Will Humble Disease Control, Vaccination, Wills Blog

Federal Pharmacy Program Making Significant Inroads Toward Vaccine Access

A few weeks ago the Biden Administration announced an initiative to increase vaccine supply in states through the new Federal Retail Pharmacy Program.

Last week the program kicked off with the direct distribution of vaccine to about 200 pharmacies in Arizona. AZ pharmacies around the state received an average of 100 doses of vaccine through the program. All of the vaccine is Moderna.

The participating pharmacies in AZ are Safeway, Fry’s and Walgreens. I also saw that some appointments will be available at a few Albertsons. The program will be expanded in subsequent weeks will be based on vaccine availability. The goal is to include more than 40,000 locations nationwide (that would be about 800 pharmacies in AZ- or about ½ of all AZ pharmacies).

Here’s a link to the Maricopa County Department of Public Health website where you can look for appointments.

Importantly, the vaccine is distributed directly from the federal government to the participating pharmacies. This is important because it prevents state health departments from diverting the vaccine to other priorities that they may have like state-run vaccination sites.

It’s critical that we diversify the ways in which people can find vaccine because the current one-size-fits-all allocation and distribution system does not serve lower income communities well.  See last week’s blog post to get an idea of the health disparities that are emerging.

The federal pharmacy program provides a direct way of building far more access points while giving people an alternative to state allocation schemes that provide advantages to wealthier persons.

FQHC Distribution Programs Announced

The Biden Administration has also announced another new federal program whereby the federal government will directly distribute to Federally Qualified Health Centers.

This is also a terrific new program because it will directly allocate vaccine to FQHCs who focus their services on rural and underserved areas, precisely the folks that are at a disadvantage right now getting appointments through the ADHS system.  Importantly, appointments for vaccine at FQHCs can be made without going through the convoluted ADHS appointment website.

The federal pharmacy and FQHC programs will become increasingly significant when the Johnson & Johnson vaccine is authorized next weekend. The J&J vaccine is perfect for pharmacies to use. Storage and handling for that vaccine is just like most other vaccines.

The FDA committee is meeting on February 26 to consider the J&J emergency use application. I expect authorization to happen by March 1 with shipments starting March 2. Hopefully the destination for many if not most of the J&J vaccines will be through this new federal pharmacy program.

CNN is reporting that “… a J&J official stated that the company currently has less than 10M doses manufactured and available for distribution in the US”. This is a disappointing number as it amounts to about 200,000 doses for Arizona. At least this is a single dose vaccine so it’s equivalent to 400,000 doses of Moderna or Pfizer.

Editorial Note: The Association for State and Territorial Health Officials sent a letter to the President urging him to better coordinate the allocation of vaccine through the FQHC and retail pharmacy programs. Thankfully, the letter stops short of urging the federal government to relinquish control of these programs to governors and state health directors…  but the letter goes right up to that edge.

We have seen and continue to see, first-hand, that governors and state health directors often allocate vaccine toward their preferred sites (e.g. State Farm) that aren’t focused on providing vaccine to underserved areas.

If the federal government were to hand over allocation control to state health directors and their governors, we can expect to see vaccine that is intended for local pharmacies and Federally Qualified Health Centers get diverted to pet high-profile vaccination sites that are not focused on helping low-income communities.

Will Humble Disease Control, Vaccination, Wills Blog

Johnson & Johnson Vaccine Clinical Trial Data Shows That It’s Safe & Effective

With FDA Authorization, Some Limited Deliveries Could Start Monday or Tuesday

A few weeks ago Johnson & Johnson applied for emergency use authorization of their candidate vaccine. The FDA’s review committee is meeting Friday morning. The FDA just posted all the data on their website.  There are several documents in the meeting packet but the one that I like to look at is the FDA’s briefing document to the committee.

I didn’t see any surprises in todays reports. The results from the Phase III clinical trial look good (about 43,000 participants in the trial).  Here’s the bottom-line effectiveness (from the summary report):

“…  vaccine efficacy against central laboratory confirmed and blind-adjudicated severe/critical COVID-19 occurring at least 14 days and at least 28 days after vaccination of 76.7% and 85.4% respectively.”

In other words, this single dose vaccine is 77% effective at preventing severe COVID disease 14-days after the jab and 85% effective after 28 days.

There were 2 hospitalizations from COVID in the vaccine group (both before 28 days post vaccination) compared with 29 cases in the placebo (saltwater injection) group.  None of the persons that were given the vaccine died while 7 people died of COVID in the placebo group.

The vaccine worked equally among subgroups in the trial (age, comorbidity, race, ethnicity) but effectiveness among folks 60 years of age and older with comorbidities was a little lower early on in the study (i.e., counting cases from 14 days rather than 28 days and including cases not yet centrally confirmed).

Side effects within 7 days of injection were the statistically the same among the vaccine and placebo (saltwater) groups. In other words, side effects were no different whether the person got the vaccine or the saltwater injection.  Those side effects included injection site pain (48.6%), headache (38.9%), fatigue (38.2%), and myalgia (33.2%).

The independent review committee concluded that:

“… the analysis supported a favorable safety profile with no specific safety concerns identified that would preclude issuance of an EUA”.

The bottom line is that this vaccine is very likely to be authorized for use in the U.S. as early as Monday. Shipments to states will likely start on March 2. I’ve had a really hard time pinning down exactly how much vaccine is actually available and ready for distribution in the U.S. The best info I could find is from a media report in the Washington Post quoting 2 anonymous FDA officials that said there are about 2 million doses available right now and that the supply of this vaccine will be 20 million by the end of March.

If true, that’s pretty disappointing because 2 million doses nationally translates into only 40,000 doses for Arizona right now. If they can really ramp up to 20 million doses by the end March that will be better. That would translate into 400,000 doses but is the equivalent to 800,000 doses of the Pfizer or Moderna vaccines because J&J doesn’t require the booster shot.

The Friday, Feb. 26 at 7 a.m. AZ time FDA Center for Biologics Evaluation and Research’s Vaccines and Related Biological Products Advisory Committee meeting will be online.

  • The agenda can be found here.

  • FDA’s Briefing Document – Janssen Ad26.COV2.S Vaccine for the Prevention of COVID-19 – can be found here.

  • Janssen Biotech Inc. Briefing Document Addendum can be found here.

  • The live meeting will be available here and here.

The online web conference meeting will be available at the following: 

Note: Globally and in the U.S. this is a very important vaccine. It is simple, inexpensive, doesn’t require complicated storage and handling, and (perhaps most importantly) is a single dose vaccine. This vaccine belongs in doctor’s offices, pharmacies, and community health centers. Using it at mass vaccination sites would be a big mistake because one of this vaccine’s strengths is its flexibility. This vaccine’s flexibility means that we can bring the vaccine to the people rather than bringing the people to the vaccine… which can help us overcome the large disparities that exist in Arizona: ADHS Vaccine Appointment System Favors the Wealthy & Creates Health Disparities

In the U.S., it will be a terrific addition to our current vaccines because it’s perfect for doctor’s offices and pharmacies. Because it’s single dose, it will be a lot less labor intensive. In developing nations, it would be a game changes for the same reasons and because it is inexpensive to make.

Will Humble Opioids, Prevention, State Legislature, Wills Blog

Despite January 2018 Arizona Opioid Epidemic Act Opioid Deaths Continue to Increase

New AzPHA Report:

Report: Rates and Trends of Opioid Overdose Deaths in Arizona 1999 – 2019: Implications for Public Health Policy

Increasing deaths from opioid drug overdoses have been and remain a serious public health problem in Arizona and throughout the U.S. To address the crisis, Arizona State Legislature, the ADHS, AHCCCS, and the Governor’s Office collaborated to pass and implement the Arizona Opioid Epidemic Act in January 2018.

The Act made wide-ranging policy changes throughout the healthcare system including big changes to prescribing practices. Our report explores the nature of the epidemic in Arizona at the 3-year mark since the Act was passed using data from 1999 through the end of 2019.

Major Findings:

Despite the implementation of the evidence-based policies within the Arizona Opioid Epidemic Act, our report found no evidence to suggest that the epidemic is slowing. Indeed, the rates of opioid and other drug related deaths have further accelerated, particularly in the synthetic opioid category that includes fentanyl.

The data presented in this report indicate that existing intervention efforts (Arizona Opioid Epidemic Act) have not measurably slowed the overall opioid overdose epidemic in Arizona. 

Our report found a slight decline in mortality rates from prescribed opioids after implementation of the Act. However, profound increases in mortality from fentanyl have continued and even accelerated since implementation of the Act.

We urge Arizona’s Executive Branch and the Arizona State Legislature to use our report findings to explore whether changes made to prescribing practices and other portions of the Act have been effective and to implement additional evidence-based public health policy interventions to mitigate this continuing public health crisis.

Will Humble Disease Control, Vaccination, Wills Blog

Why Is the U.S. the Global Laggard Authorizing the AstraZeneca Vaccine?

Study results continue to pile in showing that the AstraZeneca vaccine is safe and effective, yet it’s crickets when it comes to getting Emergency Use Authorization of the vaccine here in the U.S. The entire European Union as well as the U.K have authorized its use and are administering the vaccine big time… but not here in the U.S.

Now that vaccination infrastructure is really ramping up – especially within the federal pharmacy and community health center direct shipment programs it’s getting increasingly frustrating to see nation after nation authorizing use of the AstraZeneca vaccine yet we are unable to deploy it to our communities.

Previous clinical trial data has been showing that the Oxford/AstraZeneca vaccine is safe and effective, and now a new study published in The Lancet this week that shows real-world evidence of the same. The study (in pre-print) entitled Efficacy of ChAdOx1 nCoV-19 (AstraZeneca) Vaccine Against SARS-CoV-2 VOC 202012/01 (B.1.1.7) finds that the AstraZeneca vaccine is reducing hospital admissions from covid-19 in Scotland by 85%.

A study published a couple of weeks ago of the Phase III AstraZeneca candidate vaccine found that it not only protects people from serious illness and death but also substantially slows the transmission of the virus. That was published in The Lancet. See blog post: New Data Published On the Key AztraZeneca Vaccine: Promising Results

The U.S. government has a contract with AstraZeneca that’s even bigger than the contracts with Moderna and Pfizer combined and manufacturing has been underway during the clinical trials. The new AstraZeneca vaccine could really help push us to the end of this pandemic much faster if we could get it authorized here and deploy it to pharmacies and community health centers.

What I can’t figure out is what’s taking the Emergency Use Application so long?

Will Humble Disease Control, Wills Blog

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

Takeaways from Dr. Gerald’s weekly analysis of the epidemiology and hospital capacity report:

This week saw a fifth straight week of meaningful declines in Covid-19 cases and hospital occupancy. Nevertheless, absolute levels of SARS-CoV-2 viral transmission remain above the 100 new cases per 100,000 residents per week threshold which marks elevated risk.

As of February 14th, new cases were being diagnosed at a rate of 158 cases per 100,000 residents per week (Figure 10 below). This rate is declining by 86 cases per 100,000 residents per week. Despite this improvement, Arizona has the 19th highest viral transmission rate in the US according to the CDC. Overall, Arizona remains the 6th hardest hit state in terms of cases identified.

While residents and businesses should continue to follow the recommended public health mitigation efforts, normalization of lower risk activities will be reasonable once case rates fall below 100 new diagnoses per 100,000 residents per week.

Hospital Covid-19 occupancy is declining in the ward and ICU. However, access to care remains restricted with only limited numbers of medically necessary non-Covid procedures being scheduled.

According to the CDC, 4.9% of Arizona residents have received at least 2-doses of vaccine while another 9.8% have received 1-dose. The ADHS Dashboard is reporting slightly higher levels. To date, Arizona has administered 84% of its delivered doses. Arizona vaccination roll-out ranks in the bottom half of US states.

Many have asked about herd immunity and the risk of a spring outbreak. While I believe this winter’s outbreak will be Arizona’s largest, a smaller wave is possible this spring. However, a spring wave should it occur will pose a lesser threat as most of those at risk of hospitalization and death will have been vaccinated. For this reason, the short-term outlook remains favorable.

Will Humble Disease Control, Wills Blog

Arizona’s January 2021 Total Mortality Rate A Shocking 64% Higher than January 2020

The COVID-19 pandemic is having a profound impact on public health in Arizona.

In our report that summarized total mortality during 2020 we found clear evidence that total mortality has substantially increased during 2020, particularly in June, July, and December. Indeed, the total mortality rate per 100,000 during July 2020 was 64% higher than July 2019. December 2020 was 61% higher than 2019.

The grim trend is continuing into 2021. Total mortality rates in AZ during January 2021 were 64% higher than the total mortality rate in January 2020 (see chart). The increases in deaths are the result of the effects of the pandemic including COVID-19 disease and delayed or suspended care for non-COVID illnesses.

For some perspective, if Arizona were a country, we would have the highest COVID-19 mortality rate in the world, edging out Belgium and Peru. Just think about that.

Editorial Note: Arizona’s poor performance has not been because of bad luck or fate as has been suggested by Governor Ducey and Director Christ. It is largely because of an inability to learn from policy successes and failures, bad decisions, misplaced priorities, and an inability to execute core responsibilities.

In Arizona we saw first-hand what worked to lower COVID case rates and save lives: face masks mandates implemented by cities/counties and mitigation/enforcement strategies in high-spread businesses like bars and nightclubs.

Sadly, many of these COVID cases and deaths could have been avoided if Governor Ducey and Director Christ had learned from their successes in the spring and early summer of 2020 and used evidence to drive their decision-making.

Because they did not, many thousands of lives will have been lost. It is an unimaginable tragedy. Everyone lost was a mother, a father, a sister or brother, or son or daughter. They had kids. They left loved ones behind.

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For more perspective you can see our reports including our COVID-19 reports

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

CDC Report: Operational Strategy for K-12 Schools through Phased Mitigation

The CDC published new guidance for schools to safely manage COVID risks. The report is called the K-12-Operational Strategy for mitigation strategies that K-12 school administrators can use to help protect students, teachers, and staff and slow the spread of COVID-19.

If mitigation strategies are strictly adhered to , K-12 schools can safely open for in-person instruction and remain open20. In addition, the association between COVID-19 incidence and outbreaks in school settings and levels of community transmission underscores the importance of controlling disease spread in the community to protect teachers, staff, and students in schools.

The document provides an operational strategy for safe delivery of in-person instruction in K-12 schools through the integration of a package of mitigation and control components.

  • Consistent implementation of layered mitigation strategies to reduce SARS-CoV-2 transmission in schools

  • Indicators of community transmission to reflect levels of community risk

  • Phased mitigation and learning modes based on levels of community transmission The following public health efforts provide additional layers of COVID-19 prevention in schools.

  • Testing to identify individuals with a SARS-CoV-2 infection to limit transmission and outbreaks

  • Vaccination for teachers, staff, and in communities as soon as supply allow

Regardless of the level of community transmission, the report says that it’s critical that schools use and layer mitigation strategies. Five key mitigation strategies are essential to safe delivery of in-person instruction and help to mitigate COVID-19 transmission in schools:

  • Universal and correct use of masks

  • Physical distancing

  • Handwashing and respiratory etiquette

  • Cleaning and maintaining healthy facilities

  • Contact tracing in combination with isolation and quarantine, in collaboration with the health department

Schools providing in-person instruction should prioritize two mitigation strategies:

  • Universal and correct use of masks should be required, at all levels of community transmission.

  • Physical distancing (at least 6 feet) should be maximized to the greatest extent possible. In hybrid instruction, scheduling should be planned to ensure physical distancing.

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

What is COVAX & Why Does It Matter?

At an early stage during this pandemic, it quickly became apparent that to end this global crisis we don’t just need COVID-19 vaccines, we also need to ensure that everyone in the world has access to them. This triggered global leaders to call for a solution that would accelerate the development and manufacture of COVID-19 vaccines, as well as diagnostics and treatments, and guarantee rapid, fair and equitable access to them for people in all countries.

That organization is called COVAX. Up until a couple of weeks ago the U.S. was not a member of COVAX, but we did join the organization on the first day of the Biden Administration.  Extraordinary, don’t you think?  The country with the highest GDP in the world and a leading democracy wasn’t a member?

Here’s a PowerPoint that I’ve prepared describing COVAX

Well, that changed on 1/21/21 along with the U.S. rejoining the World Health Organization.  What a difference a change in leadership can make!

COVAX brings together governments, global health organizations, manufacturers, scientists, private sector, civil society and philanthropy, to provide equitable access to COVID-19 vaccines. It is the only truly global solution to this pandemic because it is the only effort to ensure that people in all corners of the world will get access to COVID-19 vaccines once they are available, regardless of their wealth.

For lower-income funded nations, who would otherwise be unable to afford these vaccines COVAX is the only viable way in which their citizens will get access to COVID-19 vaccines. 

Last week COVAX published their first interim COVAX Global Supply Forecast. You can see that as of right now their supply of vaccine is dominated by the Johnson & Johnson candidate vaccine- which makes sense because it is most widely tested vaccine that is a single dose and it has simple storage and handling requirements.

Ninety-two low- and middle-income economies are eligible to participate in receiving vaccine through COVAX AMC… here is the list of countries authorized to receive vaccine under the program.

Here’s a PowerPoint that I’ve prepared describing the COVAX program

Will Humble Disease Control, Vaccination, Wills Blog

ADHS Could Do Much Better at Equitably Vaccinating Arizonans

Fix the Appointment System

Most states have a much better system that is not only less complex but more equitable than the ADHS’ convoluted appointment system. For example, in Minnesota, folks can register on the state health department website any time, any day. This levels the playing field for persons with jobs that require them to be at their post during the few minutes when appointments become available. 

As vaccines become available (about once a week), the health department randomly selects qualified registrants from the list. People that are selected are given a password that ensures them an appointment that week.

Folks without an email address or internet access are called to let them know they have an appointment, and they schedule it with them. Simple decisions could be made to make an allowance for a guest or two that is in a qualifying category (e.g. a spouse).

Such a system would allow us to ensure we are allocating vaccine with a lens to health equity. 

One could even look at the vaccination trends geographically. When  you see that certain low-income parts of the state (or city) have been under-served you could proactively make statistical adjustments to improve their chances of being selected.

A letter to the editor in the Arizona Republic this week by Kirk Kobert today said it well:

“Whose idea was this Lord of the Flies method for choosing who gets shots and who doesn’t? My old algebra teacher said, ‘Work smart, not hard’. Time to use technology and our God-given reason to do this better”.

Building a better system for allocating and distributing vaccine isn’t rocket science, but it does require some strategic thinking and a tad bit of creativity.

Equitably Allocate Vaccine

Arizona’s original vaccination system plan hinged on leveraging county health departments to execute their vaccination plans. A core element of all those plans include prioritizing hard to reach and under-served areas by making vaccine available at Federally Qualified Health Centers, mobile clinics and the like.

Those plans were jettisoned in early January when Director Christ began prioritizing “state run” sites over the needs and plans that the county health departments have.

Note: While the State Farm is branded as a ‘state run’ site, the vast majority of the coordination work is being done by Blue Cross Blue Shield of Arizona. 

ADHS is prioritizing “their” PODs for each week’s supply at the expense of the county health departments. In addition, weekly county allocation is highly erratic making planning at the county level next to impossible.

It also makes it impossible for the county health departments to implement their plans to reach into underserved areas.

For additional background on how the decisions that are being made by Director Christ and the ADHS are impairing county health departments ability to roll out vaccine equitably read this piece by Stephanie Innes and Alison Steinbeck in the Arizona Republic: Rollout of the COVID-19 vaccine differs along rural-urban lines.

Editorial Note: I write this with a sense of resignation. I realize at this point that Director Christ and Governor Ducey are going to do whatever they want to do regardless of the needs and interests of stakeholders like county health departments and their community vaccinator partners. Nevertheless, we will continue to expose what we see are unjust decisions if for no other reason than to document their actions and the impacts that their decisions are having on ordinary Arizonans.

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