We Can and Must Do A Much Better Job of Equitably Vaccinating Arizonans

The  Arizona Republic Editorial Board  was right on the mark today that we need detailed demographic data so that the public can have a clear eye into the equity and effectiveness of Arizona’s vaccine distribution system. Such detailed demographic information, including age distribution, zip code and even income data (via insurance information), already exists. It’s just that the ADHS is not disclosing the information

When people try to get one of the coveted vaccine appointments in Arizona, they input their date of birth (age), race and ethnicity, and address, complete with a Zip Code into the state’s appointment system. Because the appointment site also captures insurance information, the ADHS even has some information about what percentage of folks are insured through AHCCCS (Medicaid) or private insurance. 

Arizona remains one of the very few states that still doesn’t disclose this important information- info that the people can use to hold the state agency and the governor accountable for their decisions. They are collecting important demographic fields, but they aren’t using the data to inform their vaccine allocation and policy decisions. Why? Perhaps it’s because they don’t want to admit that the current appointment system favors the wealthy.

To get one of the coveted appointments in AZ, you need to have a flexible job so you can be ready to hit their server in the few minutes when appointments become available. You need good Wi-Fi, a new computer, and enough technology skills to navigate their convoluted system. If you don’t have a rapid digital connection, time to repeatedly refresh the site or sit on hold for hours, and don’t have the ability to travel to a vaccination site, you’re far less likely to obtain a COVID-19 vaccine. Many who are at highest risk also face language and cultural barriers, or simply distrust the process and the vaccine.

Is the state avoiding transparency because we will see that the current system gives an advantage to wealthy (and overwhelmingly white) Arizonans? Is ADHS unwilling to take responsibility for the unfair playing field created by the flawed appointment registration system?

You might ask what would work better and be more equitable?

Most states have a much better system that is not only less complex but more equitable. For example, in Minnesota, folks can register on the state health department website any time any day.

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 you to ensure you were allocating vaccine with a lens to health equity. For example, build a selection algorithm to ensure that folks over 75 are given a higher chance of being selected. You could even look at the vaccination trends geographically. If you were to see that certain low-income parts of the state (or city) you could make it more likely that registrants from that part of the state or city are selected the next week.

A letter to the editor in the Arizona Republic today 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.

Johnson & Johnson Submits Emergency Use Authorization Application to FDA

Johnson & Johnson applied for Emergency Use Authorization (EUA) for their candidate vaccine last Thursday. Their candidate is a single dose vaccine that uses a weakened cold virus as the vehicle for the antigen that stimulates the immune response.

The FDA has scheduled a Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Feb. 26, 2021, to discuss the request. They will likely make a recommendation whether to authorize or not during that meeting. The FDA Commissioner will then likely make a decision shortly thereafter.

Note: Former FDA Commissioner Hahn resigned and has been replaced by Acting Commissioner Janet Woodcock M.D. Dr. Woodcock is a Career FDA professional – having served at the FDA since 1984.

The company says they have vaccine immediately ready for shipment as soon as the FDA authorizes emergency use of the vaccine. The FDA hasn’t posted the application data on their website yet, but I’ll keep an eye out for it.

An NIH and J&J press release (not the full published data) said that their clinical trial of 43,783 participants “met all primary and key secondary endpoints”. The topline safety and efficacy data are based on 43,783 participants accruing 468 symptomatic cases of COVID-19.

Both the NIH and J&J have stated that their vaccine candidate: 

“… is 66% effective overall in preventing moderate to severe COVID-19, 28 days after vaccination. The onset of protection was observed as early as day 14. The level of protection against moderate to severe COVID-19 infection was 72% in the United States, 66% in Latin America and 57% in South Africa, 28 days post-vaccination.”

Dr. Gerald’s Weekly Epidemiology and Hospital Capacity Report

Here is a link to Dr. Gerald’s new epidemiology and hospital capacity report. Below is a summary:

  • This week saw a meaningful decline in Covid-19 cases which now cements the recent trends as a real decrease in viral transmission. This decline has been accompanied by reductions in hospital and ICU occupancy. While these trends are welcomed, the absolute level of SARS-CoV-2 virus transmission remains exceptionally high, about on par with those of the summer peak.

  • As of January 31st, new cases were being diagnosed at a rate of 412 cases per 100,000 residents per week. Arizona now has the 5th highest viral transmission rate according to the CDC. Overall, Arizona remains the 6th hardest hit state.

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

  • So far, 1.9% of Arizona residents have received at least 2-doses of vaccine while 6.8% have received at least 1-dose. To date, Arizona has administered about 65% of its delivered doses. Arizona vaccination roll-out ranks in the bottom half of US states.

  • Arizona is still reporting large number of weekly deaths and this count may considerably underestimate true fatalities (see Woolf, Woolf, or Weinberger). Many of these deaths were preventable had the state adopted more aggressive public health practices.

  • AZPHA released a report on all-cause mortality during the Covid-19 pandemic. Briefly, all-cause mortality was 23% higher in 2020 with July and December being outliers with 64% and 61% higher mortality, respectively. This translates into approximately 15,000 excess deaths.

  • AzPHA also released a report examining the leading causes of deaths in Arizona over time. In brief, the main finding is that Covid-19 ranks as the leading cause of death in Arizona since the pandemic began.

  • AzPHA also released a report that describes the chronological course of the Covid-19 outbreak in Arizona and the state’s response or lack thereof.

New AzPHA Report: COVID-19 The Leading Cause of Death in AZ During the Pandemic

One of our newest AzPHA members, Allan N. Williams, MPH, PhD (who recently retired as an epidemiologist at the Minnesota Department of Health) analyzed ADHS vital statistics data and developed our newest epidemiology report entitled: “How Do COVID-19 Death Rates Compare to the 15 Leading Causes of Death in Arizona?”  

Not surprisingly, the report found that COVID-19 has been the leading cause of death in Arizona during the pandemic (Nationally, it has been the 3rd third leading cause of death).  The fact that COVID deaths are currently comparable in prevalence to our two long-standing major killers – heart disease and cancer – is a sobering statistic and represents a deadly failure to implement evidence based interventions to better manage the pandemic in Arizona. Furthermore, the toll from COVID-19 is likely to be considerably higher than the currently reported numbers.

As previously noted in our January 24, 2021 AzPHA Report 2020 All-Cause Mortality Trends in Arizona During the COVID-19 Pandemic and in recent media (Arizona Republic, Feb. 1, 2021 “Arizona Deaths Rose 25% in 2020”), preliminary 2020 mortality data show a significant increase (14,972 additional deaths) in overall deaths compared to 2019. While most of this increase is clearly attributable to COVID-19 deaths, the AzPHA mortality analysis indicated that some 3,444 of the excess deaths were not reported as COVID-19 deaths.

This is consistent with estimates indicating that 35% of COVID-19 deaths are unreported.  It is also possible that deferral of care for serious non-COVID-19 medical conditions or reduced screenings during the pandemic also account for a portion of the non-COVID-19 excess. 

While there is room for optimism as vaccinations slowly ramp up and new vaccines are now imminent, there is at the same time growing concern about the rapid spread of more transmissible variants of the SARS-CoV-2 virus and whether current vaccines will be less effective against these variants. Unfortunately, COVID-19 will remain a significant cause of death well into 2021.

A huge thanks to Dr. Williams for his work bringing this important information to light.

Novavax Announces Encouraging Vaccine Trial Data

Novavax also announced (but did not publish) encouraging results of their Phase III Clinical Trial. Their press release (not published data) said that their clinical trial met the primary endpoints for safety and effectiveness. They said that upcoming results will show that their vaccine candidate was 89% effective in the Phase III clinical trial conducted in the UK.

“With today’s results from our UK Phase 3 and South Africa Phase 2b clinical trials, we have now reported data on our COVID-19 vaccine from Phase 1, 2 and 3 trials involving over 20,000 participants.”

“In addition, our PREVENT-19 US and Mexico clinical trial has randomized over 16,000 participants toward our enrollment goal of 30,000. NVX-CoV2373 is the first vaccine to demonstrate not only high clinical efficacy against COVID-19 but also significant clinical efficacy against both the rapidly emerging UK and South Africa variants,” (from Stanley Erck, President and CEO of Novavax.

No word on when the trial data will be published nor when they will ask the FDA for emergency use authorization. This is also an important vaccine as it too has simple storage and handling requirements and is perfect for doctor’s offices, pharmacies, mobile clinics and community health centers.

Drama Over Vaccine “Wastage”: Telling the Truth Matters

There was some drama yesterday about how much vaccine has been “wasted” at various Maricopa County mass vaccination sites.  Journalists submitted public records requests to Maricopa County Department of Public Health and the ADHS asking for data about how many doses of vaccine were unusable at the various PODs. Maricopa County produced the data, sharing that a total of 553 doses out of 153,196 administered have been discarded at county PODs between December 17, 2020 and Jan. 20, 2021.

This represents 0.3% or 3 of every 1,000 doses that have been administered through these PODs to that date. For perspective, standard wastage for all vaccines in doctors’ and pediatric offices is between 3% and 5%.

I did a few interviews on the issue of accidents and problems that can happen when administering vaccinations including this one from FOX10 saying that a 0.3% wastage rate is a testament to good performance at the PODs. By comparison, wastage rates at pediatric offices are typically between 3-5%.

The drama came when Governor Ducey tweeted the following statement:

“The COVID19 vaccine is a precious and limited resource – that any doses would be wasted is shocking and unacceptable. This has not and will not happen at any state-run sites, and local leaders must prevent it from ever happening again at any county-run site.”

The statement that no problems have come up nor mistakes made at their branded State Farm POD is, of course, preposterous. There’s no way that a mass vaccination site like State Farm has never had an issue that led to a discarded vaccine.  ADHS has not disclosed how many vaccines have been discarded at State Farm, but I can guarantee you that it is not zero. I’m hopeful ADHS will be quick to respond to press inquiries about its own data about vaccine wastage.

The fact that a small number of issues may have come up at State Farm and some vaccines discarded isn’t the issue. The problem is a when the Governor makes a false statement disparaging the performance of a key partner (performance that is, in fact, good) when the state itself is unwilling to disclose its own performance on that same metric… and then fabricates a tale that no vaccine has ever been discarded.

If there is any concern about the quality of the vaccine or any information is not readable on the label, manufacturers have advised providers to throw out the vaccine to maintain a safe operation.  That can mean things like:

1) A vial does not have a readable label or expiration date and cannot be used;

2)  There is particulate matter or “floaters” present in the vial and all 5 doses are wasted;

3) A vial is partially filled and none of the contents can be used;

4) Equipment malfunction, such as a bent needle, recapping issues, or the plunger is depressed accidentally; and

5) Draw-up issues like having a bubble in the syringe or a needle stick injury or an error mixing the dose.

These are issues that occur any time vaccines are given, particularly during large volume operations (this is not an exhaustive list of ways that vaccine doses can be unusable). Any large vaccine administration site that claims that “no doses are wasted” is not operating safely or not being honest about wasted doses.

Persons in key elected and appointed positions should be honest and transparent with the people of Arizona. We deserve at least that.  

Do the Current and Upcoming Vaccines Cover the New Variants?

The data are still coming in, but so far it looks like the Pfizer and Moderna vaccines are close to equally protective for the new UK strain. It’s also looking like both vaccines are less effective against the south African strain because some of the mutations on that variant code for the protein coat (that’s the queue that the immune system uses to build antibodies, B cells and T cells (see our discussion of the immune system in these previous posts Part I and Part II). 

Because there is a wide margin of safety for the protective threshold of neutralizing antibody action against the virus- the vaccine is still protective of that strain as well (although at a lower level- perhaps 70% protective against infection or so).

A new study was published this week entitled mRNA Vaccine-elicited Antibodies to SARS-CoV-2 and Circulating Variants. You can read the study yourself, but basically they found that people who have been vaccinated had high antibody titer levels of IgM, and IgG that are highly effective at neutralizing the virus. Interestingly, it found no difference in the memory B cells when comparing people that were fully vaccinated compared to people with a natural infection.

They found that the UK (B1.1.7/501Y.V1), South Africa (501Y.V2) and Brazil (B1.1.28/501.V3) have a reduced antibody neutralization potency compared to the classic strain.  However, those differences had “comparatively modest” effects on viral sensitivity.

The study does forecast, however, that:

it is possible that these mutations and others that emerge in individuals with suboptimal or waning immunity will erode the effectiveness of natural and vaccine elicited immunity. The data suggests that SARS-CoV-2 vaccines may need to be updated and immunity monitored in order to compensate for viral evolution.”

Johnson & Johnson and Vaccine Data Encouraging

The Company is Expected to Apply for Emergency Use Authorization This Week

Johnson & Johnson announced (but have not published) encouraging results of their Phase III Clinical Trial. Their press release (not published data) said that their clinical trial of 43,783 participants “met all primary and key secondary endpoints”. The topline safety and efficacy data are based on 43,783 participants accruing 468 symptomatic cases of COVID-19.

They say that their vaccine candidate: 

“… was 66% effective overall in preventing moderate to severe COVID-19, 28 days after vaccination. The onset of protection was observed as early as day 14. The level of protection against moderate to severe COVID-19 infection was 72% in the United States, 66% in Latin America and 57% in South Africa, 28 days post-vaccination.”

Here is the info from the full media release: Johnson & Johnson Announces Single-Shot Janssen COVID-19 Vaccine Candidate Met Primary Endpoints in Interim Analysis of its Phase 3 ENSEMBLE Trial

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 important is a single dose vaccine. 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.

Here’s A Good Webinar Called “How Vaccines Work” that Will Help Your Employees Make Informed Decisions

I’ve had several requests to have Zoom conversations with organizations to help educate their staff about the SARS CoV2 vaccines that prevent COVID-19. I’ve been able to do a few of them but because my time is limited these days I can’t do them all. But- there are some good resources out there for this. The best one that I know of was done by the UA called “ How COVID-19 Vaccines Work”

Presenters:

Deepta Bhattacharya, Ph.D. Associate Professor, Department of Immunobiology

Karl Krupp, Ph.D. Research Associate, Mel and Enid Zuckerman College of Public Health

Here’s where to WATCH the webinar and here are the Presentation materials

I also had a session for the Arizona Association for the Education of Young Children which might be helpful as well… here is a link to that conversation: https://youtu.be/8wJ9ocFTA28