AzPHA Member Public Health Policy Update
February 7, 2021
New AzPHA Report:
COVID-19: The Leading Cause of Death in AZ During the Pandemic
One of our newest AzPHA members, Allan N. Williams, MPH, PhD (he recently retired from at the Minnesota Department of Health and moved to AZ) analyzed ADHS vital statistics data and developed our newest epidemiology report entitled: “How Do COVID-19 Death Rates Compare to the 15 Leading Causes of Death in Arizona?”
Not surprisingly, the report found that COVID-19 has been the leading cause of death in Arizona (Nationally, it has been the third third leading cause of death). The fact that COVID deaths are currently comparable in prevalence to our two long-standing major killers – heart disease and cancer – is a sobering statistic and represents a deadly failure to control this pandemic.
As previously noted in our January 24, 2021 AzPHA Report 2020 All-Cause Mortality Trends in Arizona During the COVID-19 Pandemic, 2020 mortality data show a significant increase (14,972 additional deaths) in overall deaths compared to 2019. While most of this increase is clearly attributable to COVID-19 deaths, the AzPHA mortality analysis indicated that some 3,444 of the excess deaths were not reported as COVID-19 deaths.
This is consistent with estimates indicating that 35% of COVID-19 deaths are unreported. It is also possible that deferral of care for serious non-COVID-19 medical conditions or reduced screenings during the pandemic also account for a portion of the non-COVID-19 excess.
While there is room for optimism as vaccinations slowly ramp up and new vaccines are now imminent, there is at the same time growing concern about the rapid spread of more transmissible variants of the SARS-CoV-2 virus and whether current vaccines will be less effective against these variants. Unfortunately, COVID-19 will remain a significant cause of death well into 2021.
A huge thanks to Dr. Williams for his work bringing this important information to light.
___________________
Drama Over Discarded Vaccine: Telling the Truth Matters
There was some drama last week about how much vaccine has been discarded at the various mass vaccination sites.
Journalists submitted public records requests to Maricopa County Department of Public Health and the ADHS asking for how many doses of vaccine were unusable at the various PODs. Maricopa County immediately produced the data, sharing that a total of 553 doses out of 153,196 administered have been discarded at their county PODs between December 17, 2020 – Jan. 20, 2021.
This represents 0.3% or 3 of every 1,000 thousand doses that have been administered through these PODs to that date. For perspective, standard wastage for all vaccines in doctors’ and pediatric offices is normally between 3% and 5%.
I did a few interviews on the issue of accidents and problems that can happen when administering vaccinations including this one from FOX10 saying that a 0.3% wastage rate is a testament to good performance at the PODs. By comparison, wastage rates at pediatric offices are typically between 3-5%.
The drama came when Governor Ducey tweeted the following statement:
“The COVID19 vaccine is a precious and limited resource – that any doses would be wasted is shocking and unacceptable. This has not and will not happen at any state-run sites, and local leaders must prevent it from ever happening again at any county-run site.”
– Governor Douglas A. Ducey
The statement that no problems have come up nor mistakes made at their branded State Farm POD is, of course, preposterous. There’s no way that a mass vaccination site like State Farm has never had an issue that led to a discarded vaccine.
Furthermore, Director Christ has still not disclosed how many vaccines have been discarded at State Farm, but I can guarantee you that it is not zero. I’m hopeful but not optimistic that Director Christ will respond to the existing records requests about their own data about vaccine waste.
If there is any concern about the quality of the vaccine or any information is not readable on the label, manufacturers have advised providers to throw out the vaccine to maintain a safe operation. That can mean things like:
A vial does not have a readable label or expiration date and cannot be used;There is particulate matter or “floaters” present in the vial and all 5 doses are wasted;A vial is partially filled and none of the contents can be used;Equipment malfunction, such as a bent needle, recapping issues, or the plunger is depressed accidentally; andDraw-up issues like having a bubble in the syringe or a needle stick injury or an error mixing the dose.
These are issues that occur any time vaccines are given, particularly during large volume operations (this is not an exhaustive list of ways that vaccine doses can be unusable). Any large vaccine administration site that claims that “no doses are wasted” is not operating safely or not being honest about wasted doses.
Editorial Note: The fact that a small number of issues may have come up at State Farm and some vaccines have been discarded isn’t the issue.
The problem is a when the Governor makes a false statement disparaging the performance of a key partner (performance that is, in fact, good) when the state itself is unwilling to disclose its own performance on that same metric… and then he fabricates a tale that no vaccine has ever been discarded at the state branded site.
Persons in key elected and appointed positions should be honest and transparent with the people of Arizona. We deserve at least that.
________________________
Johnson & Johnson Submits Emergency Use Authorization Application to FDA
Johnson & Johnson applied for Emergency Use Authorization (EUA) for their candidate vaccine last Thursday. Their candidate is a single dose vaccine that uses a weakened cold virus as the vehicle for the antigen that stimulates the immune response.
The FDA has scheduled a Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Feb. 26, 2021, to discuss the request. They will likely make a recommendation whether to authorize or not during that meeting. The FDA Commissioner will then likely make a decision shortly thereafter.
Note: Former FDA Commissioner Hahn resigned and has been replaced by Acting Commissioner Janet Woodcock M.D. Dr. Woodcock is a Career FDA professional – having served at the FDA since 1984.
The company says they have vaccine immediately ready for shipment as soon as the FDA authorizes emergency use of the vaccine. The FDA hasn’t posted the application data on their website yet, but I’ll keep an eye out for it.
The J&J press release (not published data) said that their clinical trial of 43,783 participants “met all primary and key secondary endpoints”. The topline safety and efficacy data are based on 43,783 participants accruing 468 symptomatic cases of COVID-19.
They say that their vaccine candidate:
“… is 66% effective overall in preventing moderate to severe COVID-19, 28 days after vaccination. The onset of protection was observed as early as day 14. The level of protection against moderate to severe COVID-19 infection was 72% in the United States, 66% in Latin America and 57% in South Africa, 28 days post-vaccination.”
_________________
New Data Published On the Key AztraZeneca Vaccine: Promising Results
A new publication 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. The (not yet peer-reviewed) study was published in The Lancet this week.
This study was different from some clinical trials in that the research team measured the impact on transmission by swabbing participants every week. They found a 67% reduction in positive swabs among those vaccinated compared to the placebo group.
The team found that a single dose of the vaccine was 76% effective at preventing Covid-19.
Interestingly, they also found that the vaccine is more effective when the interval between the two shots was longer than the normal 28-day gap. The vaccine was 82% effective when there was 3 months between the 1st and 2nd jab compared to 55% when the doses were given less than six weeks apart.
AstraZeneca says they’ll have enough data by early March to ask the FDA for EUA. The UK authorized the vaccine before New Years and has deployed missions of doses. The E.U. authorized the vaccine last week. I can’t figure out why it’s taking so long in the U.S.
HHS has a contract for delivery of 300M doses of the vaccine but neither the company nor HHS has said when and in what quantities those doses will be available after the vaccine is approved.
Below is an excerpt from the study:
“Vaccine efficacy after a single standard dose of vaccine from day 22 to day 90 post vaccination was 76% (59%, 86%), and modelled analysis indicated that protection did not wane during this initial 3-month period. Similarly, antibody levels were maintained during this period with minimal waning by day 90 day (GMR 0.66, 95% CI 0.59, 0.74). In the SD/SD group, after the second dose, efficacy was higher with a longer prime-boost interval: VE 82.4% 95%CI 62.7%, 91.7% at 12+ weeks, compared with VE 54.9%, 95%CI 32.7%, 69.7% at <6 weeks.
