Will Humble Vaccination, Wills Blog

Pfizer Vaccine May Be Available for Kids 5-11 by Halloween

Pfizer Announces Positive Topline Results of COVID-19 Vaccine in Children 5 to 11

Pfizer and BioNTech issued a press release suggesting that their Phase 2/3 trial in kids 5 to 11 years old showed a “favorable safety profile and robust neutralizing antibody response” in children 5 to 11 years of age. Their trial used a two-dose regimen of 10 µg administered 21 days apart (1/3 of the dose that’s in the adult vaccine).

Because their vaccine already demonstrated clinical effectiveness in the first trial, they did the study a little differently- focusing on the antibody titer that the vaccine stimulated (rather than comparing the number of persons that contracted COVID-19 in the vaccine and placebo groups).

They say that the antibody responses in the participants given 10 µg doses were comparable to those recorded in a previous Pfizer-BioNTech study in people 16 to 25 years of age that got the 30 µg doses.

There were 2,268 participants in the trial. The SARS-CoV-2–neutralizing antibody geometric mean titer (GMT) was 1,197.6 (95% confidence interval [CI, 1106.1, 1296.6]), demonstrating strong immune response in this cohort of children one month after the second dose.

“This compares well (was non-inferior) to the GMT of 1146.5 (95% CI: 1045.5, 1257.2) from participants ages 16 to 25 years old, used as the control group for this analysis and who were administered a two-dose regimen of 30 µg. Further, the COVID-19 vaccine was well tolerated, with side effects generally comparable to those observed in participants 16 to 25 years of age.”

The company has submitted the data for peer review and will be asking FDA for EUA shortly. If they do submit the data quickly as promised, the FDA could make that EUA by mid-October, giving parents of elementary school kids an opportunity to vaccinate their progeny before Halloween.

Will Humble Wills Blog

Annual AzPHA Public Health Awards: Accepting Nominations Now!

Public health professionals and health care workers across Arizona are performing extraordinary services to our community in the midst of the coronavirus.

Please take a few minutes to share those stories and others so that we may recognize them appropriately at our 2021 Arizona Public Health Awards to be held November 9th from 5 – 8:30 pm at the University Club (39 E. Monte Vista Road) in Phoenix.

It will be an outdoor, happy hour event. Tickets will be $40 per person. We expect to begin registration in October.

Please take a moment to view our award  categories and submit your entries by October 15, 2021

Nominate Here!

View Our Past Award Winners
Will Humble Disease Control, Public Health Law, Vaccination, Wills Blog

Unvaccinated Adults Packing AZ Hospital ICU’s – COVID-19 Patients Now Occupy 30% of All ICU Beds

Takeaways:
  • Slow Decline in New Cases Continue
  • Hospital Influx Moderating but Rural Hospitals Unable to Transfer Patients as ADHS is Unwilling to Open Surge Line
  • Mid September Deaths Now Exceed 300/Week
View the Full Report
Weekly Report Introduction by Dr. Gerald:
Case counts continue to trend down slowly in most places with Yuma being the first county to fall below the threshold marking high transmission, <100 cases per 100K residents per week. Although still absurdly high, test positivity is receding following the Labor Day disruption in testing patterns.
Hospital occupancy has finally begun to drop off its plateau but available occupancy (excess capacity) remains on a razor thin margin. Rural hospitals are complaining about not being able to transfer their patients to urban centers. There’s just not much slack in the system and our ability to respond to any new threat is compromised. Let’s just hope we don’t find out the hard way.
Arizona’s judiciary is poised to rule on the governors’ and legislature’s attempts to prevent schools from requiring masking.  New data was released in the MMWR this week, some from ASU/MCDPH/PCHD confirms what we already suspected/knew – fewer outbreaks occur in schools requiring masks compared to those that do not.  Good data from local and national sources bear this out.
In an important reversal of my prior communication, it looks like COVID-19 deaths will almost certainly reach 300 deaths per week the week ending September 5th (already at 280) and/or September 12th (already at 218).  I just wasn’t patient enough to allow death notifications to make their way through the system.
The big news this week is that the FDA advisory panel on vaccines recommended Pfizer third dose boosters for those 65+ or at high risk but the CDC director over-ruled her advisory panel and recommended occupation as reason among those younger than 65.
Everyone is weighing in on this so I might as well. I support the FDA and CDC advisory committees’ original recommendations and think the CDC Director erred in over-ruling them. Use of executive privilege in these situations is becoming all too common and panders to the extremes no matter which party’s appointee does it. One of the potential benefits of advisory committee decisions is that they are at least somewhat insulated from political considerations, not that they always get it right.
Will Humble Disease Control, Early Childhood, Public Health Law, Wills Blog

New CDC MMWR Shows that Governor Ducey’s Hostility Toward Universal Classroom Masking is Causing Kids to Get Sick & Miss School

CDC MMWR: Association Between K-12 School Mask Policies and School-Associated COVID-19 Outbreaks in Maricopa and Pima Counties, July – August 2021

More evidence was published today in a new CDC MMWR showing that Governor Ducey’s hostility toward universal classroom masking is causing kids to get sick and miss out on in-person learning. Researchers from ASU, CDC and the Maricopa and Pima County health departments found that schools without a mask requirement were 350% more likely to have a COVID-19 outbreak than schools with a mask requirement in place at the start of school year.  

The team examined COVID-19 outbreak data among 999 K-12 public, non-charter schools in Maricopa and Pima Counties during the first six-weeks of the school year from July 15 to August 31, 2021.  After controlling for grade levels, enrollment size, Title 1 status, county school location & COVID-19 community case rates, schools without a mask requirement were 350% more likely to have an outbreak than schools that had a mask requirement in place at the start of the school year.

Among the 999 schools, 21% had a mask requirement when school started, 31% implemented a mask requirement a median of 15 days after school started and 48% had no mask requirement during the entire time period.  

Of the 191 school-associated outbreaks in July and August, almost 60% occurred in schools without a mask requirement. Only 8% occurred in schools with a mask requirement in place at the start of the school year. About 1/3 of outbreaks occurred in schools with mask requirements implemented later in the year.

From the Report:

“In the crude analysis, the odds of a school-associated COVID-19 outbreak in schools with no mask requirement were 3.7 times higher than those in schools with an early mask requirement (odds ratio [OR] = 3.7; 95% CI = 2.2–6.5). After adjusting for potential described confounders, the odds of a school-associated COVID-19 outbreak in schools without a mask requirement were 3.5 times higher than those in schools with an early mask requirement (OR = 3.5; 95% CI = 1.8–6.9).”

“In the two largest Arizona counties, with variable K–12 school masking policies at the onset of the 2021–22 academic year, the odds of a school-associated COVID-19 outbreak were 3.5 times higher in schools with no mask requirement than in those with a mask requirement implemented at the time school started. Lapses in universal masking contribute to COVID-19 outbreaks in school settings; CDC K–12 school guidance recommends multiple prevention strategies. Given the high transmissibility of the SARS-CoV-2 B.1.617.2 (Delta) variant, universal masking, in addition to vaccination of all eligible students, staff members, and faculty and implementation of other prevention measures, remains essential to COVID-19 prevention in K–12 settings.”

Fortunately, courageous school districts have challenged the constitutionality of Governor Ducey’s prohibition of universal masking requirements in public schools, scheduled to kick in next Wednesday. Judge Katherine Cooper from the Maricopa County Superior Court heard the lawsuit filed by a coalition of organizations including the Arizona School Boards Association, the Children’s Action Alliance, the Arizona Education Association, and the Arizona Advocacy Network See the Complaint.

The suit asks the court for Injunctive Relief on the portions of the health and K-12 budget bills that prohibit school districts from implementing universal masking policies. The action 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.

Regardless of how Cooper rules in the coming days, the case will be quickly appealed to the Arizona Supreme Court. I expect a Preliminary Injunction stopping the implementation of Ducey’s harmful policy will be issued pending a final ruling on the merits of the case.

The case has far-reaching implications. If the court holds that the Budget Bills were unconstitutional because they violate the single subject requirement, then those aspects of the BRB that pertain to the case will need to be excised.

The court could even rule that the budget reconciliation bills (BRBs) are unconstitutional in their entirety, which would result in a special legislative session to draw up a new state budget for 2022.

It’s too bad that we’re stuck with a Governor that is so hostile to science and who cares so little about whether kids are safe and have a chance at in-person learning.

Will Humble Disease Control, Wills Blog

Rural Hospitals Ask Arizona Department of Health Services for Help with Patient Transfers

Interim Director Don Herrington Tells Them to Pound Sand

Representatives of rural county hospitals in Cochise, Santa Cruz, Pima and Yuma Counties sent ADHS Interim Director Don Herrington a letter this week urging him to help them by facilitating patient transfers from saturated rural hospitals to urban facilities. Rural hospitals are very different from large urban hospital systems in that don’t have sister hospitals to smooth out care to meet patient needs.

One of the few successful initiatives that former Director Christ implemented was the Surge Line, which helped rural hospitals’ ability to transfer patients to other facilities. The Surge Line was critically important during the July and December – February hospital crises’ (precipitated by Governor Ducey and former Director Christ’s poor decision-making and operational failures).

Yesterday, Don sent this letter to those rural hospital representatives telling them to ‘Pound Sand’:

“The capacity challenges facing hospitals in the Southern region are similar across all regions of the state. Due to the healthcare staffing shortages across the entire state limiting available beds across the healthcare system, expansion of the Arizona Surge Line to all patient transfers is not currently a viable option to improve patient transfers. As you’ve stated, the most immediate way to bolster capacity and improve patient outcomes in Arizona is to enhance staffing in hospitals across the state. This initiative is currently underway with over 70 nurses contracted through the Surge Staffing Initiative expected to start in Arizona this week and nearly 200 expected to start by the end of September. Contracting for additional nurses is ongoing.”

Astonishingly, Interim Director Herrington said “no” we will not help you with patient transfers. Furthermore, he suggested that the solution will come when “…70 nurses contracted through the Surge Staffing Initiative” arrive in the state.

Are you kidding me? 70 nurses over 3 shifts can cover like 70 ICU patients. He really thinks that bringing in 70 nurses is going to solve the problems of a saturated rural hospital system?

Furthermore, the letter throws another shiny mirror into the corner of the room by again promoting Regeneron (a monoclonal antibody treatment that is marginally effective in some people with high-risk conditions very early in their infection). The Regeneron reference is clearly included in the letter to throw a bone to the governor. Many right-wing governors hostile to vaccine requirements and masking are touting Regeneron as a solution to saturated hospitals.

Governor Ducey has hopped on that hay-ride big time, and now it appears that Interim Director Herrington has too.

Those of us that were hoping that the leadership change at ADHS was going to make a difference are losing faith fast. I’ve lost it.

Will Humble Climate Change, Wills Blog

Support Corporation Commission Clean Energy Rules: Call In To AZ Corporation Commission Town Halls this Week

The Arizona Corporation Commission is hosting three virtual town halls this week on Tues., Sept. 21st; Wed., Sept. 22nd; and Sat., Sept. 25th to get input from stakeholders about their pending Clean Energy Rules and a recent report (the “Ascend Report”) that analyzed the costs of them.

If finalized later this fall, the Clean Energy Rules will modernize Arizona’s outdated policies for clean energy by enacting new requirements for APS and TEP to deliver 100% carbon-free electricity; expand programs that help customers save energy and money; and issue competitive bids as they invest in a growing power system.

The Ascend Report put its thumb on the scales against clean energy by relying on the utilities to conduct the modelling; failing to consider early closure dates for expensive, uneconomic coal plants; assuming gas to be the cheapest option, when in reality it is not; using inflated costs for wind, solar, and battery storage; and ignoring the many benefits of clean energy.

If the report is allowed to stand unquestioned, it could influence the Commission’s final vote to adopt the Clean Energy Rules or not. And, if regulators fail to adopt the Rules, Arizona will miss out on new jobs and economic development opportunities, as other states in the region adopt far more aggressive policies that hasten their transition away from fossil fuels and to clean energy.

While the Commission is hosting these town halls to take public comment on the report, it is also an opportunity to let Commissioners know how much you support clean energy and why they should act immediately to adopt the Rules. This moment is crucial, and your input could influence what Commissioners decide to do!

Tues., Sept. 21 at 6 p.m.

Join via Zoom:https://azcc.zoomgov.com/j/1619423958?pwd=cytTZlFJLzNDa2Eyb0ltRXFnVWxxdz0

Passcode: 439386
Webinar ID: 161 942 3958

 

Wed., Sept. 22 at 6 p.m.

Join via Zoom:
https://azcc.zoomgov.com/j/1611208892?pwd=UGhITFUwR2IrblZOM2JoNUJOdXR6QT09
Passcode: 183367
Webinar ID: 161 120 8892

Join via Telephone:
833-568-8864 (Toll Free)

Sat., Sept. 25 at 1 p.m.

Join via Zoom:
https://azcc.zoomgov.com/j/1612841002?pwd=TGdnUm1vdnh4WjdlelBQTG4wYlY3dz09
Passcode: 335983
Webinar ID:161 284 1002

Join via Telephone:
833-568-8864 (Toll Free)

ACC Here’s Info for You to Use to Inform Your Comments. Comments are limited to three minutes each. The attached document gives you pointers on key elements you can comment on.
Will Humble Climate Change, Wills Blog

The Next Few Weeks are Critical for Addressing Climate Change

President Biden built a $150 billion clean-energy plan into the Build Back Better initiative. The $150B investment will wean the U.S. power grid off carbon-based fuels by 2035. The plan would reduce the use of coal and natural gas substituting non carbon sources.

The idea is to use financial incentives to make non carbon fuels lower cost- driving the energy production market toward greener sources of energy. For example, energy suppliers would be eligible for grants if they increase the amount of clean electricity supplied to customers by 4% compared with the previous year.

Other highlights of the plan before congress include funding electric-grid improvements, decarbonizing federal buildings and vehicle fleets, providing home and appliance efficiency rebates, and subsidizing solar projects in low-income communities.

The plan is part of the larger budget reconciliation package working its way through congress. Budget reconciliation bills only need a majority in the Senate, rather than the usual 60 votes needed to break a filibuster. An open question is whether all Democratic members of the Senate will vote for the package- and specifically the energy efficiency and non-carbon energy source portions of the package.

AzPHA participated in this press conference last week with a main goal of letting Senators Sinema and Kelly as well as Representative O’Halloran the importance of making sure that the green portions of the budget reconciliation package make it into the final budget. Here’s the story in the Republic about that presser:  Arizona advocates urge Congress to address climate change.

Will Humble Vaccination, Wills Blog

FDA Committee Recommends Pfizer Booster for Seniors; Committee Declines to Recommend Universal Boosters

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) met to discuss Pfizer-BioNTech’s supplemental Biologics License Application for administration of a third dose, or “booster” dose, of the COVID-19 vaccine for all persons 16 years of age and older last Friday.

The staff of the FDA declined to take a stance on whether to back booster shots of Pfizer’s Covid-19 vaccine in their report to the VRBPAC, saying U.S. regulators haven’t verified all the available data.

Pfizer’s application to amend their license for their vaccine was based on observational data from Israel rather than actual clinical trials or studies. FDA staff said observational studies have suggested declining efficacy of the Pfizer vaccine over time against symptomatic infection while others have not.

The committee (VRBPAC) voted 16-2 to NOT recommend amending Pfizer’s vaccine license to include a 3rd booster shot for all populations. Later that afternoon, the Committee voted to recommend that the Commissioner add and Emergency Use Authorization (not approval) for the booster in folks 65+ and those with medical conditions that put them at substantial risk.  That recommendation was largely symbolic, as clinicians can already use the Pfizer vaccine off-label.

The CDC’s Advisory Committee for Immunizations Practices will likely meet next week to decide whether to recommend the booster to the elderly and those with medical conditions that put them at risk. At some point, the ACIP will need to meet and make a recommendation for persons that had the Janssen & Moderna vaccines (regarding boosters). Clinicians and patients increasingly have questions about whether elderly persons that got the Janssen vaccine get a Pfizer booster.

Editorial Notes: Another global health equity is at play when it comes to routinely providing booster shots with little if any clinical benefit when persons in the developing world haven’t even had an opportunity to get a single dose yet. For example, only 1.3% of persons in Africa have been vaccinated. Even if FDA ends up approving the Pfizer booster, the CDC and ACIP should examine those global health equity issues before recommending a booster to already protected Americans, when those doses could and should go to developing nations.

I believe that the Biden Administration learned (or should have learned) an important lesson this week. Several weeks ago the Surgeon General and the CDC and NIH Directors expressed full-throated support for universal boosters before data supported that decision. As we saw last week, that support was not only premature, but it short-circuited the normal approval process. 

Will Humble Public Health Law, Vaccination, Wills Blog

Brnovich Files Bogus Lawsuit Challenging Non-existent Regulations

Last week Attorney General Brnovich filed a ‘lawsuit’ in federal court challenging Biden’s announcement that he is asking OSHA to issue an emergency rule requiring employers with more than 100 staff to make sure their team is vaccinated or undergo weekly testing.

The thing is that OSHA hasn’t even proposed the regulation yet!

Nevertheless, the Brnovich filed the lawsuit to challenge a NONEXISTANT regulation! If he were interested in changing public policy regarding vaccine mandates, he would have waited to file a suit until OSHA promulgates a rule.

Of course, his goal wasn’t to influence policy…  his purpose was to get the attention of the bookers on FOX News and Newsmax and get him on national television – where his Republican primary voters reside. Arizona Attorney General Mark Brnovich sues over Biden vaccine rules

In that sense, Mission Accomplished.

Will Humble Disease Control, Vaccination, Wills Blog

FDA Committee Recommends Pfizer Booster for Seniors; Committee Declines to Recommend Universal Boosters

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) met to discuss Pfizer-BioNTech’s supplemental Biologics License Application for administration of a third dose, or “booster” dose, of the COVID-19 vaccine for all persons 16 years of age and older last Friday.

The staff of the FDA declined to take a stance on whether to back booster shots of Pfizer’s Covid-19 vaccine in their report to the VRBPAC, saying U.S. regulators haven’t verified all the available data.

Pfizer’s application to amend their license for their vaccine was based on observational data from Israel rather than actual clinical trials or studies. FDA staff said observational studies have suggested declining efficacy of the Pfizer vaccine over time against symptomatic infection while others have not.

The committee (VRBPAC) voted 16-2 to NOT recommend amending Pfizer’s vaccine license to include a 3rd booster shot for all populations. Later that afternoon, the Committee voted to recommend that the Commissioner add and Emergency Use Authorization (not approval) for the booster in folks 65+ and those with medical conditions that put them at substantial risk.  That recommendation was largely symbolic, as clinicians can already use the Pfizer vaccine off-label.

The CDC’s Advisory Committee for Immunizations Practices will likely meet next week to decide whether to recommend the booster to the elderly and those with medical conditions that put them at risk. At some point, the ACIP will need to meet and make a recommendation for persons that had the Janssen & Moderna vaccines (regarding boosters). Clinicians and patients increasingly have questions about whether elderly persons that got the Janssen vaccine get a Pfizer booster.

Editorial Notes: Another global health equity is at play when it comes to routinely providing booster shots with little if any clinical benefit when persons in the developing world haven’t even had an opportunity to get a single dose yet. For example, only 1.3% of persons in Africa have been vaccinated. Even if FDA ends up approving the Pfizer booster, the CDC and ACIP should examine those global health equity issues before recommending a booster to already protected Americans, when those doses could and should go to developing nations.

I believe that the Biden Administration learned (or should have learned) an important lesson this week. Several weeks ago the Surgeon General and the CDC and NIH Directors expressed full-throated support for universal boosters before data supported that decision. As we saw last week, that support was not only premature, but it short-circuited the normal approval process. 

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