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Tuesday, November 9, 2021

Naturally-Acquired Immunity Versus Vaccine-Acquired Immunity

by Jennifer Margulis via The Epoch Times,

Science and public policy seem to disagree over which one is better...

 “He’s got a pass!” said the dad sitting across from me at the airport in Bismarck, North Dakota, where we were both stranded due to flight delays. He gestured to his 5-year-old son.

“Had a slight fever and tested positive for COVID. We had to keep him home from school for a couple weeks. Then, he tested negative and was good to go. I got the vaccine. My wife did, too. But he can travel anywhere without any testing, and there’s no vaccine for his age anyway.”

In Germany Natural Immunity Counts

Since the beginning of July in Germany, where that family lives, if you can demonstrate proof of being COVID-recovered and then have a subsequent negative COVID test, you are considered immune. For six months anyway, according to the German government.

But in the United States, where my family lives, even those who are COVID-recovered (and show high protection via either antibody or T-cell testing) are being told they also must get vaccinated. Indeed, the CDC has been actively urging Americans who have already had COVID to get the vaccine.

America’s federal and state health officials, via the mainstream media and social media, as well as on their official channels, insist that COVID vaccines offer better protection than natural immunity alone.

CDC Urges Vaccination for COVID-Recovered

A CDC statement from August sums up the official position nicely: “New CDC Study: Vaccination Offers Higher Protection Than Previous COVID-19 Infection.”

“If you have had COVID-19 before please still get vaccinated,” CDC Director Dr. Rochelle Walensky urged the public in that release.

“Getting the vaccine is the best way to protect yourself and others around you, especially as the more contagious Delta variant spreads around the country.”

But is it really?

Natural Immunity Versus Vaccine Immunity

Despite sensationalist headlines, reinfection with COVID-19 appears to be exceedingly rare. If you are unvaccinated and have had COVID, the chances of you getting it again are slim. A preliminary report from Israeli scientists shows that out of 149,735 people in Israel with confirmed COVID-19 cases (documented via positive PCR tests) only 154 people had evidence of reinfection, which is about 1 in 1,000.

Another study, however, suggests that the chances of reinfection are even lower than 1 in 1,000. Cleveland Clinic scientists who examined a cohort of 52,238 employees found no cases of reinfection among unvaccinated people with evidence of prior SARS-Co-V-2 infections.

The same study showed that vaccinated people who hadn’t had COVID-19 had a lower risk of infection than unvaccinated people. Still, the researchers concluded that “individuals who have had SARS-CoV-2 are unlikely to benefit from COVID-19 vaccination, and vaccines can be safely prioritized to those who have not been infected before.”

Sarbecovirus Infections Protect Against Future Disease

The benefits of naturally acquired immunity may go beyond protection against COVID. SARS-CoV-2, the virus that causes COVID-19, is part of a family of viruses known as sarbecoviruses. Symptoms vary widely in different people, but these viruses can create severe acute respiratory syndromes that usually begin with a fever and body aches, according to the CDC.

There have been two previous SARS outbreaks. A 2003 outbreak thought to have originated in China in 2002 infected about 8,098 people and led to about 774 deaths, according to the World Health Organization. Another smaller SARS outbreak occurred in 2004.

Both of these outbreaks were self-limiting: humans managed to overcome the illnesses naturally without mass vaccination campaigns. Research on these other sarbecovirus infections is limited, but it seems that when we acquire natural immunity to these viruses, it helps protect us against future disease.

To study this, scientists in San Francisco took blood from people who had had previous COVID infections (SARS-CoV-2 and SARS-Co-V) and assessed 12 antibodies in the blood. As reported in Nature, the California researchers found that one antibody in particular (S2H97) was able to bind to a range of sarbecovirus infections and keep the viruses from spreading in lab experiments. When they tested the antibody in hamsters, it kept the rodents from getting sick.

This “super antibody,” which was acquired naturally, essentially blocked SARS viruses from spreading to other cells. While the research is being used to promote the idea of developing a broad-ranging vaccine, it also shows that there may be long-lasting benefits to natural infection.

Viral Illness: Natural Immunity Provides Long-Lasting Protection

With other infectious diseases caused by viruses, we have seen that natural infection provides longer-lasting protection than vaccine immunity. For example, a 2017 study of adults in the Czech Republic published in the scientific journal PLOS One showed that the highest protection against the measles, as measured by antibody levels in people’s blood, was in people over 50 years of age who were naturally infected before the implementation of a measles vaccine.

Other research on swine flu (H1N1) published in the Journal of Experimental Medicine in 2011, found “extraordinarily” powerful antibodies in the blood of nine people who caught the swine flu naturally and recovered from it.

Though, again, this research was showcased by news reports as evidence that it may be possible to develop a one-size-fits-all vaccine against different strains of flu viruses, what it actually demonstrates is that recovering from naturally acquired viral infections not only gives people short-term immunity against other viruses but may also be of lasting benefit in fighting off other viral infections as well.

Because SARS-CoV-2 is a novel virus and the vaccines to protect against it only became available in January, it isn’t scientifically possible to know the long-term protection offered by either the infection or the vaccines.

As more data comes in, however, it appears that even mild infection can provide robust protection from COVID-19 infection. A study from July evaluated 254 COVID-19 patients for up to eight months and found “durable broad-based immune responses,” even among COVID-recovered patients who had only mild symptoms.

Other recent data also suggests that natural immunity is long-lasting. A study from Finland published in September in the European Journal of Immunology found that in COVID-recovered patients protection against reinfection persisted for over a year.

Immunologist: Natural Immunity Better Than Vaccination

Yet another large study from August looked at a database of 2.5 million Israelis and found that “natural immunity confers longer-lasting and stronger protection against infection, symptomatic disease and hospitalization caused by the Delta variant of SARS-CoV-2, compared to the BNT162b2 two-dose vaccine-induced immunity.”

This Israeli study found that people who were vaccinated who hadn’t been previously infected were 6 to 13 times more likely to get infected with COVID-19 than unvaccinated people who had already had the illness.

“It’s a textbook example of how natural immunity is really better than vaccination,” Charlotte Thalin, an immunology researcher and specialist in internal medicine who is based in Stockholm, Sweden, told Science.org.

Where Is The Science Behind The CDC’s Vaccine Push?

Given the natural protection provided to people who recover from COVID, why is the CDC so eager to get every eligible American vaccinated, even those who have recovered and have naturally acquired immunity?

The CDC press release references only two reports. The first report showed that unvaccinated people in Kentucky were nearly 2 1/2 times more likely to get re-infected with COVID compared to fully vaccinated individuals.

The second CDC report, co-authored by more than 40 medical doctors and public health officials (several of whom disclose direct ties to the pharmaceutical companies manufacturing and profiting from these vaccines), looked at hospitalization rates of adults aged 65 and older. It concluded that “among adults aged 65-74 years, effectiveness of full vaccination for preventing hospitalization was 96 percent for Pfizer-BioNTech, 96 percent for Moderna, and 84 percent for Janssen COVID-19.”

The second report cited by the CDC excluded hospitalized patients who had only one dose of any COVID vaccine less than 14 days prior. It also didn’t specify if those who were vaccinated or those who were unvaccinated had a history of prior infection.

So that report sheds no light on whether vaccine immunity is more long-lasting than immunity from infection and offers no evidence to justify the idea that COVID-recovered patients should get vaccinated.

The CDC didn’t mention other studies that showed findings contrary to the Kentucky study. It’s unclear whether the agency reviewed those studies and found the Kentucky study to be stronger or only considered the Kentucky study in making their policy to recommend and require that the previously infected get the vaccine.

Meanwhile, much of the established science supports the superiority of acquired immunity. That fact has put some people, such as Laurie Lentz-Marino, in a difficult position as they try to balance the consequences of not complying with vaccine mandates against their understanding of what’s in the best interest of their health.

“Vaccine-induced immunity can never be as long-lasting and robust as naturally acquired immunity,” said Lentz-Marino, who taught chemistry and biology classes at Mount Holyoke College in South Hadley, Massachusetts, for more than 20 years.

“The human immune system knows what it’s doing. We are an incredibly successful species. There would not be close to 8 billion people on the planet otherwise.”

Lentz-Marino, 61, recently resigned from her teaching position over vaccine and mask mandates at the college.

“It’s a sad joke to think that we know better than Mother Nature. We’re going in the wrong direction. It’s really arrogant to think that we can re-design our immune systems.”

https://www.zerohedge.com/covid-19/naturally-acquired-immunity-versus-vaccine-acquired-immunity

Jazz Raises Full Year Earnings Guidance

 2021 Financial Guidance1

Jazz Pharmaceuticals is updating its full year 2021 financial guidance. This guidance reflects the Company's current and future expected operational performance, including COVID-19 related impacts, the strength of its underlying operations and the prioritization of new and ongoing value creating development projects.

The Company is raising its full-year earnings guidance, resulting in a reduced GAAP net loss and increased non-GAAP adjusted net income (ANI) on an absolute and per share basis. The updated non-GAAP ANI range exceeds the upper end of the prior range. The Company is reducing both SG&A and R&D expense guidance on a GAAP and non-GAAP adjusted basis, reflecting progress within its transformation initiatives, improved financial discipline and strategic capital allocation. The Company is narrowing its net sales guidance range for neuroscience and oncology, with a reduced mid-point for oncology net sales guidance which reflects the ongoing impacts of COVID-19 on our legacy products and the Rylaze competitive landscape at launch in 3Q21, resulting in a reduced mid-point for total revenues guidance.


Guidance provided as of

(In millions)

August 3, 2021


November 9, 2021

Revenues

$3,020 - $3,180


$3,020 - $3,100

-Neuroscience

$2,260 - $2,360


$2,275 - $2,345

-Oncology

$715 - $835


$715 - $735

GAAP:


Guidance provided as of

(In millions, except per share amounts and percentages)

August 3, 2021


November 9, 2021

Gross margin %

85%


85%

SG&A expenses

$1,468 - $1,560


$1,400 - $1,451

SG&A expenses as % of total revenues

46% - 52%


45% - 48%

R&D Expenses

$542 - $596


$514 - $548

R&D expenses as % of total revenues

17% - 20%


17% - 18%

Effective tax rate

(58%) - (102%)


(110%) - (183%)

Net loss

($560) - ($400)


($420) - ($320)

Net loss per diluted share

($9.40) - ($6.70)


($7.00) - ($5.40)2

Weighted-average ordinary shares used in per share calculations

60


60

Non-GAAP:


Guidance provided as of

(In millions, except per share amounts and percentages)

August 3, 2021


November 9, 2021

Gross margin %

93%


93%3,7

SG&A expenses

$1,120 - $1,180


$1,060 - $1,1004,7

SG&A expenses as % of total revenues

35% - 39%


34% - 36%

R&D Expenses

$500 - $540


$465 - $4855,7

R&D expenses as % of total revenues

16% - 18%


15% - 16%

Effective tax rate

13% - 15%


11% - 13%6,7

Adjusted net income

$830 - $910


$925 - $965

Net income per diluted share

$13.40 - $14.70


$15.10 - $15.802,7

Weighted-average ordinary shares used in per share calculations

62


61



Federal workers' union asks Biden to delay vaccine deadline

 The American Federation of Government Employees on Tuesday urged the Biden administration to delay the deadline for federal workers to get vaccinated against COVID-19 from Nov. 22 to Jan. 4.

The request comes after the Biden administration pushed back the deadline for federal contractors to get vaccinated from Dec. 8 to Jan. 4 to align with the vaccine-or-test mandate for large businesses. 

The labor union, which represents around 700,000 federal and Washington, D.C., government workers, said it is unfair that the deadline for federal employees was not delayed as well.

“This double standard has caused confusion and distress among federal employees due to disparate treatment and incongruent deadlines for people who perform the government’s work in the same settings,” Everett Kelley, the union’s president, wrote in a letter to White House officials Tuesday. 

“It is inexcusable that contractors are being given the entire holiday season to meet the mandates, while federal employees continue to be subject to the November 22 deadline,” he added. “The effect upon morale of federal employees being subject to possible discipline at this time of the year cannot be overstated.”

President Biden’s federal vaccine mandate will affect around 4 million federal workers, who will not have the option of undergoing weekly testing as an alternative to the vaccine.

Congressional Republicans have warned that the federal vaccine requirement could lead to staffing issues at agencies like the Bureau of Prisons and the Border Patrol where large numbers of federal employees are still not vaccinated.

White House Coronavirus Response Coordinator Jeff Zients said last month that federal employees who do not comply would undergo “counseling” as a first step. They would later face suspensions and eventually be fired.

“It’s important to remember that this is a process and the point here is to get people vaccinated, not to punish them,” he said. “So, agencies will not be removing employees from federal service until after they’ve gone through a process of education and counseling.”

https://thehill.com/regulation/labor/580795-federal-workers-union-asks-biden-to-delay-vaccine-deadline

Ligand Pursuing Plans for OmniAb to Become a Standalone Public Company

 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) today announced it is pursuing plans to split Ligand into two separate, publicly traded companies with one featuring the OmniAb business, and the other featuring Ligand’s existing collection of core royalties and the technologies, pipeline and contracts associated with the Pelican protein expression platform and the Captisol business. The spin-off is intended to create two companies with dedicated operational focus, business-specific capital allocation, agility to meet partner needs, and compelling focused investment profiles.

“Our OmniAb business continues to have an outstanding year with the first regulatory approval for an OmniAb-derived antibody received during the third quarter and a second approval anticipated by year-end,” said John Higgins, CEO of Ligand. “We believe more than ever that OmniAb offers one of the industry’s leading antibody discovery platforms and that the business is primed for success for years to come. After significant planning and analysis, we have concluded we are operating two distinct, high-growth companies within Ligand. Along with outside advisors we have determined the time is right to pursue a strategic plan to create two independent companies and accelerate investment into the OmniAb platform and technologies to further drive value.”

Based on initial management and advisor review, an IPO and eventual distribution of OmniAb shares to Ligand shareholders is the leading option under consideration at this time. The IPO would be of newly issued shares of OmniAb, Inc., which would include the Ab Initio computational antigen design technology, Icagen’s ion channel technology, the xPloration high-throughput screening technology, and the suite of OmniAb transgenic animals used for antibody discovery. In an IPO, Ligand expects OmniAb to issue less than 20% of its common stock, with Ligand retaining the remaining interest, which would eventually be distributed to Ligand stockholders in a manner generally intended to qualify as a tax-free transaction. Ligand's OmniAb strategic review is in response to the ongoing success of OmniAb, as well as the opportunity to unlock the value of this business. Ligand’s Board of Directors has not approved a specific course of action, and Ligand will continue to evaluate other options to optimize value and ensure flexibility to invest in growth. There can be no assurance that this process will result in Ligand pursuing a particular transaction or consummating any such transaction.

This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, and shall not constitute an offer, solicitation, or sale in any jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.

The latest corporate presentation can be accessed at investor.ligand.com.

Conference Call

Ligand management will host a conference call today beginning at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) to discuss third quarter financial results as well as this announcement, and to answer questions. To participate via telephone, please dial (833) 540-1167 from the U.S. or (929) 517-0358 from outside the U.S., using the conference ID 5486177. To participate via live or replay webcast, a link is available at www.ligand.com.

https://investor.ligand.com/press-releases/detail/454/ligand-pursuing-plans-for-omniab-to-become-a-standalone

Judge rules that United’s employee vaccine mandate can continue

 A federal judge in Texas on Monday ruled that United Airlines’ employee vaccine policy can proceed.

The Chicago-based airline has one of the strictest employee vaccine policies in the country. In September, it said that staff who receive medical or religious exemptions would be placed on unpaid leave.

Six employees filed suit to block the policy in September.

U.S. District Judge Mark Pittman wrote in his ruling: “it is not for the Court to decide if United’s vaccine mandate is bad policy. Rather, it is the Court’s role to determine if Plaintiffs carried their burden to obtain a preliminary injunction.”

United said Monday that the roughly 2,000 employees who were granted religious or medical exemptions to its policy could apply for non-customer facing roles and that those who do not apply will be put on leave.

“We are working to identify non-customer facing roles where accommodated employees can apply and continue working until it is safe for them to their return to their current positions,” it said.

United has said that more than 96% of its 67,000-person U.S. workforce is vaccinated.

https://www.cnbc.com/2021/11/08/us-judge-rules-that-uniteds-employee-vaccine-mandate-can-continue.html

Novan Plans to Advance SB019 for Treatment of Covid

 Novan Inc. on Tuesday said it had favorable preclinical safety data and intends to advance SB019 for treatment of Covid-19.

Shares rose 6% to $7.37 in premarket trading.

The pharmaceutical company said data indicate intranasal administration of SB019 formulation containing berdazimer sodium is well-tolerated and safe under the conditions of the preclinical study. The company said it believes the conclusions from this good-laboratory practices study support advancement of the SB019 program toward in-human clinical development.

Novan said pre-investigational new drug application activities are underway with a target of an IND submission no later than the second quarter of 2022.

The company said it also completed additional dose-range finding studies in SARS-CoV-2 infected golden Syrian hamsters through work conducted at the Institute for Antiviral Research at Utah State University.

https://www.marketscreener.com/quote/stock/NOVAN-INC-31370488/news/Novan-Plans-to-Advance-SB019-for-Treatment-of-Covid-19-36954824/

Pf'izer CEO calls people who spread vaccine misinformation 'criminals

 Pfizer CEO Albert Bourla on Tuesday described people who spread false information about the coronavirus vaccines as “criminals.”

“Those people are criminals,” Bourla said to Atlantic Council CEO Frederick Kempe, CNBC reported. “They’re not bad people. They’re criminals because they have literally cost millions of lives.”

Bourla said it is a “very small” group of people who have been spreading misinformation about the vaccines.

Bourla’s comments come after a Kaiser Family Foundation (KFF) poll that found 8 in 10 Americans believe or are unsure of at least one statement about the vaccines that are false. 

"Belief in COVID-19 misinformation is correlated with both vaccination status and partisanship, with unvaccinated adults and Republicans much more likely to believe or be unsure about false statements compared to vaccinated adults and Democrats," the poll said.

Millions in the United States have yet to be vaccinated despite the fact the COVID-19 vaccines have been available to people above the age of 12 for months. 

“The only thing that stands between the new way of life and the current way of life is, frankly, hesitancy to vaccinations,” Bourla said.

The KFF poll found 17 percent of people think pregnant women shouldn’t get the vaccine, 18 percent believe deaths from the vaccines are hidden by the government and 38 percent believe the government is exaggerating how many people died from the virus.

https://thehill.com/policy/healthcare/580762-pfizer-ceo-labels-people-who-spread-vaccine-misinformation-criminals