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Covid News Watch
University of Florida Officials Have No ‘Standing’ to Review Ladapo’s COVID Vaccine Guidance + More
University of Florida Officials Have No ‘Standing’ to Review Ladapo’s COVID Vaccine Guidance
A group of University of Florida medical-school faculty members challenged controversial guidance by state Surgeon General Joseph Ladapo on COVID-19 vaccinations, but a university official said Wednesday the guidance is outside the scope of Ladapo’s work with the school.
Ladapo, who holds a faculty position in the UF College of Medicine, was tapped in September 2021 by Gov. Ron DeSantis to serve as surgeon general and secretary of the Florida Department of Health. Ladapo has become a controversial national figure because of his positions on issues such as COVID-19 vaccines and mask requirements.
In October, Ladapo issued guidance advising males ages 18 through 39 to avoid getting shots with COVID-19 mRNA vaccines. The Department of Health published an analysis that showed an increase “in the relative incidence of cardiac-related death” among males in that age group roughly a month after receiving the shots.
“As this work was done by Dr. Joseph Ladapo in his role as the state of Florida Surgeon General and not in his role as a UF faculty member, the UF Office of Research Integrity, Security and Compliance has no standing to consider the allegations or concerns regarding research integrity set forth in the Faculty Council task force report,” said David Norton, vice president for research at the university.
Healthcare Workers Cry Foul on FDA Claiming It Didn’t Prohibit Ivermectin for COVID
Jennifer Wright, a nurse practitioner and clinical director who practices in Florida, but can prescribe across state lines, told The Epoch Times she received a letter from the Office of the Attorney General of New York ordering her not to prescribe ivermectin.
“You know, basically threatened me. If I don’t stop prescribing, then they’re going to fine me,” Wright said about the letter, which threatened legal action with fines of up to $5,000 per violation. The citation in the letter appears to be from an FDA advisory issued in March 2021 titled “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19.
That advisory and other anti-ivermectin messaging from the FDA are now the subject of a lawsuit brought by three doctors against the agency. The doctors argue that the FDA illegally interfered with their ability to treat patients. The suit was dismissed but an appeal has been filed by the plaintiffs.
During a hearing in 2022, attorneys defending the government argued that the agency’s missives were just a recommendation. “They did not say it’s prohibited or it’s unlawful. They also did not say that doctors may not prescribe ivermectin,” Isaac Belfer, one of the lawyers for the government, said during a Nov. 1, 2022, hearing in a federal court in Texas.
White House Cautions Against Panic as XBB.1.5 Omicron Subvariant Spreads
White House health officials are cautioning against a rush to panic over the XBB.1.5 Omicron subvariant, which has rapidly grown to account for 40% of U.S. COVID-19 cases, with officials stating it is not yet known if this version is more dangerous.
As of last week, the XBB.1.5 Omicron subvariant is responsible for at least 40% of COVID-19 cases in the U.S. As a recombinant virus, the subvariant carries genetic data from two previous strains that descended from the BA.2 subvariant. Roughly 75% of cases in the Northeast are now attributed to this strain.
Robert Califf, the commissioner of the Food and Drug Administration (FDA), posted his own thread on XBB.1.5 in response to what he characterized as “misinformation/disinformation” in an editorial published by The Wall Street Journal earlier this week.
The opinion piece suggested that repeated vaccination could be making people more susceptible to infection due to XBB subvariants and fueling viral mutations.
Here’s What to Know About XBB.1.5 — Its Immune Evasiveness Didn’t Come at a Cost in Transmissibility, Virologist Says
The new Omicron subvariant XBB.1.5 is growing rapidly in the U.S., becoming the most common strain as the proportion of cases for which it’s responsible for doubled in just a week. XBB.1.5 now accounts for an estimated 41% of COVID cases in the U.S., up from 22% the week prior, according to CDC data. It’s particularly prevalent in the Northeast, found in about three-quarters of infections there, according to the agency.
XBB.1.5 evolved from XBB.1, which evolved from XBB — an Omicron subvariant that emerged in India in mid-August and quickly became predominant there, as well as in Singapore and other regions in Asia, according to a paper in Cell Reports.
XBB involved the recombination of two descendants of the BA.2 variant, according to virologist Jesse Bloom, Ph.D., of Fred Hutchinson Cancer Center in Seattle.
Notably, in Singapore, XBB was responsible for a surge in cases, but it didn’t cause an increase in hospitalizations or deaths, Ali Mokdad, Ph.D., of the Institute for Health Metrics and Evaluation (IHME) at the University of Washington in Seattle, previously told MedPage Today.
The WHO Says It’s Not yet Seeing New COVID Variants in China — but Data ‘Underrepresent’ Deaths
Governments like the U.S. say they’re worried about the rise of new variants in China’s massive COVID outbreak, but the World Health Organization says it has yet to see any new strains in the country. In a statement released Wednesday, the WHO said that a sample of genomic data provided by China’s Center for Disease Control and Prevention reported that almost all cases were of BA.5.2 and BF.7 strains, which are two variants of Omicron.
“These variants are known and have been circulating in other countries, and at present time no new variant has been reported by the China CDC,” the WHO said in its statement.
In a separate briefing, WHO officials said that Chinese data minimized the true scope of its COVID outbreak. Current Chinese numbers “underrepresent the true impact of the disease,” especially regarding hospitalizations and deaths, said Mike Ryan, the WHO’s executive director for health emergencies.
U.S. New Drug Price Exceeds $200,000 Median in 2022
After setting record-high U.S. prices in the first half of 2022, drugmakers continued to launch medicines at high prices in the second half, a Reuters analysis has found, highlighting their power despite new legislation to lower costs for older prescription products.
The median annual price of the 17 novel drugs the U.S. Food and Drug Administration (FDA) approved since July 2022 is $193,900, down from $257,000 in the first half of 2022, Reuters found. For the full-year 2022, the median was $222,003.
In 2021, the median annual price was $180,000 for the 30 drugs first marketed through mid-July, according to a study published recently in JAMA. The latest numbers imply double-digit year-over-year price growth.
Africa CDC Says Uganda’s Ebola Outbreak Is Coming Under Control
Africa’s top public health body said on Thursday that the Ebola outbreak in Uganda was coming under control, as it had been 39 days since the last confirmed case of the virus had been reported in the country.
Last month Uganda discharged its last known Ebola patient from the hospital and President Yoweri Museveni lifted all Ebola-related movement restrictions, reflecting progress in curbing the spread of the virus.
The Africa CDC’s acting director, Ahmed Ogwell Ouma, told a briefing that if no new cases were reported in Uganda by Jan. 10 then the outbreak would be over.
California Bill to Punish Doctors for ‘False’ COVID Information Goes Into Effect + More
California Bill to Punish Doctors for ‘False’ COVID Information Goes Into Effect
A bill that allows the state of California to punish doctors over ‘false information about COVID-19 vaccinations and treatments’ went into effect on Jan. 1. Under the new law (AB 2098) which took effect Jan.1, the state’s Medical Board would categorize dispensing information — such as the effectiveness of ivermectin, or the COVID-19 vaccine’s rapidly waning efficacy, as unprofessional conduct.
The law was challenged in court by two California doctors, who said that it would restrict their free speech in violation of the first amendment and that it was “vague” under the Due Process Clause of the Fourteenth Amendment of the Constitution.
However, on Dec. 28, Biden Nominee Judge Fred Slaughter refused to halt the law, ruling that the law trumps free speech claims and that it falls “within the longstanding tradition of regulations on the practice of medical treatments.”
Moderna Snaps up Japan’s OriCiro Genomics in mRNA Manufacturing Push
Moderna Inc. (MRNA.O) on Wednesday agreed to buy Japan-based OriCiro Genomics for $85 million to boost the U.S. drugmaker’s messenger RNA (mRNA) manufacturing capabilities.
The Japanese company is working on the development and commercialization of cell-free synthesis and amplification of a type of DNA molecule for use in mRNA manufacturing.
OriCiro’s technologies will support Moderna’s portfolio of therapeutics and vaccines, the companies said. Moderna’s mRNA technology has been used in developing COVID-19 vaccines.
Last month, an experimental cancer vaccine from Moderna based on the technology was shown to work against melanoma, a type of skin cancer.
COVID Could Alter the Immune System, But Your Gender Matters
U.S. News & World Report reported:
Researchers studying whether COVID-19 affects how the human immune system responds to subsequent viral threats found changes in men that differed from those in women. Researchers from the National Institute of Allergy and Infectious Diseases (NIAID) analyzed the immune responses of healthy people who had received the flu vaccine. They then compared responses in those who had never had COVID with those who had mild cases and recovered.
They were surprised to find that men who had had mild COVID cases showed a stronger response to flu vaccines compared to either women with mild COVID infection or people of either sex who were never infected.
This means that the baseline immune status in previously infected men was altered in ways that changed the response to a different virus, said the authors, who included John Tsang, now a professor of immunobiology and biomedical engineering at Yale University in New Haven, Conn.
Researchers said these new findings may be linked to an observation made early in the pandemic — that men were much more likely to die from a runaway immune response than women after contracting SARS-CoV-2. Researchers said even mild cases of COVID may trigger stronger inflammatory responses in males than in females. This may result in more pronounced changes to the male immune system, even long after recovery, they said.
XBB.1.5 Omicron Subvariant Is the Most Transmissible Version of COVID yet, WHO Says
The XBB.1.5 Omicron subvariant that’s currently dominating the U.S. is the most contagious version of COVID-19 yet, but it doesn’t appear to make people sicker, according to the World Health Organization.
Maria Van Kerkhove, the WHO’s COVID-19 technical lead, said global health officials are worried about how quickly the subvariant is spreading in the northeastern U.S. The number of people infected with XBB.1.5 has been doubling in the U.S. about every two weeks, making it the most common variant circulating in the country.
“It is the most transmissible subvariant that has been detected yet,” Van Kerkhove told reporters during a press conference in Geneva on Wednesday. “The reason for this is the mutations that are within this subvariant of Omicron allowing this virus to adhere to the cell and replicate easily.”
It has been detected in 29 countries so far but it could be even more widespread, Van Kerkhove said. Tracking COVID variants has become difficult as genomic sequencing declines across the world, she said.
Weak Data as Booster for Comirnaty Close off Opportunity for Valneva’s COVID Vaccine
Valneva’s plans to establish its COVID-19 vaccine as a booster to Pfizer and BioNTech’s Comirnaty have taken a blow, with a clinical trial of the shot eliciting “only a marginally increased neutralizing antibody response.”
France’s Valneva has continued to try to carve out a space for VLA2001, a vaccine made of inactivated whole virus particles of SARS-CoV-2, despite seeing other companies establish dominant positions in the COVID-19 market. The bid for relevance led the company to run two trials of VLA2001 as a heterologous booster, one in recipients of Comirnaty and another in people primed with AstraZeneca’s Vaxzevria.
Valneva’s data drop comes around one year after an independent trial, the U.K.’s COV-Boost, generated evidence that VLA2001 is a lackluster booster in people primed with Pfizer and BioNTech’s Comirnaty. In COV-Boost, VLA2001 was the only one of the seven tested vaccines to fail to meet the preestablished minimum clinically important difference in antibody levels when used to boost Comirnaty.
Omicron Subvariants BA.5.2 and BF.7 Driving China’s Latest COVID Outbreak — WHO
China’s recent COVID-19 outbreak is predominantly led by the Omicron subvariants BA.5.2 and BF.7, which together account for 97.5% of all local infections, the World Health Organization said on Wednesday.
The data was based on an analysis of more than 2,000 genomes by the Chinese Center for Disease Control and Prevention, the WHO said.
Oral Antiviral Matches Paxlovid in High-Risk COVID — Remdesivir Analogue Demonstrates Non-Inferiority, Good Safety in Chinese Randomized Trial
An oral remdesivir analogue (VV116) was just as good as nirmatrelvir-ritonavir (Paxlovid) for the treatment of mild-to-moderate COVID-19 in adults at risk for severe disease, and may be safer, results of a phase III trial from China suggested.
Sustained clinical recovery of COVID-19 symptoms with a 5-day course of VV116 proved non-inferior to nirmatrelvir-ritonavir, with patients recovering at a median 4 days versus 5 days, respectively, from the start of treatment (HR 1.17, 95% CI 1.02-1.36), according to Ren Zhao, MD, Ph.D., of Shanghai Jiao Tong University School of Medicine, and colleagues.
Among more than 800 randomized patients, none progressed to severe COVID-19 or died during the study, which was conducted during a period of Omicron B.1.1.529 predominance.
Although remdesivir (Veklury) is a recommended option for individuals with high-risk COVID, it needs to be administered intravenously over the course of 3 days, “which limits its widespread use during the pandemic,” the researchers explained in the New England Journal of Medicine.
Nepal to Receive 1.5 Million Doses of Pfizer COVID Vaccine
Nepal is all set to receive 1.5 million doses of COVID-19 vaccines (for booster doses) from the Global Alliance for Vaccine and Immunization (GAVI) next month.
According to the government, the GAVI has confirmed the dispense of such a quantity of vaccine to Nepal on Feb. 2. The vaccine will be arriving in the Himalayan Nation in the first week of February.
Belgium Declares Flu Epidemic
Belgium’s national public health institute Sciensano officially declared a flu epidemic Wednesday, with cases surging to similar levels as COVID-19.
In addition to the influenza virus, the bronchiolitis virus, coronavirus and other respiratory viruses that can cause the same symptoms are currently circulating, the institute added.
The healthcare sector is already struggling due to the high cases, but experts predict the worst could be yet to come. The peak is expected in three or four weeks, according to Van Gucht, who added that “it is always possible to get a flu shot.”
Other countries like Germany and Slovakia had already declared an epidemic and more countries are expected to do so.
Drugmakers to Raise Prices on at Least 350 Drugs in U.S. in January + More
Exclusive: Drugmakers to Raise Prices on at Least 350 Drugs in U.S. in January
Drugmakers including Pfizer Inc. (PFE.N), GlaxoSmithKline PLC (GSK.L), Bristol Myers Squibb (BMY.N), AstraZeneca PLC (AZN.L) and Sanofi SA (SASY.PA) plan to raise prices in the United States on more than 350 unique drugs in early January, according to data analyzed by healthcare research firm 3 Axis Advisors.
The increases are expected to come as the pharmaceutical industry prepares for the Biden Administration’s Inflation Reduction Act (IRA), which allows the government’s Medicare health program to negotiate prices directly for some drugs starting in 2026. The industry is also contending with inflation and supply chain constraints that have led to higher manufacturing costs.
To date, Pfizer announced the most increases, with prices rising on 89 unique drug brands and an additional increase on 10 drug brands at its Hospira arm. That was followed by GSK, with planned increases so far on 26 unique drugs, including nearly a 7% increase on its popular shingles vaccine Shingrix.
49% of Americans Say It’s ‘Likely’ COVID Vaccines Caused ‘Significant Number’ of Mysterious Deaths
A new poll shows that nearly half of Americans believe that the COVID-19 vaccines probably caused a “significant number of unexplained deaths,” while over a quarter said they personally know someone whose death may have been caused by vaccination side effects.
While previous polling showed that a majority of Americans think that COVID-19 vaccines are effective, they also have concerns about the side effects of the jab.
The latest Rasmussen Reports survey, released on Jan. 2 and based on a representative sample of 1,000 American adults, sought to gauge public opinion on the perceived safety of COVID-19 vaccines.
A large majority (71%) said they themselves have been vaccinated against COVID-19, with 38% of those believing that the vaccine side effects are at least somewhat likely responsible for unexplained deaths.
Omicron Offshoot XBB.1.5 Could Drive New COVID Surge in U.S.
For weeks, scientists have been watching a slew of Omicron descendants duke it out for dominance of COVID-19 transmission in the United States, with the BQs — BQ.1 and BQ.1.1 — seeming to edge out all the others to claim a slight lead.
The result has been a gradual rise in cases and hospitalizations that never seemed to reach the peaks of this summer’s BA.5 wave and was certainly nothing like the tsunami of illness caused by the original Omicron strain a year ago.
But on Friday, the U.S. Centers for Disease Control and Prevention’s COVID-19 variant dashboard revealed a new dark horse that could soon sweep the field: XBB.1.5.
The CDC estimates that XBB.1.5 has more than doubled its share of the COVID-19 pie each week for the last four, rising from about 4% to 41% of new infections over the month of December. In the Northeast, the CDC estimates, XBB.1.5 is causing 75% of new cases.
Once-Favored COVID Drugs Ineffective on Omicron May Be Putting Millions at Risk
The lack of specialized COVID-19 treatments for people with weak immune systems has left millions of Americans with limited options if they get sick as the pandemic heads into an uncertain winter.
Once heralded as game-changers for COVID patients considered at risk for getting seriously ill — one was used to treat then-President Donald Trump in 2020 — monoclonal antibodies are now largely ineffective against current COVID variants. Easier-to-administer antiviral drugs, such as Paxlovid, have largely taken their place but aren’t safe for all immune-compromised people because they interact with many other drugs.
But the federal government funding that drove drug development in the early days of the pandemic has dried up, and lawmakers have rebuffed the Biden administration’s pleas for more. Without that, there’s little incentive for drugmakers to work on new antibody treatments that could be more effective.
Monoclonal antibodies — which have been made by companies like Regeneron, Eli Lilly and Vir — are lab-created molecules designed to block a virus’ entry into human cells. But they must bind to the virus’ spike protein to neutralize it, and the coronavirus’ many mutations since its 2019 emergence have gradually rendered the available products ineffective.
Exclusive: U.S. Considers Airline Wastewater Testing as COVID Surges in China
As COVID-19 infections surge in China, the U.S. Centers for Disease Control and Prevention is considering sampling wastewater taken from international aircraft to track any emerging new variants, the agency told Reuters.
Such a policy would offer a better solution to tracking the virus and slowing its entry into the United States than new travel restrictions announced this week by the U.S. and other countries, which require mandatory negative COVID tests for travelers from China, three infectious disease experts told Reuters.
China Media Plays Down COVID Severity as WHO Seeks Detail on Variants
State media in China played down the severity of a surge of COVID-19 infections ahead of a briefing on Tuesday by its scientists to the World Health Organization, which was hoping for a “detailed discussion” on the evolution of the virus. China’s abrupt U-turn on COVID controls on Dec. 7, as well as the accuracy of its case and mortality data, have come under increasing scrutiny at home and abroad.
The WHO has urged Chinese health officials to regularly share specific and real-time information on the outbreak. The global body has invited Chinese scientists to present detailed data on viral sequencing at a technical advisory group meeting on Tuesday. It has also asked China to share data on hospitalizations, deaths and vaccinations.
On Tuesday, the People’s Daily, the Communist Party’s official newspaper, cited Chinese experts as saying the illness caused by the virus was relatively mild for most people. “Severe and critical illnesses account for 3% to 4% of infected patients currently admitted to designated hospitals in Beijing,” Tong Zhaohui, vice president of the Beijing Chaoyang Hospital, told the newspaper.
COVID Vaccines and Fever: Scientists Have Discovered a New Potential Link
There has been some concern about the side effects of mRNA COVID-19 vaccines, such as fever and fatigue, which are generally considered normal and transient. However, the relationship between these adverse reactions and antibody production after receiving the vaccine has not been thoroughly studied.
A team of researchers from Okayama University recently conducted a study to examine this link. They recruited 49 university staff and students who had not previously had COVID-19 and found that there is a relationship between the incidence of fever and antibody counts, particularly after the third dose of the vaccine. Their findings were published in the Journal of Epidemiology.
All subjects were surveyed for adverse reactions a week after they received the third mRNA-1273 vaccine dose. Simultaneously, antibody levels of all subjects were measured just before receiving the vaccine, 3 days after, ~1 week after and finally 1 month after the dose. Using statistical modeling, correlations between the incidence of fever and antibody levels at various time points were stipulated. To account for factors contributing to the onset of fever post-vaccination, the team also looked at sex, age differences, a history of allergy and the use of antipyretics (fever-reducing drugs) amongst the participants.
This is the first study to highlight associations between the induction of fever and antibody levels at various time points after the third dose of the mRNA-1273 vaccine. “Antibody titers after mRNA-1273 vaccination may be faster in the group with post-vaccination fever, but the difference may not be significant 1-month post-vaccination,” concludes the team. The researchers also suggest that while these contradictory observations may not have significant clinical relevance, a study with a larger sample size might provide better insights.
Cancer Vaccine Hunt Makes Progress, Finally
The long-awaited cancer vaccine revolution is getting a little closer to reality. New data from Moderna Inc. and Merck & Co. suggest that after decades of failures, researchers are finally figuring out the right way to design a vaccine that can teach immune cells how to recognize and combat tumors.
Earlier this month, the companies said that when used in concert with Merck’s cancer immunotherapy Keytruda, Moderna’s mRNA cancer vaccine reduced the risk of certain skin cancers from returning or patient deaths by 44% compared with Keytruda alone.
That number justly generated a lot of excitement. It’s the first time an mRNA-based cancer vaccine has proven itself in a randomized study, and with an unambiguously positive outcome. If that result holds up in larger trials, it would be a huge advance both for the mRNA technology behind COVID vaccines and for the field of cancer vaccines in general.
But there are a lot of steps between achieving early, positive data for a subset of melanoma patients and developing a widely accessible, cost-effective treatment. Among the more daunting challenges: The vaccine needs to be tailored to the genetic makeup of an individual patient’s tumors.
Probe: Alzheimer’s Drug Approval ‘Rife With Irregularities’
The Food and Drug Administration’s contentious approval of a questionable Alzheimer’s drug took another hit as congressional investigators called the process “rife with irregularities.”
The 18-month investigation by two House committees detailed “atypical collaboration” between FDA regulators and a company it’s supposed to oversee — Aduhelm manufacturer Biogen. The probe also cited Biogen documents saying the company intended to “make history” when it set what investigators called an “unjustifiably high” initial price of $56,000 a year for the drug.
The criticism comes as the FDA is expected to decide whether to approve another new Alzheimer’s drug in January. Last Thursday’s report urged the agency to “take swift action” to ensure that any future Alzheimer’s approvals aren’t met with “the same doubts about the integrity of FDA’s review.”
Moderna Fires Back at Pfizer Counterclaims in COVID Vaccine Patent Lawsuit + More
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.