When the Pfizer and Moderna vaccines were first approved, it was clear that they were highly effective at preventing covid and that they would be in short supply for months.  The clinical trial data also suggested that, at least in the short-run, one dose of the vaccines would provide almost as much protection against covid as the two-dose protocol that was tested and approved by the FDA. 

This led a number of economists and public health professionals to argue that we could gain an edge in the fight against covid – and likely save tens of thousands of lives – by prioritizing first doses and delaying second doses (“first doses first”).  We could also stretch existing supplies by giving people half-doses, and by giving one dose to people who have recovered from covid and have some degree of natural immunity to reinfection, or simply by delaying their vaccination until more vulnerable people have been protected.

Most of the debate over vaccine stretching policies has been technocratic.  Proponents argue that first-doses-first and other vaccine stretching policies will save lives, and opponents point to various risks.  In my view the technocratic case for first-doses-first and other vaccine stretching policies is strong, but the politics are difficult.  Unfortunately, proponents of these policies have failed to think creatively about how to overcome political obstacles to vaccine stretching.  So let’s think about the political challenges and ask how the Biden administration might have been persuaded to try using first-doses-first, half-doses, and similar policies

The politics of first doses first are challenging

Coronavirus dashboard for March 15: good news, and cause for concern

A year ago today I wrote about the accuracy of Jim Bianco’s forecast of exponential spread of COVID-19. At that time there were exactly 2952 cases, but increasing at 30% each day, and I wrote, “I have not seen any government action significant enough to stop this exponential projection being correct.” 

As of yesterday, there have been 29,438,775 *confirmed* cases – 9% of the total US population. There have certainly been many more cases which have never been confirmed by testing, primarily but not always because they were mild or asymptomatic.

The good news is that vaccinations in the US are making better and better progress. In the past week, about 2.5 million doses were administered each day. At this rate, the entire adult population could be vaccinated by the end of June.   

Reader and poster Coberly updating Angry Bear readers on recent Social Security findings in the 2020 report. Reader Bruce Krasting had alerted Angry Bear to the publication by the Social Security Trustees of a “revised baseline” that includes effects of the Covid recession on their projections otherwise from the 2020 Trustees Report. “Updated Baseline for Actuarial Status of the OASI and DI Trust Funds, Reflecting Pandemic and
Recession Effects“

The Trustees have better information than I have and assumed a lower unemployment rate with effects of the recession lasting over several years, but returning to “normal” by the year 2029.  Their new projections bring the Trust Fund exhaustion date one year closer, but the ultimate 75 year deficit remains at about 4% of payroll.

Using their revised baseline, and attendant projected changes in some of the parameters they use for their projections, I was able to replicate their calculations, giving me confidence that my own findings regarding necessary payroll tax changes are consistent with their projections.

The necessary payroll tax changes amount to an average tax increase of less than one tenth of one percent (each) per year.  This is different from my pre-covid findings only in that the tax increases would need to be a bit larger in the first years than previously estimated.

Just doing the local rounds and reading. One of three writers over at Naked Capitalism had this up on a small way escape the boredom of Covid.  It is more than just a promotion about chocolate and it does make you smile. When I was working in Riethim-Weilheim area of Germany near Tuttligen, on the weekend I would drive into Switzerland to a  Chocolatier in Schaffhausen and buy a nice box of chocolates to share with my German associates and then wander over to  Konstanz to explore along the lake.  Good stuff and it made friends. A little bit about the writer: Jerri-Lynn Scofield has worked as a securities lawyer and a derivatives trader. She is currently writing a book about textile artisans.

I just finished compiling today’s Links and they are particularly dire. COVID-19 is not going away. There is no vaccine or cure in sight. Even some places that had seemed to control spread of the disease – much of Europe – are imposing more draconian restrictions, in response to an uptick in cases. The only positive thing I can think of to say is the virus does not seem to have evolved into a more virulent form and that treatment is getting better. Small comfort.

According to today’s New York Times, As the Coronavirus Surges, a New Culprit Emerges: Pandemic Fatigue:

There is a big push by trump and Republicans to bring a Covid to market quickly.

Remember the Thalidomide Disaster, The Morning Call, May 12, 2020

Thalidomide

In the rush to find a vaccine or treatment for the coronavirus, let’s not forget the bitter lesson learned in the 1950s and ’60s when thalidomide was prescribed to pregnant women for morning sickness. Thalidomide was approved for European use in 1957 although it was never tested on pregnant women.

Our Food and Drug Administration never approved the drug, but 20,000 pills had been given to doctors for distribution to patients in clinical trials. After reports surfaced about babies born with birth defects to mothers who had taken the drug, thalidomide was taken off the market.

Worldwide, an estimated 10,000 to 20,000 babies were born with deformed or shortened limbs; about 40% died around the time of birth. Children who didn’t die in infancy suffered from eye, ear, heart, and urinary tract problems.

Thalidomide was taken off the market in 1961. In the years since the tragedy, several countries, including the U.S., have tightened their drug regulations.

“The Thalidomide Tragedy: Lessons for Drug Safety and Regulation,” Helix, Bara Fintel, Athena T. Samaras, Edson Carias, September 2009

Clinical Trials

In a  recent conversation with one person who I would consider knowledgeable, I was led to this site. COVID-19 Live Vaccine Tracker. This is an initial rundown of various Covid vaccines being worked on by international companies and the phase they are in today. I will attempt to update this from time to time.

“A compilation of the active vaccine candidates being studied for coronavirus 2019 (COVID-19) cures. This tracker will update periodically and will have the latest news and information.” The COVID-19 Live Vaccine Tracker, ContagionLive

Phase 3

Vaccine Name: mRNA-1273
Company: Moderna
Moderna’s phase 1 trial, mRNA-1273 vaccine: Results of treating novel coronavirus (COVID-19) were published July 14, 2020 in The New England Journal of Medicine. The NEJM reported on the results of potential vaccine induced protective responses in 45 adult participants receiving doses of 25, 100, or 250 μg (micrograms) throughout March and April 2020.  Antibodies did occur and correlated with higher doses of the mRNA-1273 vaccine as by anti–S-2P antibody GMT (geometric mean titer) ; 40,227 in the 25-μg group, 109,209 in the 100-μg group, and 213,526 in the 250-μg group.

With the second vaccination on day 57, the titers  had again showed increased antibody GMT when tested; 299,751, 782,719, and 1,192,154 μg. Serum-neutralizing activity (antibody that defends a cell from a pathogen or infectious particle by neutralizing any effect it has biologically) was detected by two methods in all participants evaluated, with values generally similar to those in the upper half of the distribution of a panel of control convalescent serum (blood serum containing antibodies  from disease or inoculation) specimens.

Adverse effects, includes half of the participants were fatigued, exhibiting chills, headache, myalgia, with pain at the injection site. Systemic adverse effects occurred after the second vaccination  particularly with the highest dosage. Three participants (21%) in the 250-μg dose group reported one or more severe adverse events.

The mRNA-1273 vaccine had induced anti–SARS-CoV-2 impact with an immune response in all participants of varying intensity with no trial-limiting safety concerns were identified.

mRNA-1273 vaccine was given a  Fast Track designation enrollment for a phase 2 trial at the end of May with an enrollment of 600 in 2 cohorts of those aged 18-55 years and those over 55 years.

A phase 3 trial involving 30,000 volunteers is receiving funding from BARDA and Operation Warp Speed. Participants in the study will receive either an injection of 100 μg mRA-1273 on Days 1 and 29 or a placebo.

Vaccine Name: Inactivated Vaccine
Company: Wuhan Institute of Biological Products; China National Pharmaceutical Group (Sinopharm)

The project involving Sinopharm and the Wuhan Institute of Virology are funded by the China Ministry of Science and Technology to achieve a goal of developing a vaccine utilizing inactivated vaccine. Phase 1 and 2 clinical trials with individuals of ages 6 and up are underway. As of June 16th, 1,120 volunteers participated in the phase 1 and 2 trials. The volunteers have received two injections of the vaccine at low, middle, or high dosing strengths or a placebo scheduled 14 days, 21 days or 28 days apart as reported by China National Biotec Group (CNBG). The seroconversion rate (time period during which a specific antibody develops and becomes detectable in the blood) for the 14-day and 21-day schedule of the mid-dose was 97.6%. At 28 days, it was 100%.

The Inactivate Vaccine appears to be working best at the middle strength when given 28 days apart. All participants in middle strength dosing regime developed neutralizing antibodies.

Sinopharm has initiated a phase 3 trial to evaluate their vaccine candidate in the United Arab Emirates. The country has authorized up to 15,000 participants aged 18 to 60 years to enroll.

“China’s Sinopharm touts 100% antibody response for COVID-19 vaccine with workers”

CDC tells states: Be ready to distribute vaccines on Nov. 1, Modern Healthcare, September 2, 2020

The federal government told states to prepare for a coronavirus vaccine to be ready to distribute by Nov. 1; from which the declaration of the early timeline raised concern among public health experts about the  “October surprise” of a vaccine approval and use being driven by political considerations ahead of a presidential election, rather than science.

The planning  documents here and here sent to governors Aug. 27 by CDC Director Robert Redfield advises states they will receive permit applications “in the near future” from the authorized distributor, McKesson Corporation, to distribute vaccines to places which include state and local health departments and hospitals. Dr Redfield wrote in an accompanying  letter,

“CDC urgently requests your assistance in expediting applications for these distribution facilities and, if necessary, asks that you consider waiving requirements that would prevent these facilities from becoming fully operational by November 1, 2020,”

There is not even a hint or a suggestion of partial Phase 3 testing being given beforehand which causes me to wonder if the extent of this is allowed under the 21st Century Cures Act passed in 2018. The act allowed for the skirting of some testing and the use actual data outside of the normal testing protocol to show a drug works? I believe the Cures Act only allowed a partial go-live on new drugs during a phrase 3. We must be following Putin lead. He gave the vaccine to his daughter. Perhaps, Trump will have Ivanka inoculated ?

Any volunteers at AB?

C.D.C. Tells States How to Prepare for Covid-19 Vaccine by Early November, New York Times, September 2, 2020

In comments to NDD’s post, Terry says:

Wisconsin—except for Milwaukee and Madison —basically opened up with no restrictions as a result of the Wisconsin Supreme Court ruling 4 weeks ago and much to the delight of the late night comics people flocked to taverns without regard of masks or social distancing. I certainly expected to see numbers bump up by now but in fact they have fallen steadily

Cool if true, but, as Warner Wolf said, let’s go to the video tape data:

author calculations from NYT County-level data

I’m seeing a pop in cases about two to three weeks after the ruling, which rather matches Terry’s (and the world’s) initial expectations.

If you look at the time after those two well-predicted spikes, they look as if they might—best case—return to the mid-May, still pre-“reopening” levels. This is most likely because large firms and stores and most non-alcoholics (unlike the gerrymandered abomination that is the lame-duck Wisconsin Supreme Court) are taking a cautious approach to returning people to work and restaurants and shops to full capacity (assuming they still have disposable income).

Chattahoochee County, Georgia, had a significant increase in cases from a relatively high (ca. 50) base. Fort Benning’s new cases appear to be the source, even as those are not fully reported in the NYT data yet.

Scurry County, Texas, is more typical; a 1200% (not a typo) increase—but from a base of two (2). Curiously, the Snyder, TX, website still lists 33 cases in the county, while the NYT data indicates about seven of those have been removed.

This is independent of the Huntsville, Texas, prison facility with significant issues, which is in Walker County. There have been more than 900 new cases there in the past eight days.

Arkansas has been a microcosm of what not to do, so it’s no surprise that both Jackson and Nevada Counties there are showing huge increases, though from relatively small bases. I can find no online explanation for the growth in either location.

Cache County, Utah, is home to Logan, now showing one of the fastest growth rates in cases—including nearly a ten-fold increase since Memorial Day: “The growth in northern Utah is driven by the increase of cases at the JBS meat packing plant in Hyrum.” I’m going to tell my students next semester that being an omnivorous human, in addition to decreasing your lifespan, creates negative externalities.

The State of Virginia may well be trending in a positive direction, but Greensville County is an exception, with a four-day increase of just under 70%, and more than a 400% increase since Memorial Day. There is a prison facility there, but local authorities say that isn’t the reason for the increase.

As a final note for today, Otero County in New Mexico, is the home of an “immigration detention facility.” Those cases were previously allocated to Otero and Doña Ana counties, have been treated as State only for the past month, but another prison (one authorities admit is one) is still counted as being in the county. Given the data, it seems likely that the NYT source is still counting the ICE black ops site as part of Otero county.

Shot:

Protecting Your Business From Legal Liability During Reopening
May 15 @ 11:00 am – 12:00 pm

In this brief 30-minute webinar, we will step business owners through the liability concerns when reopening following the COVID-19 shutdown. Bobbi Berkhof will inform entrepreneurs why following local, state, and federal recommendations may help protect the business from lawsuits, potentially stemming from employees and customers.

Chaser:

Or, in table form: