The Number of Diagnostic Kits is Expanding

The FDA has a very streamlined process for authorizing the emergency use of a host of testing kits for the novel coronavirus (2019-nCoV).  Some are the classic PCR tests and some are antibody tests (IgM and IgG).

So far there are 30 different tests on the Emergency Use Authorization list.  Here is a link to the FDA’s  Test Kit Manufacturers Table which includes the manufacturer and their contact information, fact sheets for providers and patients and instructions.

COVID-19 Vaccine Update

Various health and research agencies in the United States have begun work to create and develop a safe vaccine to combat COVID-19. Since the beginning of this year there has been a growing number of clinical trials for COVID-19 because of its increase incidence rate and mortality.

The first-in-human vaccine trial was administered in early March by the National Institute of Allergy and Infectious Diseases (NIAID) in Seattle, Washington. This vaccine trial is being conducted with 45 healthy males and non-pregnant women, ages 18-55 over approximately six weeks. The vaccine trial is expected to end in June 2021.

Additionally, the U.S. Department of Human and Health Services is working with New Jersey-based Janssen Research and Development, part of Johnson & Johnson, and Moderna of Cambridge, MA. The Biomedical Advanced Research and Development Authority, part of the HHS Office of the Assistant Secretary for Preparedness and Response, will support Phase 1 clinical trial of Janssen’s COVID-19 investigational vaccine.

This clinical trial will evaluate the vaccine’s safety in healthy adult volunteers and its ability to induce an immune response. This trial is expected to begin in Fall 2020, with the goal of making COVID-19 vaccinations available for emergency use in the U.S. in early 2021.

For more information about the COVID-19 vaccine clinical trials visit this site.

Natural Experiments Underway Across the Globe

Natural experiments are happening real-time during this pandemics and different countries take various public health intervention approaches to the COVID-19 pandemic. 

For example, Sweden is implementing calibrated precautions and isolating only the most vulnerable rather than imposing a full lock-down.  Gatherings of more than 50 people are prohibited but they have kept their borders open as well as its preschools, grade schools, bars, restaurants, parks, and shops. 

The strategy is to focus on social distancing among the known risk groups, like the elderly… and to develop herd immunity as their young people spread the virus (mostly asymptomatically) generating protective antibodies that make it harder for the virus to find a new host.  In the meantime, the social distancing measures focus primarily on the elderly and folks with chronic medical conditions.

The controls (Norway and Switzerland) are implementing measures much like the ones underway here in the U.S., with aggressive social distancing of the entire population (of course each state has a different idea about what the definition of an essential service or industry is). 

University researchers will be able to compare the effectiveness of the various public health intervention strategies and determine which were effective and how. The research will be able to shed light on the intervention effectiveness with respect to hospital capacity and mortality from the virus, but also compare the short and mid-term impact to the economy, GDP and the effects that those economic changes influence the social determinants and outcomes.

At the end of this pandemic we should have a rich base of public health literature to draw upon for future pandemics. Up until now, we’ve had to rely on old literature from 1918 and experiences from the less impactful H1N1 pandemic.

Evidence Mounts that Existing AZ Hospital Capacity is Adequate for the Surge

Social Distancing Successes Provide Policy Opportunities

Evidence continues to mount that the public’s social distancing measures are slowing the spread of new COVID-19 infections in AZ. The IHME model as run by Joe K. Gerald, MD, PhD now predicts hospitalizations will peak on April 26th. The mid-range estimate calls for 1,460 beds at the peak, suggesting that bed capacity (including ICU beds) will be fine – with a safety margin (even without the 50% bed capacity increase directed by Executive Order). For perspective, we currently have 6,017 regular beds available- a wide safety margin indeed.

On the intensive care front, the Model now predicts ICU usage will peak on April 27th. The mid-range estimate calls for 293 beds at the peak, below the 508 available (a nice safety margin). Again, suggesting that ICU bed capacity will be fine even without the mandated 50% ICU bed capacity increase.

These models assume that we continue to maintain our social distancing efforts over the coming weeks. According to Dr Gerald’s analysis, the lag between new infections and hospitalizations and ICU admissions means that the pace of these outcomes will increase for the next 1-3 weeks before slowing.

Over the next 2 weeks, hospitals should prepare for a continued increase in admissions until a peak around April 27th. The strain is likely to be greater in critical care settings than general floor beds, but there appears to be adequate capacity to meet demand.

Our mitigation successes provide policy makers with an opportunity to revise some earlier policy decisions that will improve public health while continuing to ensure that Arizona has the hospital surge capacity to meet peak demand for patients with COVID-19. 

Hospital Capacity

Under Executive Order 2020-16, Arizona hospitals have already implemented plans to increase hospital capacity by 25%. The Order further directs that hospitals implement an additional 25% increase by April 26. Given the success of Arizona’s control measures (and the predictive models suggesting that Arizona already has adequate capacity to meet peak demand with a wide safety margin) we urge the governor to suspend the directive that Arizona hospitals increase capacity by another 25% by April 26.

Elective Procedures

The resulting safety margin for hospital capacity and our hospital system’s improving planning regarding the use of personal protective equipment also provides an opportunity to relax the limitations on elective procedures under Executive Order 2020-10. Specifically, we believe that adjusting Executive Order 2020-10 to allow hospitals more discretion regarding elective procedures would benefit public health by allowing Arizonans access to procedures while ensuring hospital capacity.

Note: Here is Maricopa County Department of Public Health’s hospital admissions epi-curve data… updated 4/14/20.

All of Us Research Program Could End Up Being a Great Tool for Tracking Herd Immunity to COVID-19

The All of Us Research Program is a historic effort to collect and study data from one million or more people living in the United States. The program began national enrollment in 2018 and is expected to last at least 10 years. The core objective of the program is to build the evidence base to facilitate healthcare’s increasing use of precision medicine. But it might also end up serving as an opportunity to track the path of herd immunity to the Coronavirus over time. More about that later- but first lets explore what All of Us is all about.

Too often, health care is one size fits all. Treatments meant for the “average” patient may not work well for individual people. Health care providers may find it difficult to coordinate care among specialists or to access all of a patient’s health information. Researchers may spend lots of time and resources creating new databases for every study.

All of Us is working to improve health care through research. Unlike research studies that focus on one disease or group of people, All of Us is building a diverse database that can inform thousands of studies on a variety of health conditions. This creates more opportunities to:

  • Know the risk factors for certain diseases

  • Figure out which treatments work best for people of different backgrounds

  • Connect people with the right clinical studies for their needs

  • Learn how technologies can help us take steps to be healthier

All of Us is creating a database on the All of Us Research Program website. Everyone can use this database to make discoveries. There are different levels of access. Some information is visible to the public. Some information can only be seen by approved researchers. The information in the database that anyone can see will be about the group of participants. For example, it might tell the average age of the people who have joined the All of Us Research Program. It will not include information about individual people.

Only researchers approved by the All of Us Research Program will be allowed to see data from individual participants. The data will not include your name or other information that directly identifies you. These researchers may be from anywhere in the world. They may work for commercial companies, like drug companies. The research may be on many different topics.

Will one be about COVID-19?

The program started collecting bio samples in 2018. I was one of the first participants in the program, and I provided samples for the program a couple of years ago. That means that the bio samples are being collected before, during and after the COVID-19 pandemic.

That means researchers might be able to use blood samples from before, during and after the pandemic to track the progression of the disease (and the pathway toward herd immunity) by looking at IgG antibodies over time- producing an epidemiological record how, where, among whom the virus spread.

You can participate in All of Us too. It’s simple and easy. You can sign up directly through JoinAllofUs.org or at a participating health care provider organization

Check it out!

E.O. Requires More Hospital Capacity Reporting

The data will be useful in adjusting hospital capacity directives

The governor issued an executive order last Tuesday that requires hospitals to report (daily): 

  • Number of inpatient COVID-19 positive patients;

  • Number of ventilators in use by COVID-19 positive patients;

  • Number of ICU beds in use by COVID-19 positive patients;

  • Number of COVID-19 positive patients discharged; and

  • The estimated number of N95 masks, surgical masks, face shields and surgical gowns used per day.

These data will be valuable to the county health departments as they continue to manage the epidemic.

Perhaps the new data will be used to develop a more refined Executive Order regarding the cancellation of elective procedures (to provide patients and hospitals some relief). For example, the E.O. could be changed to require elective procedures to be canceled when a hospital reaches 85% capacity.

The Order says that the data needs to be reported to the ADHS daily. The data is posted on the ADHS COVID-19 website. 

The Role of Modeling in Public Health Emergency Response Planning

Updated 4/14/20

Should the Best Available Data or Worst Case Scenarios Drive Public Health Policy?

Imagine you’re an elected official and you need to increase hospital capacity to respond to a pandemic.

Imagine you don’t have a national health system like the UK, so you need to issue executive orders to compel the hospitals you regulate to increase capacity at their own expense.

How do you decide what to order the facilities to do? What percentage increase in their bed and ICU capacity should you require them to implement?  How many ventilators should you acquire?

State-of-the-art modeling using the best available data may be your best bet for informing important policy decisions.

At the beginning of an epidemic there may be unreliable data with which to use in the model. As the epidemic progresses more data becomes available, it allows you to refine your model and your policy directives.

That’s where we are right now.  It’s time to use better modeling to improve the evidence base for policy directives.

On March 26, the governor issued an executive order directing AZ hospitals to increase their bed and ICU capacity by 50% by April 24.  Half of that increase needs to be in place by yesterday (April 10). The media release announcing the Order said that it’s based on a worst-case scenario.

But is it best to base public policy on a worst-case scenario?

That depends on who is paying the invoice, doesn’t it?  If you’re a hospital that’s responsible for complying with the order, perhaps you’d rather see it based on more likely scenarios using models with contemporary data.  If you’re an elected or appointed official who’s not paying the bill, perhaps you’d rather see the Order based on a worst case scenario to cover your downside risk. 

Our elected and appointed health officials and public health staff are busy putting together a host of response plans designed to minimize the health impact of the virus.  Modeling should be a key element in those plans.  It’s always best to use evidence-based criteria in planning, especially when you’re asking private hospitals to expand their capacity at their own expense.

New evidence suggests our interventions are working

Indeed, there’s evidence that our social distancing interventions are working, providing new information that our policy-makers should consider as they consider their interventions.

For example, an Arizona public health associate professor has released a COVID-19 disease outbreak outlook that suggests our Arizona interventions are working. Joe K. Gerald, MD, PhD, acting in a personal capacity, studied data from Arizona COVID-19 cases and states…  “Mounting evidence indicates that social distancing, including the current stay-at-home order, is slowing the spread of new infections.” He also says the “lag between new infections and hospitalizations and ICU admissions means that the pace of these outcomes will increase for the next 1-3 weeks before slowing.” Here’s the analysis and discussion (results from 4/14/20).

The results also suggest that our aggregate hospital system is already adequate to handle the peak number of cases. With that in mind, does it still make sense to require hospitals to cancel all of their elective procedures and increase their bed and ICU capacity by 50%? Those directives are putting intense financial stress on our hospital system and at this point are likely doing more harm than good (as long as folks still continue to practice good social distancing).

We urge our policy makers in Arizona to tap our University expertise (like Dr. Gerald) and use their analyses to adjust their interventions and directives.  Evidence based policy-making demands it.

P.S. Here’s a good article from the Arizona Republic that talks about the financial impact that these Executive Orders are having on our hospital systems.

P.S.S. Here’s a good high-level 10-minute You Tube video about how models are developed and can (and should) be used.

P.S.S.S. The ADHS began displaying COVID-19 cases by Primary Care Area or ZIP Code ion 4/12, including hospital capacity data. That data is posted here.

COVID Response Volunteers Needed

State and local officials are looking for emergency response volunteers to help with the COVID-19 response.  Your knowledge and skills can make a difference.  If you’re interested in volunteering you can register with the “Arizona Emergency System for the Advance Registration of Volunteer Health Professionals” (AZ-ESAR-VHP) at Arizona Emergency System for the Advance Registration of Health Professionals.

New Crisis Standards of Care Decision-making Guidelines Established

The State Disaster Medical Advisory Committee met last week and approved Crisis Standards of Care Staffing Guidance for Short-Term Acute Care FacilitiesCOVID-19 Pre-Hospital Triage Guidance; and COVID-19 Guidance for Expansion of Healthcare Facility Staff.

If you go to those links you’ll see that the guidance provides suggestions for how to go through the decision-making process for alternate care standards rather than actually making alternate standards care decisions.  

Here’s the Roster of people on that committee.

Pitt School of Medicine COVID-19 Vaccine Program Shows Promise

The University of Pittsburgh School of Medicine published a peer-reviewed paper this week in EBioMedicine suggesting that their COVID-19 vaccine candidate produces antibodies specific to SARS-CoV-2 (in mice), at quantities thought to be sufficient for neutralizing the virus.  The vaccine would be delivered through a fingertip-sized patch. This is the 1st peer-reviewed study that describes a candidate vaccine for COVID-19.

The paper titled, “Microneedle array delivered recombinant coronavirus vaccines: Immunogenicity and rapid translational development” is in EBioMedicine.

The anti-vaccination crowd sure has been quite these days, don’t you think?