Will Humble Vaccination, Wills Blog

FDA & CDC Pause the Administration of the Johnson & Johnson (Janssen) Vaccine Pending Data Review

More than 6.8M doses of the Johnson & Johnson vaccine have been administered in the U.S. The enhanced surveillance system that’s in place to detect adverse events found 6 cases of a type of blood clot called cerebral venous sinus thrombosis in women that received that vaccine.  Since the cases are all occurring among women from 18 to 50 years old, the rate is more like 1/100,000 for that demographic.

Their diagnosis occurred 6 to 13 days after their vaccinations. Symptoms of this kind of blood clot include severe headache, abdominal pain, leg pain, or shortness of breath- but mostly severe headache.

The treatment for this kind of blood clot is different from what’s typically given for other kinds of blood clots. Usually, an anticoagulant drug called heparin is used to treat blood clots. In the 6 cases that were observed (called cerebral venous sinus thrombosis) heparin is dangerous and patients need a different kind of treatment.

The CDC & FDA recommended that state and county health departments suspend the administration of the J&J shot last Monday. The vaccine is still under emergency use authorization by the FDA. Last week’s advisory was just a recommendation.

CDC held their Advisory Committee on Immunization Practices (ACIP) last Wednesday to review the 6 cases last Wednesday. The ACIP’s job is to assess the potential significance of the adverse events and consider the benefits of the vaccine and make recommendations to CDC and FDA about how CDC and FDA should proceed.

The ACIP’s review examined the details of the cases and concluded that the number of cases is likely above what would normally be expected in that number of people and that the cases are likely related to administration of the J&J vaccine.

I listened to the entire meeting and to be honest I was disappointed at the lack of interest that the committee’s showed about what the public health impacts would be from an extended removal of the J&J vaccine. They seemed to believe that the J&J vaccine is interchangeable with the mRNA vaccines. It is not. 

They failed to appreciate that the J&J vaccine is far more flexible, has an easier cold chain, and is a one dose shot…  making it valuable for getting vaccine to vulnerable and hard to reach populations. They also seemed unconcerned that removal of the vaccine would hurt health equity.

All in all, a disappointing meeting. While they didn’t vote on anything, they appeared to be poised to recommend at least a one month suspension of this important and safe shot. Not a good call.

The ACIP will be meeting again this Friday at 8am AZ time. I hope public health stakeholders like ASTHO and NACCHO reach out to better educate ACIP voting members about the public health costs of a continued suspension of the administration of the J&J vaccine. 

P.S. Keep in mind that ACIP’s recommendations are just advisory and the CDC & FDA Director and Commissioner (or state and county health departments) don’t have to take their advice. Also, FDA does not appear to be considering revoking J&J’s Emergency Use Authorization.

Editorial Note: Anytime you decide to suspend administration of a vaccine like this you need to consider both the costs (risks) and benefits of the decision. One cost is that hundreds of vaccine clinics and events that are prepped and ready to administer the J&J vaccine now have to suspend their operations.

Another risk is that the tens of thousands of persons that would have been vaccinated with the J&J shot in the coming days (weeks) won’t receive their vaccine. Some folks may not come back and may get infected later. The J&J vaccine is uniquely positioned to reach vulnerable populations because of its flexibility.

If the FDA hadn’t temporarily suspend use of the vaccine there’s a risk that additional cases of the rare clot will occur without clinicians having had an opportunity to learn more about the unique treatment for these rare clots.  

The bottom line is that I agree with the CDC and FDA’s decision to temporarily suspend use of the J&J vaccine pending the deeper analysis of these cases last week. However, I was disappointed with the ACIP’s lack of interest in how removal of the J&J vaccine might injure efforts at vaccine access equity.

Will Humble Disease Control, Wills Blog

Dr. Gerald’s Weekly Epidemiology Report

Below is an excerpt from Dr. Joe Gerald’s weekly epidemiology and hospital capacity report. As always, see the full report for all the discussion and informative graphs and analysis.

For the week ending April 4th, 4281 Covid-19 cases were diagnosed in Arizona. This represents a 2% increase from last week’s initial tally of 4200 cases and marks the second week of slightly increasing case rates. The prior week’s tally was upwardly revised by <1% (29 cases) to 4229 cases this week.

Case rates among those ≥65 years of age have fallen below those of children for the first time, 28 versus 37 cases per 100K residents per week, respectfully.

The highest rates remain among those 15 – 24 years and 25 – 64 years of age, 95 and 70 cases per 100K residents per week, respectfully. Arizona case rates remain “stuck” just above the threshold differentiating substantial and moderate risk.

As predicted in the March 26 Update, our 3-month streak of sustained improvements has stalled owing to more transmissible variants (e.g., B.1.1.7) and/or normalization of business and social activities (e.g., EO 2021-06).

Nevertheless, hospital capacity remains adequate to meet Arizona’s needs even though the backlog of non-Covid care has yet to be fully addressed. While residents and businesses should continue to follow public health recommendations, normalization of low-risk activities remains reasonable.

New cases are now being diagnosed at a rate of 59 per 100K residents per week; this rate is neither increasing nor decreasing. For reference, September 8th marked the fall nadir between the summer and winter outbreaks at 38 cases per 100K residents per week.

Post-holiday case rates reached a low of 53 cases per 100K residents on March 23, 2021. Unvaccinated Arizonans who are at risk of developing severe disease (e.g., age or comorbid conditions) or who simply wish to remain uninfected should continue to shelter as much as feasible because viral activity remains widespread.

Will Humble Disease Control, Health Equity, Social Determinants, Vaccination, Wills Blog

AzPHA Statement Clarifying Deceptive ADHS Leadership Remarks About Vaccine Administration Equity in Arizona

Director Christ and her communications assistant Steve Elliott have been making statements in the media recently suggesting that Arizona is doing terrific when it comes to the equity of vaccine administration in Arizona.

They have been basing their statements on this CDC MMWR that found AZ had a high level of COVID vaccine coverage in Arizona counties that have a high social vulnerability index. The method used by the CDC compared COVID vaccination rates in counties with high and low social vulnerability indices.

The report did not examine vaccine coverage within counties. CDC’s study design was not designed to detect equity differences inside counties with urban areas like Maricopa and Pima counties (where more than 80% of Arizonans live).

The conclusions in the CDC report that AZ performs well reflect the fact that tribal nations, governments, and the IHS have done a good job vaccinating Native Americans that live in counties  with large numbers of Native Americans (and a high social vulnerability index).

The CDC report cannot and should not be used to draw a conclusion that Arizona is doing well vaccinating lower income and persons of color in Arizona. We are not.

For example, even though 32% of Arizonans are of Hispanic descent, only about 11% of all the persons of Hispanic ethnicity have been vaccinated so far in Arizona. Only 6% of the persons that have been vaccinated at the “state run” PODS have been Hispanic.

The county health departments are working hard to address this disparity with community-based vaccination events. We believe that county health departments should be given a much larger share of the allocated vaccine because their equity performance is much better than that of the “state run” PODS.

Sadly, Director Christ does not see it that way, as she continues to over-allocate vaccine to the stadium-type mega sites at the expense of community-based vaccine sites. We urge her to change this practice, although we do not expect her to do so.

Will Humble Uncategorized, Wills Blog

National Public Health Week Message from AzPHA Board President Pele Peacock Fischer

This week marks the 25th annual celebration of National Public Health Week, a celebration that usually passes without much notice.

This year is starkly different. The COVID19 pandemic has put public health in the national spotlight, with many Americans suddenly attuned to the importance of public health in our communities.

Many Arizonans have come to recognize just how essential our public health efforts and public health workers truly are. To quote the White House proclamation:

“Whether it is the scientists and researchers who developed life-saving vaccines in record time; or local leaders who have taken evidence-based action to keep their communities safe; or the staff and volunteers who have worked to slow the spread of the virus through testing, case investigation, and contact tracing; or the doctors, nurses, and clinicians who continue to provide around-the-clock care to those who have fallen ill, dedicated public health professionals on the front lines of our response to COVID-19 deserve our gratitude.”

In Arizona, our county and state health departments worked tirelessly and made many sacrifices to protect our communities, despite years of budget cuts and neglect. There are many unsung heroes toiling away in county buildings in fields like epidemiology and health statistics that until this year were vastly misunderstood and undervalued.

This is an unprecedented time of change, and also an opportunity to finally recognize the importance of a maintaining a robust public health system.

So this year, to mark National Public Health Week, please join us in thanking those public health professionals who work every day – and sometimes put their lives on the line — to ensure our health and safety.

– Pele Peacock Fischer, JD

  Board President,

  Arizona Public Health Association 

Will Humble Disease Control, Wills Blog

AZ Attorney General Opinion Temporarily Unravels the Governor’s Prohibition of County Mask Mandates

Ducey Promptly Follows Up by Signing HB2770 Which Says that Businesses Can Ignore Mask Requirements and Regulations – Even in Hospitals or Factories

 The Arizona Attorney General issued an opinion last week saying that Governor Ducey can’t use his emergency authority (under the declared public health emergency) to stop counties from enacting their own mask mandates. As you recall, a couple of weeks ago he issued an edict that counties and cities can’t have and enforce mask mandates.

The legal opinion rests on the fact that the governor used executive authority derived from the public health emergency declaration in the emergency management statutes (ARS 26-307) to prevent counties from having and enforcing mask mandates.

The problem for him is that Pima County (and the other counties with mask mandates) used separate authority in their normal public health statutes (36-183.02 – Sanitary regulations) to require masks in public.

“Each county shall investigate all nuisances, sources of filth and causes of sickness and make regulations necessary for the public health and safety of the inhabitants.” 

Interestingly, the A.G. opinion says that Director Christ can overturn county mask mandates if she so desires. Because of the public health emergency, she has broad authority under 36-787 – Public health authority during state of emergency or state of war emergency) to set statewide policy through rules or regulations regarding face coverings according to the A.G. opinion.

So basically, she needs to decide if it’s important enough to her that counties don’t have mask mandates that she’ll impose a statewide prohibition on mask mandates. I’d say the odds are about 60-40 that she does.

Governor Signs HB2770 Which States that Businesses Aren’t Required to Enforce Mask Mandates – Even in Hospitals and Factories

The Governor signed HB2770 Friday which will completely eliminate any enforcement of mask mandates that are imposed by the state, counties or cities. Once the bill takes effect 90 days after the end of this legislative session, businesses (including medical and manufacturing facilities) can ignore any mask mandates that are in place- regardless of what regulation currently requires them.

Had this bill been in place before the pandemic, there never could have been a business based mask mandate by any jurisdiction. It even negates the regulations that ADHS has that require infection control masks in medical facilities like hospitals. Additionally, it negates any protective equipment mask requirements that the Industrial Commission has for chemical or infection control purposes.

Astonishingly irresponsible to sign a bill that completely gets rid of this non-pharmaceutical intervention during an emergency and also stripping all regulations from the Administrative Code that require infection control or environmental exposure masks.

Of course, the ADHS under the leadership of Director Christ offered no statement or testimony in committee expressing any concern whatsoever about the bill.

Such is the state of the public health leadership in this state.

Will Humble Maternal Health, Prevention, Wills Blog

Leveraging Doulas to Improve Birth Outcomes

Doulas are professionals who provides physical, emotional, and informational support to a woman throughout pregnancy, childbirth, and postpartum. Doula’s act as a facilitator between the laboring women and her physician by ensuring that mom and dad get the information they need in a way that they understand so they can make informed decisions.

A growing body of evidence suggests that continuous support from doulas or other non-clinical labor support can improve birth outcomes for both mothers and infants, fewer preterm and low-birth weight infants, and reductions in cesarean sections. In fact, when doula services are included throughout the pregnancy and birth process, births cost less. A recent study found that when a doula is included in the process births cost an average of $986 less – including the doula service fee.

SB 1181 would go a long way toward building doula’s into the public health and healthcare workforce by providing a way for doula’s to get a ‘certificate to practice’ from the ADHS as a state-certified doula. A person providing doula services wouldn’t be required to get a certificate in order to practice. However it would provide baseline professional standards and ultimately provide a pathway for reimbursing doula’s for their services – which would build the doula workforce.

Currently, Minnesota and Oregon take advantage of the fact that doulas can reduce healthcare costs while improving outcomes in their state Medicaid programs. Oregon Medicaid program provides direct payments to doulas through their contracted managed care organizations as does Minnesota. Last year, Minnesota increased the reimbursement rates for doulas after recognizing the role they play in improving outcomes and reducing overall costs. 

Several organizations, such as DONA International, provide doula training and certification. Women can also choose to become certified as community-based doulas through HealthConnect One. This community-based doula program model, which has been replicated nationwide to serve unique populations, trains doulas to provide culturally sensitive pregnancy and childbirth education to underserved women in their own community.

While all doula services can be beneficial, creating a standard for the training and certification of doulas may improve understanding and acceptance of doula care.

Fortunately, SB 1181 is receiving bipartisan support this year and it looks like it may be going to a final floor vote in the House this week. We certainly hope so!

Looking for more info? Access this UA Issue Brief on Doula Coverage to Help Minimize Arizona’s Birth Woes.

Will Humble Vaccination, Wills Blog

Special Vaccination Event Set for Persons with Developmental & Intellectual Disabilities 

We’ve been helping a host of partners over the last few months to get the ADHS to prioritize persons with developmental and intellectual disabilities for vaccination. Our original goal (going back to December) was to get the ADHS to put folks with disabilities into Category 1b like many other states had done. While those living in group homes were prioritized, all others were not, despite the compelling evidence that many of them are at high risk for a bad outcome. We were unsuccessful at convincing Director Christ to take this important action but we didn’t give up.

When the ADHS went to the strictly age-based system, we pointed out that persons with disabilities under the age of 55 (who had been waiting patiently in line in Category 1c) now had to wait even longer- until their age was called. It didn’t work, but we didn’t give up.

Fortunately, continued advocacy by the ARC of Arizona, Special Olympics, the DDPC, the ACDL, and Ability 360 was successful in scoring a special-needs vaccination event next weekend at the Disability Empowerment Center in Phoenix.

The event will be on Saturday, April 10 from 2:30pm to 9:00pm and on Sunday, April 11 from 8am to 6pm. Appointments are required and can be scheduled with Passport Health at Clinic Sign Up Information (passporthealthglobal.com).

Spread the word!

Will Humble Disease Control, Vaccination, Wills Blog

If You’ve Recovered from COVID-19 Should You Still Get Vaccinated?

The short answer is YES…  but emerging research shows that (among people that have been infected and recovered) the the first dose gets you to a very high level of protection but that the booster shot is unlikely to provide you with any extra benefit – at least in the short-run.

Here’s the story:

Dr. Joe Gerald’s best estimate is that close to 35% of Arizonans have been infected with and recovered from the SARS CoV2 virus that causes COVID-19. Now that all adults qualify to try to get a vaccine, more people are wondering if they need to or should get a vaccine even though they had COVID-19 and recovered?

The short answer is yes. After looking at the current evidence it looks like people that have been infected and recovered benefit from higher immunity if they get a vaccine. But, research that came out today suggests that the booster shot is unlikely to provide any additional benefit (again this is just among people that have been infected and recovered).

Infection with the virus provides good immunity for most folks. Research shows that antibody and T-cell responses post infection provide good protection against reinfection. Research also shows that 91% of people who recover are unlikely to be infected again for six months (even if they just had a mild infection or even no symptoms).  But…  infected but asymptomatic people make fewer antibodies than people that had symptoms.

Before actual data existed, I had expected that those with a natural infection would have better protection than people who had been vaccinated but never caught COVID-19. I was wrong about that.

A Research Letter in The New England Journal of Medicine found that antibody levels are higher in fully vaccinated people (Moderna or Pfizer) than in those who had recovered from infection. That was surprising to me.

It’s clear that people that have been infected but recovered should get vaccinated. But do they need the follow up booster? Data published today in the journal Nature suggest that while the first dose of Pfizer or Moderna provides a clear benefit for previously infected folks the booster shot is unlikely to provide extra benefit – at least in the short-run.

The article in Nature is called Antibody responses to the BNT162b2 mRNA vaccine in individuals previously infected with SARS-CoV-2 found that:

“…  individuals previously infected with SARS-CoV-2 developed vaccine-induced antibody responses after a single dose of the Pfizer–BioNTech mRNA vaccine were similar to antibody responses seen after a two-dose vaccination course administered to infection-naive individuals.”

“… a second vaccine dose did not offer previously infected individuals a substantially greater benefit over a single dose in antibody neutralizing potential. Thus, our data suggest that a single dose of the Pfizer–BioNTech vaccine is sufficient for individuals with prior SARS-CoV-2 infection…”.

Bottom line: folks that have been previously diagnosed with COVID-19 should get vaccinated, but the research published today suggests that booster shot is unlikely to provide additional benefit.

Editorial Note: Future research might show that there is a benefit to people that had previously been infected – especially over the long run. Also, at some point those vaccination cards might be used for travel and other privileges so there may be an administrative benefit for getting the Moderna or Pfizer booster if you’ve previously been infected with SARS CoV2.

Will Humble Uncategorized, Wills Blog

Vaccine Mega-site Business Model in Peril

Vaccine Eligibility Expansion Leads to Big Changes in Volunteer Incentives & Participation

The “state-organized” mega-sites that have become the flagship of the ADHS’ vaccination brand are built upon a foundation of volunteer labor.  A primary incentive to recruit volunteers for the sites has been the thank-you vaccine at the end of a shift. Of course, not everybody has been volunteering for a vaccine- but a significant portion of volunteers are.

Last week I warned that opening vaccine eligibility to all adults would undermine the incentive to volunteer and therefore the business model under which these “state managed” mega-sites operate. The reason is simple. Any adult now qualifies for a vaccine and can now make an appointment at a pharmacy, community health center, county vaccination site or even one of the “state run” mega-sites. They no longer need to volunteer to get a shot.

This week it became clear that the lack of volunteers has resulted in poor throughput at the flagship State Farm mega-site, causing long lines and unacceptable wait times.

I’m not arguing that opening eligibility to all adults was foolish. What I am saying is that it’s foolish not to anticipate how your decisions in one area of the response impact other areas. In this case, how opening eligibility to all adults changes the incentive to volunteer – and what impacts that will have on a business model that RELIES on volunteers.

Effective leaders anticipate what impact their decisions will have and implement plans to overcome response shortcomings. For example, before making all adults eligible, the ADHS should have activated a contract to supplement volunteers with paid staff to the sites using their CDC funding or even money that the Governor has at his disposal through the American Rescue Act.  Alternatively, members of the Arizona National Guard could have been scheduled in anticipation of the need to supplement labor needs.

Other solutions could have included shifting the vaccination business model to a more distributed one- with more vaccine going to pharmacies, community health centers, county run PODs and primary care doctor’s offices. Even simply booking fewer appointments per hour would have made a difference.

Over the last week or so, 2 to 3+ hour waits have become commonplace at the flagship State Farm mega-site, making it clear that the state leadership team didn’t anticipate the impact that opening eligibility would have on the incentive to volunteer. Or, if they did, the didn’t implement plans to overcome the challenges that they knew might occur.

Now that there’s increasing media attention on the unacceptable wait times at their flagship site, I expect that they’ll make some decisions to at least make the optics look better, like reducing the number of appointments per hour at their branded mega-sites, or maybe even implementing staffing contingency plans.

One thing is for sure- they’ve invested too much in their State Farm site brand to let it sour.

5pm Update: After denying all day yesterday and today that a lack of volunteer labor was at the heart of the unacceptable delays of the last week, Governor Ducey and Director Christ announced a host of interventions:

  • Using Arizona National Guard troops at their sites (90 per day)

  • Switching to a paid model for their branded mega-sites

  • Adding 30 paid staff per shift

  • Reducing volunteer shifts to 6 hours

They’re still not conceding that the lack of volunteers (and their failure to anticipate that shortage) is the reason why there have been huge wait time over the last week However, all the above interventions are about staffing, so it’s a tacit admission I guess.

At least they’re fixing it now that the media covered the story.

Will Humble Uncategorized, Wills Blog

ADHS Expands Vaccine Eligibility to All Adults

Decision Jeopardizing Business Model for the Vaccine Mega-Sites

Given how chaotic last week was, it might seem like the decision to open up vaccine eligibility to all adults happened a few weeks ago- but it was just a week ago tomorrow.

It looks like what happened is that the ADHS observed that the demand for vaccinations in the 55+ year-old group had waned quickly. Ever since December, any appointments that had been released by the state were snapped up in a matter of minutes (which presented big problems for underserved communities, but I digress).

But over last weekend, appointments just sat there on the ADHS website – suggesting that demand among the eligible groups has waned quickly. Their response was to open up eligibility to all adults, an announcement that was made on Monday.

The county health departments are accustomed to finding out about policy changes on the Governor’s twitter account or in an ADHS media release…  but in this case some of the county health directors got a text 9 minutes before the policy change was announced, so that’s an improvement.

There’s some merit to going to an age-based system… but the problem is that Director Christ made no accommodation for persons with intellectual and developmental disabilities before this policy change – and now folks in that category need to compete with four million other adults for those appointments (see our blog from last week). At least they qualify for a vaccine now.

Note: By expanding eligibility to all adults this quickly, the ADHS is jeopardizing the business model for the vaccination centers. Vaccine PODs (including the ones organized by the state) rely on volunteer labor.

One of the key motivations to volunteer is that one gets a vaccine at the end of the shift. Now that all adults qualify, I expect to see fewer persons to self-present as volunteers because now they can simply make an appointment without volunteering.

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