With RBG’s Passing, the ACA May Be On Borrowed Time

The passing of Associate Justice Ruth Bader Ginsberg may very well have a profound impact on healthcare in the U.S. It appears likely that the Senate will confirm Amy Coney Barrett shortly. Perhaps it will be before the election, but if not, it will likely be in the early weeks after the election but before the new Senate opens session on January 3.

New justices are sworn in very quickly after they’re confirmed by the Senate. Prospective nominees are typically screened using criteria that expose their thoughts on major policy issues like Affordable Care Act. Their opinion history will also be reviewed. In any event, Barrett is far more likely than RBG to overturn the ACA.

A few weeks ago, the Supreme Court scheduled oral arguments on the future of the Affordable Care Act on November 10.  My bet is that they’ll postpone the case (called Texas v. Azar is now called California v. Texas) until Barrett is sworn in.

The case mostly revolves around the ACA’s individual mandate, which is a critical component to the rationale that the Supreme Court used back in 2012 to uphold the ACA. More about that in a bit.

The Court’s Changing Ideology

With RBGs passing and Barrett likely to be installed shortly, the US Supreme Court will have a much different cast of characters than it did when the ACA was originally upheld back in 2012 (by a 5-4 vote). Since then, Justice Gorsuch replaced Scalia and Justice Kavanaugh replaced Kennedy.  Both Justices Scalia and Kennedy voted against the ACA- so not much on that score has changed.  But, the late Justice Ruth Bader Ginsberg voted with the majority to uphold the ACA in 2012… so her replacement (Barrett) could prove pivotal.

Background on the 2012 Ruling

Chief Justice Roberts voted with the majority that upheld the law, but his majority opinion rested on the fact that the individual mandate to have health insurance also includes a penalty “tax “for those who don’t comply with the mandate. That tax was the “hook” that authorized the Act in that Ruling.

In the 2012 Ruling, Chief Justice Roberts wrote that:

“… the Affordable Care Act’s requirement that certain individuals pay a financial penalty for not obtaining health insurance may reasonably be characterized as a tax… because the Constitution permits such a tax, it is not our role to forbid it, or to pass upon its wisdom or fairness.” 

Chief Justice Roberts rejected the Administration’s argument that Congress’s authority to regulate interstate commerce provides the authority needed for the ACA to be constitutional (the Court struck down that argument 5-4).

The California v. Texas Case

The California v. Texas case which is scheduled to be heard in November was filed in 2018 by Texas, Arizona and 18 other states. The states claimed that once Congress eliminated the penalty underlying the individual mandate, the mandate must fall away because no revenue is directly produced.

Revenue production, noted Chief Justice Roberts in 2012, is a central component of the constitutional exercises of Congress’ tax power. The Trump administration and several Republican-led states including Arizona argue that the mandate to buy insurance unconstitutional, and lower courts have so far agreed.

Even if the individual mandate is found to be unconstitutional (or moot) by the court, the fate of the remaining provisions of the ACA in part hinges on a legal doctrine called “severability.” Basically, the question is, if one part of the law is found unconstitutional, must the rest of the law  also be found unconstitutional or would some portions remain intact? 

Arizona and other states say that the individual mandate is so central to the ACA that if the Supreme Court finds it unconstitutional, then the remainder of the 2,000-page ACA “must also fall.”

A key question is whether Barrett will agree with the lower courts. If she does, then the ACA will likely be ruled unconstitutional in its entirety because the individual mandate tax is gone and therefore the Act would likely be considered unconstitutional.  

But, it may not turn out like that.  For example, Judge Roberts ruled in his 2012 opinion that the Medicaid expansion of the ACA was severable from the rest.  Perhaps he will think the same this time but on a different provision?  Remember, Justice Roberts has already ruled that Congress’ ability to regulate interstate commerce doesn’t extend to the ACA.

The Impacts of the Demise of the ACA

A new white paper from the ASU College of Health Solutions explores how Arizona has benefitted from the ACA – and what’s at stake in the Supreme Court. For more information and references, view the full report.  Here’s a shorter Infographic with the Arizona impact.

A full repeal would have profound consequences for ordinary Americans. In addition to recent estimates that more than 23M people in the US who would lose coverage, repeal would eliminate essential consumer protections, Medicaid Expansion, Health Insurance Marketplaces, and extension of Dependent Coverage to age 26. Before the COVID-19 crisis erupted, coverage losses for Arizonans were estimated to be 297,000; additional coverage losses due to the pandemic have increased this estimate to 363,000.

Disappointing Trends Emerge in this Week’s COVID Trends Update by Dr. Gerald

For the week ending September 20th, 4048 new Covid-19 cases were diagnosed in Arizona, representing a 32% increase over last week. Last week was the first week-over-week increase since late June. While half of the increase is attributable to those 15 – 24 years of age, trends among other age groups are increasing too. Viral transmission is beginning to increase broadly in Arizona, but particularly among university-age individuals in Maricopa, Pima, and Coconino counties.

While current levels of viral transmission are comparable to those of mid-to-late May, history shows that increases can compound quickly; and once momentum builds, it can be difficult to stop.

Many more details and additional figures including Figure 10 showing the dramatic rise in cases among 15 – 24 year old and Figure 11 which shows the deteriorating face mask wearing trends in AZ are in this week’s report.

Positive Antigen Tests Now Routinely Counted as Probable COVID-19 Cases

Over the last few months, the FDA has given Emergency Use Autorizations to 4 different antigen tests. Antigen tests aren’t as accurate as the Polymerase Chain Reaction tests but provide nearly immediate results which provides timely and actionable information. This feature makes antigen tests a very valuable tool in many settings like testing staff in assisted living and skilled nursing facilities. 

Until last week, Arizona’s public health system counted a person with a positive antigen test as a case only if they also had a known exposure to a person with COVID-19 or have symptoms of COVID-19 like shortness of breath, cough, or sore throat.

Last week, AZ’s public health system changed how they count cases by including anyone with a positive antigen test as a probable case, consistent with the recently updated national case definition for COVID-19 from the Council of State and Territorial Epidemiologists. A good decision.

COVID-19 Vaccine Update

At least 11 SARS CoV2 vaccines are under development by 9 manufacturers. Five of these vaccines are in Phase III Trials. You can Click here to access the New York Times Coronavirus vaccine tracker for more information.

  • About half the candidate vaccines require 2 doses. Vaccines with 2 doses significantly complicate deployment because they require that folks that have been vaccinated return for the 2nd dose, usually within a tight timeframe.

  • Several of the vaccines require ultra-low cold storage (-70c). Stringent cold chain requirements like this can cause real challenges in putting together vaccination campaigns. Interestingly, the CDC is not recommending that vaccinators buy special freezers. The CDC Vaccine Storage and Handling Toolkit provides additional information about the cold storage for the various vaccines.

  • Arizona County Health Departments are busy mapping high priority populations who will be eligible to receive the initial doses including healthcare practitioners, healthcare support workers, and first responders. Counties are generally aligning their plans with the National Academy of Medicine’s preliminary framework for COVID 19 vaccine prioritization.

  • In the event that the vaccines are made available under an emergency use authorization (rather than regular FDA approval), providers may need a clear informed consent agreement to ensure that patients fully understand that it is an EUA vaccine. 

  • We urge vaccine manufacturers to seek full approval of their vaccines rather than Emergency Use Authorization before deploying their vaccine to the public because public confidence that the vaccine is both safe and effective is critical. Our previous blog explains the process.

Last week, HHS released their strategy for the public distribution of a COVID-19 vaccine. The release provides a distribution overview along with an interim playbook for state and local public health programs and their partners on how to plan and operationalize COVID-19 vaccination response within respective jurisdictions.

I didn’t have time to review the HHS report before putting this out, so I’ll loop back next week on that.

AzPHA Recommends a YES Vote on Proposition 449

Maricopa County voters are being asked to continue the property tax levy for the Maricopa County Special Health Care District. The assessment is due to expire in 2024 when its 20-year life span comes to its conclusion.

The tax levy represents about 12% of the District’s revenue which is approximately $81.9M and is crucial to maintaining Valleywise Health’s mission. 

Valleywise Health (formerly known as Maricopa Integrated Health System) is Arizona’s only public teaching health system and serves the needs of anyone who comes through its doors. Its mission is to “provide exceptional care, without exception, to every patient, every time.”

More than 65% of Valleywise patients are uninsured, underinsured, or covered by AHCCCS, Arizona’s Medicaid program, or Federal Emergency Services. Annually, Valleywise serves nearly 400,000 patients with its staff of nearly 3,700 medical and healthcare professionals.

Valleywise Health was established in 1877 as a place to care for the sick in the one of the fastest growing areas in our country and is governed by an elected Board of Directors. Today, Valleywise is a growing presence for health care services in Maricopa County.

That extended system of health care consists of:

  • Valleywise Health Medical Center, the only hospital in Maricopa County verified by the American College of Surgeons to provide adult (Level I) and pediatric (Level II) trauma care;

  • The Arizona Burn Center;

  • Three behavioral health centers;

  • 12 Community Health Centers – Federally Qualified Health Centers throughout the Valley;

  • The McDowell Healthcare Center, the largest provider of HIV primary care in Arizona, women’s and pediatric refugee health services;

  • The Arizona Children’s Center.

Valleywise has been working hard to keep Arizonans safe from Covid-19 and has acquired an advanced testing technology that can detect the virus in 45 minutes or less. It has conducted community education projects across the county in ten languages.

Valleywise is also home to the Arizona Burn Center, widely regarded as the finest in the US for emergency treatment and burn survivorship. First responders across the Valley routinely express their wishes to be taken to Valleywise for treatment if injured on the job.

Valleywise has expanded behavioral health services across Maricopa County, including the creation of the Valleywise Behavioral Health Center in Maryvale where medical care and behavioral health care services are administered together, at the bedside.

The First Episode Center in Tolleson serves patients and their families experiencing their first episode of psychosis. Valleywise is also the largest provider of court-ordered behavioral health testing and care in Maricopa County.

Valleywise is addressing a nationwide doctor shortage through a partnership with Creighton University Medical School, District Medical Group, Dignity Health and St. Joseph’s Medical Center. Its goal is to grow the number of new doctors, nurses and medical professionals in Arizona, which currently ranks near the bottom of all states in the number of practicing physicians per capita.

Residencies at Valleywise continue to be some of the most sought-after in the nation. As an example, each year there are 14 ED (emergency department) residencies available at Valleywise. The hospital receives 1600 applications for those 14 spots.

The Arizona Public Health Association strongly recommends a YES vote on Proposition 449.

AzPHA Recommends a YES Vote on Proposition 208: Invest in Ed

Fact Sheet: Arizona’s Education System is Critical in Promoting Public Health Goals

According to the CDC, the direct contact and amount of time schools have with 95% of our nation’s children and youth make them critical in promoting student health and safety and helping them to establish lifelong health patterns. The National Longitudinal Study of Adolescent Health found that student connection to adults at school is strongly positively correlated with reductions in violence, substance-use, emotional distress and pregnancy. 

Adult health status is directly associated with higher educational levels, regardless of income. Children who do not learn to read in the first few grades, who read poorly, or who are retained in grade more than once are more likely than their peers to be drawn into a pattern of risky behaviors. People who acquire more education not only are healthier and practice fewer health risk behaviors, but their children also are healthier and practice fewer health risk behaviors. 

According to 2020 U.S. Census data, Arizona spent $8,239 per pupil in FY2018 (federal, state and local sources) as compared to the U.S. average of $12,612. The chart below displays the trend in Arizona public education funding over the past two decades (all sources, in 2007 dollars).  Total funding has recently begun to approach levels in the early years of the recession but has not reached the funding level of 2007. 

One of the greatest impacts of inadequate funding is inadequate pay for teachers and Arizona ranks 48th in the nation for elementary teacher pay and 49th for secondary teacher pay.  Chronic underfunding and inadequate pay for staff translate into underserved students:

  • 1800 unfilled teacher vacancies (Arizona School Personnel Administrators Association, December 2019)

  • Largest class sizes in the nation

  • Over 3000 teachers not meeting standard requirements, for example, not certified

  • Highest student to counselor ratio in the nation with 903 to 1

  • Enough nurses to serve only one-third of schools

Invest in Ed Initiative

The Invest in Ed Initiative, supported by education, health, small businesses, faith and civic groups, and now AzPHA raises revenue for K-12 education by creating a dedicated, voter-protected fund.  Funds raised must be spent according to the following requirements:

  • 50% for hiring and pay increases for teachers and classroom support personnel including counselors and nurses

  • 25% for hiring and pay increases for student support services personnel, including classroom aides, school safety and student transportation

  • 10% for teacher mentoring and teacher retention

  • 12% for Career and Technical Education vocational training programs

  • 3% for the Arizona Teachers Academy for scholarships

The Initiative generates necessary revenue through a 3.5% surcharge on earnings over $250,000 for single filers or on earnings over $500,000 for married filers. The surcharge is applied only after deductions, on taxable income. The vast majority of Arizonans (99%) including the average small business owner, lawyer, doctor and dentist will not pay this surcharge. Only the top 1% of earners will contribute.

The federal tax cuts of 2017 saved these highest earners over $47,000 on average. This method of revenue generation avoids further negative impact on low wage earners, who pay a higher portion of their income in state and local taxes.

References:

About CDC Health Schools. U.S. Department of Health and Human Services, 2019., https://www.cdc.gov/healthyschools/about.htm

Blum, Robert. “Forward.”  Prevention Science in School Settings, edited by Kris Bosworth, Springer, 2015, p. v.

National Center for Education Statistics, Office of Educational Research and Improvement, U.S. Department of Education. The Condition of Education 2002. NCES 2002–025, Washington, DC: U.S. Government Printing Office. May 31, 2002. Online: http://nces.ed.gov/pubs2002/2002025.pdf.

Tyson H. Kappan special report–A load off the teachers’ backs: Coordinated school health programs. Phi Delta Kappan. Jan 1999:K-1. Online: http://www.pdkintl.org/kappan/ktys9901.htm.

Lowry R, Kann L, Collins J, Kolbe L. The effect of socioeconomic status on chronic disease risk behaviors among U.S. adolescents. JAMA 1996;276:792-97.

Arizona Interfaith Network. “Education in Arizona.” Education Civic Academy, 2020, Phoenix AZ.

Teacher Pay. Expect More Arizona, 2020, https://www.expectmorearizona.org/progress/teacher_pay/

School District Employee Report, Arizona Department of Education, 2020, http://www.ade.az.gov/sder/PublicReports.asp

Where Will the Money Go? Invest in Education, 2020, https://investined.com/get-the-facts/where-will-the-money-go/

Arizona Interfaith Network. “Education in Arizona.” Education Civic Academy, 2020, Phoenix AZ.

Proposition 207 (Smart and Safe Arizona Act) Poses both Public Health Risks and Benefits

AzPHA is Not Taking a Position on Proposition 207 because of the Nuanced Public Health Risks and Benefits

AzPHA is neutral on Proposition 207 aka the Smart and Safe Arizona Act. It would legalize the possession and use of up to 1 ounce of marijuana (for people 21 and over) and set up licensed retail stores where up to 1 ounce of Cannabis can be sold to adults 21 and over. It would also offer expungement of some previous convictions for marijuana convictions. Here’s a link to the statutory language

AzPHA has an existing Resolution regarding the legalization and retail sale of marijuana (it’s posted on our members only website) but the Resolution doesn’t specifically address the Initiative that will likely be before Arizona voters this fall. 

There are public health risks and benefits with the Initiative. One public health risk is that it will likely increase access to marijuana for adolescents (it is clearly harmful to them). It will likely cause increases in ED visits from edible overdoses and may increase impaired driving and it’s consequences.

On the benefit side, everybody with convictions of less than an ounce can apply for expungement of their conviction, which will help their ability to make a living and improve the social determinants of health for themselves and their families.

Another big benefit is the criminal justice reform parts of the law. Adults will no longer be charged with nor convicted of possession of less than an ounce, with benefits to social determinants of health in my opinion (currently, possession of even very small amounts of marijuana are a Class 6 felony unless the person has an Arizona Medical Marijuana Certification).

Also, people of color are disproportionately charged with and convicted of marijuana possession even though they don’t disproportionately use the substance.

We had some interns do an analysis of the risks and benefits… here are their reports:

In short, the AzPHA Board of Directors elected to not take a position on Proposition 207 because there are both clear public health benefits and risks.

We also encourage Arizona voters to read the reports from our interns and think through whether they believe the public health benefits of the criminal justice reform portions of the law as well as the increased funds that would become available for public purposes outweigh the public health risks from increased access to Cannabis

We believe that individual voters should carefully examine those benefits and threats before deciding how to vote on Proposition 207.

Dr. Gerald’s Latest Analysis of AZ’s COVID Trajectory

University campuses remain an area of concern while broader trends continue to improve.

Summary of Dr. Gerald’s Analysis:

• Arizona is transitioning to a new phase of the outbreak where viral transmission is declining in the working-age and older adult populations but increasing among adolescents and young adults. This change is most likely attributable to re-opening of university campuses.

o Rising cases on university campuses pose an unknown risk to the broader community as it is unclear to what extent that the social networks of students and the broader community overlap.

o While the risk of severe disease in young adults is low, that is not the same as no risk. As case counts increase, some young adults will invariably require hospitalization and it is not out-of-the question that a small number of deaths could result.

o Reporting lag for PCR results has improved such that ≥90% of results are returned within 48 hours; however, the rapid rise in saliva testing on university campuses presents new challenges in data reporting and interpretation.

• Outside of young adults, levels of community-driven viral transmission are on par with those observed in mid-May just before Arizona re-opened its broader economy.

o For all locales, mask-wearing ordinances will be needed for the foreseeable future to mitigate the spread of Covid-19.

o As additional actvities (e.g., schools and businesses) resume, they will bring more people into closer contact and will facilitate additional viral transmission. Therefore, continued adherence with mask wearing, physical distancing, hand hygiene, and surface decontamination will be needed to mitigate these risks.

• Covid-related hospital utilization continues to decline while excess capacity is not being replenished owing to larger amounts of non-Covid care. However, adequate capacity is available for the foreseeable future.

o From now until January, non-Covid hospitalizations are expected to increase putting additional strain on hospital capacity.

o Hospitals will continue to experience large volumes of elective care to address the backlog of patients waiting elective procedures.

• Current Covid-19 test capacity appears adequate as evidenced by quick turn-around for PCR results and a PCR test positive percentage of 4% which is within the recommended 3 – 5% threshold.

o As more Covid-19 testing transitions to saliva testing, it is unclear how this might impact test positivity trends. A rising test positive percentage should raise the possibility of resurgence.

Next update scheduled for September 18.

County Data (weekly crude and population-adjusted cases counts) appear in Appendix.

AHCCCS Takes the Initiative in Suicide Prevention

This week is National Suicide Prevention Week. Suicide in Arizona is the 8th leading cause of death, with certain groups at higher risk. This essential public health work is run by AHCCCS. The team has grown to four employees in the last year – each managing a different aspect of the work.  

The team’s rallying cry is to prevent suicides, we must all participate. Some opportunities to do so include

Get trained in an evidence-based suicide prevention training. The Arizona Department of Education is offering free online training (QPR). This training meets the requirement for the Mitch Warnock Act, which goes into effect this fall.

Speaking of the Mitch Warnock Act, which requires school staff who work with students between 6-12th grades to be trained in suicide preventions – ask some tough questions. What is your student’s school doing to meet the new mandate? Do they have a training in place? A tracking mechanism? Do they have a suicide prevention policy on their district website? Does your student’s school have a behavioral health provider on campus? If school leaders don’t have answers, refer them to the AHCCCS team. (Contact information below.)

Do you know of someone who needs crisis counseling, or is feeling depressed? www.resilientarizona.org is a new, free resource for anyone in Arizona who may need to talk to someone. You can also call 2-11 for these services.

And the easiest way to get involved in suicide prevention? Check in on your neighbors, friends, and family – especially those who live alone. Isolation is a risk for suicide. A simple hello can go a long way to helping someone feel cared for.

The AHCCCS suicide prevention team:

Zeruiah Buchanan is the state suicide prevention epidemiologist. She is working closely on health equity to ensure all Arizonans have the ability to access necessary behavioral health services.

Brian Planty is the Project AWARE suicide prevention lead. He serves as the AHCCCS liaison with their partnership with the Arizona Department of Education on this five-year grant that brings suicide prevention and behavioral health resources to schools.

Albert Swanson manages a new $800k emergency suicide prevention grant that brings together domestic violence and behavioral health services in Pima County.

Kelli Donley Williams, the AzPHA treasurer, leads the team and oversees AHCCCS’ push to have behavioral health providers in schools statewide. Contact the team: kelli.williams@azahcccs.gov

Thank you for your leadership!

How Are New Vaccines and Drugs Approved?

Could the SARS CoV2 Vaccines Take a Short Cut?

The U.S. has an organized way of approving new vaccines and drugs for use and regulating them once they’re approved. However, during public health emergencies, the FDA is allowed to provide for short cuts. This week we explore the normal approval process, investigational new drugs, and the Emergency Use Authorization process which can be used in public health emergencies.

Normal Approval Processes

A key player in the process of approving new drugs is within the FDA’s Center for Drug Evaluation and Research. The center’s job is to evaluate new drugs before they can be sold. Their core mission is to ensure that drugs work and that their health benefits outweigh their known risks.

The first step in getting a new drug or vaccine approved is testing it in clinical trials. Drug companies do that testing and send their evidence to the Center.  Next, a series of tests (clinical trials) determines whether the vaccine or drug is safe when used to treat a disease and whether it provides a real health benefit.  Basically, do the benefits of the vaccine exceed the risks?

That’s where the independent review comes in. The FDA Center for Drug Evaluation and Research has a team of physicians, statisticians, chemists, pharmacologists, and other scientists that review the company’s data and proposed labeling. This is an independent review to make sure that a vaccine’s health benefits outweigh its known risks. If a drug or vaccine is considered safe and effective, then it can proceed through the approval process.

Part of the approval process includes developing a Package Insert that describes how the drug or vaccine should be used. The Package Insert has 2 main parts, the “highlights of prescribing information” and the “full prescribing information”. Together this information provides clinicians with access to the information they’ll need to responsibly prescribe the medication.

Clinicians that prescribe drugs are encouraged (but not required) to follow the instructions in the package insert. Clinicians can use professional judgment as they prescribe the drug and can decide to use a drug in a way that’s different from what is described in the Package Insert. When clinicians do this, it’s called prescribing off-label.

Prescribing off-label also has its risks. One obvious one is that since the clinician is prescribing in a way that may not be well-researched, he or she may be taking a risk with their patient.  Also, if a patient has a bad outcome, the prescriber’s actions will be measured against the standard of care…  and one tool considered by the courts in damages lawsuits is whether the clinician was prescribing according to the package insert.

Investigational New Drugs

The Investigational New Drug program allows drug makers to get permission to start human clinical trials before a drug or vaccine is approved. Drug makers or researchers file an application with the FDA that discloses the pre-clinical testing, manufacturing information, investigator information, the clinical trial protocols, and commitments to get informed consent.

If an investigational new drug application is approved, then the researchers can begin using the drug, but they’re supposed to stay within the boundaries of their application and be diligent and measure and report their findings.

An example of an investigational new drug for COVID-19 is convalescent plasma (plasma donated by folks that have recovered from COVID-19). Applications for using convalescent plasma were authorized in early April to fill an urgent need to provide patient access to a medical product when FDA was working with researchers to facilitate randomized clinical trials to study convalescent plasma.

Emergency Use Authorization

Another process by which new drugs or vaccines which aren’t yet approved is called an Emergency Use Authorization (EUA). An EUA doesn’t constitute approval of a drug, but facilitates availability of an unapproved drug (or an expressly unapproved use of an approved drug).  EUAs can only be used during a state of emergency (as is the case right now with the COVID-19 pandemic).

The standard for approval of an EUA is lower than a regular approval of a drug. All the applicant needs to show is that it’s “reasonable to believe” that the drug (or vaccine) “may be effective to prevent, diagnose, or treat serious or life-threatening diseases”.

Over the course of the pandemic, the FDA has approved scores of drugs, tests and medical devices under EUA protocols including Drug and Biological ProductsIn Vitro Diagnostic ProductsHigh Complexity Molecular-Based Laboratory Developed TestsSARS-CoV-2 Antibody TestsPersonal Protective Equipment and Related Medical Devices, and Ventilators and Other Medical Devices.

For example, last week the FDA approved convalescent plasma under an EUA. The FDA cited what was learned about the efficacy and safety of convalescent plasma in the authorized Investigational New Drug studies.

The EUA was issued despite the fact that COVID-19 Treatment Guidelines Panel concluded that there are insufficient data to recommend either for or against the use of convalescent plasma for the treatment of COVID-19 and that plasma should not be considered the standard of care for the treatment of patients with COVID-19. For more information, please read the full statement on the COVID-19 Treatment Guidelines website.

Another example is hydroxychloroquine. A couple of months ago the FDA authorized the use of hydroxychloroquine as a treatment for COVID-19 under an EUA. However, the FDA later removed the EUA after evidence was discovered that the harms of using hydroxychloroquine for treating COVID-19 exceeded the benefits.

Which Path will COVID-19 Vaccines Take?

Every vaccine in use so far has gone through the traditional FDA approval process. Phase I, Phase II and Phase III followed by the traditional data review process. Vaccines have needed to establish that they are safe and effective and publish that data publicly. If the review is successful it is approved. Sometimes the vaccine is approved for just certain populations. 

For example, the first time the HPV vaccine was approved it was licensed just for females because they only tested the vaccine in women. That has since been expanded to males after additional clinical trials and a modified approval process.

The COVID-19 vaccines in development might take an alternative route. Because of the public health emergency status, the FDA has the authority to authorize vaccines for use among the general public before it’s formally approved under an EUA.

Making that choice would be unprecedented. It would mean that the vaccine becomes available for general use without the rigorous review process. Additionally, the FDA could even elect to not publish the data that they considered for their EUA review.

Fortunately, in a joint letter signed this morning, the manufacturers of the vaccines currently under development have agreed to complete Phase III trials before applying to the FDA. However, the statement doesn’t commit to seeking full approval of the vaccine leaving emergency use authorization on that table. Such a move would short-circuit the FDAs data review and approval vetting process.

The joint letter signed by AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck & Co., Moderna., Novavax., Pfizer and Sanofi. pledges to:

  • Always make the safety and well-being of vaccinated individuals our top priority.

  • Continue to adhere to high scientific and ethical standards regarding the conduct of clinical trials and the rigor of manufacturing processes.

  • Only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA.

  • Work to ensure a sufficient supply and range of vaccine options, including those suitable for global access.

Editorial Note I: Waiting for the normal review process and official approval before distributing the vaccine to the general public would take an additional 6 to 8 weeks. During that time, the review team would have time to analyze the data and determine whether the vaccine is safe and effective and in what doses and to determine whether there are any sub-populations who may have adverse effects.

However, there will be intense pressure in some circles for the FDA to issue an EUA rather than the full licensing review. That may work out in the end, bit it might not.  And with several vaccines in the pipeline, even if the first one doesn’t work or had adverse effect there will be several others right behind it.

If a vaccine is distributed under an EUA and it doesn’t work out and there are bad adverse effects or if it’s ineffective but distributed anyway, it could do serious and lasting damage the overall confidence that vaccines are safe and effective- and that could have longer-lasting deleterious effects to public health.  Something to think about as we approach the end of the Phase III trials.

Editorial Note II: The Association for State and Territorial Health Officials (ASTHO) put out a clear statement urging the FDA to complete Phase III trials before making a decision either through an EUA or via Approval to release COVID-19 vaccine to the public. Here is an excerpt from their statement last week: 

“Our nation’s health officials are concerned by recent statements from FDA Commissioner Hahn and NIAID Director Fauci indicating they would consider authorizing the use of a COVID-19 vaccine prior to the completion of phase 3 clinical trials. The safety and efficacy of vaccines is paramount to protecting the health of the American public and to building confidence in our state and territorial immunization programs.

 “The nation’s health officials strongly encourage FDA to require the completion of phase 3 trials—or an equally rigorous evaluation—prior to approving a COVID-19 vaccine. Leadership must use the best available science to guide vaccine distribution decisions and timelines.”

 “We must also address concerning racial and ethnic inequities in vaccination rates and speak to the mistrust that many Americans have of governmental immunization efforts. Vaccinations are a monumental public health accomplishment built on decades of research and transparency by the world’s scientists. We must work together to ensure the COVID-19 vaccine builds upon this legacy.”

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