Dr. Gerald’s Weekly Epidemiology and Hospital Report

Excerpts from this week’s report below. 

Click here for the full analysis.

Arizona has now clearly transitioned from a period of crisis to one of elevated risk. With continuing, albeit slower, improvements being forecast for the coming weeks, hospital capacity will remain adequate to meet Arizona’s most critical needs for the foreseeable future. However, it will be several months before the backlog of non-Covid care is fully addressed.

This week saw a sixth straight week of meaningful declines in Covid-19 cases and hospital occupancy. Nevertheless, absolute levels of SARS-CoV-2 viral transmission remain above the 100 new cases per 100,000 residents per week threshold which approximates elevated risk.

As of February 21st, new cases were being diagnosed at a rate of 135 cases per 100,000 residents per week (Figure 10). This rate is declining by 30 cases per 100,000 residents per week. The pace at which conditions are improving is slowing. It is possible that we might see improvements cease before April.

Despite these improvements, Arizona has the 17th highest viral transmission rate in the US according to the CDC. With regard to cases, Arizona remains the 6th hardest hit state overall.

All residents should continue to wear a mask in public, avoid social gatherings, maintain physical distance from non-household contacts, avoid >15 minutes contact in indoor spaces, especially if physical distancing is inadequate and adherence to face masks is low.

While residents and businesses should continue to follow the recommended public health mitigation efforts, normalization of lower risk activities will be reasonable once case rates fall below 100 new diagnoses per 100,000 residents per week.

The test positivity rate for traditional nasopharyngeal PCR testing was unchanged this week at 15% indicating testing is inadequate to the scale of the problem as positivity should be <10%.

Moving forward it will be necessary to remain adherent to our public health mitigation practices in the face of improving conditions. For example, absolute levels of transmission and test positivity remain about 1.5X higher than recommended for in-person instructional activities (see Arizona Department of Health Services Benchmarks).

Hospital Covid-19 occupancy continues to decline in the ward and ICU. Access to care, while somewhat restricted, is being scheduled at greater frequency. Nevertheless, it will be several months before the backlog of medically necessary non-Covid procedures is addressed.

According to the CDC, 6.7% of Arizona residents have received at least 2-doses of vaccine while another 9.7% have received 1-dose. The ADHS Dashboard is reporting slightly higher levels. To date, Arizona has administered 84% of its delivered doses.

NPR released a well-done simulation/animation that shows the impact of past infections, vaccinations, and increased transmissibility on future cases among remaining susceptibles.

Arizona is still reporting a large number of weekly deaths and this count may considerably underestimate true fatalities. The week ending January 17th will be Arizona’s deadliest with >1000 deaths. Arizona’s weekly tally of deaths ranks it 5th in the nation. Overall, we rank 6th since the outbreak began.

FDA Authorizes Emergency Use of the Johnson & Johnson Vaccine: CDC Likely to Recommend It’s Use Later Today

The FDA’s review committee met last Friday to discuss the Johnson & Johnson’s application for emergency use of their vaccine in the U.S. and recommended that the FDA commissioner authorize use of the vaccine. The FDA Commissioner signed the official authorization last evening. 

The CDC’s Advisory Committee on Immunization Practices is meeting this afternoon to discuss whether the vaccine should be given to Americans. The ACIP will vote on their recommendation this afternoon and I expect the CDC director, Dr. Rochelle Walensky, to make the final decision to release the vaccine this evening.

The FDA posted all the J&J vaccine applicatio data on their website.  There are several documents in the meeting packet but the one that I like to look at is the FDA’s briefing document to the committee.

The results from the Phase III clinical trial look good (40,000 participants in the trial).  Here’s the bottom-line effectiveness (from the summary report):

“…  vaccine efficacy against central laboratory confirmed and blind-adjudicated severe/critical COVID-19 occurring at least 14 days and at least 28 days after vaccination of 76.7% and 85.4% respectively.”

In other words, this single dose vaccine is 77% effective at preventing severe COVID disease 14-days after the jab and 85% effective after 28 days.

There were 2 hospitalizations from COVID in the vaccine group (both before 28 days post vaccination) compared with 29 cases in the placebo (saltwater injection) group.  None of the persons that were given the vaccine died while 7 people died of COVID in the placebo group.

The vaccine worked equally among subgroups in the trial (age, comorbidity, race, ethnicity) but effectiveness among folks 60 years of age and older with comorbidities was a little lower early on in the study (i.e., counting cases from 14 days rather than 28 days and including cases not yet centrally confirmed).

Side effects within 7 days of injection were the statistically the same among the vaccine and placebo (saltwater) groups. In other words, side effects were no different whether the person got the vaccine or the saltwater injection.  Those side effects included injection site pain (48.6%), headache (38.9%), fatigue (38.2%), and myalgia (33.2%).

The independent review committee concluded that:

“… the analysis supported a favorable safety profile with no specific safety concerns identified that would preclude issuance of an EUA”.

Note: Globally and in the U.S. this is a very important vaccine. It is simple, inexpensive, doesn’t require complicated storage and handling, and (perhaps most importantly) is a single dose vaccine. This vaccine belongs in doctor’s offices, pharmacies, and community health centers… using it at mass vaccination sites would be a big mistake because one of this vaccine’s strengths is its flexibility.

This vaccine’s flexibility means that we can bring the vaccine to the people rather than bringing the people to the vaccine… which can help us overcome the large disparities that exist in Arizona:

See: ADHS Vaccine Appointment System Favors the Wealthy & Creates Health Disparities

JAMA Article: “Changing the COVID-19 Conversation: It’s About Language”

new article reveals the results of a nationwide online poll on public perceptions of COVID-19 language and messaging. The poll identified words, messages, and the messengers most likely to influence health behavior.

Read it to find out whether the words fact-based or evidence-based work better.  What’s better, “protocol” or “mandate”? Is it better to say, “face mask” or “facial covering”?  Is it better to say “essential workers” or “frontline workers”?

Dramatic phrases don’t work well. Respondents found “warlike,” and fear-based messages off-putting.

Among the primary takeaways from the poll, COVID-19 communications are more likely to be effective if they focus on the benefits of success, not just the consequences of failure. People are less likely to follow public health measures based on fear alone.

New Report on Vaccine Equity

The Johns Hopkins Center for Health Security published a new report: Equity in Vaccination: A Plan to Work with Communities of Color Toward COVID-19 Recovery and Beyond.

The report is designed for elected and appointed officials and focuses on addressing the inequities that Black, Indigenous, and People of Color (BIPOC) communities face. In addition to including a plan for creating, implementing, and supporting vaccine campaigns that focus on BIPOC communities, the report outlines how to minimize future burdens and enable broader social change.

New Report on Vaccine Equity

The Johns Hopkins Center for Health Security published a new report: Equity in Vaccination: A Plan to Work with Communities of Color Toward COVID-19 Recovery and Beyond.

The report is designed for elected and appointed officials and focuses on addressing the inequities that Black, Indigenous, and People of Color (BIPOC) communities face. In addition to including a plan for creating, implementing, and supporting vaccine campaigns that focus on BIPOC communities, the report outlines how to minimize future burdens and enable broader social change.

Federal Pharmacy Program Making Significant Inroads Toward Vaccine Access

A few weeks ago the Biden Administration announced an initiative to increase vaccine supply in states through the new Federal Retail Pharmacy Program.

Last week the program kicked off with the direct distribution of vaccine to about 200 pharmacies in Arizona. AZ pharmacies around the state received an average of 100 doses of vaccine through the program. All of the vaccine is Moderna.

The participating pharmacies in AZ are Safeway, Fry’s and Walgreens. I also saw that some appointments will be available at a few Albertsons. The program will be expanded in subsequent weeks will be based on vaccine availability. The goal is to include more than 40,000 locations nationwide (that would be about 800 pharmacies in AZ- or about ½ of all AZ pharmacies).

Here’s a link to the Maricopa County Department of Public Health website where you can look for appointments.

Importantly, the vaccine is distributed directly from the federal government to the participating pharmacies. This is important because it prevents state health departments from diverting the vaccine to other priorities that they may have like state-run vaccination sites.

It’s critical that we diversify the ways in which people can find vaccine because the current one-size-fits-all allocation and distribution system does not serve lower income communities well.  See last week’s blog post to get an idea of the health disparities that are emerging.

The federal pharmacy program provides a direct way of building far more access points while giving people an alternative to state allocation schemes that provide advantages to wealthier persons.

FQHC Distribution Programs Announced

The Biden Administration has also announced another new federal program whereby the federal government will directly distribute to Federally Qualified Health Centers.

This is also a terrific new program because it will directly allocate vaccine to FQHCs who focus their services on rural and underserved areas, precisely the folks that are at a disadvantage right now getting appointments through the ADHS system.  Importantly, appointments for vaccine at FQHCs can be made without going through the convoluted ADHS appointment website.

The federal pharmacy and FQHC programs will become increasingly significant when the Johnson & Johnson vaccine is authorized next weekend. The J&J vaccine is perfect for pharmacies to use. Storage and handling for that vaccine is just like most other vaccines.

The FDA committee is meeting on February 26 to consider the J&J emergency use application. I expect authorization to happen by March 1 with shipments starting March 2. Hopefully the destination for many if not most of the J&J vaccines will be through this new federal pharmacy program.

CNN is reporting that “… a J&J official stated that the company currently has less than 10M doses manufactured and available for distribution in the US”. This is a disappointing number as it amounts to about 200,000 doses for Arizona. At least this is a single dose vaccine so it’s equivalent to 400,000 doses of Moderna or Pfizer.

Editorial Note: The Association for State and Territorial Health Officials sent a letter to the President urging him to better coordinate the allocation of vaccine through the FQHC and retail pharmacy programs. Thankfully, the letter stops short of urging the federal government to relinquish control of these programs to governors and state health directors…  but the letter goes right up to that edge.

We have seen and continue to see, first-hand, that governors and state health directors often allocate vaccine toward their preferred sites (e.g. State Farm) that aren’t focused on providing vaccine to underserved areas.

If the federal government were to hand over allocation control to state health directors and their governors, we can expect to see vaccine that is intended for local pharmacies and Federally Qualified Health Centers get diverted to pet high-profile vaccination sites that are not focused on helping low-income communities.

Johnson & Johnson Vaccine Clinical Trial Data Shows That It’s Safe & Effective

With FDA Authorization, Some Limited Deliveries Could Start Monday or Tuesday

A few weeks ago Johnson & Johnson applied for emergency use authorization of their candidate vaccine. The FDA’s review committee is meeting Friday morning. The FDA just posted all the data on their website.  There are several documents in the meeting packet but the one that I like to look at is the FDA’s briefing document to the committee.

I didn’t see any surprises in todays reports. The results from the Phase III clinical trial look good (about 43,000 participants in the trial).  Here’s the bottom-line effectiveness (from the summary report):

“…  vaccine efficacy against central laboratory confirmed and blind-adjudicated severe/critical COVID-19 occurring at least 14 days and at least 28 days after vaccination of 76.7% and 85.4% respectively.”

In other words, this single dose vaccine is 77% effective at preventing severe COVID disease 14-days after the jab and 85% effective after 28 days.

There were 2 hospitalizations from COVID in the vaccine group (both before 28 days post vaccination) compared with 29 cases in the placebo (saltwater injection) group.  None of the persons that were given the vaccine died while 7 people died of COVID in the placebo group.

The vaccine worked equally among subgroups in the trial (age, comorbidity, race, ethnicity) but effectiveness among folks 60 years of age and older with comorbidities was a little lower early on in the study (i.e., counting cases from 14 days rather than 28 days and including cases not yet centrally confirmed).

Side effects within 7 days of injection were the statistically the same among the vaccine and placebo (saltwater) groups. In other words, side effects were no different whether the person got the vaccine or the saltwater injection.  Those side effects included injection site pain (48.6%), headache (38.9%), fatigue (38.2%), and myalgia (33.2%).

The independent review committee concluded that:

“… the analysis supported a favorable safety profile with no specific safety concerns identified that would preclude issuance of an EUA”.

The bottom line is that this vaccine is very likely to be authorized for use in the U.S. as early as Monday. Shipments to states will likely start on March 2. I’ve had a really hard time pinning down exactly how much vaccine is actually available and ready for distribution in the U.S. The best info I could find is from a media report in the Washington Post quoting 2 anonymous FDA officials that said there are about 2 million doses available right now and that the supply of this vaccine will be 20 million by the end of March.

If true, that’s pretty disappointing because 2 million doses nationally translates into only 40,000 doses for Arizona right now. If they can really ramp up to 20 million doses by the end March that will be better. That would translate into 400,000 doses but is the equivalent to 800,000 doses of the Pfizer or Moderna vaccines because J&J doesn’t require the booster shot.

The Friday, Feb. 26 at 7 a.m. AZ time FDA Center for Biologics Evaluation and Research’s Vaccines and Related Biological Products Advisory Committee meeting will be online.

  • The agenda can be found here.

  • FDA’s Briefing Document – Janssen Ad26.COV2.S Vaccine for the Prevention of COVID-19 – can be found here.

  • Janssen Biotech Inc. Briefing Document Addendum can be found here.

  • The live meeting will be available here and here.

The online web conference meeting will be available at the following: 

Note: Globally and in the U.S. this is a very important vaccine. It is simple, inexpensive, doesn’t require complicated storage and handling, and (perhaps most importantly) is a single dose vaccine. This vaccine belongs in doctor’s offices, pharmacies, and community health centers. Using it at mass vaccination sites would be a big mistake because one of this vaccine’s strengths is its flexibility. This vaccine’s flexibility means that we can bring the vaccine to the people rather than bringing the people to the vaccine… which can help us overcome the large disparities that exist in Arizona: ADHS Vaccine Appointment System Favors the Wealthy & Creates Health Disparities

In the U.S., it will be a terrific addition to our current vaccines because it’s perfect for doctor’s offices and pharmacies. Because it’s single dose, it will be a lot less labor intensive. In developing nations, it would be a game changes for the same reasons and because it is inexpensive to make.

Despite January 2018 Arizona Opioid Epidemic Act Opioid Deaths Continue to Increase

New AzPHA Report:

Report: Rates and Trends of Opioid Overdose Deaths in Arizona 1999 – 2019: Implications for Public Health Policy

Increasing deaths from opioid drug overdoses have been and remain a serious public health problem in Arizona and throughout the U.S. To address the crisis, Arizona State Legislature, the ADHS, AHCCCS, and the Governor’s Office collaborated to pass and implement the Arizona Opioid Epidemic Act in January 2018.

The Act made wide-ranging policy changes throughout the healthcare system including big changes to prescribing practices. Our report explores the nature of the epidemic in Arizona at the 3-year mark since the Act was passed using data from 1999 through the end of 2019.

Major Findings:

Despite the implementation of the evidence-based policies within the Arizona Opioid Epidemic Act, our report found no evidence to suggest that the epidemic is slowing. Indeed, the rates of opioid and other drug related deaths have further accelerated, particularly in the synthetic opioid category that includes fentanyl.

The data presented in this report indicate that existing intervention efforts (Arizona Opioid Epidemic Act) have not measurably slowed the overall opioid overdose epidemic in Arizona. 

Our report found a slight decline in mortality rates from prescribed opioids after implementation of the Act. However, profound increases in mortality from fentanyl have continued and even accelerated since implementation of the Act.

We urge Arizona’s Executive Branch and the Arizona State Legislature to use our report findings to explore whether changes made to prescribing practices and other portions of the Act have been effective and to implement additional evidence-based public health policy interventions to mitigate this continuing public health crisis.

Why Is the U.S. the Global Laggard Authorizing the AstraZeneca Vaccine?

Study results continue to pile in showing that the AstraZeneca vaccine is safe and effective, yet it’s crickets when it comes to getting Emergency Use Authorization of the vaccine here in the U.S. The entire European Union as well as the U.K have authorized its use and are administering the vaccine big time… but not here in the U.S.

Now that vaccination infrastructure is really ramping up – especially within the federal pharmacy and community health center direct shipment programs it’s getting increasingly frustrating to see nation after nation authorizing use of the AstraZeneca vaccine yet we are unable to deploy it to our communities.

Previous clinical trial data has been showing that the Oxford/AstraZeneca vaccine is safe and effective, and now a new study published in The Lancet this week that shows real-world evidence of the same. The study (in pre-print) entitled Efficacy of ChAdOx1 nCoV-19 (AstraZeneca) Vaccine Against SARS-CoV-2 VOC 202012/01 (B.1.1.7) finds that the AstraZeneca vaccine is reducing hospital admissions from covid-19 in Scotland by 85%.

A study published a couple of weeks ago of the Phase III AstraZeneca candidate vaccine found that it not only protects people from serious illness and death but also substantially slows the transmission of the virus. That was published in The Lancet. See blog post: New Data Published On the Key AztraZeneca Vaccine: Promising Results

The U.S. government has a contract with AstraZeneca that’s even bigger than the contracts with Moderna and Pfizer combined and manufacturing has been underway during the clinical trials. The new AstraZeneca vaccine could really help push us to the end of this pandemic much faster if we could get it authorized here and deploy it to pharmacies and community health centers.

What I can’t figure out is what’s taking the Emergency Use Application so long?

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

Takeaways from Dr. Gerald’s weekly analysis of the epidemiology and hospital capacity report:

This week saw a fifth straight week of meaningful declines in Covid-19 cases and hospital occupancy. Nevertheless, absolute levels of SARS-CoV-2 viral transmission remain above the 100 new cases per 100,000 residents per week threshold which marks elevated risk.

As of February 14th, new cases were being diagnosed at a rate of 158 cases per 100,000 residents per week (Figure 10 below). This rate is declining by 86 cases per 100,000 residents per week. Despite this improvement, Arizona has the 19th highest viral transmission rate in the US according to the CDC. Overall, Arizona remains the 6th hardest hit state in terms of cases identified.

While residents and businesses should continue to follow the recommended public health mitigation efforts, normalization of lower risk activities will be reasonable once case rates fall below 100 new diagnoses per 100,000 residents per week.

Hospital Covid-19 occupancy is declining in the ward and ICU. However, access to care remains restricted with only limited numbers of medically necessary non-Covid procedures being scheduled.

According to the CDC, 4.9% of Arizona residents have received at least 2-doses of vaccine while another 9.8% have received 1-dose. The ADHS Dashboard is reporting slightly higher levels. To date, Arizona has administered 84% of its delivered doses. Arizona vaccination roll-out ranks in the bottom half of US states.

Many have asked about herd immunity and the risk of a spring outbreak. While I believe this winter’s outbreak will be Arizona’s largest, a smaller wave is possible this spring. However, a spring wave should it occur will pose a lesser threat as most of those at risk of hospitalization and death will have been vaccinated. For this reason, the short-term outlook remains favorable.

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