Will Humble Disease Control, Vaccination, Wills Blog

Moderna Vaccine Receives Emergency Authorization Use from FDA and Approved Use Recommendations from CDC

Last week the current CDC Director signed the Advisory Committee on Immunization Practices’ recommendation for using Moderna’s COVID-19 vaccine in people ages 18 and older. That official CDC recommendation followed FDA’s decision to authorize the emergency use of Moderna’s vaccine. The recommendation is published in CDC’s Morbidity and Mortality Weekly Report.

Other CDC resources on the Moderna vaccine include: Evidence to Recommendations;  Interim Clinical Considerations; and  Local Reactions, Systemic Reactions, Adverse Events, and Serious Adverse Events.

Will Humble Disease Control, Prevention, Wills Blog

ADHS Director Scraps COVID-19 Spread Metrics for Business Operations

Substantial Spread No Longer Exists as a Category in Arizona

Over the summer, a host of stakeholders including the business community developed COVID-19 metrics to inform policy decisions like when it’s time to pause the operation of bars and have restaurants go to take out and outdoor dining.  Shortly after the ideas were presented to the Governor’s Office, the ADHS quickly adopted the metrics and highlighted them as a key tool for driving future intervention decisions. Those metrics were then used when the state decided to lift the limitations put on bars, restaurants and gyms during the summer “pause”.

Under the former criteria bars and in-person dining are not allowed to operate when a county is in the Substantial category (based on more than 100 cases per 100,000 residents, more than 10% of people testing coming back positive, and more than 10% of people showing up at hospitals having COVID-like illness). We supported those metrics (although we pointed out that COVID-Like Illness is a very poor metric for decision-making).

As community spread began to increase in late October and into November & December, county after county moved into the Substantial spread category. When asked why the ADHS was not advocating for enhanced interventions because of the substantial spread, Dr. Christ (the agency director) said that while the metrics were valuable for deciding when to open businesses, they were irrelevant for deciding when to close them.

As that argument became increasingly untenable, Dr. Christ late last week quietly changed the standards governing business operations such that it is impossible to reach a threshold in which community spread is high enough to warrant enhanced interventions on bars and restaurants, no matter how serious the infection rate gets.  Basically, Substantial Spread has been eliminated as a category.

If you don’t believe me, you can check it out for yourself. Go to the ADHS Business Dashboard. You can see that the state as a whole and all the counties are well into the Substantial Spread range in terms of cases per 100,000, percent positivity, and even COVID Like Illness. 

Yet, the business reopening status is Moderate…  meaning steady as she goes.

Astonishing.

Will Humble Disease Control, Prevention, Vaccination, Wills Blog

Pre-screening Being Used to Prioritize Vaccine Recipients in Tier 1A

Pre-screening is open for all Phase 1A healthcare workers interested in being vaccinated for COVID-19. Because supplies are limited it will be available by appointment only and pre-screening is required to determine eligibility in most counties. For example, in Maricopa County you can go to their Phase 1A prescreening worksheet to check you or your family member’s eligibility. That site also lays out the various eligibility categories.

The first allocation of vaccine doses will be prioritized to individuals that ACIP has recommended to be in Phase 1A: those working in a healthcare setting, especially those with the most potential exposure to COVID-19, as well as residents and staff of long-term care facilities.

To determine your eligibility, please complete this pre-screen survey as the first step to scheduling an appointment. Your response will help MCDPH determine your eligibility and connect you with your assigned regional vaccine provider, based on the location of your primary worksite.

I tested the system out so I could write about how it works, but I was (appropriately) screened out at Step 1.

Note: Through the Pharmacy Partnership for Long-term Care Program, CDC has engaged retail pharmacy partners (CVS and Walgreens) to secure vaccine and provide on-site vaccination of residents, at no cost to the facility. Skilled Nursing Facilities residents and staff will receive the vaccine first followed by Assisted Living and other adult congregate settings. 

Will Humble Disease Control, Vaccination, Wills Blog

FDA Authorizes Moderna’s Vaccine for Emergency Use

FDA’s Vaccines and Related Biological Products Advisory Committee met last Thursday to discuss the request for emergency use authorization for a COVID-19 vaccine from Moderna. They recommended Emergency Use Authorization of the Vaccine and the FDA commissioner promptly approved their recommendation.

See: FDA Authorizes Pfizer Vaccine for Emergency Use & ACIP Recommends Administration Schedules. Meeting information on the Moderna meeting this week can be found here.

The CDC’s Advisory Committee on Immunization Practices met yesterday and are meeting today to make their administration recommendations to the CDC director.

Today’s ACIP meeting is from 9am to 2:30pm.  Here’s the ACIP Final Agenda for today and yesterday & here is the Webcast Link. Here are the Presentation slides from this weekend’s ACIP meetings.

Data released by Moderna in their application for EUA stated the following:

“The EUA request includes safety and efficacy data from an ongoing Phase 3 randomized, double-blinded and placebo-controlled trial of mRNA-1273 in approximately 30,400 participants. Efficacy in preventing confirmed COVID-19 occurring at least 14 days after the second dose of vaccine was 94.5% (95% CI 86.5%, 97.8%) with 5 COVID-19 cases in the vaccine group and 90 COVID-19 cases in the placebo group. Subgroup analyses of the primary efficacy endpoint showed similar efficacy point estimates across age groups, genders, racial and ethnic groups, and participants with medical comorbidities associated with high risk of severe COVID-19.”

Analysis of approximately 30,350 participants ≥18 years of age randomized 1:1 to vaccine or placebo with a median of 7 weeks of follow-up after the second dose supported a favorable safety profile, with no specific safety concerns. The most common solicited adverse reactions associated with mRNA-1273 were injection site pain (91%), fatigue (68%), headache (63%), muscle pain (59%), joint pain (44%), and chills (43%). Severe adverse reactions occurred in 0.2% to 9.7% of participants, were more frequent after dose 2 than after dose 1, and were generally less frequent in participants ≥65 years of age as compared to younger participants.

See these documents for the particulars: Vaccines and Related Biological Products Advisory Committee December 17, 2020 Meeting Briefing Document – FDA and Vaccines and Related Biological Products Advisory Committee December 17, 2020 Meeting Briefing Document Addendum- Sponsor

Will Humble Disease Control, Vaccination, Wills Blog

Dr. Gerald’s Weekly COVID Report: The March to Crisis Standards of Care Continues Unabated

Dr. Gerald’s weekly epidemiology and hospital capacity is hot off the presses. No surprises in this week’s report. No good news again, as expected, given the dearth of policy and operational interventions under the governor and health director’s leadership. As always, several good Figures in this week’s report document the severity of this unmitigated crisis.

Arizona is now experiencing a public health crisis where access to critical care services is limited due to shortages of space, personnel, and critical supplies. We are undergoing a great “displacement”. Hospital services are being rationed so that patients with severe Covid-19 illness are displacing others who have slightly less severe non-Covid medical conditions.

As Covid-19 illness continues to increase, delaying others’ care will become ever more difficult. At some point, hospitals will have to expand their physical capacity and implement Crisis Standards of Care. The Covid-19 crisis is now placing a greater share of Arizonans’ at-risk, not just those unfortunate enough to contract Covid-19.

With 617 deaths, the week ending July 19th is still Arizona’s deadliest week, but not for long. Because cases have been increasing, deaths are also increasing. Sharper rises are expected over the coming weeks as deaths lag new cases by 14- days and are often only made known weeks later.

By Christmas, Arizona will be experiencing >500 deaths per week. However, this toll will not be apparent until mid-January once all deaths are accounted for. As a rule of thumb, multiply the number of weekly deaths by 1.5% (approximate case fatality rate) to estimate the number of expected deaths in 2–3 weeks time.

It is now clear that there will be no interventions from the governor or health director to mitigate this crisis. Their plan appears to be to slowly vaccinate persons with the highest risk of hospitalization and death. Such a strategy will be quite slow owing to: 1) the slow pace of vaccinations given the totality of the population at highest risk; and 2) the lag time between vaccination and the development of protective neutralizing antibodies and T cells.

Will Humble Disease Control, Public Health Law, Wills Blog

AzPHA Joins a Host of Healthcare Heavy Hitters to Urge the Governor and Health Director to Act

Today the Arizona Public Health Association joins with the Arizona Hospital and Healthcare Association (AzHHA), Arizona Medical Association (ArMA), Arizona Osteopathic Association (AOMA), Maricopa County Medical Society (MCMS), and the Arizona Organization of Nurse Leaders (AAONL) to urge the governor to issue executive orders to temporarily pause the operation of certain types of businesses or further limit their operations, to temporarily limit gatherings, and to additionally mandate statewide mask wearing.

We know there is deep-seated opposition to some of these recommendations. And there are negative economic consequences to others, which have a down-stream impact on public health. However, we believe urgent action is needed on a temporary basis to protect the immediate fragility of the healthcare delivery system.

In our letter, we urge the governor and health director to take the following steps for the next six to eight weeks—while vaccines are being administered to healthcare workers and long-term care residents under Phase 1a of the state’s COVID-19 Vaccine Plan:

  • Close bars and nightclubs. These could be reopened earlier if the state returns to moderate community spread.

  • Limit restaurant operations to outside dining and take-out service. These restrictions could be lifted earlier if the state returns to moderate community spread.

  • Except for essential services, limit public gatherings to no more than 25 people. Encourage people to only socialize with members of the same household. With holiday celebrations continuing through the New Year, we are incredibly concerned about multi-household gatherings which will become super spreader events.

  • Implement a statewide and enforceable face covering mandate that focuses on business compliance rather than individuals.

Arizona finds itself in a potentially catastrophic situation. The healthcare system is overwhelmed and on the brink of considering the need to implement crisis standards of care. We also face the reality that our hospital systems will likely run out of available staff to care for patients who need our help.

Editorial Note: Sadly, the recommendations above to close bars and have restaurants go back to take out service could have been avoided if mitigation measures like a statewide, uniform, and enforceable face covering mandate (placing the responsibility for compliance on businesses and organizations) and far better enforcement of mitigation measures in bars and restaurants had been implemented weeks ago.

If those less dramatic interventions been implemented in October when the case rate and trajectory began to increase, those interventions would have been able to slow down the spread enough to decrease the imminent hospital capacity crisis.

Many weeks of opportunities to benefit from better enforcement in bars and restaurants and a uniform and enforceable statewide mask mandate (with enforcement focused on businesses and organizations rather than individuals) have now been missed, necessitating the recommendations above.

Editorial Note II Regarding Bars & Restaurants:  For the last many months I have been in favor of much better enforcement of the existing required mitigation measures. Sadly, the opportunities to put together an efficient compliance system (and benefit from it) have been lost.

We’ve learned a lot about this virus and we now know that the virus thrives in closed indoor environments where people typically don’t wear masks.

When these businesses started back up a couple of months ago, they were required to sign attestations that they’d follow required mitigation measures (restaurants at 50% capacity and bars operating like restaurants and also using capacity limits). While there is a complaint hotline and some follow up of those complaints (I’ve heard that many are simply phone calls) there is little if any proactive compliance checks and sporadic enforcement.

Any effective regulatory program requires routine proactive compliance checks that include enforcement when necessary. Had we been doing better proactive compliance checks, there would be far fewer bars, restaurants and nightclubs ignoring the existing mitigation requirements. Businesses that are complying are frustrated that their competitors are cheating and getting away with it. That causes more businesses to cheat.

But how could such a system have worked? There were at least 2 possibilities. The existing food safety workforce in AZ (called Sanitarians) could have been reassigned to COVID mitigation detail for the next few months. Alternatively, the National Guard (who is currently helping with the response on other areas like food banks and shelf stocking among other things) could have been put on mitigation compliance check detail at bars restaurants and nightclubs. An Executive Order could have given authority to nullify the Attestations made by those businesses that are not complying, suspending their individual operation.

If better compliance and enforcement had been in place several weeks ago, we would be in a different place. As it stands, we are now in exponential growth of the virus and at the brink of a hospital capacity crisis.

My point has been that shutting the bars again could have been avoidable if better compliance and enforcement of the existing required mitigation measures had been in place many weeks ago.

Will Humble Disease Control, Vaccination, Wills Blog

Billing and Coding for the COVID Vaccines

The Arizona Partnership for Immunization put together this super informative PowerPoint summarizing the billing and coding for administering the COVID 19 vaccines. Topics include Medicaid and Medicare reimbursement details, AHCCCS administration fee schedules for both doses ($16.94 for the 1st dose and $28.39 for the booster), how administration fee claims will be handled for uninsured patients, which provider categories need to re-enroll as mass immunizers, ordering and billing links, and more.

A huge shout-out to Jennifer Tinney and the team at TAPI for their terrific leadership over the years and during the pandemic. We’re very lucky to have them assisting with the COVID vaccination planning in Arizona.

Will Humble Disease Control, Prevention, Wills Blog

Hospitals Continue to Urge for Additional Interventions to Stem the Tide of COVID Hospitalizations (to no avail so far)

Last week several hospital Chief Medical Officers wrote to the state health director urging her to implement several specific interventions to slow the tide of patients deluging Arizona’s hospitals. The memo didn’t work as the governor and health director didn’t implement any interventions last week.

This week the Arizona Hospital and Healthcare Association put together a template letter encouraging community leaders and hospital CEOs to circulate to elected officials in their jurisdictions.

Over the next 2 weeks we expect hospitals to delay important non-emergency surgeries. Patients will be transferred to alternate hospital sites using the ADHS’ surge line. Patients presenting in emergency departments with troubling symptoms and who would normally be admitted will be sent home. Likewise, patients will likely be discharged from hospitals earlier than normal.

Finally, when the system reaches saturation after these interventions have been implemented, we will need to operate under the Crisis Standards of Care. It means that doctors will need to triage and score critically ill patients to decide which patients to withhold care based on their likelihood of survival and life expectancy of they were to recover.

Sadly, there have been many missed opportunities to prevent or mitigate the coming crisis. Because these opportunities weren’t taken advantage of in time, we are now in the position of asking the governor and local elected officials to take immediate action in hopes that the worst of this crisis can be prevented (implementing Crisis Standards of Care).

Will Humble Disease Control, Vaccination, Wills Blog

FDA Authorizes Pfizer Vaccine for Emergency Use & ACIP Recommends Administration Schedules

The FDA Commissioner granted emergency use authorization (EUA) of the Pfizer/BioNTech COVID19 vaccine on Friday. The decision was made by following last Thursday’s FDA’s Vaccines and Related Biological Products Advisory Committee meeting. Here’s a top line summary of the FDA’s analysis Pfizer/BioNTech’s application.

The CDC’s Advisory Committee on Immunization Practices also held meetings on over the weekend and recommended that the Pfizer vaccine be given to “persons 16 years of age and older in the U.S. population under the FDA’s emergency use authorization“. Importantly, they voted to add the vaccine to the immunization schedules. Within 15 days of being added to the schedule health plans need to cover administration of the vaccine. 

While the clinical trial didn’t include people 16 or 17 years old, that age group was added because many folks in this age range work in fields that put them at risk for exposure. The Committee recommended that pregnant women be able to choose whether to be vaccinated (encouraging them have a conversation with their physician before vaccinating).

While no pregnant women were in the trials, 23 became pregnant after administration of the vaccine. The Committee was in consensus that persons who have had severe allergic reactions to other vaccines should talk with their doctor before being vaccinated.

The ACIP recommendations aren’t on their website yet but I expect them to be posted soon. The CDC Director still needs to approve the recommendations, which I expect to happen later today.

Now that the Pfizer vaccine has EUA status and the ACIP has made their recommendation, the vaccine can now be distributed and used even though it hasn’t been fully approved by the FDA. Because of the ACIP decision, health plans will be required to pay for the administration of the vaccine (15 days after the CDC director approves the ACIP recommendation).

The federal government contracted with the companies to manufacture the vaccine during their Phase III clinical trial- agreeing to pay for the vaccine even if it had not been granted EUA or Approval. Therefore there is already a stockpile of vaccine available for distribution.

Maricopa will be receiving 47,000 doses next week and Pima 11,000. Vaccination at assisted living and skilled nursing facilities is being handled via a state contract with that effort beginning the week between Christmas and New Years. My sources tell me that rural counties will get their first vaccine the week of December 21.

A statewide stakeholder meeting met last week to prioritize the initial doses of vaccine (see the priority populations here).

Note: The New England Journal of Medicine published a study of the Safety and Efficacy of the Vaccine last Thursday. Overall, a two-dose regimen of the vaccine provided 95% protection against Covid-19 and the safety over the 2-month study period was similar to other viral vaccines. The safety profile found short-term, mild-to-moderate pain at the injection site, fatigue, and headache. The incidence of serious adverse events was low and was similar in the vaccine and placebo groups. 

Will Humble Disease Control, Wills Blog

This Week’s Epidemiological and Hospital Capacity Report Shows a Continuing Runaway Epidemic

Dr. Joe Gerald’s weekly epidemiology and hospital capacity report continues to show a runaway epidemic in Arizona. Here’s the full report. There are several revealing and troubling charts in this week’s report. I highly recommend reading it or at least reviewing the charts and graphs. Below is a quick summary:

Viral transmission is increasing throughout Arizona. New Covid-19 cases will overwhelm our capacity to provide hospital care in the next few weeks. New cases are being diagnosed at a rate of 567 cases per 100,000 residents per week, far into the substantial range.

This rate is increasing by approximately 179 cases per 100,000 residents per week. We have now all but locked in a hospital care crisis during the Christmas – New Year holiday with hundreds of preventable deaths per week.

Holiday travel, commerce, and social gatherings between Thanksgiving and New Years are likely to accelerate transmission rates without additional public health interventions.

A state-wide shelter-in-place order in addition to an enforceable statewide face covering mandate would be needed at this point to slow transmission and to mitigate the worst of overcrowding in our hospital system. This could likely have been avoided with better enforcement of required mitigation measures agreed to by bars and restaurants when the opened after the summer “pause”

Hospital Covid-19 occupancy has now exceeded the previous peak number of hospitalized patients and ICUs will set new records by the end of next week. Hospitals are already postponing scheduled procedures; essentially additional capacity is being created at the expense of others with serious non-Covid medical conditions. However, this coping mechanism will be exhausted by the end of the month.

Health professionals are being asked to work additional hours and assume new duties. Shortages and burn-out will degrade our capacity to provide critical care services over the coming weeks.

The test positive rate for traditional PCR testing reached 25% this week. The growing mismatch between testing capacity and demand indicates viral transmission is growing faster than estimated here.

Covid-19 mortality continues to increase. While case fatality rates remain lower than those observed with this summer’s outbreak, deaths are rising quickly. Arizona will record >500 Covid-19 deaths per week by Christmas. 

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