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.

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.

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.

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.

Governor Takes Direct Aim at School Health & Safety

EXECUTIVE ORDER PAYS SCHOOLS EXTRA TO JEOPARDIZE STUDENT HEALTH & SAFETY

Just when you thought you’d seen the limits of the governor’s poor decision-making, he goes a step further. Last week he went so far as to provide financial incentives for K-12 schools to ignore CDC COVID mitigation recommendations.

In a second Executive Order, he offers $7K per pupil in federal money to families that live in districts following CDC mitigation measures.

Let’s start with the school bribery scheme. In that E.O. the governor offers to increase per pupil funding by $1,800 per year for schools that ignore CDC mitigation measures (universal masking).

Only schools that haven’t already received $1,800 per pupil federal pandemic funds qualify, so many districts (including Phoenix Union High School District) couldn’t qualify for the extra money even if they were ignoring CDC mitigation (which is what the governor desires). Schools ignoring CDC’s universal masking recommendation  qualify for the difference between $1,800 per pupil and whatever they have already received.

Just think about this. He is actually paying schools extra to jeopardize student’s health by ignoring CDC mitigation measures. Amazing.

Here’s the list of schools that qualify for at least some of the $1,800 per pupil assuming they ignore CDC mitigation measures. Note that not a single school could qualify for the $1,800 per capita.

Now on to the scheme where parents get $7,000 ‘cash on the barrelhead’ if they live in a district that is following CDC mitigation measures and they don’t want to send their kid there because of that. Perhaps Chris Kotterman (@mrkotter) from the Arizona School Boards Association said it best on Twitter last week:

“If your school district is following @CDCgov guidance to reduce the spread of COVID, here is $7,000 of federal COVID relief money to send your child to a place where they do not do that.”

Interestingly, the free cash is only available to families that have an income less than 350% of poverty or about $66K per year. My guess is that limitation is because of some provision in the Rescue Act funding, otherwise I would expect this governor to have no income limit so that his wealthy patrons could get free cash too.

US Treasury and Education Departments Push Back

Less than 24 hours after the governor outlined his scheme by Executive Order, the US Departments of Treasury and Education pushed back, suggesting that Ducey’s move is an inappropriate use of American Rescue Plan Act funds (the federal dollars to states flow through those federal agencies). Here’s the statement from Treasury:

“No state should use federal funds to prevent or discourage schools from using evidence-based approaches to stopped the spread of Covid-19,” a Treasury spokesperson said. “Treasury is monitoring all proposed expenditures and expects any state or local government that uses State and Local funds in violation of the eligible uses to repay the misused funds to the federal government.”

Likewise, the U.S. Department of Education read the governor the riot act in this letter to Ducey:

“Arizona’s actions to block school districts from voluntarily adopting science-based strategies for preventing the spread of COVID-19 that are aligned with the guidance from the Centers for Disease Control and Prevention (CDC) puts these goals at risk and may infringe upon a school district’s authority to adopt policies to protect students and educators as they develop their safe return to in-person instruction plans required by Federal law.”

“The Department recognizes that several LEAs in your State have already moved to adopt such policies in line with guidance from the CDC for the reopening and operation of school facilities despite the State-level prohibitions. The Department stands with these dedicated educators working to safely reopen schools and maintain safe in-person instruction.

Note: The governor better be careful here. He is playing with federal funds and dealing with an administration that is committed to evidence based public health practice (unlike himself). Because the federal government holds the purse strings, they can punish the governor in different ways, just as the governor tries to punish schools and students.

Dr. Gerald’s Latest Analysis: Infection Rates Among Children Accelerating

Mixed news this week. There are suggestive indicators that transmission has moderated among adults this week but transmission among children continues to increase. In a complete reversal, case rates among those 5 – 15 are poised to exceed those of all other age groups. In fact, rates among those 5 – 9 years are at 93% of their prior pandemic peak while rates among those 10 -14 are at 89% of their prior pandemic peak.

No question that resumption of K – 12 in-person instruction in the presence of Delta is driving it. Governor Ducey’s response continues to be, “rub some dirt on it.”

With 979,580 confirmed COVID-19 infections, I’m surprised the state hasn’t yet offered a $1 million reward for the 1 millionth customer. Unless someone in marketing gets on this soon, it will be a missed tourism opportunity.

VIEW THE FULL REPORT

School Mask Bans: Injunctive Relief on the Way

A coalition of organizations including the Arizona School Boards Association, the Children’s Action Alliance, the Arizona Education Association, and the Arizona Advocacy Network filed a legal complaint in Superior Court late Thursday asking 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.

Below is a guest blog from AzPHA member James G. Hodge, Jr., J.D., LL.M., the Peter Kiewit Foundation Professor of Law and Director, Center for Public Health Law and Policy, Sandra Day O’Connor College of Law, Arizona State University that explains the suit.

________________________________________

ARIZONA SCHOOL BOARD ASSOCIATION V. STATE OF ARIZONA

James G. Hodge, Jr., J.D., LL.M.

In a Complaint filed on August 12, 2021 in Arizona School Board Association v. State of Arizona with the Arizona Superior Court – Maricopa County, multiple litigants challenge legislative provisions prohibiting public health interventions to tamp down COVID-19 infections in Arizona’s K-12 schools and universities. In addition to the Association, litigants include advocacy organizations, state legislators, educators, doctors, and parents interested in “ensuring that the Legislature complies with its constitutional obligations and that Arizonans are safe in their educational and work environments.”

Contrary to a case brought earlier this month by a teacher challenging Phoenix Union High School District’s mask mandate, the parties allege the state legislature and Governor have unconstitutionally attempted to prohibit masks and vaccinations through multiple legislative provisions passed in violation of: (1) Arizona’s “single-subject rule” (Ariz. Const. Art. IV, pt. 2, § 13) and (2) students’ rights to equal protection (Ariz. Const. Art. II, § 13 ).

Single-subject rule

The single subject rule requires any state bill passed in Arizona to focus on a specific subject described in the title of the bill itself. Consequently, bills may not include topics tacked on in such a way as to muddle the legislative objectives or inhibit democratic processes. The litigants claim that several budget reconciliation bills (“BRBs”) (HB 2898, SB 1819, SB 1824, and SB 1825) passed during the summer 2021 violate this rule by imbedding “substantive policy provisions that have nothing to do with the budget.”

In a well-documented argument, they allege that state legislators knowingly added mask mandate prohibitions, COVID-19 vaccination and passport limitations, local government restrictions, and other provisions to BRBs with no plausible connection to the title or purpose of the bills. Several legislators allegedly sought to add questionable provisions that failed to pass in other bills. If true, the tacked on provisions may be struck from the larger BRBs signed by the Governor.

The public health and political stakes are high. With reports of rising  COVID infections across the state, and outbreaks and closures within Arizona (and other states’) schools, multiple K-12 districts and Arizona universities are currently implementing mask mandates. Over 2 dozen state legislators have recently described the situation as “anarchy.” Litigants suggest the legislature has “[n]ever before . . . so ignored the normal process and procedure for enacting laws,” but prior BRBs passed in Arizona have survived similar arguments, perhaps on less obvious grounds.

Equal protection

Litigants also allege that HB 2898 prohibiting K-12 public and charter schools (but not private schools) from instituting mask mandates discriminates against public and charter school students in violation of equal protection principles. They ask the court to strictly scrutinize the legislature’s ban on grounds it interferes with students’ fundamental rights to education.

As the court awaits the State’s formal response to the Complaint and schedules hearings, it faces the question whether provisions in the BRBs are in fact unconstitutional. If so, the litigants seek an immediate temporary injunction ceasing enforcement of such provisions after their effective date in late September.

School-based Testing is Important & Free: Get Your School With the Program!

Ideally we’d have a governor and health department director that support evidence-based interventions to prevent COVID-19 infections in K-12 schools while maximizing the chance for in-person instruction by supporting CDC’s Guidance for COVID-19 Prevention in K-12 Schools.

Sadly, that’s not the deck that Arizona voters dealt us. We’ve been dealt a hand that includes a governor who is actively hostile toward universal indoor K-12 masking and a health director unwilling to push back.

That doesn’t mean schools are helpless. Identifying COVID cases early and removing infected kids and their unvaccinated close contacts can prevent cascades of classroom cases and improve the chances for in-person school.

A key to making that happen is school-based testing. Fortunately, classroom COVID testing will be much easier this fall because of the American Rescue Plan Act.  Arizona received $219M CDC to pay for voluntary COVID-19 testing in schools at no cost to schools.

These federal funds allow schools to do both diagnostic testing of symptomatic kids and staff and surveillance screening testing to help schools identify infected individuals without symptoms so they can take action to prevent further transmission.

Pooled Testing

Thanks to the Rescue Plan Act schools can implement routine ‘pooled testing’ of asymptomatic kids for free, including administrative and technical support.

Here’s how it works. The free technical support team comes to the school and coordinates the sampling. Samples from multiple students in the same classroom are combined and taken to a Sonora Quest Lab’s main facility in Phoenix. The pooled specimen is analyzed the same day as collection (using PCR).  Results are available in less than 24 hours. If the test is negative, all students in the pool are presumed negative and no further action is necessary.

If the pooled test is positive, students in the positive pool are tested the next morning using the BinaxNOW 15-minute antigen test to determine which student is positive.

The biggest “game-changer” for schools that use pooled testing is that the program provides free technical and administrative on-site support to minimize the burden on staff. Healthcare providers manage all collection and logistical activities on all testing days taking the burden off school staff.

It’s all 100% federally funded making it reasonable for any district or school to implement. Of course, the program is voluntary both for schools and for parents and kids participate only if their parent provides consent.

Schools interested in exploring this opportunity can visit this K-12 Pooled Testing Website and email healthyschools@azdhs.gov to get started.

Rapid Testing

Last semester, schools generally needed to partner with a community lab that is CLIA certified to do on-site rapid testing. The availability of the new Over-the-Counter BinaxNOW Rapid COVID-19 Test means that schools will no longer need to partner with a lab. On top of that, the Rescue Plan Act provides more than enough CDC money for the state and counties to buy the test kits and for schools to use them routinely for screening.

Arizona’s county health departments have been buying the BinaxNOW at-home testing kits and making them available to schools. Schools can ask their county health department for free test kits. Most counties (including Maricopa) have the BinaxNOW kits. In Maricopa County, schools can order these test kits through their School Resource Request Tool.

Schools can use the kits in ways they prefer. They could have tests available in the nurses or administrative offices and could do on-site testing (with parental consent of course). Alternatively, they can just send a kid home with the rapid test kit in their backpack and ask the parent to do the test at home. Results come in about 15 minutes.

Here is a comprehensive PowerPoint explaining the importance of school based testing: TFS Assets for APHA – Dropbox

Summary

Even though our governor is actively hostile toward universal indoor K-12 masking, schools still have tools to prevent classroom infections. Routine testing to identify COVID cases and removing infected kids and their unvaccinated close contacts can prevent cascades of classroom cases and improve the chances for in-person school.

Thanks to the Rescue Plan Act, schools can implement free routine testing in classrooms this fall.  They can use a pooled testing approach (which comes with free administrative and technical support) or use rapid tests.  Both approaches are free, and provide critical information that schools can use to keep kids safer this fall and minimize cascading cases that result in unnecessary distance learning.

Make sure to ask your school principal what their testing plan is. If they don’t have a testing plan, send them to this blog post to get them started!

SCHOOL TESTING INFOGRAPHIC

School-based Testing is Important & Free: Get Your School With the Program!

Ideally we’d have a governor and health department director that support evidence-based interventions to prevent COVID-19 infections in K-12 schools while maximizing the chance for in-person instruction by supporting CDC’s Guidance for COVID-19 Prevention in K-12 Schools.

Sadly, that’s not the deck that Arizona voters dealt us. We’ve been dealt a hand that includes a governor who is actively hostile toward universal indoor K-12 masking and a health director unwilling to push back.

That doesn’t mean schools are helpless. Identifying COVID cases early and removing infected kids and their unvaccinated close contacts can prevent cascades of classroom cases and improve the chances for in-person school.

A key to making that happen is school-based testing. Fortunately, classroom COVID testing will be much easier this fall because of the American Rescue Plan Act.  Arizona received $219M CDC to pay for voluntary COVID-19 testing in schools at no cost to schools.

These federal funds allow schools to do both diagnostic testing of symptomatic kids and staff and surveillance screening testing to help schools identify infected individuals without symptoms so they can take action to prevent further transmission.

Pooled Testing

Thanks to the Rescue Plan Act schools can implement routine ‘pooled testing’ of asymptomatic kids for free, including administrative and technical support.

Here’s how it works. The free technical support team comes to the school and coordinates the sampling. Samples from multiple students in the same classroom are combined and taken to a Sonora Quest Lab’s main facility in Phoenix. The pooled specimen is analyzed the same day as collection (using PCR).  Results are available in less than 24 hours. If the test is negative, all students in the pool are presumed negative and no further action is necessary.

If the pooled test is positive, students in the positive pool are tested the next morning using the BinaxNOW 15-minute antigen test to determine which student is positive.

The biggest “game-changer” for schools that use pooled testing is that the program provides free technical and administrative on-site support to minimize the burden on staff. Healthcare providers manage all collection and logistical activities on all testing days taking the burden off school staff.

It’s all 100% federally funded making it reasonable for any district or school to implement. Of course, the program is voluntary both for schools and for parents and kids participate only if their parent provides consent.

Schools interested in exploring this opportunity can visit this K-12 Pooled Testing Website and email healthyschools@azdhs.gov to get started.

Rapid Testing

Last semester, schools generally needed to partner with a community lab that is CLIA certified to do on-site rapid testing. The availability of the new Over-the-Counter BinaxNOW Rapid COVID-19 Test means that schools will no longer need to partner with a lab. On top of that, the Rescue Plan Act provides more than enough CDC money for the state and counties to buy the test kits and for schools to use them routinely for screening.

Arizona’s county health departments have been buying the BinaxNOW at-home testing kits and making them available to schools. Schools can ask their county health department for free test kits. Most counties (including Maricopa) have the BinaxNOW kits. In Maricopa County, schools can order these test kits through their School Resource Request Tool.

Schools can use the kits in ways they prefer. They could have tests available in the nurses or administrative offices and could do on-site testing (with parental consent of course). Alternatively, they can just send a kid home with the rapid test kit in their backpack and ask the parent to do the test at home. Results come in about 15 minutes.

Here is a comprehensive PowerPoint explaining the importance of school based testing: TFS Assets for APHA – Dropbox

Summary

Even though our governor is actively hostile toward universal indoor K-12 masking, schools still have tools to prevent classroom infections. Routine testing to identify COVID cases and removing infected kids and their unvaccinated close contacts can prevent cascades of classroom cases and improve the chances for in-person school.

Thanks to the Rescue Plan Act, schools can implement free routine testing in classrooms this fall.  They can use a pooled testing approach (which comes with free administrative and technical support) or use rapid tests.  Both approaches are free, and provide critical information that schools can use to keep kids safer this fall and minimize cascading cases that result in unnecessary distance learning.

Make sure to ask your school principal what their testing plan is. If they don’t have a testing plan, send them to this blog post to get them started!

SCHOOL TESTING INFOGRAPHIC

Weekly COVID Epidemiology & Hospital Capacity Update Finds Continuing Sobering Trends

DECISIONS BY GOVERNOR DUCEY CONTINUE TO EXACERBATE THE EPIDEMIC

BELOW IS A SUMMARY OF DR. GERALD’S WEEKLY EPIDEMIOLOGICAL & HOSPITAL CAPACITY REPORT VIEW THE FULL REPORT HERE

Arizona is experiencing high and rapidly increasing levels of community transmission that will be sustained to create another surge of cases and hospitalizations as big as the summer of 2020. While I am hopeful we will not reach the levels seen in the winter of 2021, the experience of other states (e.g., Louisiana) combined with inaction of our local and state officials suggests this may be wishful thinking.

As of August 8th, new cases were being diagnosed at a rate of 255 cases per 100,000 residents per week. The rate was increasing at 59 cases per 100,000 residents per week. Another wave of cases and hospitalizations caused by the Delta variant is now certain; the only question remaining is just how big.

Vaccination remains the most important public health priority to reduce viral transmission and severe illness over the long-term; however, in the short-term only mask mandates, restrictions on indoor gatherings in public settings, and targeted business restrictions will reduce transmission we are now experiencing.

Resumption of in-person instruction in K – 12 schools now, and universities in the coming weeks, will lead to frequent school-associated outbreaks and contribute to accelerating community transmission. Vaccine and mask mandates along with weekly surveillance testing, adequate ventilation, and physical distancing is required to stave-off a worst-case scenario in schools.

Hospital COVID-19 occupancy is increasing and is likely to exceed 20% of all beds in the general ward and 25% of beds in the ICU for many weeks. Access to care is becoming more restricted as COVID-19 occupancy is increasing. Expect delays in elective procedures to once again mount.

There is no evidence that existing vaccination levels will meaningfully blunt the impact of community transmission on hospitals. Hospitals should (and likely are) preparing for another meaningful surge that will strain staffing in critical care areas and lead to critical shortages.

Arizona is now experiencing >100 deaths per week. This amount will increase in the coming weeks and will almost certainly reach 300 per week by the end of August.

According to the CDC, 56% of Arizona adults have received at least 2-doses of vaccine while another 10% have received 1-dose. In the face of the Delta variant, this is wholly insufficient.

Despite evidence of limited immune escape to the Delta variant, especially before completion of the full vaccination sequence, vaccination continues to provide extraordinarily high levels of protection from severe illness.

The CDC revised its mask guidance for vaccinated individuals in part due to a large outbreak in Massachusetts where the majority of cases was among fully vaccinated residents. Fully vaccinated individuals should mask when indoors in public spaces where community transmission is high or substantial. If exposed to a known case, individuals should be tested in 3 – 5 days regardless of symptoms and wear a mask for 14 days post-exposure.

VIEW THE FULL REPORT HERE

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