Will Humble Vaccination, Wills Blog

Evidence Is Emerging Suggesting that the Moderna Vaccine Provides More Robust Protection than Pfizer

Both the Pfizer and Moderna vaccines provide very good protection against becoming infected with the SARS CoV2 virus and terrific protection against becoming hospitalized or dying from an infection.

That said, in the last few weeks, a couple of studies have been released showing that the Moderna vaccine elicits a more robust antibody response when compared with the Pfizer vaccine. It’s still unclear whether this will be validated by future research and/or whether any differences in immunity that the vaccines elicit and/or whether if there is a difference, whether it will turn out to be clinically significant. Here are a couple of those studies:

Comparison of SARS-CoV-2 Antibody Response Following Vaccination With BNT162b2 and mRNA-1273 

Both the Pfizer and Moderna vaccines provide great protection against COVID infections and terrific protection against needing to be hospitalized or dying of COVID. This serology study shows that the antibody titer response to the Moderna vaccine is significantly higher than that achieved with Pfizer.

Two reasons for that include the higher mRNA content in the Moderna product and the extra week interval in the Moderna administration protocol. It’s still unclear whether this difference is or will be clinically important (e.g. will Moderna provide longer-lasting protection) but it’s plausible.

“Higher antibody titers were observed in participants vaccinated with 2 doses of mRNA-1273 compared with those vaccinated with BNT162b2 (geometric mean titer [GMT], 3836 U/mL [95% CI, 3586-4104] vs 1444 U/mL [95% CI, 1350-1544]; P < .001) (Figure, A).

This study demonstrated a significantly higher humoral immunogenicity of the SARS-CoV-2 mRNA-1273 vaccine (Moderna) compared with the BNT162b2 vaccine (Pfizer-BioNTech), in infected as well as uninfected participants, and across age categories.”

The higher mRNA content in mRNA-1273 compared with BNT162b2 and the longer interval between priming and boosting for mRNA-12733 (4 weeks vs 3 weeks for BNT162b2) might explain this difference.

A relationship between neutralization level after SARS-CoV-2 vaccination and protection against COVID-19 has been demonstrated by several studies.4 As such, the height of the humoral response after vaccination, which correlates with neutralizing antibody titers,5 might be clinically relevant.”

Comparison of SARS-CoV-2 Antibody Response by Age Among Recipients of the BNT162b2 vs the mRNA-1273 Vaccine

This cohort study found that the Pfizer vaccine elicited relatively lower antibody levels in older adults when compared to younger adults. There was no difference in antibody levels between older and younger adults who received Moderna.

One explanation for the difference could be the difference in the amount of mRNA used in the respective vaccines. Pfizer uses 30 μg of MRNA while Moderna uses 100 μg.

Will Humble Disease Control, Uncategorized, Wills Blog

Voters Support Mask and Proof of Vaccine Requirements

Statewide survey shows that 57% of likely voters support mask requirements and 52% would support proof of vaccine requirements for in local government, schools, or charter schools.

 PHOENIX (September 7, 2021) – A newly released statewide survey funded by the Arizona Public Health Association and the Arizona School Boards Association reveals that likely Arizona voters support proven strategies for mitigating the spread of COVID-19 in in local government, schools, and charter school facilities.  Not only do voters support mask requirements and allowing entities to choose their own mask rules, but they also support efforts to require proof of vaccine for employment if a private business or public entity chose to implement such a requirement.

“As the Delta variant continues increase the wave of cases and hospitalizations in Arizona, voters clearly understand the importance of masks when it comes to health and public safety.  In fact, a new study published in BMJ found that universal masking in classrooms reduced aerosol transmission by 800%.  The combined interventions of universal masking, natural ventilation, and HEPA filtration reduced transmission 3,000%.  When it comes to masks, a large majority of the public supports their use in our government buildings and schools,” said Will Humble, Executive Director of the Arizona Public Health Association.

At this time, do you think that individuals should be required to wear a mask while 
in local government, schools, or charter school facilities?
57.0%    Total Yes

40.8%    Total No

2.2%      Don’t know, Refused

48.8%    Definitely Yes

8.2%      Probably Yes

8.5%      Probably No

32.3%    Definitely No

2.2%      Don’t know/Refused

Ann O’Brien, ASBA President and a member of the Deer Valley Unified School District governing board, explained, “For the Arizona School Boards Association, the heart of the mask issue is local control.  We believe that our member districts and their locally elected school board should be able to decide what’s best for their students and staff.  In general, voters support masks, but most importantly, they also support allowing our local school districts to have a choice on whether or not they would like to implement a mask mandate.

Do you think that local governments, school districts, and charter schools should be able to determine their own rules regarding mask requirements for entering buildings, attending schools and participating in activities?

53.0%    Total Yes

42.8%    Total No

4.2%      Don’t know, Refused

38.2%    Definitely Yes

14.8%    Probably Yes

9.3%      Probably No

33.5%    Definitely No

4.2%      Don’t know/Refused

As part of the budget, the Arizona State Legislature passed a law as part of the state budget that made it illegal for schools to implement a mask mandate.  The law is currently being challenged in Maricopa Superior Court and a judge ruled that schools can keep a mask mandate in place until at least September 29th when the law is supposed to go into effect.

In addition to mask requirements, some private businesses and government entities are considering proof of vaccination as a requirement for individuals to keep their job or to be able to return to work in-person.  For example, the City of Tucson requires city employees to get the COVID vaccine (with exceptions) or face some financial consequences.  By a similar margin as the mask requirements, likely voters in Arizona support proof of vaccine requirements for both private and public entities.

Do you think that a private business should be able to require their employees to show proof of vaccination in order to keep their job or to be able to return to work in-person?

53.8%    Total Yes

42.0%    Total No

4.3%      Don’t know, Refused

43.5%    Definitely Yes

10.3%    Probably Yes

4.7%      Probably No

37.3%    Definitely No

4.3%      Don’t know/Refused

Do you think that local governments, school districts, and charter schools should be able to require proof of vaccination to keep their job or to return to in-person employment?

52.2%    Total Yes

44.8%    Total No

3.0%      Don’t know, Refused

42.5%    Definitely Yes

9.7%      Probably Yes

4.3%      Probably No

40.5%    Definitely No

3.0%      Don’t know/Refused

 

“Vaccines are effective against the Delta variant, but transmission risk remains elevated among unvaccinated persons – particularly in schools,” said Humble, “Once again, the public understands this and a majority think that a private business or local public entity should be able to require proof of vaccination to help stop the spread of COVID-19.”

Dr. Sheila Harrison-Williams, ASBA Executive Director, added “Voters see the wisdom in the notion of schools having the ability to make their own policy to protect students and staff.  Efforts like the law prohibiting school mask mandates and the executive order preventing entities from requiring proof of vaccine limit our choices and prevent our local elected officials from doing their jobs.  The public understands these issues and the survey shows without a doubt that voters support local decision making.”

About the Survey

The N=400 survey was conducted among likely voters August 30 through 31. The poll surveyed likely Arizona 2022 General Election voters who have a history of electoral participation and was balanced to model the likely turnout of voters across party, age, region, and gender.  The sample was provided from the internal voter database maintained by HighGround Public Affairs.

The live interview survey of voters was conducted by HighGround Public Affairs to both landline and cell phone users.  The questions regarding the mask mandate and proof of vaccine were funded by the Arizona Public Health Association and Arizona School Boards Association as part of a statewide survey that tested other policy issues.

The partisan advantage was set at +8% GOP based on previous midterm election trends, including the uptick in Democratic participation in past two election cycles combined with expected increase in enthusiasm among Republicans in the Gubernatorial Election.  The margin of error is ±4.9%.  For more information regarding the study, contact Paul Bentz at 602-528-3684.

Survey Demographics

The HighGround team has built a reputation of reliable and accurate polling over the past dozen years – our research has been featured on Nate Silver’s 538, Real Clear Politics, Huffington Post, and many other publications.  Paul Bentz has been named back-to-back-to-back winner of “Best Pollster” by the Arizona Capitol Times.

Will Humble Disease Control, Public Health, Wills Blog

Ducey Allocates $60M In Federal Funds to Patch a Nursing Shortage He Largely Created

Last week the governor allocated $60M in federal funding to go toward contracts for a total of 750 nurses that will be available to work at qualifying hospitals for an 8 weeks period.

To qualify, hospitals need to establish that they have a protocol for using a particular brand-name monoclonal antibody treatment called Rogeneron and that they offer “vaccination at discharge”.

Rogeneron is a product that is under EUA for treatment of the persons at highest risk of progressing to severe COVID. That list includes older age, obesity, diabetes, and heart disease. The product can be useful if used early in the infection but has a nominal effect once the disease progresses to severe symptoms. ADHS will write the nursing contracts and approve hospital participation (and scale).

This extraordinary $60M measure became necessary in large part because of the governor’s hostility toward evidence-based and effective interventions like universal masking in crowded indoor spaces and in classrooms.

The chains of transmission that end up infecting and hospitalizing mainly unvaccinated persons frequently start in crowded indoor environments where people aren’t wearing masks. The governor has prohibited cities and counties from imposing universal masking requirements.

Beginning September 29, he will also begin banning mask mandates in classrooms. He is already paying schools extra to jeopardize student health and safety if they DO NOT implement universal mask requirements.

Will Humble Disease Control, Early Childhood, Wills Blog

Even More Evidence that Universal K-12 Masking is Important for Keeping Kids Safe 

Analysis Finds that Universal Masking Reduces Classroom Transmission by 800%

A new study published in BMJ last week called SARS-CoV-2 aerosol transmission in schools: the effectiveness of different interventions found that universal masking in classrooms reduced aerosol transmission by 800%. Ventilation “… through the full opening of six windows all day during the winter reduces transmission by 14x“.

The combined interventions of universal masking, natural ventilation, and HEPA filtration) reduced transmission 3,000%. Sadly, we have a governor that is actually paying schools extra money to ignore CDC recommendations on universal masking knowing full well that his policy is jeopardizing student’s health and safety.

Results: The most effective single intervention was natural ventilation through the full opening of six windows all day during the winter (14-fold decrease in cumulative dose), followed by the universal use of surgical face masks (8-fold decrease).

One HEPA filter was as effective as two windows partly open all day during the winter (2.5-fold decrease) while two filters were more effective (4-fold decrease).

Combined interventions (i.e., natural ventilation, masks, and HEPA filtration) were the most effective (≥ 30-fold decrease). Combined interventions remained highly effective in the presence of a super-spreader.

______________________

New Evidence: 33% of COVID-19 Infections are Asymptomatic: Results Support School Testing/Masking/Ventilation

Asymptomatic SARS-CoV-2 infection: A systematic review and meta-analysis | PNAS

By analyzing over 350 papers in this systematic review, the researchers found that more than one-third of infections are truly asymptomatic. The review found more asymptomatic infections among kids and fewer among older folks and people with underlying health conditions.

These results suggests that heightened vigilance is needed in schools (e.g. masking and testing) to prevent spillover into the broader community.

____________________________

Outbreak Associated with SARS-CoV-2 B.1.617.2 (Delta) Variant in an Elementary School | MMWR (cdc.gov)

Conclusion: Vaccines are effective against the Delta variant, but transmission risk remains elevated among unvaccinated persons in schools. In addition to vaccination, strict adherence to multiple nonpharmaceutical prevention strategies, including masking, are important to ensure safe school instruction.

Governor Ducey will have absolutely no interest in these new findings, as the results don’t support his pre-existing belligerence toward mitigation measures in schools.

Will Humble Uncategorized, Wills Blog

Congress Should Seize the Day and Finally Pass Popular Drug Pricing Reform 

It’s no secret that we’re living through a particularly heated period in American politics, and Arizona is a perfect example of the partisan divide facing the nation. In the 2020 presidential election, the Grand Canyon State was decided by a mere 10,475 votes, or 0.3 of a point, transforming political spectators across the country into Arizona election law experts and avid consumers of Maricopa County polling data.

However, drug pricing reform has cut through the thick partisan atmosphere and emerged as a rare subject of agreement between Republicans and Democrats.

Voters across the country are pushing back against the absurdly high cost of drugs with a uniquely unified voice. In our current political landscape, issues are often divided strictly along party lines, and arguments are neatly packaged into quippy talking points to be posted on Facebook and Twitter.

However, even the brutal rhetoric clogging social media and the war of words between partisan politicians have proven ineffective at dividing everyday Americans struggling to afford their medications.

It’s not just national polling numbers skewed by dark blue states that prove voters are simply sick and tired of paying a premium for their prescriptions. Even in the country’s most divided states, support for lowering the cost of drugs has incredible support across the political spectrum.

One recently released survey found that a majority of voters in key battleground states, including Arizona, support drug pricing reform. Remarkably, the survey found that eighty-seven percent of Arizona voters support allowing Medicare to negotiate with drug companies for lower prices.

This data isn’t just some blip on the radar or a result of poor polling — it’s the culmination of decades-long abuse suffered by the American public at the hands of drug giants. Over the years, the pharmaceutical industry has artificially inflated the cost of prescription drugs and passed those prices onto consumers looking to fill their prescriptions.

A recently released report demonstrated that the price of prescription drugs has skyrocketed at double the rate of inflation, spiking the cost of healthcare for the 66% of Americans who have to fill at least one prescription.

While the price of drugs is a major issue nationally, the effects of the high cost of medications are felt acutely here in Arizona, where over nine billion dollars were spent in 2019 alone on prescription drugs and over two million Arizonans reported they didn’t seek treatment for a health problem due to the cost.

Recently, politicians have finally started to listen to their constituents – making efforts to lower the cost of drugs. During the last administration, a flurry of reform bills flew around the Senate, including a bipartisan bill co-sponsored by Arizona Senator Kyrsten Sinema.

Drug pricing reformers have been buoyed by recent remarks from President Biden, who asked his colleagues in Congress to prioritize drug pricing reform.
Achieving prescription drug pricing reform (allowing Medicare to negotiate drug prices) has been out of reach for decades because the drug company lobby is so powerful that meaningful reform has been impossible.

It looks like there is finally a critical mass of support in Congress and the President to deliver widely supported reform. However, any meaningful movement on the drug pricing reform front will require the support of Kyrsten Sinema.

In the past, Senator Sinema has proven herself to be a maverick of her own in the Senate, working tirelessly to promote policies popular with both red and blue voters, and in the coming months, she’ll have the opportunity to unite Republicans and Democrats in Arizona and across the country by delivering relief to those suffering from high prescription prices.

The time is now for drug pricing reform, specifically, allowing Medicare to finally negotiate drug prices. Senator Sinema has a chance to continue leading on issues that are best for Arizona and the Country and we applaud her for doing so.

Will Humble is the Executive Director for the Arizona Public Health Association and former Director of the Arizona Department of Health Services.

Will Humble Uncategorized

Finally, A President Decides to Tackle Unreasonable Prescription Drug Prices

It’s no secret that prescription drug prices in the U.S. are far higher than in other countries and that the current system costs taxpayers, insurance plans and people far more than it should. A huge barrier has been language in the Medicare law that prevents HHS from directly negotiating drug prices under the Medicare Part D drug benefit program. 

Achieving prescription drug pricing reform (allowing Medicare to negotiate drug prices) has been out of reach for decades because the drug company lobby is so powerful that meaningful reform has been impossible.

That may be changing. A few weeks ago President Biden held a press conference where he advocated large changes to what prices drug companies can charge. His plan is included in the next infrastructure bill that’s being discussed in congress.

He proposes to FINALLY allow Medicare (the biggest buyer of drugs by far) to negotiate drug prices with the drug manufacturers. Unbelievably, Medicare has never been able to negotiate drug prices. How would you like it if you could never comparison shop for anything you buy. You’d just have to pay whatever the one store that sells it says. Period.

Well, it’s already that way for us as a country- Medicare has to just basically pay whatever the company says (and we. the people, pick up the tab).

The US House of Representatives has already passed a measure called “H.R. 3, the Lower Drug Costs Now Act of 2019” which would require HHS to negotiate the price of between 25-125 brand-name drugs without generic competitors. That negotiated price would be available Medicare, Medicaid and private payers. Importantly, HR 3 also provides some negotiating leverage to HHS.

For one thing, it would establish an upper limit for the negotiated price equal to 120% of the Average International Market price paid by Australia, Canada, France, Germany, Japan, and the UK.

It would impose financial penalties on drug companies that don’t comply with the negotiating process. Manufacturers that fail to negotiate would face an escalating excise tax on the previous year’s gross sales of the drug in question, starting at 65% and increasing by 10% every quarter to a maximum of 95%.

President Biden’s plan goes further than H.R. 3 by allowing Medicare to negotiate drug prices across the board, not just on 25–125 drugs.

He proposed allowing Medicare to negotiate a fair drug price for all drugs – including the costs of the research and development and a reasonable profit. Drug companies could then only set prices based on the rate of inflation after it’s determined how much they’ve invested and what a reasonable profit constitutes.

Once Medicare negotiates a lower drug price, employer-based plans would get access to the same drug for the same price as Medicare.

This is a common sense intervention that would help both Medicare beneficiaries and the Medicare Trust Fund. Let’s hope that there’s finally enough support in congress to pass this long needed reform.

Will Humble Disease Control, Vaccination

Booster Shots for All to be Considered by the Advisory Committee for Immunization Practices Next Week

The FDA revised the Emergency Use Authorization for the Pfizer and Moderna vaccines to include a booster shot for persons that are immunocompromised on August 12. The CDC’s Advisory Committee for Immunization Practices met the next day (here are the meeting materials) and unanimously voted to recommend an extra dose of Covid-19 vaccine for some immunocompromised people. Director Wilensky immediately signed off on the recommendation. That recommendation will cover about 7 million Americans.

Last week, statements were leaking out of the White House suggesting that persons in the White House would like to see booster shots available to all Americans US to Advise Booster Shots for Most Americans 8 Months After Vaccination.

Those leaks were followed up by remarks made simultaneously by Surgeon General Murthy, Anthony Fauci, and Director Wilensky, suggesting that this is a coordinated effort to make vaccine recommendation policy at the top rather than the normal process of listening to the Advisory Committee for Immunization Practices and learning about the evidence base before recommending vaccines.

Recommendations for booster shots are supposed to start with an approval or EUA from the FDA followed by an in-depth review by the  CDC’s Advisory Committee on Immunization Practices. That group is supposed to conduct a thorough evidence review including a GRADE assessment of the evidence, meet, deliberate, and vote on whether to recommend boosters for all. That recommendation would then go to the CDC director for consideration.

Top officials expressed their support for universal boosters before the ACIP met and before a full an evidence review was even done, basically making policy by press release rather than by using evidence.

It’s also critically important for them to consider the fact that the developing world has largely not had access to vaccine yet. In fact, 10% rich countries have administered 90% of all global vaccines. Administering 200M more vaccines to Americans that already have very good protection would take 200M doses out of the global supply chain that could be used in developing countries.

It also reinforces the feedback loop in which the vaccine manufacturers focus business model and manufacturing capacity on selling boosters to rich countries rather than ramping up production for COVAX.

Read this opinion piece in the Washington Post this week (which I agree with): Why the Biden administration’s recommendation on booster shots is a mistake:

This decision is a mistake. Not only does it risk depriving millions throughout the world of the vaccine, but there also is no evidence that additional shots meaningfully reduce death or hospitalization from covid-19 for healthy Americans. Far better would be to wait for solid trial data on booster shots.

High-income countries have used bilateral contracts with vaccine manufacturers to achieve vaccination rates as much as 50 times that of low-income countries. A campaign for boosters could lock in that apartheid. This profound global inequity would not only be a humanitarian disaster, but also a significant long-term risk for Americans, as scientists agree that accelerating global vaccination is the only way to prevent the formation of deadly new variants.

The booster for all Americans isn’t official policy yet. The CDC is at least officially waiting for ACIP to meet on August 30-31 to make the policy recommendation. Hopefully there will be a full evidence review by the 30th. But the fact that this policy was announced well in advance of ACIP means to me that this is a railroad job.

Will Humble Public Health Law

City of Phoenix Joins the Crowd Suing the State (Governor)

The city of Phoenix sued Arizona last week, correctly arguing that the Legislature & Governor folded dozens of provisions into a state budget bill which is a violation of the State’s constitution.

This new suit filed in Superior Court also focuses on the “single subject rule”.  The Arizona Constitution lays out a transparent process where bills must mean what they say. Budget bills have to be about the budget and substantive, general legislation has to be about one subject at a time. This ensures that proposed laws are debated and voted on only with other provisions that relate to them—rather than buried among countless other provisions.

This suit is making similar arguments as the one filed by the Arizona School Boards Association et.al (see: School Mask Bans: Injunctive Relief on the Way). When successful, these suits will not only reverse the harmful restrictions on school districts but they may also  unravel the entire FY 22 state budget because the budget bills violate the state constitution’s single subject requirements.

Will Humble Disease Control, Public Health Law

Court Concludes that Ducey’s Anti Universal School Masking Law Isn’t Effective Until September 29

Judge Randall Warner in Maricopa Superior Court ruled last Monday that the budget bill that the governor signed designed to prohibit public schools from implementing a universal masking doesn’t kick in until September 29. That ruling makes it crystal clear that school districts and charter schools can implement a universal masking policy at least up until September 29.

That ruling came out of the case in which a vocational-technical teacher sued the Phoenix Union HS District over their universal masking policy.

Still to be resolved is whether the prohibition is constitutional. That question will be tested in a legal complaint in Superior Court 10 days ago asking for Injunctive Relief on the portions of the health and K-12 budget bills that prohibit school districts from implementing universal masking policies.

That lawsuit (filed by the Arizona School Boards Association et.al.)  rightly points out that the legislature passed, and the governor signed three budget bills (HB 2898, SB 1824, and SB 1825) that “… include substantive policy provisions that have nothing to do with the budget” in direct violation of the state constitution.

I’m sure that the courts will hear and at least partially rule on the question of constitutionality before September 29 arrives.

Will Humble Disease Control, Public Health Law, Vaccination

Governor Tries to Prevent Cities & Counties from Mandating Vaccine for their Employees

In addition to the jaw dropping anti-school kid executive orders, Ducey also issued an Executive Order designed to stop cities from requiring their employees to get vaccinated. That EO, called E.O. 2021-18  says that:

  • Any county, city, town or political subdivision official that implements a vaccine mandate is in violation of A.R.S. 36-114 and 36-184 and such actions are punishable by a class 3 misdemeanor and subject to legal action by individuals for violation of their rights under Arizona law.

The state budget included a provision that prevents political jurisdictions from requiring vaccines of their staff, but that law doesn’t take effect until September 29 (Valleywise Health was exempted from that statute).

So, the governor decided to try to make it effective immediately. His executive orders refer to statures that have been on the books for decades that aren’t specific to vaccines. It may or may not apply to staff vaccine requirements:

ARS 36-114: Nothing in this title shall authorize the department or any of its officers or representatives to impose on any person against his will any mode of treatment, provided that sanitary or preventive measures and quarantine laws are complied with by the person. Nothing in this title shall authorize the department or any of its officers or representatives to impose on any person contrary to his religious concepts any mode of treatment, provided that sanitary or preventive measures and quarantine laws are complied with by the person.

The City of Tucson already requires city employees to get the COVID vaccine (with exceptions) or face some financial consequences. Whether the courts will enforce ARS 36-114 to stop that policy decision remains to be seen.

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