Mailing in the Politics

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The mail-in ballots of more than 84,000 New York City Democrats who sought to vote in the presidential primary were disqualified, according to new figures released by the Board of Elections.

The city BOE received 403,103 mail-in ballots for the June 23 Democratic presidential primary.

But the certified results released Wednesday revealed that only 318,995 mail-in ballots were counted.

That means 84,108 ballots were not counted or invalidated — 21 percent of the total.

One out of four mail-in ballots were disqualified for arriving late, lacking a postmark or failing to include a voter’s signature, or other defects. The Post reported Tuesday that roughly 30,000 mail-in ballots were invalidated in Brooklyn alone.

The high invalidation rate provides more proof that election officials and the Postal Service were woefully underprepared to handle and process the avalanche of mail-in ballots that voters were encouraged to fill out to avoid having to go the polls during the coronavirus pandemic, critics said.

Gov. Andrew Cuomo signed an executive order to make it easier to vote by mail-in or absentee ballot. The state also footed the bill by providing pre-paid envelopes for voters to mail the ballots.

“A 26 percent invalidation rate is astounding. It’s very troubling,” said Arthur Schwartz, who represented several candidates in a federal lawsuit claiming voters were disenfranchised over the BOE and Postal Service’s handling of ballots..

A federal judge ruled Monday that thousands of voters were disenfranchised because of the tardy mailing and processing of the ballots.

The mess included votes not being counted because the prep-paid ballots were not post-marked.

Manhattan Judge Analisa Torres ordered that ballots received by June 25 be counted, though the state Board of Election said it is appealing the ruling.

Aside from tardy mailings and processing, Schwartz said scores of ballots were tossed out because the voters failed to sign the interior envelope that came with it.

But he said it wasn’t the voters’ fault.

“The envelope with directions for the signature was so poorly designed,” Schwartz said.

Doug Kellner, co-chair of the state Board of Elections, agreed with the criticism.

Meanwhile the embattled BOE found itself in hot mired in controversy again after emails obtained by The Post show the agency blew off Kellner, who proposed reforms to prevent another absentee balloting nightmare in November.

His six-page proposal urged city BOE officials to ensure proper staffing at polling places during the November election to ensure lines are no longer than 30 minutes; to tally absentee ballots more quickly than the six weeks it took to certify results from the primary; and to plan for processing “double or triple” the number of absentee applications.

“Add new capacity to process the applications in a timely manner now. Do not wait for a backlog from which you can never recover,” Kellner said.

City lawyers admitted in Manhattan federal court last week that they were still mailing absentee ballots the day before the June primary, leaving little chance they could reach voters in time.

Kellner’s memorandum even suggested that city election administrators should apologize for the mess.

“To those voters who did not have an opportunity to cast their ballots in the primary election, we should apologize for not doing more,” he wrote. “Elected officials and others warned that we were not deploying sufficient resources to mail out absentee ballots in a timely manner, and in hindsight, we could have done more to address the problem.”

Lockdown Effects = What Nobody Talks About...

SCOTT W. ATLAS, JOHN R. BIRGE, RALPH L KEENEY AND ALEXANDER LIPTON, The COVID-19 shutdown will cost Americans millions of years of life

Our governmental COVID-19 mitigation policy of broad societal lockdown focuses on containing the spread of the disease at all costs, instead of “flattening the curve” and preventing hospital overcrowding. Although well-intentioned, the lockdown was imposed without consideration of its consequences beyond those directly from the pandemic.

The policies have created the greatest global economic disruption in history, with trillions of dollars of lost economic output. These financial losses have been falsely portrayed as purely economic. To the contrary, using numerous National Institutes of Health Public Access publications, Centers for Disease Control and Prevention (CDC) and Bureau of Labor Statistics data, and various actuarial tables, we calculate that these policies will cause devastating non-economic consequences that will total millions of accumulated years of life lost in the United States, far beyond what the virus itself has caused.

Pandemics have afflicted humankind throughout history. They devastated the Roman and Byzantine empires, Medieval Europe, China and India, and they continue to the present day despite medical progress.

The past century has witnessed three pandemics with at least 100,000 U.S. fatalities: The "Spanish Flu," 1918-1919, with between 20 million and 50 million fatalities worldwide, including 675,000 in the U.S.; the "Asian Flu," 1957-1958, with about 1.1 million deaths worldwide, 116,000 of those in the U.S.; and the "Hong Kong Flu," 1968-1972, with about 1 million people worldwide, including 100,000 in the U.S. So far, the current pandemic has produced almost 100,000 U.S. deaths, but the reaction of a near-complete economic shutdown is unprecedented.

The lost economic output in the U.S. alone is estimated to be 5 percent of GDP, or $1.1 trillion for every month of the economic shutdown. This lost income results in lost lives as the stresses of unemployment and providing basic needs increase the incidence of suicide, alcohol or drug abuse, and stress-induced illnesses. These effects are particularly severe on the lower-income populace, as they are more likely to lose their jobs, and mortality rates are much higher for lower-income individuals.

Statistically, every $10 million to $24 million lost in U.S. incomes results in one additional death. One portion of this effect is through unemployment, which leads to an average increase in mortality of at least 60 percent. That translates into 7,200 lives lost per month among the 36 million newly unemployed Americans, over 40 percent of whom are not expected to regain their jobs. In addition, many small business owners are near financial collapse, creating lost wealth that results in mortality increases of 50 percent. With an average estimate of one additional lost life per $17 million income loss, that would translate to 65,000 lives lost in the U.S. for each month because of the economic shutdown.

In addition to lives lost because of lost income, lives also are lost due to delayed or foregone health care imposed by the shutdown and the fear it creates among patients. From personal communications with neurosurgery colleagues, about half of their patients have not appeared for treatment of disease which, left untreated, risks brain hemorrhage, paralysis or death.

Here are the examples of missed health care on which we base our calculations: Emergency stroke evaluations are down 40 percent. Of the 650,000 cancer patients receiving chemotherapy in the United States, an estimated half are missing their treatments. Of the 150,000 new cancer cases typically discovered each month in the U.S., most – as elsewhere in the world – are not being diagnosed, and two-thirds to three-fourths of routine cancer screenings are not happening because of shutdown policies and fear among the population. Nearly 85 percent fewer living-donor transplants are occurring now, compared to the same period last year. In addition, more than half of childhood vaccinations are not being performed, setting up the potential of a massive future health disaster.

The implications of treatment delays for situations other than COVID-19 result in 8,000 U.S. deaths per month of the shutdown, or about 120,000 years of remaining life. Missed strokes contribute an additional loss of 100,000 years of life for each month; late cancer diagnoses lose 250,000 years of remaining life for each month; missing living-donor transplants, another 5,000 years of life per month — and, if even 10 percent of vaccinations are not done, the result is an additional 24,000 years of life lost each month.

These unintended consequences of missed health care amount to more than 500,000 lost years of life per month, not including all the other known skipped care.

If we only consider unemployment-related fatalities from the economic shutdown, that would total at least an additional 7,200 lives per month. Assuming these deaths occur proportionally across the ages of current U.S. mortality data, and equally among men and women, this amounts to more than 200,000 lost years of life for each month of the economic shutdown.

In comparison, COVID-19 fatalities have fallen disproportionately on the elderly, particularly in nursing homes, and those with co-morbidities. Based on the expected remaining lifetimes of these COVID-19 patients, and given that 40 percent of deaths are in nursing homes, the disease has been responsible for 800,000 lost years of life so far. Considering only the losses of life from missed health care and unemployment due solely to the lockdown policy, we conservatively estimate that the national lockdown is responsible for at least 700,000 lost years of life every month, or about 1.5 million so far — already far surpassing the COVID-19 total.

Policymakers combatting the effects of COVID-19 must recognize and consider the full impact of their decisions. They need to be aware of the devastating effects in terms of lost life from shutting down significant parts of the economy. The belated acknowledgement by policy leaders of irreparable harms from the lockdown is not nearly enough. They need to emphatically and widely inform the public of these serious consequences and reassure them of their concern for all human life by strongly articulating the rationale for reopening society.

To end the loss of life from the economic lockdown, businesses as well as K-12 schools, public transportation, parks and beaches should smartly reopen with enhanced hygiene and science-based protection warnings for any in the high-risk population. For most of the country, that reopening should occur now, without any unnecessary fear-based restrictions, many of which repeat the error of disregarding the evidence. By following a thoughtful analysis that finally recognizes all available actions and their consequences, we can save millions of years of American life.

When the next pandemic inevitably arises, we need to remember these lessons and follow policies that consider the lives of all Americans from the outset.

New Vaccines Promise to Be a Greater Disappointment with Poorer Results than Hydroxychloroquine

from Yahoo News

Nearly $6 billion has been allocated. Clinical trials are entering a crucial third phase, and Operation Warp Speed is getting closer to the goal of delivering 300 million doses of a COVID-19 vaccine by January.

But when Americans line up for their immunizations, the vaccine they receive might not be what they expect. The popular notion of a vaccine — a shot in the arm that prevents diseases such as measles, polio or shingles for years or a lifetime — may not apply.

Under recently released federal guidelines, a COVID-19 vaccine can be authorized for use if it is safe and proves effective in as few as 50% of those who receive it. And "effective" doesn't necessarily mean stopping people from getting sick from COVID-19. It means minimizing its most serious symptoms, experts say.

“We should anticipate the SARS-CoV-2 vaccine to be similar to the influenza vaccine,” said Dr. Kathleen Neuzil, director of the Center for Vaccine Development at the University of Maryland. “That vaccine may or may not keep people from being infected with the virus, but it does keep people out of the hospital and the ICU.”

Even with expectations scaled back, the development of a vaccine against a virus that no one knew about seven months ago is considered remarkable. One assessment calls it “the compression of six years of work into six months.”

Of the more than 150 vaccines in the works worldwide, Operation Warp Speed has identified 14 "promising candidates." (A vaccine being developed by El Segundo-based ImmunityBio, headed by Times owner Dr. Patrick Soon-Shiong, is among the 14. It has not yet been tested in humans.)

Of those 14, seven have been designated as front-runners, including three whose early clinical trial results have undergone independent evaluation.

The vaccine being developed by Moderna and the National Institutes of Health was deemed “promising” in an editorial published in the New England Journal of Medicine, and two studies in the Lancet delivered a similar message for vaccines being developed at Oxford University and by the Chinese company CanSino.

These vaccines have induced an immune response in people participating in early tests, but inducing an immune response does not always mean success in fighting a disease. For instance, scientists recently developed a vaccine for another respiratory virus that increased antibodies but failed its Phase 3 clinical trial.

While there is no way to predict what lies ahead, experts say, the first round of COVID-19 vaccines will likely not eliminate the need for other public health measures, such as masks and social distancing.

The minimum 50% efficacy recommendation spelled out in late June by the Food and Drug Administration would likely ease the burden on hospitals. And to whatever extent a COVID-19 vaccine prevents infection, it could reduce the spread of the virus and help to create pockets of immunity throughout the country, said Dr. Peter Hotez, dean of Baylor College of Medicine’s National School of Tropical Medicine.

“Ideally, you want an antiviral vaccine to do two things," Hotez said. "First, reduce the likelihood you will get severely ill and go to the hospital, and two, prevent infection and therefore interrupt disease transmission.”

In this case, he added, "the bar does not seem that high."

Developing a vaccine capable of inducing “sterilizing immunity” — that is, the ability to prevent the virus from causing an infection — takes time and research, which might not be possible as death tolls continue to rise and the recession grows deeper. Yet with so many companies on the hunt for that vaccine, there is hope one of them might actually achieve it.

Dr. Mark Feinberg, CEO of the International AIDS Vaccine Initiative, cites the success of the Ebola vaccine. Not only did it speed through its clinical trials — from starting Phase 1 to getting early Phase 3 results in 10 months — but it also was nearly 100% effective within 10 days of a single dose being administered.

That's not likely to be the case now. “The challenge is that the novel coronavirus hasn’t been around long enough,” Feinberg said.

Scientists had studied other coronaviruses — SARS and MERS — and mapped the novel coronavirus' genome not long after the first COVID-19 deaths were recorded. They identified the spike protein on the virus’ outer shell, which the virus uses to infiltrate the host cell and created a three-dimensional model of the virus to see how antibodies block infection by binding onto the spike protein.

Even so, scientists don't yet know what immunity against the virus looks like. That information typically comes from studying the body’s natural response to disease. The number of T-cells and neutralizing antibodies that fight off an infection can become a blueprint for a vaccine.

But the novel coronavirus is not easily giving up those secrets.

Physicians have noted a wide range of immune responses to COVID-19, Feinberg said. Some patients produce high levels of neutralizing antibodies, while others produce only low levels.

“What’s interesting is that all have recovered, and we do not know how they did this,” said Feinberg, a former chief public health and science officer with the pharmaceutical giant Merck.

Scientists are also uncertain how long immunity — from a natural infection or a vaccine — lasts and whether a decline in antibodies in two to three months is cause for concern.

The third phase of clinical trials might answer some of these questions. Moderna is enrolling 30,000 people for its Phase 3 trial, which started Monday.

“If we get a vaccine that is 60% efficacious, we can use the information to identify what distinguishes people who are protected from those who are susceptible, ” Feinberg said. "Then we will know what the minimum target is for an immune response.”

But the absence of that information does not preclude the distribution of a vaccine. Many vaccines are effective even though scientists don't know the amount of antibodies needed to prevent infection. A vaccine can even be effective if it doesn’t prevent infection.

The polio vaccine that Jonas Salk developed does not stop the poliovirus from infecting the gastro-intestinal tract, said Feinberg, but it stops the virus from traveling to the central nervous system where it causes the disease’s worst symptom, paralysis.

With so many questions still unanswered, the effectiveness of a COVID-19 vaccine may not be known until well after Americans have received their shots.

Among the recommendations in the FDA guidelines is a provision for emergency use authorization, allowing for the distribution of a vaccine if “the known and potential benefits of a product … outweigh the known and potential risks of the product.”

“I imagine that it is likely that the FDA will issue an emergency use authorization if any of the vaccines in development show significant and convincing evidence of efficacy and safety,” said Feinberg, whose research organization is collaborating with Merck to develop a COVID-19 vaccine.

Under an emergency use authorization, the vaccine could be administered before the completion of the Phase 3 trials, potentially helping to flatten the curve but giving scientists little time to study side effects or understand how it interacts with other vaccines.

Dr. Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia, has raised concerns that the FDA would greenlight manufacturing and distribution of vaccines before the necessary reviews have been completed.

Offit worries that a vaccine with limited efficacy delivered prematurely might give people “a false sense of being protected” and “lead to serious outbreaks of the disease.”

“We should wait for the completion of Phase 3 trials, no matter how long they take,” he said. “With luck, they could be finished in six to nine months.”

But postponing the delivery date for a vaccine would not align with the January goal of Operation Warp Speed.

The Trump administration's ambitious timeline has led to $5.7 billion being allocated to seven companies, and critics like Hotez and Offit wonder if speed is getting in the way of science.

Dr. Robert Gallo, director of the Institute Human Virology at the University of Maryland, argues that Operation Warp Speed, a private-public partnership, is “science by committee,” directed by a few individuals, when there needs to be robust debate and exchange of information.

“If science problems need innovation, then there needs to be wide openings for original thinking and a means to argue or counter without the worry that you cannot get funded,” he said.

Gallo, who cofounded the Global Virus Network, is concerned that the seven front-runners in Operation Warp Speed are each using the same strategy for their vaccine, one designed to neutralize the spike protein.

If that method proves ineffective, then the timeline for delivering a vaccine will be extended.

“I’m sure it is not wise to put all these eggs in one basket,” he said.