Will Humble Disease Control, Prevention, Vaccination, Wills Blog

Pfizer Announces Encouraging Phase III Clinical Trial Results

Early last week Pfizer suggested that their candidate vaccine now in late Stage III trials is about 90% effective in preventing symptomatic Covid-19 infections. The announcement was in a press release, not in a journal article and they didn’t disclose the Phase III data to support the claim, but nevertheless you gotta believe that there must be some data to back this up.

The Phase III Trial was conducted in the U.S. and has enrolled about 44,000 volunteers. Most of the participants were given the vaccines (a series of 2 vaccines 28 days apart), with some participants getting the placebo.

The company said that almost all the 94 persons in the trial that ended up contracting COVID-19 were in the placebo group. Statistically speaking, they said that the Phase III data (which has not been disclosed) suggests that the vaccine is 90% effective at preventing COVID-19.

Immunity is established 7 days after the booster is administered. They also said that serious adverse events have not yet been identified.

There are numerous vaccines in Phase III trials right now including several in the U.S. This Pfizer vaccine as well as Moderna’s candidate use a new Messenger RNA technology. Both Moderna and Pfizer expect to submit full Phase III trial data in the coming weeks.

The U.S. government contracted with Pfizer to manufacture the vaccine during the Phase III trials with a guarantee that the company will get paid even if the vaccine isn’t given Emergency Use Authorization or full FDA Approval. As a result, there is already significant inventory of this vaccine in storage.

HHS Secretary Azar earlier this week suggested that there will be 50M doses of the Pfizer vaccine available for distribution by December 31. Arizona’s proportionate share of those 50M doses would be about 1M. But remember, this vaccine requires a booster at 28 days, so it takes 2 doses for each person to be fully immunized.

Here’s a link to one of my previous blog posts that discusses how vaccines are tested and approved.

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

New Research Identifies Restaurants and Bars as the Highest Risk Locations for Amplifying COVID-19

A new and super-interesting study was published in Nature this week examining the relative risk of SARS CoV2 virus spread in various environments like restaurants and bars, gyms, grocery stores and a host of other environments.

The researchers used a model that integrates fine-grained, dynamic mobility networks to simulate the spread of SARS-CoV-2 in 10 of the largest US metropolitan statistical areas. They used cell phone data to map the hourly movements of 98 million people from neighborhoods to evaluate the relative contribution to viral spread from places like restaurants and bars, gyms, retail stores, churches, and other places. They developed a model that accurately fits the real case COVID-19 trajectory.

Just as other research has shown, their model predicts that a small minority of “super-spreader” places account for a large majority of infections. Restaurants and bars were far and away the riskiest environments. Gyms were a distant second with 4x less risk than restaurants and bars.

They conclude that interventions like restricting maximum occupancy at restaurants and bars is a more effective intervention than uniformly reducing mobility (e.g. a broad-based stay at home order):

“This highlights the non-linearity of predicted infections as a function of visits: one can achieve a disproportionately large reduction in infections with a small reduction in visits. Reopening full-service restaurants has the largest predicted impact on infections, due to the large number of restaurants as well as their high visit densities and long dwell times.”

Important information to take into consideration as we again enter exponential amplification of the virus and diminishing hospital capacity.

Will Humble Disease Control, Wills Blog

Dr. Gerald’s Weekly Epidemiology & Hospital Report is Alarming

Dr. Gerald just published this week’s AZ epidemiology and hospital capacity report, and the results are alarming. Those of you that read this blog seldom see me using that kind of language (at least since June and July) but there’s no other way to say it. This week’s report feels a lot like early June.

We’re now entering exponential growth of cases especially in the 15 to 24 year-old group but also among 25-64 year-olds. As Dr. Gerald says in his report this week:

“We are now entering a crisis, one in which we have little time to walk-back from. While hospitals still have capacity to care for critically ill patients, we are nearing the point at which noticeable shortages of personnel and resources are going to emerge. owing to rapidly increasing case counts and the lag between case identification and hospitalizations. If this “surge” is not quickly addressed, new Covid-19 cases will overwhelm our capacity to provide optimal hospital care within a matter of weeks.”

Community-driven transmission has surpassed the rates we experienced during the second week of June when 13,000 cases were diagnosed. At current transmission levels, Arizona is not far from exceeding the weekly cases we had just before the state authorized using Crisis Standards of Hospital Care in early July.

We’re also are seeing significant viral amplification in rural areas (that generally have no mask mandates in place) with Graham, Gila, Coconino, Yuma, and Navajo counties having higher than average per capita rates.

Hospital admissions and eroding capacity are lagging the case rates just as we saw in June and July. The percentage of ICU beds occupied by patients with Covid-19 has increased from a low of 6.2% on September 13th to 18.4% on November 10th.

The current hospital surge differs from the one in June in that Covid-19 infections have shifted towards younger patients who are less likely to require hospital and ICU care. Also, better infection control practices and staff testing capacity in long-term care settings have led to proportionately fewer cases among the most vulnerable long-term care facility residents (Figure 8 in Dr. Gerald’s report shows the Pima County data).

Those factors, along with improving treatments, more experienced providers, and greater testing accessibility have led to a 23% reduction in hospitalizations and a 45% reduction in ICU cases for the same number of Covid-19 diagnoses (Figure 9). However, when rising community-transmission spills over into long-term care settings, admissions will rise more quickly. Arizona hospitals also have less reserve capacity now than when hospital occupancy was lower this summer.

The return of part-time residents, a backlog of elective procedures, and non-Covid respiratory illnesses also mean that hospitals will reach capacity sooner than they did this summer. If that happens, Arizona can expect less external staffing assistance this time since many other states are experiencing their own hospital capacity crises.

WHAT CAN BE DONE?

Face Coverings

For the last several weeks we’ve been calling for a statewide face covering mandate. Face coverings are increasingly recognized as the highest return on investment intervention to slow the spread of the SARS CoV2 virus (besides vaccines). Evidence from the National Academies of Medicine and Science demonstrated this effectiveness. More compelling results have been shown in a recent Systematic Review of studies in The Lancet.  It’s past time for Arizona to implement a sensible statewide face covering mandate similar to the one implemented by Utah’s governor last weekend.

Mitigation Measures in Bars and Restaurants

A recent model reported in Nature, shows that many infections are likely  coming from bars and restaurants. Indeed, in Arizona the combination of allowing local jurisdictions to implement face covering ordinances and temporarily closing bars and scaling back restaurant capacity to 50% had a dramatic effect on the spread of the virus.

The best thing we can do as a state right now is to learn from last summer’s lessons and significantly reduce the number of people allowed in bars and restaurants at one time. We know these mitigation strategies work and they are our best option for reducing spread and ensuring that our healthcare system will be able to provide high-level care.

The enhanced mitigation measures will need to be accompanied by better compliance and enforcement than we currently have in place. The governor  should consider an executive order to give enhanced enforcement authority to county health departments so they can get bars and restaurants that aren’t following the mitigation measures back into compliance. Counties will also need CARES Act funds to finance the effort.

Personal Responsibility

As we press into the holiday season, the urge to gather socially with friends and family will be tempting, especially given the stress of 2020. However, it’s important that we think through the ramifications of our decisions. Decisions we make through November and December could be with us for months to come and could impact how we visit loved ones in hospitals or long term care facilities, whether our kids can return to school as well as the level of care we receive from our healthcare system.

Failure to act now in proactive ways will likely result in completely closing bars, nightclubs, schools, hospitals and visitations in long-term care facilities in early December when hospital capacity is exceeded and Crisis Standards of Care are again authorized.

Will Humble Disease Control, Wills Blog

New SARS CoV2 Research

Age specific mortality and immunity patterns of SARS CoV2

In this study researchers explored the case fatality ratio for COVID-19 among all age ranges. They found that mortality is lowest among kids 5-9 years old and that there’s a log-linear increase by age among individuals over 30. They conclude that age and risks from living in a nursing home explains some (but not all) of the differences between countries when it comes to infection-fatality ratios.

“Among the 45 countries included in our analysis, we estimate approximately 5% of these populations had been infected by the 1st of September 2020, with much higher transmission likely to have occurred in a number of Latin American countries. This simple modelling framework can help countries assess the progression of the pandemic and can be applied wherever reliable age-specific death data exists.”

MMWR: Transmission of COVID-19 in Households 

A new MMWR from the CDC describes COVID-19 transmissions in households. The report found that there was a 53% secondary infection rate in households. The results reinforce the idea that folks should self-isolate and wear masks in shared household spaces.

SARS-CoV-2 Neutralizing Antibody LY-CoV555 in Outpatients with Covid-19

In a phase 2 trial, outpatients with Covid-19 who received a single infusion of a 2800-mg dose of the neutralizing antibody had a greater reduction in viral load compared to people who got the placebo. Hospitalization was less frequent among antibody-treated patients too (1.6% vs. 6.3%). Here’s the article.

New and Updated MMWR: Characteristics of Symptomatic Women and Infants Following COVID-19 Infection in Pregnancy

In a new MMWR, authors describe pregnancy outcomes among women with COVID-19 infection. Through the Surveillance for Emerging Threats to Mothers and Babies Network, 16 jurisdictions collected information on pregnancy and infant outcomes among 5,252 women with COVID-19 infection reported during March 29–Oct. 14, 2020.

Both preterm birth and adverse infant outcomes were observed at higher rates among women with COVID-19 infection. Additionally, CDC provided an update on characteristics of symptomatic women of reproductive age with COVID-19 infection.

Will Humble Marijuana, Public Health Law, Social Determinants, Wills Blog

Prop 207 Achieves Criminal Justice Reform & Sets Up a Retail Marijuana System

Arizonans approved Proposition 207 which will dramatically reform marijuana possession laws including allowing for the retail sale of up to 1 ounce of marijuana in authorized stores to folks over 21 years old. The law will take effect when the election is certified later this month.

There are many provisions in the new law. Here are a few highlights:

  • Adults 21 and older would be able to possess 1 ounce of marijuana with no more than 5 grams of it being marijuana concentrates (extracts).

  • Possessing more than 1 ounce but less than 2.5 ounces would be a petty offense. Minors caught with less than 1 ounce would receive up to a $100 fine and 4 hours of drug counseling for a first offense. A second offense would be up to a $100 fine and 8 hours of drug counseling. A third offense would be a class 1 misdemeanor.

  • Beginning July 12, 2021, people convicted previously of possessing less than an ounce of marijuana or six or fewer plants or paraphernalia can petition to have the record expunged.

  • Allows home cultivation of marijuana but limits it to 12 plants at a residence where two or more individuals who are at least 21 years old reside at one time.

  • The ADHS will need to establish recreational marijuana regulations before April 5, 2021, and existing medical marijuana dispensaries will be allowed to add a retail line of business when their licenses are approved in the spring of 2021. Medical marijuana dispensaries will be able to sell recreational marijuana to adults as a bridge until the ADHS issues licenses for recreational dispensaries).

  • A 16% excise tax (the same as cigarettes and alcohol) will be placed on recreational marijuana products. Money from the excise tax would fund various state agencies and be dispersed between community college districts, police and fire departments, and the Highway User fund. Medical marijuana will not be subject to this tax.

  • Marijuana use would remain illegal in public places (restaurants, parks, sidewalks, etc.). Smoking in a public place would be a petty offense.

  • No marijuana products could be sold that imitate brands marketed to children or look like humans, animals, insects, fruits, toys, or cartoons.

  • Marijuana edibles will be limited to a maximum of 10mg of THC per edible and limited to a maximum of 100mg of THC per package of edibles. This does not apply to medical marijuana.

  • Employers have the right to maintain a drug- and alcohol-free workplace.

  • Driving under the influence of marijuana remains illegal.

There are currently tens of millions of excess dollars in the Arizona Medical Marijuana in large part because I set the medical marijuana card fees way too high. Once certified, the law requires the transfer of $10M from the existing fund to the ADHS to fund programs for teen suicide prevention, maternal mortality review, poison control centers and programs to prevent Adverse Childhood Experiences. I imagine that the ADHS will be reaching out to stakeholders as they prepare to deploy those funds.

Prop 207 also releases $4M from the MM fund for grants to organizations to help people file for expungement of previous convictions of qualifying possession of marijuana charges.

Will Humble Disease Control, Wills Blog

Pfizer Announces Promising Efficacy Data for Their mRNA SARS CoV2 Vaccine

Pfizer announced on Monday that an early analysis of its coronavirus vaccine trial suggested the vaccine was robustly effective in preventing Covid-19. The announcement didn’t come with many details so I don’t have many details to share except the following:

The Phase III Trial was conducted in the U.S. and has enrolled about 44,000 volunteers. About half of the participants were in the placebo group and about half were in the group that got the vaccine (with a booster a month later). The company said that almost all of the 94 persons in the trial that ended up contracting COVID-19 were in the placebo group. Statistically speaking, they said that the Phase III data (which has not been disclosed) suggests that the vaccine is 90% effective at preventing COVID-19. They also said that no serious adverse events were identified.

A couple of cautionary notes are that these results haven’t been released or published in a peer-reviewed journal article. Also, many of the participants in the Phase III trial haven’t been followed up for even a full 60 days yet (important for identifying adverse events).

There are 11 vaccines in late Phase III trials right now including 4 in the U.S. This Pfizer vaccine as well as Moderna’s candidate use a new Messenger RNA technology that has never before been used to create a vaccine. Both Moderna and Pfizer expect to submit full Phase III trial data in the coming weeks.

Here’s a link to one of my previous blog posts that discusses how vaccines are tested and approved.

Will Humble Affordable Care Act, Disease Control, Federal Budget, Public Health, Public Health Law, Wills Blog

Election Result Musings

Federal

The result of the presidential election will no doubt have profound implications for public health. We can expect to see new leadership in most if not all the agencies under the US Department of Health and Human Services including CDC, HRSA, CMS, FDA etc. Those agencies have a great deal of latitude in the decisions they make and can change their regulations (CFR’s)… although changing regulations takes a lot more time than simple policy changes.  

Congress may be split between a House controlled by Democrats and a Senate controlled by Republicans (pending Senate run-off elections in Georgia). If there is a split, the we’re unlikely to see major public health legislation passed but we will see dramatically different decisions being made by the various federal agencies. We can also expect to see a series of Executive Orders issued in mid-January that will have implications for public health and the response to the pandemic.

The transition to the new administration will be happening over the next 72 days. Transitions are always a bit tumultuous and this one will be particularly so because of the pandemic. For example, the FDA will be making critical decisions about the safety and efficacy of the various SARS CoV2 vaccines during the transition period. The CDC is expected to be developing guidance for the prioritization of the early vaccine doses. Several of the HHS agencies will be working on plans to deploy the vaccines.

Dr. Fauci is in a particularly interesting position. As the most credible national voice for COVID public health policy he must be thinking about whether he can be more useful as a member of the existing administration or whether he can be more valuable if he were to retire from his position at the NIH (at least temporarily) and work with the incoming administration’s transition team.

State

At our last Public Health Policy Committee meeting we discussed developing a more aggressive public health policy agenda for the upcoming legislative session in anticipation of either the State House or Senate flipping to Democratic control.

As it turns out, it looks like the Democrats will remain in the minority in both chambers again. We’ll continue to think through our policy agenda.  In the mean-time, here’s the policy agenda from 2020: 2020 Legislative Session Priorities (ppt).

Will Humble Disease Control, Wills Blog

Dr. Gerald’s Latest Epidemiological Report

Here is Dr. Gerald’s latest weekly epidemiology and hospital capacity report. Here is his narrative summary (below) and here’s his full weekly report.

 Cases and hospitalizations continue to increase state-wide with the more rural, previously spared counties leading the charge. Pima County saw a second straight week with a fairly large increase. Last week’s increase was due in part to a confirmed outbreak in a correctional facility. Even so, there is ample evidence of broader community-level transmission.

While not yet a crisis, hospitals capacity is at the point where Covid and non-Covid occupancy is placing a noticeable strain on personnel and resources.

Will Humble Disease Control, Wills Blog

Interesting New Studies and Essays

More than 90% of Mild to Moderate COVID-19 Patients have Strong Antibody Response

Most people with mild-to-moderate COVID-19 produce antibodies that can fight off the infection that remain at similar levels in the body for at least 5 months, suggests research carried out at Icahn School of Medicine at Mount Sinai in New York.

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Regeneron’s Two-Antibody COVID-19 Treatment “Cocktail” Reduces Viral Load

REGN-COV2, has met its primary endpoint of significantly reducing viral load and medical visits in ambulatory adults with COVID-19. However, the company is reviewing a possible change of dosages in the study after finding no significant difference in efficacy between the high and low doses of the treatment.

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Facial Masking for Covid-19 — Potential for “Variolation” as We Await a Vaccine

M. Gandhi and G.W. Rutherford N Engl J Med 2020;383:e101

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Evaluating and Deploying Covid-19 Vaccines — The Importance of Transparency, Scientific Integrity, and Public Trust

J.L. Schwartz N Engl J Med 2020;383:1703-1705

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CDC Releases Two New MMWRs

The first release describes an investigation of a university’s men’s and women’s soccer team where 17 COVID-19 cases were identified. Lax social distancing and mask use during social gatherings were thought to contribute to the spread.

The second release describes results from the Data Foundation’s COVID Impact Survey. Self-reported adherence to COVID-19 mitigation measures was lowest in the 18-29 age group, while those 60 years or older reported the highest adherence.

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