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. 

Dr. Gerald’s Epidemiology & Hospital Capacity Report: Hospitalizations Very High as Adult Cases Continue; Kids Cases Dropping

View the Full Report with Graphs

From Dr. Gerald:

Once again, more good news than bad. Case counts continue to trend down slowly in most places except Greenlee County which is nearing its all-time pandemic high. Despite modest improvements in transmission, test positivity continues to inch up unexpectedly after the Labor Day holiday.

Hospital occupancy remains stubbornly plateaued. This is most likely because the biggest improvement in cases is occurring among children.  So, let us hope that Arizona’s judiciary makes a good decision and blocks the governors’ and legislature’s attempts to prevent schools from requiring masking.
COVID-19 deaths topped 200 per week for the first time in a long while. While I don’t expect them to go much higher, they are still much higher than they should be.
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 not for everyone. A lot of data appeared this week regarding vaccine efficacy and safety. A good bit of it is linked in the attached report. Short story is that all 3 vaccines continue to provide high levels of protection against severe illness resulting in hospitalization.
Yes, Moderna does appear to be separating itself from the others so Pfizer boosters are likely warranted for some now and perhaps more in the future. All safety signals continue to favor getting vaccinated versus getting infected by a LARGE margin.

Program Spotlight: COVID-19 Emergency Response Suicide Prevention Grant

September is Suicide Prevention Awareness Month. AHCCCS manages the COVID-19 Emergency Response Suicide Prevention (ERSP) grant which provides suicide screening and follow-up services in Pima County to those uninsured and underinsured with suicidal ideation who are 25 years of age and older.

This screening occurs primarily in emergency departments, psychiatric facilities, and through crisis line referrals. Through Arizona Complete Health (AzCH) and a contract with CODAC, CODAC Behavioral Health Technicians (BHTs) will screen individuals in emergency departments and inpatient psychiatric facilities for suicidal ideation and identify/screen those persons who may have been or are at risk of domestic violence.

This simple screening of individuals who are experiencing suicidal ideation can go a long way toward preventing suicide because it ensures that they receive appropriate care and support, as well as follow-up services to lessen the chances of a future suicide attempt. Additional preventative follow-up services offered through CODAC include 24/7 emotional support while stabilizing someone in crisis, help with coping skills, and increased connection to community resources or outpatient treatments.

Why is this work important?
Suicide is completely preventable. The deep wounds and traumas from suicide can scar families for generations, and the pain extends so much further than just the individual suffering from suicidal ideations. For these individuals, in the darkest moments, it can feel like there is no other way out. But there is support, and there is healing, and there are many people that care and want to help these individuals into a healthier and brighter future.

How can you get involved? As part of the grant, Community Bridges Inc. leads coordination and delivery of evidence-based training including ASIST (Applied Suicide Intervention Skills Training) and SafeTALK (Suicide Alertness for Everyone: Tell, Ask, Listen, and KeepSafe) to agencies in Pima County.

These courses have a preventative focus with the goal of preparing trainees to more adequately, respond to and support someone with suicidal ideations, and to prevent suicide. Courses like SafeTALK and ASIST are available throughout Arizona. Request training from the Arizona Department of Education (ADE) here

Judge Cooper Heard Lawsuit Challenging Ducey’s Harmful Prohibition of School Mask Requirements Yesterday

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 filed a legal complaint in Superior Court on Monday.

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.

Here’s a School guest blog from James 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.

Expect that regardless of how Judge Cooper rules that the case will be quickly appealed to the Arizona Supreme Court. I expect a Preliminary Injunction stopping the implementation of Ducey’s harmful policy on 9/29 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.

White House Orders 6-Point Plan to Improve Vaccination Rates, Increase Testing & Incentivize Masking

Last week President Biden announced that his executive branch agencies are implementing a several-pronged strategy to 1) improve vaccination rates; 2) better protect folks that have already been vaccinated; 3) keep schools safer and improve chances for in-person learning; 4) increase testing and masking; and 5) improve care for the people that do get infected.

I won’t go into the details of the entire plan here, but you can read the various elements on the White House website. Perhaps the most significant initiative is an upcoming OSHA regulation that will require all employers with more than 100 staff to ensure that their team is vaccinated or be tested weekly. Noncompliance will result in financial penalties for the employer. All federal employees will need to become vaccinated. Federal contractors will even be required to vaccinate their staff or do weekly testing (presumably via contract amendment).

Legal expert and AzPHA member Jen Piatt wrote this analysis for the Network for Public Health Law which concludes that case law supports reasonable vaccine mandates by political jurisdictions. The report also delves a bit into the mission of OSHA and their enabling act which supports OSHA’s authority to implement this kind of workplace safety requirement. The report contains several supporting references. The provisions will become effective once OSHA promulgates their final emergency rule.

Another significant part of the President’s plan requires healthcare facilities that get paid via Medicaid or Medicare to ensure that their teams are vaccinated. This is important because vaccination rates are still quite low in many care settings like nursing homes. See this article in the Republic by Stephanie Innes & Alison Steinbach Vaccination rates at Arizona nursing homes vary widely.

Editorial Note: Naturally, Governor Ducey is openly hostile to the sensible measures in the President’s plan and has threatened to ‘push back hard’. Perhaps we’ll find out next week how he intends to use his authority and state agencies to ‘push back’.

Perhaps he will order the ADHS not to enforce the new CMS requirements (ADHS’ Licensing Division provides CMS Certifications). Perhaps he will order the state OSHA program at the Industrial Commission to be uncooperative? Perhaps last week’s temper tantrum will be the only push back?

September is Suicide Prevention Month

Some 1,400 Arizonans die by suicide annually; it is the eighth leading cause of death in Arizona. And yet, we can all play a role in helping to decrease this number in our communities. Remember to WAIT:

W: Watch for signs of distress and uncharacteristic behavior, including increase in substance use, sleep pattern changes, discussing death or suicide.

A: Ask, “Are you thinking of dying by suicide?”

I: It will pass. Reassure the person you’re speaking to that suicidal thoughts are treatable and you will walk alongside them to get care.

T: Talk to others. Call the crisis line for immediate guidance on next steps.

Resources:

Maricopa County served by Mercy Care:
1-800-631-1314 or 602-222-9444

Cochise, Graham, Greenlee, La Paz, Pima, Pinal, Santa Cruz and Yuma Counties served by Arizona Complete Health – Complete Care Plan:
1-866-495-6735

Apache, Coconino, Gila, Mohave, Navajo and Yavapai Counties served by Health Choice Arizona:
1-877-756-4090

Gila River and Ak-Chin Indian Communities:
1-800-259-3449

Salt River Pima Maricopa Indian Community:
1-855-331-6432

For more crisis resources, see the AHCCCS Crisis web page.

Arizona Likely Voters Give Ducey Poor/Failing Marks for his Pandemic Response, Most Disagree with his Decisions on School Masking

  • 57% of Arizona likely voters agree that students, staff, and teachers should be required to wear a mask at school
  • 59% disagree with the Governor’s decision to make it illegal for schools to require students, teachers, and staff to wear masks beginning 9/29
  • Nearly 62% disagree with Governor Ducey’s decision to offer more grant funding schools ONLY to schools that DON’T require masks

 

Contact:      Will Humble, Executive Director

                   willhumble@azpha.org

                   602.538.9692

PHOENIX (September 9, 2021) – A new statewide survey gives Arizona Gov. Doug Ducey a failing grade for his handling of the COVID-19 pandemic, with 46 percent rating his performance as poor or failing compared to 23 percent giving him “Excellent/Very Good” marks. Another 27 percent rated his performance as “OK.”

Will Humble, Executive Director of the Arizona Public Health Association said, “Throughout the pandemic, Governor Ducey and his team have consistently suggested that Arizona’s poor performance is a result of bad luck. Nothing could be further from the truth.”

Humble added, “Arizona ranks 7th in the nation in deaths per capita from COVID-19 largely because of his bad decisions, misplaced priorities, unwillingness to implement proven effective public health policy measures like universal masking, inability to learn from policy failures, and a failure to execute core responsibilities.”

A sizable 83.8% of Democrats rated the Governor’s performance as “Poor/Failing” along with 38.5% of unaffiliated voters.  However, 39.3% of Republicans gave Ducey a score of “Excellent/Very good” including 44.7% of Republican males.

Humble said it’s no surprise that likely voters disapprove of the governor’s performance. He consistently makes decisions that harm the pandemic response. A whopping 57% of likely voters agree that universal masking should be implemented in Arizona schools, with only 40% agreeing with the Governor’s decision to prohibit schools from implementing universal masks beginning September 29.

The survey also found a large disparity in vaccine acceptance by political party. Remarkably, more than 93% of Democratic likely voters surveyed report that they are vaccinated against COVID-19, while only 52% of likely voters registered as a Republican report that they are vaccinated.

Humble said, “While it’s clear that we still have vaccine access disparities because of language challenges and income disparities, our survey found that a dominant problem is political ideology.”

“Arizona’s response during the pandemic is wholly insufficient, and Governor Ducey is largely to blame” concluded Humble. “From the banning of mask requirements, to paying schools extra to jeopardize student health and safety, the Governor has not only failed to implement core public health interventions, but worse, he is making decisions that he likely knows are harming the health and safety of Arizona’s kids.”

Fortunately, the Arizona School Board Association, the City of Phoenix and the Phoenix Union High School District are challenging Governor Ducey’s harmful micromanagement of Arizona schools, cities, and towns.

The Arizona Public Health Association is hopeful that their arguments in court will carry the day and that Arizonans will get some well-needed relief from Governor Ducey’s harmful and dangerous decisions.

 

On a scale of Excellent, Very Good, Ok, Poor, or Failing, how would you rate the job Governor Ducey has done handling the COVID-19 pandemic?

 8.3%            Excellent                     Mean Score:  2.62

15.0%           Very Good

27.3%           Ok

24.2%           Poor

22.0%           Failing

3.3%            Don’t know/Refused

 

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

 

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 state budget, the Arizona State Legislature passed, and Governor Ducey signed, a law that goes into effect September 29th that makes it illegal for local school districts and charter schools to mandate wearing masks for all students and teachers. Knowing just what you know right now, do you support or oppose this law?

36.0%    Total Yes

61.7%    Total No

2.3%      Don’t know, Refused

26.7%          Definitely Yes 

9.3%            Probably Yes

7.0%            Probably No

54.7%          Definitely No

2.3%            Don’t know/Refused

 

Have you received a vaccination for COVID-19?

72.0%           Yes

21.3%           No

6.7%            Refused

 

GOP:   51.8% Yes

Dem:  93.4% Yes

PND:   75.0% Yes

IND:   81.3% Yes

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.

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.

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.