amount of time between doses, and precautions and contraindications. It’s unclear whether Tuesday’s meeting will issue those kinds of recommendations. Those might come at a meeting later in December.

ACIP recommendations are also often used to drive decisions by health insurers with respect to reimbursement and other policies.

Note that ACIP recommendations aren’t the same as FDA authorization or approval. FDA will be holding advisory committee meetings on December 10 (for the Pfizer vaccine candidate) and December 17 (for Moderna). At those meetings, the Committee will discuss those vaccines and decide whether to recommend emergency use authorization of those vaccines. It’s possible that the FDA advisory committee will recommend Emergency Use Authorization of those vaccines during their meeting. At that point, FDA Commissioner Hahn could make a final decision about EUA. If he decides to authorize, then delivery of the vaccine to vaccinate high priority populations could begin immediately.

Will Humble Disease Control, Wills Blog

Dr. Gerald’s Latest Analysis of AZ’s COVID Trajectory

Dr. Gerald just finished this week’s COVID epidemiology and hospital capacity report. You can review the full report here.

The joint US, ASU, NAU modeling team also sent the ADHS a letter with a call to action given the impending crisis. You can view that memo here. Sadly, most of have extremely low expectations that this evidence will be taken into consideration by the Department or the executive branch as a whole.

It should be no surprise that the news is grim. For several weeks now, his reports have had increasingly troubling findings. Nevertheless, there have been no policy interventions to mitigate the coming hospital capacity crisis. Below is his narrative summary- but make sure to view the full report.

The ASU Covid-19 forecasting group detected a recent acceleration in viral transmission that predicts an earlier exhaustion of hospital beds. This does not take into consideration the potential impact of holiday travel, social gatherings, and commerce.

Given that the cost of inaction is so high and our policymakers have been so slow to respond, I am growing ever more concerned that we will stumble into the Christmas holidays unprepared. While targeted measures might have sufficiently slowed transmission weeks ago, I believe shelter-in-place orders offer the most certain chance to achieve the improvements needed. Of course, these restrictions would impose substantial economic consequences. Therefore, they must be accompanied by economic relief to ensure businesses and families do not unnecessarily sacrifice for the greater good.

While I am not naive to reality that such measures are unlikely, I am ever more frustrated by our continued inaction which raises the costs and the consequences for all Arizona residents. This is made worse by the fact that it was predicted and preventable. To lose control with an effective vaccine imminent makes it even more bitter.

**NOTICE** Arizona is experiencing a public health crisis where access to critical care services is limited due to shortages of space, personnel, and critical supplies. If not addressed within the next 2 – 3 weeks, this crisis will evolve into a humanitarian crisis leading to hundreds of preventable deaths. At this point, only shelter-in-place restrictions are certain to quickly and sufficiently curtail viral transmission. Because such restrictions impose substantial economic hardships, these measures should be augmented by state expansion of programs to provide direct economic assistance, reduce food insecurity, prevent foreclosure and evictions, and protect access to health services.

Will Humble Affordable Care Act, Wills Blog

US Supreme Court Hears Oral Arguments in the California v Texas (ACA) Lawsuit

Oral arguments in the case challenging the constitutionality of the Affordable Care Act (now named California v. Texas) were heard December 10 at the US Supreme Court. If part or all the ACA is overturned, the only way to save the law, and all the protections for Americans that come with it, would be through congressional action.

AzPHA members James Hodge and Jennifer Piatt gave an AzPHA webinar last week discussing the arguments made by both sides and discussing the kinds of questions that were asked by the justices. Sometimes one can get a forecast about where the court is going by listening to the kinds of questions (and statements) made by the justices.

Here is a link to the Webinar Recording and Access Passcode: L12h*ScW. You should watch if you get a chance. The team did a great job preparing.

In a nutshell, our presenters (AzPHA members James G. Hodge, Jr., J.D., L.L.M. and Jennifer L. Piatt, J.D.) were optimistic that the Justices are leaning toward upholding the ACA or at least holding that even though the fees associated with the individual mandate are not bringing in revenue right now that the individual mandate is severable from the rest of the Act (essentially upholding the ACA again).

Let’s hope they’re right.  A decision is expected this summer.

What Happens if the Supreme Court Strikes Down the ACA?

The ACA led to tremendous gains in the rate of children’s health coverage in Arizona. As CAA’s most recent KIDS COUNT Data Book demonstrates, the rate of uninsured children in our state dropped from 13% in 2012 to 8% in 2018. While funding for outreach and enrollment support has been cut, anti-immigrant rhetoric and policies, such as the new public charge rule, has deterred many families from enrolling in health care.

The Urban Institute recently projected that more than 21M Americans will be newly uninsured in 2022, including 1.7 million children if the ACA is overturned by the Supreme Court. Those most at risk of losing coverage are people with incomes below 200% of the federal poverty level and people of color. In Arizona alone 223,000 non-elderly individuals are likely to become uninsured if the ACA is repealed. 

Other key protections that would be lost include:

  • A guarantee that plans cover the 10 essential health benefits;

  • Marketplace insurance plans and the subsidies that make them more affordable;

  • Protections for pre-existing conditions and a guarantee that folks with pre-existing conditions can’t be charged more;

  • Medicaid expansion;

  • The ability to keep dependents on health insurance plans until they’re 26The chance to keep dependents with disabilities on your insurance indefinitely, and

  • A host of other wellness incentives (and a whole lot more).

Until we have a ruling from the Supreme Court (which likely won’t happen before next spring) the ACA remains the law of the land. The annual open enrollment period began November 1, and will continue through December 15. The ACA Marketplace, Medicaid expansion, and KidsCare continue to cover tens of thousands of Arizona children and families.

Will Humble Disease Control, Wills Blog

ASU Updates Last Week’s Predictive Model

The revision was necessary because prior estimates have already been outpaced by recent data

Less than a week ago the ASU collaborative predictive modeling team released their most recent model. You can read about those results in my blog post from last weekend. Since that time, the number of new cases and the hospitalization trends have accelerated so they decided to update their model upward.

Here’s is a PowerPoint with those most recent results. The updated model results show that ICU and med-surg bed capacity is reached in early December now (the model from last week placed that estimate between December 13 and 22nd).

Policy responses to prevent or deal with the looming capacity crisis from the 9th Floor of 1700 West Washington & the 5th Floor of 150 N. 18th Avenue (my old office):

Crickets.

Will Humble Disease Control, Early Childhood, Public Health, Wills Blog

What Criteria Should School Governing Board Members Use to Make Decisions?

Making decisions about whether schools should use in-person, distance-learning, or a hybrid educational model for the rest of the year is difficult.  There are so many things to take into consideration. Here’s my best shot at distilling down the key elements that they should consider as they make these critically important decisions.

Community Spread Metrics

Governing board members should pay attention to the level of community spread in their district as part of the decision-making matrix. The elements to include are the case rate (cases per 100,000) and percent positivity.  Those 2 metrics that the ADHS used are solid and can be used to inform decisions. 

Those metrics are located on the state’s schools dashboard. Governing board members should totally ignore the Covid-like illness metric as it as an inappropriate metric to use and considering it will lead to poor decisions.

Mitigation Track Record

They should consider how well their mitigation plan has been working this far.  Have they had a cascade of cases occurring after index cases, or has contact tracing and swift return to distance learning for close contacts prevented case cascades?  What about athletics?  Have the mitigation measures been working for those programs?  What about differences in the grades?  Is the mitigation plan working for some grades and not others? 

I’ve talked to folks who are seeing the plan work well in K-8 but poorly in High Schools. Also, most HS kids can benefit more from distance learning when compared to younger elementary kids…  so, the benefit should be examined. Perhaps K-8 should stay in person, and 9-12 go distance in districts and schools that are having case cascades in high schools.  What I’m getting at here is that Governing Board members should look at the track record for mitigation and assess how it’s going and consider that in their decision-making.

Community Characteristics and Beliefs

What are the opinions of community members, teachers, staff and parents? Listen to those voices.  Take into consideration the level of multi-generational families there are living in the district/school. In-person school heightens the risk of bringing the virus home to older family members. Also, think about what the home resources are.  Some districts/schools have fewer home resources like Wi-Fi and access to computers. Those students will benefit more from in person learning.

There’s no easy answer to what to do as a governing board member- but my best advice is to weigh these three “legs of the stool” to balance risks and benefits- with a keen eye to balancing both the benefits and risks when making these important decisions.

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