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.

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