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Moderna Blasts Pfizer Counterclaims in COVID Vaccine Patent Lawsuit
Moderna Inc. fired back at counterclaims by Pfizer Inc. and BioNTech SE in a U.S. lawsuit over COVID-19 vaccines on Wednesday, arguing that Pfizer and BioNTech were “clearly aided” by Moderna’s technology in developing their shot.
Moderna said Pfizer and BioNTech copied its innovations and called their argument that its patented technology was pioneered by other scientists an attempt to “distract from the issues in this case.”
Cambridge, Massachusetts-based Moderna sued Pfizer and BioNTech in August, accusing the companies of infringing three patents related to messenger RNA (mRNA).
Moderna asked for an undisclosed amount of money damages from Pfizer COVID-19 vaccines sold since March. Pfizer’s vaccine made over $26.4 billion for the New York-based company in the first nine months of 2022, while Moderna sold over $13.5 billion worth of its vaccine over the same period.
Rite Aid Loss Hits $67 Million as COVID Shots and Testing Decline
Rite Aid reported a quarterly loss of more than $67 million due in part to “a reduction in COVID vaccine and testing revenue,” the drugstore chain said Wednesday.
Rite Aid lost $67.1 million for its fiscal 2023 third quarter ended Nov. 26 of this year compared to a loss of $36 million in the year-ago quarter, the company disclosed. For the first nine months of the year, Rite Aid has lost more than $500 million with revenue largely flat or falling amid store closures.
Drugstore chains have done well during the COVID-19 pandemic thanks in part to their addition of healthcare services and they have become the go-to place to get vaccinated and tested for COVID-19. These days, however, testing is slowing and fewer Americans are returning for booster shots despite their benefits.
Stop Screening Asymptomatic Hospital Patients for COVID, Experts Say
U.S. News & World Report reported:
A nationwide group of infection control experts recommends U.S. healthcare facilities stop testing patients for COVID-19 before hospital admission or scheduled surgeries if they have no virus symptoms. The Society for Healthcare Epidemiology of America (SHEA) statement says facilities should rely instead on enhanced layers of infection prevention.
“The small benefits that could come from asymptomatic testing at this stage in the pandemic are overridden by potential harms from delays in procedures, delays in patient transfers and strains on laboratory capacity and personnel,” said Dr. Thomas Talbot. He is chief hospital epidemiologist at Vanderbilt University Medical Center in Nashville, Tenn., and a member of SHEA’s Board of Directors.
The SHEA board said evidence is lacking that asymptomatic testing reduces healthcare-associated COVID-19 infections. These testing requirements may hit hard on disadvantaged groups with limited access to care and testing resources, the board members noted in a society news release.
Scientists Have a Theory on COVID Loss of Smell: Damage to Nasal Cells
Persistent loss of smell has left some COVID-19 survivors yearning for the scent of their freshly bathed child or a waft of their once-favorite meal. It’s left others inured to the stink of garbage and accidentally drinking spoiled milk. “Anosmia,” as experts call it, is one of long COVID’s strangest symptoms — and researchers may be one step closer to figuring out what causes it and how to fix it.
A small study published online on Wednesday in Science Translational Medicine and led by researchers at Duke University, Harvard and the University of California San Diego offers a theory, and new insight, into lingering smell loss.
Scientists analyzed samples of olfactory epithelial tissue — where smell cells live — from 24 biopsies, nine of which were from post-COVID patients struggling with persistent loss of smell. Although the sample was small, the results suggest that the sensory deficit is linked to an ongoing immune attack on cells responsible for smell — which endures even after the virus is gone — and a decline in the number of olfactory nerve cells.
Bradley Goldstein, associate professor in Duke’s Department of Head and Neck Surgery and Communication Sciences and the Department of Neurobiology, an author on the paper, called the results “striking” and said in a statement, “It’s almost resembling a sort of autoimmune-like process in the nose.”
COVID and Overdose Deaths Drive U.S. Life Expectancy to a 25-Year Low
Life expectancy in the United States dropped last year to its lowest since 1996, extending a downward trend that began in 2020, according to new data from the Centers for Disease Control and Prevention.
The latest figures from the CDC, which leave expected U.S. lifespans well below those in other large, wealthy nations, reflect the federal and local governments’ ongoing struggle to meet the demands of concurrent public health crises.
The COVID-19 pandemic has had “a domino effect,” said Nora Volkow, director of the National Institute on Drug Abuse, by “exacerbating the already very severe problem that we have in overdose deaths.”
The two crises, the COVID-19 pandemic and rising drug addiction and overdoses, are “a wake-up call” for government, added Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota. “It clearly is what’s cutting into the health of our communities, unlike almost anything we’ve seen before.”
Omicron Symptoms: What Science Tells Us About the Illness Caused by New Subvariants
The Omicron variant of the coronavirus was first detected in late 2021. It has since swept the globe, eventually vanquishing other variants including Delta.
Omicron soon began branching off into a number of subvariants: BA.2 took off in the spring, and BA.5 came to dominate towards the end of the summer. In late fall, the subvariants B.Q.1 and B.Q.1.1 together became the predominant form of the virus in the United States.
They are not alone — other Omicron subvariants including XBB, BF.7 and yes, still BA.5 are also out there. But do they cause more severe illness?
The symptoms of the latest Omicron subvariants are mostly similar to those of the earlier version of Omicron. Unlike earlier variants like Delta that affected the lungs, Omicron and its subvariants tend to cause more upper respiratory symptoms, said Dr. Armando Meza, chief of infectious disease at Texas Tech University Health Sciences Center in El Paso. Those symptoms can include congestion, sore throat and changes in taste and smell.
Pandemic Response Gets a Permanent New Home at the White House
The era of the rotating cast of public health czars at the White House may finally be over. Presidents for decades have brought fresh faces to the White House to coordinate federal responses to threats such as COVID-19, mpox, Ebola, AIDS and the bird flu.
Now, Congress aims to give pandemic response a permanent home at the White House.
Next year’s government funding package includes a brand-new White House Office of Pandemic Preparedness and Response Policy that would have a director appointed by the president and up to 25 staff members.
The provision that would create the new office was part of a larger pandemic preparedness package assembled by Senate health committee leaders Patty Murray (D-Wash.) and Richard Burr (R-N.C.). Lawmakers are aiming to pass the broader government funding package by Friday to avert a shutdown.
U.S. FDA Approves Roche’s COVID Antibody
Roche Holding AG (ROG.S) said on Wednesday the U.S. Food and Drug Administration (FDA) had approved its monoclonal antibody for treating COVID-19 in hospitalized adult patients.
The intravenous anti-inflammatory drug, Actemra, is a monoclonal antibody that reduces inflammation and was approved in 2010 to treat rheumatoid arthritis. It is the first FDA-approved monoclonal antibody to treat COVID-19, Roche said.
The FDA authorized the emergency use of Actemra last year June to treat severe cases of COVID.
In November, the regulator pulled authorization for Eli Lilly and Co’s (LLY.N) COVID monoclonal antibody treatment, bebtelovimab, saying it was not fighting the dominant BQ.1 and BQ.1.1 subvariants of Omicron as expected.
Nasal Vaccines Are Here
Since the early days of the coronavirus pandemic, a niche subset of experimental vaccines has offered the world a tantalizing promise: a sustained slowdown in the spread of disease. Formulated to spritz protection into the body via the nose or the mouth — the same portals of entry most accessible to the virus itself — mucosal vaccines could head SARS-CoV-2 off at the pass, stamping out infection to a degree that their injectable counterparts might never hope to achieve.
Now, nearly three years into the pandemic, mucosal vaccines are popping up all over the map. In September, India authorized one delivered as drops into the nostrils; around the same time, mainland China green-lit an inhalable immunization, and later on, a nasal-spray vaccine, now both being rolled out amid a massive case wave.
Two more mucosal recipes have been quietly bopping around in Russia and Iran for many months. Some of the world’s largest and most populous countries now have access to the technology — and yet it isn’t clear how well that’s working out.
“Nothing has been published; no data has been made available,” says Mike Diamond, a virologist and an immunologist at Washington University in St. Louis, whose own approach to mucosal vaccines has been licensed for use in India via a company called Bharat. If mucosal vaccines are delivering on their promise, we don’t know it yet; we don’t know if they will ever deliver.
BioNTech Doses First Patient in Herpes Vaccine Candidate Clinical Trial
BioNTech (22UAy.DE) has dosed the first patient with its BNT163 herpes vaccine candidate designed to prevent genital lesions as part of a first-in-human Phase 1 clinical research study, the German vaccine maker said on Wednesday.
The vaccine candidate is meant to prevent HSV-2, the herpes simplex virus that causes genital herpes, and potentially HSV-1, which causes oral herpes and can lead to genital herpes.
It is the first result of the research collaboration established in 2018 between the University of Pennsylvania and BioNTech aimed at developing novel mRNA vaccine candidates for the prevention and treatment of various infectious diseases.
The Mainz-based firm said in a separate news release that it is advancing two mRNA vaccine candidates for malaria and tuberculosis, which it expects to enter first-in-human trials in late 2022 or early 2023.
