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Friday, December 31, 2021

COVID Booster Protection May Wane in About 10 Weeks, New Data Show

 Booster shot protection against symptomatic COVID-19 caused by the Omicron variant appears to fade in about 10 weeks, according to new data from Britain.

U.K. health officials shared the data just before Christmas and noted that there haven't been enough severe cases of the Omicron variant to calculate how well boosters protect against severe disease. But they believe the extra shots provide significant protection against hospitalization and death.

"It will be a few weeks before effectiveness against severe disease with Omicron can be estimated," U.K. Health Security Agency officials wrote in the report. "However, based on experience with previous variants, this is likely to be substantially higher than the estimates against symptomatic disease."

Since countries began reporting Omicron cases in November, multiple studies have suggested the variant is better at escaping antibodies from vaccination and previous infection, according to The New York Times . The U.K. report adds to that, noting that both the initial vaccine series and booster doses were less effective and faded faster against the Omicron variant than the Delta variant.

Among those who received two doses of the AstraZeneca vaccine, a booster of the Pfizer or Moderna vaccine was 60% effective at preventing symptomatic disease 2 to 4 weeks after the shot. But after 10 weeks, the Pfizer booster was 35% effective, and the Moderna booster was 45% effective. (The AstraZeneca vaccine is not authorized in the U.S., but the Johnson & Johnson shot uses a similar technology, The New York Times reported.)

Among those who received three Pfizer doses, vaccine effectiveness was 70% about a week after the booster but dropped to 45% after 10 weeks. At the same time, those who received an initial two-dose series of the Pfizer vaccine and then a Moderna booster seemed to have 75% effectiveness up to 9 weeks.

The report was based on an analysis of 148,000 Delta cases and 68,000 Omicron cases in the U.K. through Dec. 20. So far, the U.K. health officials wrote, Omicron infections appear to be less severe and less likely to lead to hospitalization than Delta infections. At that time, 132 people with lab-confirmed Omicron had been admitted to hospitals, and 14 deaths had been reported among ages 52-96.

"This analysis is preliminary because of the small numbers of Omicron cases currently in hospital and the limited spread of Omicron into older age groups as yet," the report said.

The reinfection rate has also increased for the Omicron variant, the report found. Among the 116,000 people who had an Omicron infection, about 11,000 -- or 9.5% -- were linked to a previous confirmed infection, which is likely an undercount of reinfections. In the data analyzed, 69 Omicron cases were a third episode of COVID-19 infection, and 290 cases occurred 60-89 days after a first infection.

Sources

U.K. Health Security Agency: "SARS-CoV-2 variants of concern and variants under investigation in England, technical briefing 33," Dec. 23, 2021.

https://www.medscape.com/viewarticle/965612

Pushback on Study Tying Schizophrenia to Violent Behavior

 A new meta-analysis suggests the risk for violence is higher in patients with schizophrenia, but some experts beg to differ, calling out study limitations and urging caution when interpreting the findings.

The study suggests patients with schizophrenia spectrum disorder (SSD) are 4.5 times more likely than individuals in the general population to perpetrate violence against others.

While the results showed comorbid substance misuse was associated with a significantly increased risk for violence in those with SSD, data on medication nonadherence, prior exposure to violence, childhood trauma, or other known risk factors were not included in the study.

Dr Seena Fazel

"I think one of the main implications of this study is that prevention of violence outcomes really should be a focus for clinical services, because these are important outcomes to prevent and many of the factors that increase risk are modifiable, such as substance misuse and treatment adherence," study co-investigator Seena Fazel, MD, professor of forensic psychiatry at the University of Oxford, United Kingdom, told Medscape Medical News.

Still, some experts urge caution when interpreting the findings, which they fear could perpetuate stigma against individuals with serious mental illness if not taken in the context of a study that shows association, not causation.

"While potential for violence is certainly a relevant consideration in assessing persons with schizophrenia spectrum disorder, it would be wrong to conclude from this study that schizophrenia spectrum disorders per se cause people to become violent," said Ronald W. Pies, MD, professor emeritus of psychiatry at SUNY Upstate Medical University in Syracuse, New York, who commented on the findings for Medscape Medical News.

The findings were published online December 22 in JAMA Psychiatry.

No Causal Link

The meta-analysis included 24 studies involving 51,309 individuals with SSD from 15 countries over four decades.

Risk for violence perpetrated by men with schizophrenia was 4.5 times higher (95% CI, 3.6 - 5.6) than their counterparts in the general population. Among women, the rate was 10.2 times higher (95% CI, 7.1 - 14.6) vs those without SSD.

The odds of perpetrating sexual offenses (odds ratio [OR], 5.1; 95% CI, 3.8 - 6.8) and homicide (OR, 17.7; 95% CI, 13.9 - 22.6) were also increased.

When restricting analysis to studies that used outcomes only from register-based sources, indicating a criminal arrest or conviction, absolute risks of violence perpetration ranged from 2.3% to 24.7% in men with SSD and from 0% to 5.4% in women up to a 35-year follow-up.

"That means that over a 35-year period, most men are not going to be involved in these criminal register-based violent outcomes," Fazel said. "And at least 90% of the women are not going to have any register-based violent outcomes."

When accounting for substance use comorbidity, risk for violence perpetration dropped sharply. Those with no substance misuse were 3.5 times more likely than those in the general population to commit acts of violence vs 9.9 times in those with substance misuse comorbidity.

"In these subgroup studies of people with dual diagnoses of schizophrenia and substance misuse, the risk was increased 10-fold," Fazel said. "If you look at people without substance misuse comorbidity, there remains a risk there of between three- to fourfold increase. It doesn't explain the association completely."

The investigators are quick to point out that this new study identifies an association between SSD and violence, and not causation.

"One important way to consider the association is to think of clinical services for people presenting with a schizophrenia spectrum disorder: Does the evidence suggest that violence is an important enough potential adverse outcome, for a minority of those individuals, such that support for this clinical need should be improved?" study investigator Daniel Whiting, BM BCh, a doctoral research fellow in psychiatry at the University of Oxford, told Medscape Medical News. "We highlight this as an implication of the findings."

Whether the association would change if researchers controlled for substance misuse in both the study and control groups is unknown. Also unclear from this study is what impact other risk factors may have on increasing violent outcomes in individuals with SSD.

Education, Treatment Adherence Important

Pies pointed out that, "notably, the risk for violence in the study population declined more than sixfold when comorbid substance abuse was excluded from the analysis."

That aligns with an earlier study conducted in Sweden by Fazel, which showed that after controlling for substance misuse, the rate of violent crime among individuals with schizophrenia was only slightly higher than in the general population.

"The fact is that people with schizophrenia who are compliant with proper medication do not commit violent acts any more than those in the general population," Lynn DeLisi, MD, professor of psychiatry at Harvard Medical School in Boston, Massachusetts and founding editor of Schizophrenia Research, told Medscape Medical News when asked for comment.

Indeed, Fazel's own research suggests treatment with antipsychotics cuts in half the risk for violent crime by patients with severe mental illness.

"The goal should be education of school officials, families, and primary care physicians to detect this illness early and treat it. Programs that make sure patients comply with medication once they begin it are equally important," DeLisi said.

Treatment adherence is important, but the first step toward violence prevention is high-quality risk assessment, said Fazel. His research team has developed a web-based, free risk calculator shown to help clinicians evaluate the risk that a patient might become violent.

Pies agrees with the importance of comprehensive, clinical assessments of modifiable risk factors, including substance use, homelessness, medication adherence, and conflictual relationships.

This kind of assessment, "in my experience, is rarely carried out in most evaluations of persons with psychotic symptoms or SSD," he said.

Perpetuating Stigma?

Another concern raised by Pies and DeLisi is how the findings might perpetuate stigma toward individuals with serious mental illness. Results from a study published last week showed that although attitudes toward those with major depression have improved in the United States over the past few decades, stigma toward those with schizophrenia has actually worsened.

The most effective approach to reducing stigma is to "face up to the evidence, then try and prevent the negative outcomes," Fazel said.

"The conclusion of this paper is that it's all pointing toward a strategy toward prevention by developing high-quality risk assessment and then developing high-quality treatment programs that include not just pharmacological treatments but psychosocial treatments and beyond," he added. "We know that's the way it works for other disorders as well."

Although mental illness stigma is a serious problem, Pies notes, "the risk is not so much that studies of this sort are carried out and then covered in the media, but that they are de-contextualized and reduced to 'bumper sticker' headlines."

"The public needs context and perspective," he said. "It needs to be informed that violent behavior is relatively rare among persons with psychiatric illness, including persons with schizophrenia and related disorders who do not also have a substance use disorder."

Indeed, some studies have shown that individuals with mental illness are more often the victims of violence than the perpetrators.

"Frankly, the public is much more at risk from the neighborhood lout who drinks heavily and repeatedly starts bar fights than from the average patient with a schizophrenia spectrum disorder," Pies said.

Fazel reports receiving funding from the Wellcome Trust. Disclosures for other study authors are fully listed in the original article. DeLisi and Pies have disclosed no relevant financial relationships.

JAMA Psych. Published online December 22, 2021. Abstract

https://www.medscape.com/viewarticle/965816

Oracle's stock falls toward record-long losing streak in wake of Cerner buyout deal

 Shares of Oracle Corp. ORCL, -0.91% slipped 0.3% in afternoon trading Friday, putting them on track to extend their losing streak to 11 sessions. That would be the longest such streak since Oracle went public in March 1986, according to Dow Jones Market Data. The database giant's stock has now tumbled 15.3% since it last gained ground, when it rose 3.8% on Dec. 15 to close at a record $103.65. Highlighting the losing streak was the 11.2% drop in two days to Dec. 20, after The Wall Street Journal reported, and Oracle confirmed, that it agreed to buy medical-records company Cerner CorpCERN, -0.29% in a deal valued at $28.3 billion. Despite the record-long losing streak, Oracle's stock has still run up 35.7% this year.

https://www.marketwatch.com/story/oracles-stock-falls-toward-record-long-losing-streak-in-wake-of-cerner-buyout-deal-2021-12-31

Is The Peak Of NYC's Omicron Wave Just Around The Corner?

 As we noted earlier, the US and worldwide tallies for the number of new COVID cases confirmed in a day are hitting fresh record highs as the year ends, giving some the impression that the global pandemic has barely been impacted by all the lockdowns, vaccines, boosters and other restrictions that have arisen over the past 2 years.

But as political leaders scramble to keep the media stocked with omicron-oriented FUD to report, it looks like we may have been correct a little over a week ago when we surmised that the peak of the outbreak in London may already be at hand.

In the US, there's been a lot of focus on New York City, where COVID cases and hospitalizations are climbing, though still below their levels from last year's winter wave.

Source: @ScottGottliebMD

Here's where things stand in New York: Thursday was another record-breaking day, with 74,207 newly reported COVID cases in NY State, with a stunning 43,985 in NYC alone. The positivity rate continues to increase; it's now 23.1%. Hospitalizations in NYC are also rising fast, now at 3,565, with 884 new admissions in past day alone.

Fortunately for New Yorkers, across the pond, Londoners are seeing what Dr. Scott Gottlieb believes might be a peak in the omicron wave (just in time since the NHS is already building field hospitals "just in case").

If the past is any guide, as Gottlieb points out in his tweet, NYC's peak in cases could arrive within 2 weeks now that London's peak appears to have finally arrived.

Source: @ScottGottliebMD

Going by hospitalizations that require mechanical ventilation and deaths, the peak in London is well below levels from last year.

Source: @ScottGottliebMD

Scientists have inferred that the UK is about two weeks ahead of New York when it comes to the seasonal COVID waves. So, if London is already past the week, how much longer will New Yorkers need to put up with behavior like this:

At any rate, the governor's mansion has decided to extend mask and vaccine mandates through Feb. 1.

Put another way, maybe JPM's Marko Kolanovic will finally be proven correct in that the omicron wave is bullish for risk because it means the end of the pandemic phase of COVID.

https://www.zerohedge.com/covid-19/has-peak-nycs-omicron-wave-finally-arrived

CDC Sued For Withholding Post-Licensure V-Safe Data On COVID Vaccines

 by Katabella Roberts via The Epoch Times,

The Centers for Disease Control and Prevention (CDC) has been sued by the Informed Consent Action Network (ICAN), which claims the agency is improperly withholding COVID-19 v-safe data from the American public.

In a statement on Dec. 29, the non-profit group said it had filed a lawsuit (pdf) against the public health agency and the United States Department of Health and Human Services to force it to produce de-identified post-licensure safety data for the COVID-19 vaccines in the CDC’s v-safe system, to the public.

As per the CDC, v-safe is an “active surveillance program to monitor the safety of COVID-19 vaccines during the period when the vaccines are authorized for use under Food and Drug Administration (FDA) Emergency Use Authorization (EUA) and possibly early after vaccine licensure.”

Through the app, vaccine recipients can inform the agency about any side effects they have suffered after getting the COVID-19 shots.

Currently, the CDC has made data from its v-safe system available to the private computer technology company, Oracle, in de-identified form, meaning that personal identifying information has been retracted.

This data “will be collected, managed, and housed on a secure server by Oracle,” the CDC says (pdf). “Through Health and Human Services (HHS), Oracle has donated IT services to any agency conducting COVID-19 related activities … All data will be stored, processed, and transmitted in accordance with the Federal Information Security Modernization Act (FISMA) and based on NIST standards.”

However, ICAN wants the CDC to produce that same de-identified data to the general public to assure transparency regarding the CDC’s and the Biden administration’s claims that COVID-19 vaccines are “safe and effective.”

“The FDA and CDC have now made crystal clear that their promise of transparency with regard to COVID-19 vaccines was hogwash,” ICAN said in Wednesday’s statement.

The Food and Drug Administration has asked a judge to give it 75 years to produce data concerning the Pfizer and BioNTech vaccine, having previously asked to give it until the year 2076 to fully release the documents.

“As everyone now knows, the FDA has asked a federal judge to give it at least 75 years to produce the pre-authorization/licensure safety data. And we now know with certainty, federal health authorities similarly want to hide the post-authorization/licensure safety data,” ICAN said.

“Based on the CDC’s own documentation, the data submitted to v-safe is already available in de-identified form (with no personal health information) and could be immediately released to the public,” ICAN said.

The non-profit group, through its attorneys, asked in three Freedom of Information requests that the CDC produce the de-identified data, to which the health agency acknowledged (pdf) that “v-safe data contains approximately 119 million medical entries” but declined to produce it because the “information in the app is not de-identified.”

However, the third request was administratively closed (pdf) by the CDC, which claimed it was a duplicate of the original request, which was denied.

“The first request was denied by the CDC because the CDC claimed it requested data that was de-identified when entered into the app, but then the CDC closed the second request (which was identical to the first request except for making clear it was seeking data de-identified at any point—before or after it was entered into the app) by claiming the second request was duplicative of the first request!  The CDC is plainly playing games. It clearly does not want the v-safe data released,” ICAN said.

The Epoch Times has contacted the CDC and the Department of Health and Human Services for comment.

ICAN said it believes that members of the public should “have immediate access to all v-safe data in de-identified form,” particularly in light of the fact that the Biden administration is mandating vaccines to millions of Americans.

“Despite the fact that this de-identified data already exists, that it is already in the hands of a private company, and that the CDC has never objected to its production, the CDC has so far failed to produce it to ICAN or to the American public—the same people being mandated to take this liability-free product,” ICAN said.

“But don’t worry, ICAN will not rest until this data is made public and so today has commenced a lawsuit against the CDC and HHS demanding that a court compel them to release this data,” ICAN added.

ICAN was founded by Del Bigtree in 2016. Earlier this year, the organization filed a lawsuit against the CDC to request the federal agency take down its statement that claims vaccines do not cause autism from its webpage on autism and vaccines.

https://www.zerohedge.com/covid-19/cdc-sued-withholding-post-licensure-v-safe-data-covid-vaccines

Animal study suggests omicron causes less damage to lungs

 A new study released this week suggested that the COVID-19 omicron variant has less of an impact on lungs when compared to previous strains.

The study, conducted by both U.S. and Japanese scientists and published by In Review, observed omicron's effect on hamsters and mice. Researchers observed "less infection" in the bronchial cells of hamsters when compared to infections caused by the delta variant.

They also found a smaller amount of the virus in the noses of the more than 100 mice that were involved in the study. Researchers noted that the lower amount of the virus was "unexpected" given the high degree of mutations that omicron has compared to previous strains.

"Moreover, the attenuation in hamsters also was surprising, given that all prior SARS-CoV-2 variants have replicated relatively equivalently and to high levels in this animal," the researchers wrote.

Despite the unexpected results, researchers acknowledged that their findings appeared to fall in line with other studies that have suggested that omicron, while significantly more transmissible, results in a milder illness.

The researchers acknowledged that results of the study were limited due to the use of hamsters and mice and more data would be needed to corroborate the data.

Early studies on the omicron variant came out this month, with many suggesting that the new strain caused milder illness than previous waves.

However, researchers have noted that these results are likely affected by the relatively high rate of immunity many people have gained either through vaccination or prior infection.

https://thehill.com/policy/587821-new-study-on-animals-shows-omicron-does-not-cause-as-much-damage-to-lungs

Nutriband Gets Korea Patent for Abuse and Misuse Deterrent System

 Nutriband Inc. (NASDAQ:NTRB)(NASDAQ:NTRBW), has announced that the Korean Intellectual Property Office (KIPO) has fully issued its patent titled "Abuse and Misuse Deterrent Transdermal System" which is related to the Company's lead technology AVERSA™.

The patent underpins 4p Therapeutics' abuse deterrent transdermal system, AVERSA, which uses taste aversion to address the primary routes of abuse for opioid based transdermal patches.

The KIPO issued a prior notice of allowance in December 2020.

https://finance.yahoo.com/news/nutriband-inc-issued-full-patent-123000159.html