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Wednesday, December 7, 2022

China medical expert says COVID has mutated, should be renamed

 China should change its official name for COVID-19 to reflect the virus' mutation, and patients with light symptoms should be allowed to quarantine at home, a leading authority on traditional Chinese medicine was quoted as saying on Wednesday.

Gu Xiaohong told the state-run Beijing Daily newspaper that the coronavirus' Chinese name, which identifies it as a pneumonia-causing disease, should be changed to call it simply an infectious virus.

China's approach to COVID - which has emphasised widespread testing and the quarantining of positive cases in specialised facilities - should change from "passive detection" to "active prevention", with recuperation at home for light cases.

Gu said the China Association of Chinese Medicine's infectious disease arm, which she heads, had reached a consensus to change how they describe the virus.

Her remarks are in line with a recent softening of the tone from China's health experts and state media towards COVID, while authorities have loosened what remain some of the world's toughest COVID curbs.

There are widespread expectations that the moves could herald a more pronounced shift towards normalcy three years into the pandemic.

Officials have started to play down the dangers posed by the virus. On Monday, the official Xinhua news agency said in a commentary that the "most difficult period had passed", citing the weakening pathogenicity of the virus and efforts to vaccinate 90% of the population.

https://www.yahoo.com/now/china-medical-expert-says-covid-024248812.html

Chinese cheer as COVID curbs are loosened

 China on Wednesday announced the most sweeping changes to its resolute anti-COVID regime since the pandemic began three years ago, loosening rules that curbed the spread of the virus but sparked protests and hobbled the world's second-largest economy.

The relaxation of rules, which includes allowing infected people with mild symptoms to quarantine at home and dropping testing for people travelling domestically, is the clearest sign yet Beijing is pivoting away from its zero-COVID policy to let people live with the disease.

But health officials are still warning that trends in deaths will be closely watched in case a return to tougher measures is needed.

Many of the changes announced by the National Health Commission (NHC) reflected steps already taken in various cities and regions in recent days, following protests against COVID controls that were the biggest demonstration of public discontent since President Xi Jinping came to power in 2012.

Citizens cheered the prospect of a shift that could see China slowly emerging back into the world three years after the virus was first identified in the central city of Wuhan in late 2019.

Wednesday's announcement soared to the top most viewed topic on China's Weibo platform, with many hoping for normality after policies that have brought mental suffering to tens of millions.

"It's time for our lives to return to normal, and for China to return to the world," wrote one Weibo user.

For nearly three years, China has managed COVID as a disease on par with bubonic plague and cholera and as cases spread earlier this year, whole communities were locked down, sometimes for months.

Dozens of people also flocked to the Weibo account of Li Wenliang, a doctor in Wuhan who died in 2020 after sounding an early alarm about COVID-19 and whose last post has been an online haven for those looking to vent about personal woes and public policies.

Neurocrine: Pediatric epilepsy Phase 2 misses endpoint

  Neurocrine Biosciences, Inc. (Nasdaq: NBIX), a leading neuroscience-focused biopharmaceutical company, today announced that investigational NBI-827104 did not meet its primary endpoint in the Phase 2 STEAMBOAT™ study evaluating the efficacy, safety, tolerability and pharmacokinetics of NBI-827104 compared to placebo in pediatric patients with epileptic encephalopathy with continuous spike-and-wave during sleep (EE-CSWS). NBI-827104 was generally well tolerated.

https://finance.yahoo.com/news/neurocrine-biosciences-provides-phase-2-210100722.html

Indivior Capital Markets Day Highlights Strategy, Midterm Growth Potential

 

  • Peak Annual Net Revenue Potential for SUBLOCADE® Increased to >$1.5 Billion
  • Attractive and Scalable Business Outlined – Expects Strong Net Revenue Growth and Operating Margin Expansion Over the Medium-term
  • Disciplined Approach to Capital Allocation Maintained
  • NASDAQ Listing Targeted for Spring 2023

Priority Review for Biologics License Application for Pfizer’s Respiratory Syncytial Virus Vaccine Candidate

 Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) accepted for priority review a Biologics License Application (BLA) for its respiratory syncytial virus (RSV) vaccine candidate, PF-06928316 or RSVpreF, as submitted for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age and older.

https://www.biospace.com/article/releases/u-s-fda-accepts-for-priority-review-the-biologics-license-application-for-pfizer-s-respiratory-syncytial-virus-vaccine-candidate-for-the-prevention-of-rsv-disease-in-older-adults/

COVID-19 Boosters Provided Little Added Protection For People With Natural Immunity: Study

 by Zachary Stieber via The Epoch Times (emphasis ours),

COVID-19 vaccine boosters provided small boosts for people who have recovered from COVID-19, according to a new study.

Measuring the effectiveness of the Moderna and Pfizer boosters against the BA.1 Omicron subvariant, researchers found that a booster upped protection against infection by just 6.1 percent for those who had a documented prior infection, or natural immunity.

The effectiveness of a primary series 14 to 149 days after a second dose was pegged as 41 percent for the group. A booster brought the protection to 47.1 percent.

Excluding people with a documented prior infection, the booster increased infection more.

People without documentation of a COVID-19 infection had 27.1 percent protection after a primary series. A booster increased that to 54.1 percent.

“While booster vaccination was associated with additional protection against Omicron BA.1 infection in people without a documented prior infection, it was not found to be associated with additional protection among people with a documented prior infection,” researchers said.

U.S. researchers including Dr. Margaret Lind, an epidemiologist at the Yale School of Public Health, performed the research. They analyzed COVID-19 tests that were entered into the Yale New Haven Health system between Nov. 1, 2021, and April 30, 2020. They compared 11,307 COVID-19 cases, including 672 cases among people who had a documented prior case, to 130,041 controls, including 10,473 with documentation of a prior case.

The paper was published on Dec. 1 by PLOS Medicine. It received funding from the Beatrice Kleinberg Neuwirth Fund and Yale.

Pfizer and Moderna did not respond to requests for comment.

The boosters administered during the time period studied have since been replaced by updated versions.

Natural Immunity

A number of studies have analyzed the protection people enjoy after recovering from COVID-19 and found that the protection is higher than that conferred by vaccines. Both forms of protection have waned against infection and to a smaller degree against severe illness, but natural immunity has held up better against both infection and severe disease.

More recent studies have found that people sickened with strains before Omicron emerged in late 2021 have less protection against Omicron and its subvariants, but that prior Omicron infection generally protects well against reinfection. For severe disease, any infection serves as strong shielding.

Many people around the world have had at least one COVID-19 infection, according to seropositivity surveys.

COVID-19 cases first began appearing in 2019.

Some scientists promote so-called hybrid immunity, or vaccination despite prior infection. One recent paper found that people with infections prior to Omicron had 44 percent and 81 percent, respectively, protection against infection and hospitalization but that the protection was higher among those with one, two, or three doses of a vaccine.

Poor Protection

The new study identified poor effectiveness from both a primary series and a booster against infection, particularly among the naturally immune.

Unadjusted effectiveness for a primary series among people without a prior infection was just 13.5 percent less than 14 days after a second dose and negative 28.8 percent 14 to 149 days after the final shot of the primary series. At or more than 150 days following a second dose, the effectiveness was estimated at 5.8 percent.

For people with a prior infection, the figures were 1.3 percent, 5 percent, and 9.2 percent.

Adjusted effectiveness, of effectiveness after correcting for factors such as age, determined the effectiveness among the non-naturally immune group peaked at just 27.1 percent and dropped to 13.6 percent. A booster at and after 14 days increased that to 54.1 percent, but boosters quickly wane, other research has shown.

Among those with a documented prior infection, and after adjustments, effectiveness peaked at 41 percent and dropped to 32.1 percent. A booster increased effectiveness to 47.1 percent.

The study is the latest to show that a primary series—two shots—of one of the messenger RNA vaccines—both the Pfizer and Moderna vaccines—provides little protection against infection and severe illness.

https://www.zerohedge.com/covid-19/covid-19-boosters-provided-little-added-protection-people-natural-immunity-study

Novartis Kisqali® prolonged PFS benefit for HR+/HER2− metastatic breast cancer

 

  • RIGHT Choice Phase II trial is the first randomized study in patients with aggressive HR+/HER2− metastatic breast cancer (MBC), including visceral crisis, comparing a CDK4/6 inhibitor (CDK4/6i) plus endocrine therapy (ET) versus combination chemotherapy (CT)1

  • Kisqali plus ET demonstrated a statistically significant progression-free survival (PFS) benefit of one year compared to combination CT; data to be presented at SABCS 20221

  • Kisqali is a unique CDK4/6i that has consistently shown statistically significant overall survival benefit while preserving or improving quality of life across three Phase III trials in MBC, including in patients with aggressive disease1,2-13