Will Humble Disease Control, Vaccination, Wills Blog

FDA Issues Guidance on Emergency Use Authorization of the SARS CoV2 Vaccines

Last week the FDA issued guidance to vaccine manufacturers providing new criteria for requesting Emergency Use Authorization for their SARS CoV2 vaccines. The new guidance makes it clear that the FDA wants to see 2 full months of Phase III clinical trial data before they will consider an EUA application. This is good in my opinion.

The White House had earlier blocked the FDA from releasing this decision. The New York Times reported that chief of staff Mark Meadows questioned the need for 2 months of safety data and suggested that FDA Commissioner was overly influenced by the agency’s career scientists.

Fortunately, the FDA prevailed. We need to make sure that the public has full confidence that the vaccines are following a tried and true process to ensure that they are both safe and effective if we’re going to get enough folks to voluntarily get the vaccines when they become available. Making sure that adequate Phase III data are collected and adequately analyzed will be critical.

Will Humble Disease Control, Public Health, Public Health Law, Vaccination, Wills Blog

FDA to Hold Vaccines Advisory Committee Meeting

Comments currently being accepted

The Center for Biologics Evaluation and Research’s Vaccines Advisory Committee will meet on October 22 10:00 AM – 5:00 PM ET to discuss the development, authorization, and licensure of vaccines to prevent COVID-19. The meeting will be held at this website. Registration isn’t required.

Public comments can be submitted through October 14. I submitted comments urging the Committee to ensure that no shortcuts are taken with the approval process for the SARS CoV2 vaccines. The stakes are too high. The only way out of this pandemic is to make sure that the public has full confidence that the vaccines are both safe and effective. The best way to make that happen is to make sure the FDA requires the vaccine manufacturers to follow tried and true standardized approval processes.

Agenda
The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform.  No specific application will be discussed at this meeting.

Meeting Materials
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, any background material will be made publicly available at the time of the advisory committee meeting, and additional materials will be posted on FDA’s website after the meeting.

Materials for this meeting will be available at the Vaccines and Related Biological Products Advisory Committee meetings main page.

The meeting will include slide presentations with audio components to allow the presentation of materials in a manner that most closely resembles an in-person advisory committee meeting.

Public Participation Information
Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.

FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2020-N-1898. The docket will close on October 15, 2020.

Electronic Submissions
Submit electronic comments in the following way:

Will Humble Disease Control, Wills Blog

Dr. Gerald’s Weekly Epidemiology Report

Here is Dr. Gerald’s COVID-19 Disease Outbreak Outlook (published today). Below is the narrative summary- but as usual- much more detail is available in the full report.

“While cases on university campuses continue to decline, broader trends in the community continue to slowly worsen. Test positivity for traditional PCR, saliva and antigen testing have converged around 4 – 6%.  

There is a major correction this week with regard to the IHME metric reporting adherence to face mask recommendations. The data being reported on the IHME website seems too inconsistent to be valid. So, I do not think it is a good measure of Arizonan’s adherence. Overall, we remain in a relatively good spot but complacency is a concern moving forward into our traditional viral respiratory season.

I made a few tweaks to the Appendix data to try to improve readability of the most current data, but not sure I am happy with the changes. If someone has different suggestions, please let me know.”

Will Humble Disease Control, Public Health Law, Wills Blog

Journal Article of the Week

Trends in COVID-19 Incidence After Implementation of Mitigation Measures – Arizona, January 22 – August 7, 2020  Early Release / October 6, 2020 / 69

The CDC released this new Morbidity and Mortality Weekly Report Tuesday that dives into the details of the Arizona experience with the pandemic this summer. It’s great that the folks at the ADHS put together this MMWR because it builds the evidence base for what kinds of interventions are effective at slowing the spread of COVID-19.

The piece discusses the fact that the average COVID-19 cases increased more than 150% between June 1 and June 15 following the end of the Stay at Home Order in mid-May. The report documents the fact that after face covering mandates were put in place and bars and nightclubs were shut in late June, the cases stabilized (July 3 and July 12) and daily new cases declined by 75% between July 13 and August 7.

Again, it’s great that the agency published this work because it builds the evidence base and can now serve to help other states (and even countries) as they think through interventions.

But it’s also important to tell the story the way it really happened.

For example, the MMWR write up states that… “Updated guidance from state officials provided local governments the authority to implement mask policies (June 17) and enforcement measures tailored to local public health needs“.  The reality is that Executive Order 2020-36 Provision #7 prohibited local jurisdictions from implementing face covering ordinances or other mitigating measures stronger than the Governor’s orders.

Following intensive lobbying from local officials Executive Order 2020-40 (June 17) finally removed the prohibition against face mask ordinances (although not other measures). It was not updated guidance from state officials that prompted local jurisdictions to implement face covering ordinances, it was a result of rescinding an Executive Order that had been prohibiting county and state governments from implementing this evidence-based intervention.

The report further states that… “Before June 17, mask wearing had not been widely mandated or enforced.” This statement is true but misleading. In fact, local or county mask wearing mandates had been specifically forbidden by the governor’s executive orders prior to June 17, so of course mask wearing had not been widely mandated or enforced.

Further, the report neglects to mention a highlight of the epidemic in Arizona, the fact that the state authorized Crisis Standards of Care in July because the hospital system had reached saturation.

Editorial note: You might be wondering why I’m making such a big deal about the way that this MMWR is wordsmithed with respect to the face coverings. Quite simply, it’s because courageous elected officials in county and local government across the state had stridently asked the Governor and health director for their authority back and then immediately implemented face covering ordinances as soon as the Governor’s restriction was rescinded. Many of those officials faced backlash from elements of their electorate for that decision.

The MMWR piece implies that counties and cities implemented face covering requirements simply because of a change in guidance. This is misleading. As we look towards managing the pandemic through the crucial winter months ahead, it is important that we understand the actual dynamics of implementing such a public health intervention, beyond what may be stated in a publication such as the MMWR. Unfortunately, it seems that much about our pandemic response has become political. This is an example of how that politics at first prohibited local response, and how politics was then used to lift the restriction and allow local officials to do the right thing.

Local jurisdictions need the flexibility to continue to impose mask mandates, and other mitigation measures, depending upon local circumstances.  For example, had the Governor not pre-empted local control of such matters, some local jurisdictions would not have waited so long to impose mask mandates. This would have decreased the peak of wave of infection, which has an impact on the number of cases occurring even months later.  Some jurisdictions might also choose other measures.  For example, prohibiting indoor bars and nightclubs in certain areas (such as adjacent to college campuses) which would limit the number of super-spreading events that continue to drive the epidemic.  

We will likely experience another surge in cases during the coming winter months.  The more we can limit this through modest mitigation measures such as mask mandates, the more we will be able to allow most aspects of the economy to remain open and viable.  If we don’t moderate the coming surge, we risk being forced into another partial lock-down, with perhaps even worse economic outcomes than we’ve already felt.

Will Humble Disease Control, Wills Blog

Lots of Rapid Antigen Tests on the Way

Last week the federal government notified states of a plan to distribute Abbott BinaxNOW antigen rapid test kits. Arizona’s allocation is about 2 million. They’re promoted as “point of care” rapid test kits. The kit works by testing a sample collected in the nose and placed into the kit. The test can identify the antigen (unique proteins) on the coat of the SARS CoV2 virus in about 15-20 minutes.

Facilities that have a CLIA certificate of waiver can implement the test, though they do not need to be CLIA-certified laboratories. There are a couple of different routes on how this can be achieved, including applying for a waiver or being associated with a CLIA-certified or waived lab.

School nurses or school employees who have been trained can administer the test, but they’d need to be either associated with a CLIA lab authorized for moderate complexity or get a waiver.  CLIA waiver certificates are easy to get these days and approval lies within the ADHS Public Health Laboratory, so presumably the kits will be used in the field mostly under CLIA waivers. 

These rapid tests have a real opportunity to improve our response. Because results are available so quickly, it gives facilities immediate information that can inform decisions. For example, the tests could be used to screen visitors and staff at assisted living and skilled nursing facilities. Schools may be able to use it to screen students quickly and make decisions about whether to send kids home etc.

A welcome development indeed.

Will Humble Disease Control, Prevention, Wills Blog

National Academies of Medicine Release Vaccine Prioritization Recommendations

Among the most important policy decisions that need to be made in the coming weeks is how to prioritize the allocation of the early doses of vaccine. With the clinical trials showing promising results and manufacturers of several vaccines already in production (even though they are still only in Phase III Trials), it’s time to start planning how to distribute the likely vaccine(s).

Immunizing the U.S. population to prevent COVID will probably be the largest vaccination campaign ever undertaken.  A successful and equitable vaccination plan will require participation by county health departments, community health centers, healthcare providers of all kinds, emergency managers and private & nonprofit sector partners.

How should the early doses of vaccine be allocated? Fortunately the National Academies of Medicine assembled an all-star group of professionals to come up with a proposed prioritization plan that considers evidence, ethics and health disparities. It’s called the Committee on Equitable Allocation of Vaccine for the Novel Coronavirus.

They released their final report this week, entitled Framework for Equitable Allocation of COVID-19 Vaccine.  In addition to sharing an updated framework for equitable allocation of a COVID-19 vaccine, the final report includes community engagement strategies, risk communication approaches, methods to promote vaccine acceptance, and global considerations.

National Academy Plan for the equitable allocation of vaccine report was commissioned by the NIH and CDC. It’s a long document, but here’s a snapshot of the recommendations Phase 1 populations include:

  • 1a: Front-line healthcare workers (including care home workers, hospitals, home health)

  • 1a: Emergency services workers

  • 1b: Older adults in crowded settings

  • 1b: Persons of all ages w/co-morbid conditions & significantly increased risk

Chapter 3, Page 20 gives an overview of priority populations in all 4 Phases along with a detailed rational for the various selections.

This is a well thought-through document that is objective and non-partisan. Hopefully the federal, state and county governments will loom to this landmark report as they develop the SARS CoV2 vaccination plans.

Will Humble Disease Control, Wills Blog

Dr. Gerald’s Weekly COVID Analysis

Here is Dr. Gerald’s most recent update on the COVID-19 outbreak. From Dr. Gerald… “While university campuses are improving, broader trends in the general community continue to slowly worsen. For what it is worth, test positivity for traditional PCR, saliva and antigen testing have converged around 4 – 6%.”  

“While it is difficult to understand the validity of the IHME metric regarding adherence to face mask recommendations, this week’s news is disappointing as Arizona ranks at the bottom of the 50 states. Overall, we are currently in a relatively good spot but complacency is becoming an ever greater concern with the worst case scenario being low adherence to mitigation efforts during peak viral respiratory season.”

Will Humble Disease Control, Wills Blog

What’s the Treatment Plan for the President?

By now, all of you know that the president has been diagnosed with COVID-19. Reports are that his symptoms were moderate to severe on Friday but have since improved. His symptoms have included cough, fever and low oxygen saturation levels (less than 94% on room air).

His treatment plan includes administering a course of treatment of remdesivir, a drug that slows the replication of of the virus. This medication has been shown to improve outcomes in some patients when administered early. A clinical trial found that the drug accelerated recovery among patients that had advanced disease. It was a randomized, controlled trial involving 1063 patients.

The study found that patients who got remdesivir recovered 31% faster than the people that got the placebo (p<0.001). The median time to recovery was 11 days for patients treated with remdesivir compared with 15 days for those who got the placebo. Results also suggested a survival benefit, with a mortality rate of 8.0% for the group receiving remdesivir versus 11.6% for the placebo group (p=0.059).

A few months ago the FDA issued an Emergency Use Authorization for remdesivir to treat COVID. That means doc’s can now prescribe for patients without enrolling them in a clinical trial or getting compassionate use approval.

The patient is also being treated with dexamethazone, a steroid. This medication is used in COVID patients that have low oxygen saturation on room air. It tamps down inflammation and has been shown to improve clinical outcomes in patients that have lowered blood oxygen levels. He received supplemental oxygen on Friday (2/L per minute).

The patient’s treatment team also administered monoclonal antibodies produced by Regeneron. This experimental monoclonal antibody treatment is still in clinical trials (it is an investigational new drug) and is available “for compassionate use” outside of clinical trials if approved by the FDA. The FDA issued such an approval Friday.

The Regeneron CEO has made statements suggesting that the drug is quite effective, but no data (that I could find) establishes this as the case. Here’s more about the investigational new drug process from a previous blog.

The patient’s treatment plan also includes zinc, vitamin D, an antacid called famotidine, melatonin and aspirin. None of these require a prescription and none have been proven to be effective against COVID-19. 

Statistically, a 74 year-old male in reasonably good health has a 3% chance of dying from COVID19. Patients in that range have symptoms bad enough to be hospitalized in about 10-15% of cases.

Persons with other underlying medical conditions (like obesity) are more likely to have a worse outcome.

On the other hand, these statistics include patients that were infected in the Spring and Summer of 2020 when less was known about effective treatment for the infection. Treatment for this illness has improved significantly in recent weeks and I expect outcomes to continue to improve as more is learned about effective therapies.

Will Humble Disease Control, Wills Blog

Journal Articles of the Week

Prevalence of SARS-CoV-2 antibodies in a large nationwide sample of patients on dialysis in the USA: a cross-sectional study The Lancet DOI:https://doi.org/10.1016/S0140-6736(20)32009-2

For this cross-sectional study, in partnership with a central laboratory that receives samples from approximately 1300 dialysis facilities across the USA, we tested the remainder plasma of 28 503 randomly selected adult patients receiving dialysis in July, 2020.

Seroprevalence of SARS-CoV-2 was 8·0% (95% CI 7·7–8·4) in the sample, 8·3% (8·0–8·6) when standardised to the US dialysis population, and 9·3% (8·8–9·9) when standardised to the US adult population. When standardised to the US dialysis population, seroprevalence ranged from 3·5% (3·1–3·9) in the west to 27·2% (25·9–28·5) in the northeast. (0·4 [0·3–0·5]) when compared with a reduction of less than 5%.

During the first wave of the COVID-19 pandemic, fewer than 10% of the US adult population formed antibodies against SARS-CoV-2, and fewer than 10% of those with antibodies were diagnosed. Public health efforts to limit SARS-CoV-2 spread need to especially target racial and ethnic minority and densely populated communities.

MMWR: Changing Age Distribution of the COVID-19 Pandemic

The CDC released an MMWR describing the changing age distribution of COVID-19 infections in the United States from May-August 2020. During the first months of the pandemic, COVID-19 incidence was highest among older adults, but between June-August, COVID-19 incidence was highest in persons aged 20–29 years. This report provides preliminary evidence that younger adults contributed to community transmission of COVID-19 to older adults

Will Humble Disease Control, Wills Blog

New Visitation Policies for Long Term Care

Visitation policies for long term care facilities are in the process of changing, thanks to the lower level of community spread that resulted from interventions by cities and counties to require face coverings, the several week suspension of bars and nightclubs, and the better (but not great) business and bar compliance with recommended CDC mitigation measures.

Family members or friends of folks living in assisted living or skilled nursing (and designated caregivers) will be given access to the facilities during normal pre-COVID visitation hours if they meet certain conditions, like providing a negative COVID test result within the last week. Here’s a description of the policy changes.    

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