Will Humble Disease Control, Vaccination, Wills Blog

Why is the Monkeypox Vaccine in Short Supply When There Are 100 Million Doses in the Strategic National Stockpile?

Because Monkeypox virus is closely related to the virus that causes smallpox, the smallpox vaccine can protect people from getting monkeypox. Past data from Africa suggests that the newest smallpox/monkeypox vaccine (called JYNNEOSTM) is about 85% effective in preventing monkeypox (vaccination promptly after a monkeypox exposure may help prevent the disease or make symptoms less severe).

For many years, the U.S. has had a Strategic National Stockpile (SNS) of different kinds of therapeutics, vaccines and other materials that can be used in a public health emergency. Those stockpiles are stored in secret warehouses around the U.S. and can be drawn upon at the order of the HHS Secretary.

Smallpox was eradicated in 1979, but the smallpox vaccine has been included in the Strategic National Stockpile as a safeguard in case the smallpox virus is accidently or intentionally released from one of the two secure laboratories where it exists (at the CDC and the Russian Centre for Research on Virology and Biotechnology in Koltsovo, Russia).

So, if the smallpox vaccine works for monkeypox, and the smallpox vaccine is included in the SNS, how come the monkeypox vaccine is in such short supply? Note: Arizona has only received about 2,000 doses of JYNNEOSTM with 1500 doses on the way the way later this week.

The answer lies in what kind and how much of each of the smallpox vaccines are in the stockpile. The Strategic National Stockpile has three kinds of smallpox/monkeypox vaccines that are either approved or authorized for monkeypox:

  • ACAM2000® – is approved for smallpox in persons over 1 year-old & is authorized under an Investigational New Drug protocol for monkeypox.  It’s a “replication-competent live virus” (Vaccinia virus) which means that it’s a live attenuated virus that replicates. While the vaccine is fairly safe, it can cause myocarditis and/or pericarditis after administration (at an approximate rate of 5.7 per 1000). There’s also documentation that vaccinia can spread from person-to-person post-vaccination (ACAM can replicate). There are more than 100 million doses of ACAM2000® in the SNS.
  • JYNNEOSTM – is the approved for both smallpox & monkeypox – but only for persons 18 years old and up. JYNNEOSTM is also a live virus but it’s not “replication-competent” which means that it can’t replicate like ACAM can. It isn’t associated with any cardiac adverse events like ACAM2000®. It’s also better tolerated and has fewer nonserious side effects. For that reason, in November 2021, the ACIP unanimously voted in favor of JYNNEOS as an alternative to ACAM2000 for primary vaccination and booster doses for both monkeypox and smallpox. There are only about 65,000 doses of JYNNEOSTM in the SNS – although HHS has ordered 2.5 million more doses from Bavarian Nordic A/S (a fairly small manufacturer).
  • Aventis Pasteur Smallpox Vaccine (APSV) is also in the stockpile but this one is just an investigational vaccine that can only be used in a smallpox emergency under the right regulatory mechanism (Emergency Use Authorization). I can’t find how many doses the SNS has for this one.
Why Not Just Order ACAM2000 from the Stockpile to Increase the Supply Fast?

HHS will allow states to order ACAM2000® from the stockpile to increase their vaccine supply fast, but it appears that very few if any states are doing so. Why?

Like any other public health intervention, the first thing you need to do is look at the risks and benefits. ACAM2000® can cause serious reactions including myocarditis and/or pericarditis, encephalitis, encephalomyelitis, encephalopathy, progressive vaccinia, generalized vaccinia, severe skin infections, erythema, eczema, blindness, and fetal death in pregnant women.

For example, based on clinical trials, myocarditis or pericarditis (such as chest pain, raised troponin/cardiac enzymes, or ECG abnormalities) occur in 5.7 per 1000 primary vaccinations with ACAM2000. And remember, ACAM can replicate, so there’s a chance of vaccinia spreading from a vaccinated to an unvaccinated person.

Note: ACAM2000® isn’t approved for monkeypox, it’s just authorized for use with monkeypox under an IND protocol. By contrast, JYNNEOSTM is approved for monkeypox (but only for persons 18 years old and up).

JYNNEOSTM causes more typical and less problematic reactions like pain, swelling, inflammation, or itching at the injection site; muscle pain; headache; fatigue; nausea; fever; and chills.

Use of JYNNEOS (Smallpox and Monkeypox Vaccine, Live, Nonreplicating) for Preexposure Vaccination of Persons at Risk for Occupational Exposure to Orthopoxviruses: Recommendations of the ACIP | MMWR

Now for the benefit side of the equation. Monkeypox can be a painful disease characterized by fever, headache, muscle aches, chills, exhaustion, and a painful rash that can look like pimples or blisters that appears on the face, inside the mouth, and on other parts of the body, like the hands, feet, chest, genitals, or anus.

The rash goes through different stages before healing completely. The illness typically lasts 2-4 weeks. Importantly, monkeypox is rarely lethal.

I’m not in charge of deciding whether to order ACAM2000® from the stockpile (that’s up to Mr. Herrington these days) – but if I were in my old ADHS director job, I’d stick with just ordering JYNNEOSTM even if it meant that I’d have less vaccine on-hand. The risks of using the vaccine outweigh the benefits from slowing the spread of monkeypox.

If there were an accidental or intentional release of smallpox virus (e.g., from the Russian Federation) it would make total sense to order and use ACAM2000® from the stockpile for a targeted ring vaccination campaign.

Why? Because smallpox variola major (the most common type of smallpox infection) has a mortality rate of approximately 30%… and the benefits of using the vaccine for targeted ring vaccination to respond to the smallpox outbreak/epidemic would greatly outweigh the risks of using ACAM2000®.

Pediatric Note: ACAM2000® is approved for smallpox for ages 1 year and up. However, it’s only authorized under an IND protocol for monkeypox. JYNNEOSTM is approved for monkeypox but only in persons 18+.

With pediatric cases and contacts now being reported in the U.S., an emerging pediatric care question is whether to administer JYNNEOSTM to pediatric patients off-label for post exposure prophylaxis or stick with ACAM2000® under the IND protocol. Seems to me the obvious choice is to administer JYNNEOSTM or forego post-exposure prophylaxis.   

Historical Note: ACAM2000® was licensed by the FDA in September 2007. Prior to that, the smallpox vaccine was called Dryvax. If you think ACAM2000® has negative side effects and potential adverse events, wait until you read about Dryvax (Dryvax stockpiles in the U.S. have been destroyed).

Will Humble Public Health, Reproductive Health, Wills Blog

Know Your Reproductive Care Rights

Reproductive health care, including access to birth control and safe and legal abortion care, is an essential part of health and well-being. While Roe v. Wade was overturned, abortion is still legal in many states (including Nevada and California): Abortion Care for Arizonans Available in Las Vegas & Southern California

This new website ReproductiveRights.gov – Know Your Rights: Reproductive Health Care covers the federal protections still in place through various programs and laws including chapters on Birth Control; Medication; Access Abortion Services; and Other Preventive Health Services.

Will Humble Public Health, Reproductive Health, Wills Blog

AzPHA Has a Long History of Supporting Reproductive Freedom

As the independent voice for public health, you can count on AzPHA to support reproductive freedom, even as the state health department senior leadership takes a hands-off or even hostile view of reproductive freedom (for at least the next 166 days)

Many of AzPHA’s public health priorities are driven by Resolutions that are approved by our members. AzPHA has dozens of Resolutions in place dating back to the 1930s.  They are all available on our Resolutions Website.  

Early resolutions focused on the importance of food safety regulations, tuberculosis control, family planning, and other contemporary public health issues. More recent Resolutions have focused on support for addressing the Opioid epidemic, certifying community health workers, and addressing electronic cigarettes.  Our Resolutions are important to us because they set our public health advocacy priorities.

AzPHA Resolutions stay in place until and unless the Members vote to remove or update a Resolution. There is a process for developing new Resolutions.  Resolutions are developed by AzPHA Members and are sent to the Board for review.  

The Board reviews the Resolution and votes whether to send the Resolution to the Members for approval.  Proposed Resolutions can be voted on electronically before the Annual Meeting or they can be voted on in-person at the Annual Meeting.  After approval of the resolutions, final copies are posted on the members only part of our website.

AzPHA has a long history of supporting access to reproductive health services including contraception, abortion and comprehensive maternal and child health supports, from 1971 resolutions about family planning and many others.

Below are our existing resolutions related to the SCOTUS decision in Dobbs and AG Brnovich’s efforts to enforce Arizona’s territorial-era law outlawing all abortions except when the mother’s life is at risk.

The AzPHA Board of Directors is reviewing these historic resolutions to figure out whether we should update the resolutions or whether they’re sufficient to support our advocacy for access to comprehensive reproductive health services.

Will Humble Public Health, Reproductive Health, Wills Blog

Abortion Care for Arizonans Available in Las Vegas & Southern California

Here’s How to Locate Clinics & Make Appointments

Even though abortion care is currently suspended in Arizona, there are about 12 clinics in Las Vegas & Southern California within about 260 miles driving distance from metro Phoenix. 

One can locate the clinics and even make on-line appointments at I need an abortion – which is an on-line tool to help people locate clinics still providing comprehensive reproductive health services including abortion in other states.

You can also click the “How am I going to afford this?” button and the site will show you Arizona’s Practical Support Networks. If you’re under 10-weeks and in a state that allows telemedicine and abortion pills by mail, they show that as an option.

The goal of the site is to make it as easy as possible for people to find the information and resources that apply to them, without having to sift through a lot of noise or, worse, misinformation and stigma from anti-abortion organizations.

Will Humble Public Health Law, Reproductive Health, Wills Blog

Brnovich Steps on the Gas to Take Away Reproductive Freedom

Arizona is one step closer to enforcing a law from the first territorial legislature (in 1864) mandating prison for providers of abortion services. Last Wednesday Attorney General Brnovich filed this motion to lift a 1973 injunction staying the implementation of a territorial-era law [ARS 13-3603] still on the books:

13-3603. Definition; punishment A person who provides, supplies or administers to a pregnant woman, or procures such woman to take any medicine, drugs or substance, or uses or employs any instrument or other means whatever, with intent thereby to procure the miscarriage of such woman, unless it is necessary to save her life, shall be punished by imprisonment in the state prison for not less than two years nor more than five years.

The injunction he’s trying to lift is from a case filed in Superior Court in 1971 by Planned Parenthood of Tucson who had challenged ARS 13-360. After the federal court in Arizona wouldn’t take the case, Planned Parenthood sued then-Arizona Attorney General Gary Nelson in Pima County Superior Court. Planned Parenthood made many arguments including an implied right to privacy in the U.S. Constitution, an overreach of police power and that low-income people were unfairly impacted because they couldn’t afford to go to another state for an abortion.

Superior Court judge ruled for Planned Parenthood in 1972 saying that that the 1864/1901 laws were unconstitutional and placed an injunction against enforcing it. Nelson appealed to the Arizona Court of Appeals, who initially overturned the Superior Court decision in January 1973. A few weeks later the U.S. Supreme Court made its landmark ruling in Roe v. Wade and the appellate court then reversed their decision and modified the injunction.

That’s the injunction that our illustrious Attorney General is trying to lift.

See this paper to read Planned Parenthood’s arguments in the landmark 1971 lawsuit
AzPHA Special Report: Restrictions on Women’s Reproductive Freedom in Arizona: 1884-2022

Let’s imagine for a moment that Brnovich is successful, and the Court lifts the injunction. Presumably, the appellate court would need to amend their January 1973 ruling, again saying that 13-3603 is constitutional.

At that point it seems to me that Planned Parenthood could still appeal the case to the Arizona Supreme Court because their due process isn’t finished. Given the fact that Ducey has stacked the court, it’s highly unlikely that they’d take the case. Nevertheless, it seems like Planned Parenthood still would have due process left.

An Evidence Review: Does Withholding Abortion Services Harm Public Health?
Arizona Abortion Statistics & Clinic Regulations

It appears to me that abortion is still legal in Arizona, even though very few providers are performing them. If the injunction is lifted (and the Appellate Court changes their amended 1973 ruling), then it would likely become illegal, and Arizonans would probably continue to need to travel to Nevada or California for those services until a 2024 voter initiative settles the matter and makes abortion services legal again in AZ.

Here’s a very good 7-minute interview with Jen Piatt, JD by Ted Simons painting a clear picture of the legal lay of the land
Will Humble Public Health Law, Wills Blog

Several Ballot Measures Affecting Public Health Will Be on the November Ballot: A Summary

There are a couple ways Propositions make it to the ballot. You’re probably most familiar with voter initiatives. Voters can mobilize an effort to get measures on the ballot. If it’s a regular law then the organizers need to turn in 10% of the number of registered voters to get it on the ballot. If it amends the state constitution, then they’d need to turn in 15%.

The state legislature has it a lot easier. They can pass any law they want with a simple majority of legislators (unless they’re amending a previous voter initiative – when they need a supermajority). The state legislature can’t change the state constitution on their own, but they can put a measure on the ballot without collecting any signatures at all- they just need to pass a resolution by a simple majority vote in both chambers.

The November ballot will have several ballot propositions. Three voter initiatives turned in more signatures than they needed, the Predatory Debt Collection Protection Act, Arizonans for Free and Fair Elections, and the Voters Right to Know Act. 

Three will also be several Propositions that the Legislature has referred to the ballot because they change the constitution. One would add a 0.1% sales tax to help rural fire districts. One would change the line of succession for governor to a Lieutenant Governor that would run on a joint ticket with the candidate for governor.

Another would require 60% of voters to approve any voter initiative that had any kind of tax or fee. Another referendum makes changes to what’s required for mail in ballots.

Thus far, AzPHA has only endorsed Predatory Debt Collection Protection Act. Here’s our argument that will be in the voter publicity pamphlet: Our Take: Vote YES On the ‘Predatory Debt Collection Protection Act’

It’s possible that we may, before the November election weigh in for or against some of the other measures. Our Board of Directors will be shedding more light on whether we do that in the coming weeks.

In the meantime- I wrote and turned in some arguments for the publicity on 5 additional Propositions in my private capacity (not as the executive director of AzPHA). You can see those here:

Will Humble Reproductive Health, Wills Blog

Pima County Board of Supervisors Passes Resolution Supporting Continued Provision of Reproductive Health Services

Last week the Pima County Board of Supervisors voted to adopt a resolution that says the County’s support for the provision of reproductive health care and family planning services in the County and the state. It also advocates for continued access to abortion services in the County as a matter of public health.

“Abortion is healthcare. This resolution positively asserts that fact and says our Health Department will continue to aid Pima County families in their reproductive health and family planning needs,” said Board of Supervisors Chair Sharon Bronson, who brought the resolution to the Board for consideration. “While state law prohibits the County from providing full reproductive health services such as abortion, we’re not prevented from providing other services or accurate information about sexual and reproductive health.”

Bronson said Resolution 2022-40 is a reaction by the board to the June 24 Dobbs v. Jackson decision by the U.S. Supreme Court that eliminated the right to an abortion established by the court’s Roe v. Wade decision in 1973.

The Resolution states, “Abortion is a vital health care service that has been legal and safe in the United States for nearly 50 years. Access to legal, safe abortion, and comprehensive sexual and reproductive health more broadly, are critical to protecting and supporting the public’s health. The Supreme Court’s decision ends this basic right of safe access to appropriate health care for too many women and families in this country.”

The Resolution directs the County Administrator to:

  • Ensure the Health Department provides a broad range of legal reproductive health services;
  • Bring together community health care providers for the planning and delivery of reproductive care in the County;
  • Work with partners in the County, state, and nation to issue accurate information about sexual and reproductive health, and to advocate for evidence-based reproductive health care, including abortion.

To aid County residents seeking reproductive health care, the Health Department last week launched a webpage that aggregates all of the reproductive and family planning services provided by the County.

Will Humble State Legislature, Wills Blog

2022 Legislative Session | The Victories | The Setbacks | The Missed Opportunities

After a long and uniquely acrimonious session, the Arizona Legislature concluded its duties early in the morning on June 25, 2022. This session was one to be remembered (or forgotten, depending on how you see it), as the state faced a once-in-a-generation surplus of more than $5 billion that needed to be incorporated into a budget.

See the PowerPoint 

A couple of weeks ago I covered the details of what was in the final budget that was passed and signed. Legislature Passes a Bipartisan Budget for 1st Time in 14 Years: Here’s A Summary Top Line Health & Human Service Line Items

But what about all the other bills?

They’re sometimes forgotten in all the budget drama. Just like every year, there were good things, bad things and missed opportunities. This PowerPoint summarizes the details and I encourage you to go through the PPT. Here are the headline items:

Setbacks

  • Public health emergency authority is greatly reduced for future governors and health department directors (by SB009)
  • Counties and schools lost the ability to implement routine communicable disease control measures (even if not an emergency)
  • Cities lost routine disease control authority (even if not an emergency)
  • ADHS can’t add the COVID vaccine to the list for school attendance
  • Counties can’t require mitigation in churches during a public health emergency
  • Cities can’t require masking on city property – ever

Good Things

  • SB1272 AHCCCS; postpartum care; eligibility: Eligibility (SOBRA) is expanded for up to one-year post-partum (to 150% of federal poverty)
  • HB 2157 – Appropriates $1.44B in Medicaid in FY 2022 to implement the American Rescue Plan Act of 2021 (ARPA) home & community-based services for persons with developmental disabilities. AHCCCS Plan Here
  • HB2144 Health insurance coverage; biomarker testing– Requires health insurers to cover biomarker testing as part of patients’ treatment plans
  • HB2113 Developmental disabilities; Down syndrome – People with Down Syndrome are now automatically medically eligible for AHCCCS & DD services
  • SB1162 – Opioid prescriptions; intractable pain; exceptions –Expands the list of exemptions from the 90-morphine milligram equivalent (MME) limit on opioids prescriptions to include patients experiencing chronic intractable pain or receiving opioid treatment for perioperative care following an inpatient surgical procedure.

Featured Disappointment

•SB1716 Arizona State Hospital; Governing Board (Failed)

  • Would have created a badly needed independent ASH Governing Board and transfer operational control of the Arizona State Hospital from ADHS to the new Board on January 1, 2023.
  • Bill was badly needed because the ADHS both runs and regulates the Arizona State Hospital. There are serious concerns about the lack of regulatory rigor by the ADHS Licensing division, particularly during the Director Christ-era.
See the PowerPoint 
Will Humble Public Health Law, State Legislature, Wills Blog

My Take: Vote for Transparency, Accountability, Fairness, and Equality. Vote YES on the Arizonans for Free & Fair Elections Act

Over the last decade or so legislators in the majority party at the Arizona State Legislature have been manipulating election laws to give them an advantage in future elections. They’ve also been making it harder and harder for ordinary people to put forward voter initiatives because they view them as a nuisance.

They say all the laws they’ve passed that make it harder to vote and to run voter initiatives are to improve ‘voting integrity’. But make no mistake. It’s clearly being done to give them an advantage so they can continue to control all 3 branches of state government and avoid what they view as meddling by the voters with voter initiatives.

Finally, the folks at Arizona for Fair Elections said enough is enough and took matters into their own hands by collecting enough signatures to put the Arizonans for Free and Fair Elections Act on the ballot this fall.

The Proposition is simple. It basically returns the power to the people, restoring voting rights that have been lost over the years and stops the legislature from making it even harder to run a voter initiative.

Here are the nuts and bolts… it:

  • Safeguards voters’ right to pass our own laws via voter initiatives. Prevents opponents of citizen-led initiatives from abusing minor technicalities to try to disqualify petition signatures.
  • Makes voter registration more accessible and accurate. Automatically updates your registration when you sign up for a driver’s license or state ID or when you change your address at the MVD. Allows people to register at a polling place on Election Day.
  • Protects your right to vote by mail. Protects your right to stay on the permanent early voting list. Right now, you can be removed if you miss a few elections.
  • Gives people more time and options for voting. Extends in-person early voting through the day before election day. Allows voters to vote at any polling location in their county.
  • Prohibits lobbyists from giving certain gifts to politicians, including paying for lawmakers’ travel and expensive meals.
  • Lowers contribution limits. Reduces the amounts that any one individual or Political Action Committees may contribute to candidates.
  • Protects voting access for Tribal voters and voters with disabilities. Requires Tribal input on the location and hours of polling places. Protects voters with disabilities by ensuring access to a variety of voting methods, including curbside.
  • Protects voters rights to receive needed assistance. Restores voters’ rights to entrust someone to deliver their signed and sealed ballot. Restores people’s rights to provide food and hydration to voters waiting in line.
  • Prevents the state legislature from overturning presidential election results. Ensures that the voters decide who wins elections.
  • Keeps your ballot private. Guards against ballots and other election materials being turned over to unaccountable outside entities for improper uses.

To be honest, it’s kinda sad that the Arizonans for Free and Fair Elections Act is needed, but it is. Badly.

Vote for transparency, accountability, fairness, and equality. Vote YES on the Arizonans for Free and Fair Elections Act

Will Humble Professional Development, Wills Blog

AzPHA Summer Book Club About to Start

Do you find it hard to find time to read? Do you need new inspiration for your work in public health? Would you like the opportunity to meet others working in the field in Arizona?

Join the AzPHA virtual book club! We’ll meet once a month via Zoom to discuss books about the field and get know each other better. The first book is “Mountains Beyond Mountains” by Tracy Kidder. The first 30 people to sign up will receive a free copy. 

The book summary: 

In medical school, Paul Farmer found his life’s calling: to cure infectious diseases and to bring the lifesaving tools of modern medicine to those who need them most. Tracy Kidder’s magnificent account shows how one person can make a difference in solving global health problems through a clear-eyed understanding of the interaction of politics, wealth, social systems, and disease. 

Profound and powerful, Mountains Beyond Mountains takes us from Harvard to Haiti, Peru, Cuba, and Russia as Farmer changes people’s minds through his dedication to the philosophy that “the only real nation is humanity”.

Sign up by emailing AzPHA President Elect: Kellidonley@gmail.com

Meeting dates to be determined. We hope you’ll join us for this great opportunity to continue to learn and meet new colleagues. 

Amazon.com: Mountains Beyond Mountains: The Quest of Dr. Paul Farmer, a Man Who Would Cure the World : Tracy Kidder, Paul Michael
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