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.

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.

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.

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.

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 dashboardGoverning 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.

Modeling Workgroup Publishes New Predictive Model for COVID in Arizona

The ASU Biodesign Institute team has published their most recent Arizona-specific model using a framework that ties disease surveillance with the future burden on Arizona’s healthcare system. Their framework accounts for multiple COVID-19 patient outcomes and the observed time delay in epidemiological findings following public policy decisions.

Lots to unpack in their analysis. They’ve got current epidemiological curve and hospitalization trend data, and projections into the future for cases, hospitalizations including ICU use, and deaths.  They use assumptions to account for the upcoming travel that will occur because of Thanksgiving.  They incorporate that into their hospitalization utilization and capacity projections.

Here are their primary conclusions (keep in mind that their projections during the pandemic have been remarkably accurate):

  • With no additional mitigation policies to reduce community transmission hospital capacity could be reached between December 13 and 22nd. 

  • The best-case model assumptions (without additional interventions) show hospitals reaching general ward and ICU capacity between December 31 and January 11, 2021.

Here is their summary of Implications:

  • Based on the amount of community spread we are seeing now, combined with expected increases related to Thanksgiving travel and celebrations with household mixing, current hospital capacity will be exceeded in December. 

  • ·Additional emergency public health interventions will be necessary to control transmission and preserve healthcare capacity in Arizona including a state-wide mask mandate, preventing gatherings of more than 10 people, closing bars, and decreasing capacity restrictions at restaurants with effective enforcement.

  • Without additional public health measures, holiday gatherings are likely to cause 600- 1,200 additional deaths from COVID-19 in Arizona by February 1 beyond current scenario death projections.

 Dr. Gerald also published his weekly report yesterday.  Below is the summary and you can read the full report here.

  • Viral transmission in Arizona continues to increase. If not quickly addressed, new Covid-19 cases will overwhelm our capacity to provide optimal hospital care within a matter of weeks. New cases are currently being diagnosed at a rate of 244 cases per 100,000 residents per week. This rate is increasing by approximately 38 cases per 100,000 residents per week.

  • Mask-wearing ordinances will be needed for the foreseeable future to mitigate the spread of Covid-19. Additional measures are needed to address “quarantine fatigue” and other lapses in mitigation.

  • Large, social gatherings should be avoided.

  • When possible, residents should avoid prolonged contact in indoor spaces where physical distancing is not adequate and adherence to face masks is low. o Elected officials, community leaders, and businesses should model these behaviors, encourage others to follow suit, and enforce penalties for those who do not.

  • Hospital occupancy is increasing due to Covid-19 transmission. Our current safety margin is eroding and has reached levels not seen since the summer outbreak.

  • The fall-winter viral respiratory season plus the return of part-time residents who winter in Arizona will place increasing strain on our hospitals through January.

  • If current trends continue, Arizona is on track to experience a major crisis during the Thanksgiving – Christmas – New Year holiday season.

  • While Covid-19 test results continue to be returned in a timely manner, case reporting delays are making it difficult to accurately measure trends in viral transmission.

  • The test positive rate for traditional PCR testing continues to increase, reaching 16% this week. A growing mismatch between capacity and demand suggests viral transmission is growing faster than suggested by the case counts reported in this update.

  • Covid-19 mortality continues to increase, but rates remain lower than those observed with this summer’s outbreak.

  • Avoiding cases among those ≥65 years of age, particularly those residing in long-term care facilities, is critical to keeping mortality low. For example, LTC residents in Pima County have accounted for <5% of the county’s cases but about 14% of hospitalizations and 39% of deaths.

Governor Announces Minor COVID-19 Policy Tweaks

The Governor announced a few tweaks to his current policies today in response to the eye opening trajectory of the COVID epidemic in Arizona. Despite clear evidence that we are on an exponential growth curve and headed for another hospital capacity crisis in December, only minor new efforts were announced today at his media conference.

  • He doubled the public service announcement budget for messages about how people should behave, reminding them to wash their hands, keep physically distant from others and to wear a mask. Many of the PSA’s feature audio and video of the governor or the health director.  Others have more creative content.

  • The Phoenix, Tucson and Mesa airports will have testing stations where passengers can stop by for a free COVID rapid test.

  • Schools are now mandated to require that masks be worn on school campuses, on school buses, and during school-associated activities by all students, faculty, staff, contractors, and visitors. This is probably the most significant intervention that was mentioned at the press conference.

  • Hospitals will be receiving $25M in CARES Act money to pay for healthcare worker staff bonuses or to supplement their personnel costs.

  • An Executive Order was issued making it clear that the SARS CoV2 immunizations should be entered into the state’s immunization registry (called ASIIS) making it easier to track patients for their follow up SARS CoV2 booster shot.

Editorial Note: The measures announced today are wholly inadequate to prevent another hospital capacity crisis in Arizona (in December). 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 were needed many weeks ago. Had they 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 likelihood of a hospital crisis in December.

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. Because of that, far more stringent measures would be needed at this point to prevent a hospital capacity crisis. Today’s announcements were trivial and will have a negligible effect.

In my opinion, the die is cast, and we are headed for an early or mid-December hospital capacity crisis possibly including Crisis Standards of Care. The December crisis will likely be worse than our summer fiasco because there will be very few out-of-state healthcare workers to contract with, our seasonal population of at risk persons is increased now, and July represented the low-point of our normal seasonal hospital census.

Sadly, the coming hospital capacity crisis and the resulting loss of life was likely avoidable with targeted and timely evidence-based interventions a few weeks ago.

Get ready folks.

Updated – Editorial Note II Regarding Bars & Restaurants:

I’ve been getting a fair amount of criticism from folks suggesting that I have been in favor of completely closing bars and restaurants and/or a broad-based stay at home order again. That is not the case. For the last many weeks, 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. For the last many weeks I have been advocating for better enforcement of the existing mitigation measures that were required of bars, restaurants and nightclubs when they reopened after the June/July “pause”.

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 likely headed for a hospital capacity crisis in December. When that happens, I think the Governor will have no choice but to shut the bars again.

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.

How Many Arizonans Will We Need to Vaccinate to Get to Herd Immunity?

To answer this question we’ll need to make a few assumptions including what percentage of the population needs to have immune system protection in order to achieve herd immunity, what percentage of the population will have been infected and recovered, and how effective the vaccines end up being on average.

Let’s assume that herd immunity is achieved when 75% of the population has immune protection, 15% of the population has been infected and recovered, and that the vaccine is 90% effective. If that’s the case, then we’d need to vaccinate about 4.7M of the 7.2M people that live in Arizona to get to herd immunity (15% of the 75% is achieved though natural infection and 60% via the vaccine). If the vaccines are on average 70% effective, then we’d need to vaccinate closer to about 5.7M Arizonans. 

Our PowerPoint about the vaccines has a couple of slides explaining this idea.

Pfizer Announces Encouraging Phase III Clinical Trial Results

Early last week Pfizer suggested that their candidate vaccine now in late Stage III trials is about 90% effective in preventing symptomatic Covid-19 infections. The announcement was in a press release, not in a journal article and they didn’t disclose the Phase III data to support the claim, but nevertheless you gotta believe that there must be some data to back this up.

The Phase III Trial was conducted in the U.S. and has enrolled about 44,000 volunteers. Most of the participants were given the vaccines (a series of 2 vaccines 28 days apart), with some participants getting the placebo.

The company said that almost all the 94 persons in the trial that ended up contracting COVID-19 were in the placebo group. Statistically speaking, they said that the Phase III data (which has not been disclosed) suggests that the vaccine is 90% effective at preventing COVID-19.

Immunity is established 7 days after the booster is administered. They also said that serious adverse events have not yet been identified.

There are numerous vaccines in Phase III trials right now including several in the U.S. This Pfizer vaccine as well as Moderna’s candidate use a new Messenger RNA technology. Both Moderna and Pfizer expect to submit full Phase III trial data in the coming weeks.

The U.S. government contracted with Pfizer to manufacture the vaccine during the Phase III trials with a guarantee that the company will get paid even if the vaccine isn’t given Emergency Use Authorization or full FDA Approval. As a result, there is already significant inventory of this vaccine in storage.

HHS Secretary Azar earlier this week suggested that there will be 50M doses of the Pfizer vaccine available for distribution by December 31. Arizona’s proportionate share of those 50M doses would be about 1M. But remember, this vaccine requires a booster at 28 days, so it takes 2 doses for each person to be fully immunized.

Here’s a link to one of my previous blog posts that discusses how vaccines are tested and approved.

New Research Identifies Restaurants and Bars as the Highest Risk Locations for Amplifying COVID-19

A new and super-interesting study was published in Nature this week examining the relative risk of SARS CoV2 virus spread in various environments like restaurants and bars, gyms, grocery stores and a host of other environments.

The researchers used a model that integrates fine-grained, dynamic mobility networks to simulate the spread of SARS-CoV-2 in 10 of the largest US metropolitan statistical areas. They used cell phone data to map the hourly movements of 98 million people from neighborhoods to evaluate the relative contribution to viral spread from places like restaurants and bars, gyms, retail stores, churches, and other places. They developed a model that accurately fits the real case COVID-19 trajectory.

Just as other research has shown, their model predicts that a small minority of “super-spreader” places account for a large majority of infections. Restaurants and bars were far and away the riskiest environments. Gyms were a distant second with 4x less risk than restaurants and bars.

They conclude that interventions like restricting maximum occupancy at restaurants and bars is a more effective intervention than uniformly reducing mobility (e.g. a broad-based stay at home order):

“This highlights the non-linearity of predicted infections as a function of visits: one can achieve a disproportionately large reduction in infections with a small reduction in visits. Reopening full-service restaurants has the largest predicted impact on infections, due to the large number of restaurants as well as their high visit densities and long dwell times.”

Important information to take into consideration as we again enter exponential amplification of the virus and diminishing hospital capacity.

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