Will Humble Disease Control, Wills Blog

ADHS Director Scraps COVID-19 Spread Metrics for Business Operations

Substantial Spread Effectively No Longer Exists as a Category for Informing Interventions

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 impose additional operational restrictions on bars and restaurants. Shortly after the ideas were presented to the Governor’s Office, the ADHS adopted the metrics and highlighted them as a key tool for driving future intervention decisions.

The metrics were then used when the state decided to lift the limitations put on bars, restaurants and gyms during the summer “pause”.

The protocol was scrapped in mid-December to ensure that the state metrics never suggest additional operational restrictions are needed at bars and restaurants no matter how bad community spread gets.

Here’s a story from the Health Arizona Daily Star that describes the decision by Dr. Christ to scrap the business metrics and her rationale for doing so.

Under the former criteria, bars and in-person dining are not allowed to operate when a county is in the ‘Substantial’ category.

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 and protocol were valuable for deciding when to open businesses, they weren’t useful for deciding when to close them or to impose additional operational restrictions.

As that argument became increasingly untenable, the agency changed the standards governing business operations such that it’s 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.

Will Humble Disease Control, Vaccination, Wills Blog

Initial Vaccination Efforts Complicated by Glitchy ADHS Computer System

Less than 18% of the COVID19 vaccines that have been delivered in Arizona had been used as of 12/31. Clearly something is amiss, but what?

It turns out that one of the core reasons for the slow use of vaccines had to do with an ADHS computer software system. It was supposed to efficiently make vaccination appointments and provide billing information among other things. It’s built into the ADHS’ Vaccine Management System (VMS).

It’s a long story, but glitches in the ADHS’ VMS scheduling software failed to make appointments for thousands of healthcare workers that had pre-registered for vaccination. Many received no information at all back from the ADHS system. Others were instructed to go to Show Low, Globe or Snowflake for their vaccine even though they live in Maricopa County.

As a result, two of the five mass vaccination sites in Maricopa County were largely empty for many days in December. The glitches have apparently been corrected as of this weekend.

It’s a long story, but if you want to read more, check out this story by Ray Stern in the Phoenix New Times:  Arizona Vaccine Rollout Delayed by Computer Glitches, County Says.

New COVID Vaccine Executive Order Issued

Last week the Governor issued an Executive Order that he said is designed to make vaccination efforts more streamlined. The Executive Order says that the ADHS is supposed to use a statewide “vaccine allocation model”, can reallocate vaccine, and must approve all private vaccination sites. It also requires counties to post their vaccination progress and vaccination sites on their websites.

The Order doesn’t give the ADHS any authority that it doesn’t already have, but it does provide some direction and expectations to the Department.

Here’s where you can look it over. Honestly, it doesn’t look substantive to me.

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

1 … 98 99 100 101 102 … 168