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Covid News Watch
Moderna’s Spikevax Carries Higher Risk of Myocarditis Than Pfizer’s Comirnaty, Study Says + More
Moderna’s Spikevax Carries Higher Risk of Myocarditis Than Pfizer’s Comirnaty, Study Says
It’s been nearly two years since Moderna’s COVID-19 vaccine made its debut in the U.S., but research on the shot is far from over. Now, a new study has flagged higher risks of heart inflammation associated with Moderna’s shot compared with the rival from Pfizer and BioNTech.
Published in the Journal of the American College of Cardiology, the study concluded that the risk of myocarditis is two to three times higher after a second dose of Moderna’s Spikevax compared with Pfizer and BioNTech’s Comirnaty.
Cases of myocarditis, or inflammation of the heart muscle, were most prevalent in men under 40 years of age who received the Moderna vaccine, the study found. Researchers noted that the findings support the idea of recommending specific vaccines to certain populations to minimize adverse events.
The study looked at data from about three million participants who had received two primary doses of either Pfizer or Moderna’s vaccine in British Columbia, Canada, between January 2021 and September 2021.
Second, Third COVID Vaccine May up Relapse in Glomerular Disease
St. Louis Post-Dispatch reported:
Exposure to a second or third dose of the COVID-19 vaccine is associated with an increased risk for relapse for adults with glomerular disease, according to a study published online on Nov. 3 in the Journal of the American Society of Nephrology.
Mark Canney, M.B., B.Ch., Ph.D., from the University of Ottawa in Ontario, Canada, and colleagues examined the relative and absolute risks of glomerular disease relapse following COVID-19 vaccination in a retrospective population-level cohort study involving 1,105 adults with biopsy-proven glomerular disease.
The researchers found that 12.1% of patients had a relapse during 281 days of follow-up. There was no association seen for the first vaccine dose with relapse risk (hazard ratio, 0.67; 95% confidence interval, 0.33 to 1.36), but exposure to a second or third dose was associated with an elevated risk for relapse (hazard ratio, 2.23; 95% confidence interval, 1.06 to 4.71).
A similar pattern of relative risk was seen across glomerular diseases. There was variation noted in the absolute increase in 30-day relapse risk linked to a second or third vaccine dose, from 1 to 2% in antineutrophil cytoplasmic antibody-related glomerulonephritis, minimal change disease, membranous nephropathy, or focal segmental glomerulosclerosis to 3 to 5% for immunoglobulin A nephropathy or lupus nephritis. Four of 24 patients experiencing a vaccine-associated relapse had a change in immunosuppression; none required a biopsy.
One author disclosed financial ties to the pharmaceutical industry.
BioNTech Lifts Lower End of Vaccine Sales Target Range
COVID-19 vaccine maker BioNTech (22UAy.DE) on Monday raised the lower bound of its 2022 COVID-19 vaccine revenue guidance for the full year, citing demand for its adapted shots and higher prices.
The German biotech firm, the vaccines partner of U.S. pharma giant Pfizer (PFE.N), said in a statement that it is now targeting 16 to 17 billion euros ($16-$17 billion) in vaccine sales, compared with a previous range of 13-17 billion but down from 19 billion euros reported for last year.
Partner Pfizer last week raised its forecast for its 2022 sales of the COVID-19 vaccine by $2 billion to $34 billion.
Hospitalizations for Eating Disorders Grew in the Pandemic. The Problem Isn’t Over, Experts Say
Alongside the many impacts of the COVID-19 pandemic on pediatric care, researchers have seen a stark increase in young adults seeking treatment for disordered eating behaviors.
Across the United States, inpatient admissions for young adults and adolescents with eating disorders rose by a rate of about 0.7% a month in the two years before the pandemic, according to a new study published Monday in the journal JAMA Pediatrics. But in 2020, the first year of the pandemic, that growth increased to 7.2% a month on average.
From the spring of 2020 — when most COVID-19 restrictions/lockdowns were first put in place — through spring 2021, the number of eating disorder inpatient admissions about doubled. This number rose to its peak in April 2021.
Individual hospitals had reported a rise in eating disorder cases over the pandemic, but this study was the first to show the impact across the nation, said Dr. Jason Nagata, assistant professor of pediatrics at the University of California, San Francisco. Nagata was not involved in the study.
Kids’ Average Daily Screen Use Increased by More Than an Hour and Twenty Minutes During the Pandemic, Analysis Finds
Average daily screen use by children during the COVID-19 pandemic increased by more than an hour and twenty minutes, according to an analysis published in JAMA Pediatrics on Monday.
Researchers looked at screen time and the types of devices used between January 1, 2020, and March 5, 2022, by extracting data from 46 studies on nearly 30,000 kids in multiple countries. The children in the studies ranged from ages 3 to 18, with an average age of 9.
Kids’ average daily screen use increased by 1.5 times during the pandemic — from a baseline of 162 minutes a day before the pandemic to 246 minutes during the pandemic, according to the analysis.
The largest increase in screen use was seen in adolescents ages 12 to 18 because they were more likely than younger kids to “own and access digital devices,” wrote the researchers, who are from the University of Calgary, Alberta Children’s Hospital Research Institute and University College Dublin.
Telemedicine’s Popularity Has Risen During Pandemic
U.S. News & World Report reported:
Telemedicine became widespread during the pandemic, and that may have shifted patient views about using technology as a way to communicate with their doctors, a new study suggests.
In the study, data was collected on 1,600 adults who participated in the RAND American Life Panel, completing surveys in February 2019, May 2020, August 2020 and March 2021. Participants answered questions about their use of telehealth and their attitudes toward the technology.
Willingness to use video telehealth increased overall from 51% in February 2019 to 62% in March 2021.
Fewer Than 7% of Canadian Kids 5 and Younger Have Gotten a COVID Vaccine
It has been more than four months since Health Canada approved the first COVID-19 vaccine for children under five, but national uptake has been low.
The latest numbers from the Public Health Agency of Canada show, as of Oct. 9, 6.5% of kids under five have received one dose of vaccine, while one percent have received two doses. By comparison, 86.9% of Canadians five and older have received one dose, while 84.2% have received two doses.
“It hasn’t been around; parents are maybe a bit concerned about the long-term picture of what that will look like,” said Shannon MacDonald, a nursing professor at the University of Alberta who leads the university’s applied immunization research team. “The behaviors and attitudes of parents are very different around COVID vaccination.”
Vaccines for kids under five “got rolled out later, at a point in the pandemic where I think Canadians, in general, are not seeing COVID-19 as much of a threat either for the children themselves or for the population at large,” said Dr. Jesse Papenburg, a pediatric infectious disease physician at the Montreal Children’s Hospital.
Novavax Says Omicron Shot Shows Strong Immune Response as Second Booster
Vaccine maker Novavax Inc. (NVAX.O) said on Tuesday its COVID-19 shot retooled against the Omicron BA.1 variant showed a strong immune response as the fourth dose and met the main goal of strain change in a late-stage study.
Data showed the shot, NVX-CoV2515, produced 1.6 times the amount of neutralizing antibodies in people who had previously not been exposed to COVID-19 compared to Novavax’s original coronavirus vaccine.
The trial included Novavax’s so-called bivalent vaccine, the BA.1-tailored shot and its prototype vaccine.
Zinc Cut Risk of Death and ICU Stays by Nearly 40% in Study + More
COVID in California: Zinc Cut Risk of Death and ICU Stays by Nearly 40% in Study
San Francisco Chronicle via MSN reported:
Two daily doses of zinc supplements taken orally cut the rate of death and intensive care unit admissions in COVID-19 patients, according to findings from a randomized controlled trial published Thursday in Clinical Infectious Diseases.
The double-blind, multi-center trial by researchers in Tunisia compared the outcomes of 190 adult outpatients and 280 hospitalized patients randomly assigned to receive oral zinc or a placebo for 15 days between February and May.
The 30-day death rate was 6.5% among the zinc recipients and 9.2% in the placebo group, and 5.2% and 11.3%, respectively, were admitted to an ICU. The zinc recipients were not less prone to hospitalization but reported shorter stays and fewer days of experiencing symptoms. “Our results showed that in COVID-19 patients, oral zinc can decrease 30-day death and ICU admission rate and can shorten symptoms duration,” the authors wrote.
A Possible Case of Autoimmune Encephalitis After mRNA COVID Booster Vaccine: A Case Report
As the use of COVID-19 vaccines gains more prevalence, rare and uncommon side effects are reported in the medical literature. This is a case report of a 75-year-old male patient who presented on the second day after receiving the Moderna Bivalent mRNA COVID-19 booster vaccine with abrupt onset behavioral changes and global aphasia with no focal deficits. Stroke and infectious meningitis/encephalitis were ruled out. Signs of aseptic inflammation were seen on cerebrospinal fluid (CSF) analysis. Workup for autoimmune and paraneoplastic encephalitis was unyielding.
The observation of rapid clinical improvement prompted watchful waiting that concluded in the resolution of clinical manifestations within less than a week of onset. This case is reported to support the currently limited knowledge of rare neurological sequelae of mRNA vaccine and is in line with recently published few cases that suggest vaccine-related encephalitis.
Rare neurological sequelae have been more reported in association with ChAdOx1nCoV-19 vaccines (Oxford-AstraZeneca). However, serious neurological outcomes of mRNA COVID-19 vaccination have been less well reported in the literature. Previously, vaccine-induced encephalitis has already been described in vaccination for influenza, hepatitis B, Haemophilus influenzae type B, measles-mumps-rubella, tetanus, diphtheria, pertussis, polio and Japanese encephalitis.
Several neurological sequelae in association with the COVID-19 vaccine were reported including Guillain-Barré syndrome (GBS), transverse myelitis, acute disseminated encephalomyelitis (ADEM), stroke, cerebral venous sinus thrombosis (CVST) and cranial neuropathies. Multiple mechanisms of vaccine-induced encephalitis were suggested and are reviewed here. This case shows a possible autoimmune encephalitis that was likely contributed to by the mRNA COVID-19 vaccine.
Is the Lab-Made ‘80% Lethality’ COVID Real?
Recently, the news about Boston University creating a new type of virus became a red-hot topic. It is said that the virus has a lethality rate of 80%. Is it true?
The news spread as a study done by Boston University was published as a preprint on Oct. 14. But it isn’t as scary as people think, because the data is from animal models, not from human trials. However, I still disagree with this type of “gain-of-function” research because it brings a lot of unpredictable risks.
As we all know, the SARS-CoV-2 virus mutates quickly. One of those mutations resulted in Omicron this year. While its transmission rate has increased significantly, the pathogenicity has decreased significantly. Scientists hope to study Omicron thoroughly to find better treatment strategies.
CDC Warns of Tough Winter as Flu, RSV and COVID Collide
The United States continues to experience an unusually high and early uptick in flu and respiratory syncytial virus infections, straining a healthcare system trying to recover from the worst of the coronavirus pandemic.
While new coronavirus cases have leveled off in recent weeks, federal health officials warned Friday they are confronting elevated levels of other viruses that are roaring back as pre-pandemic life returns and many Americans, particularly children, lack immunity. The Centers for Disease Control and Prevention issued an advisory about respiratory viruses to thousands of healthcare providers in an attempt to bolster testing, treatment and vaccination.
CDC: Omicron Subvariants BQ.1.1, BQ.1 Spreading in U.S.
U.S. News & World Report reported:
Omicron subvariants BQ.1.1 and BQ.1 are furthering their spread across the U.S., according to data from the Centers for Disease Control and Prevention.
The subvariants, which are offshoots of BA.5, were responsible for a total of 35% of infections this week, according to CDC’s weekly variant estimate update. That’s up from just 9% of COVID-19 cases three weeks ago.
As the pair continues to spread, the prevalence of BA.5 falls. This week, it was responsible for less than 40% of infections. It’s a concerning trend considering the latest COVID-19 booster shots were updated to fight Omicron subvariants BA.5 and BA.4, but experts believe the shots will still provide protection against other Omicron subvariants.
Feds Hold Groundbreaking Ceremony for Moderna’s mRNA Vaccine Factory in Montreal Area
The Canadian Press via MSN reported:
Prime Minister Justin Trudeau today took part today in a groundbreaking ceremony for biotechnology company Moderna’s new mRNA vaccine factory in Laval, Que., a suburb of Montreal.
The factory is expected to be completed in 2024 at the earliest and produce 100 million doses of mRNA vaccines per year. It will manufacture vaccines against COVID-19 and other respiratory viruses, including influenza and respiratory syncytial virus, or RSV.
Trudeau was accompanied by several provincial and federal politicians today, including federal Innovation Minister François-Philippe Champagne and Laval Mayor Stéphane Boyer.
Champagne says Canada has committed to purchase a certain number of vaccines from the factory, but he didn’t provide details.
Man Who Had COVID for 411 Days Finally Cured With Regeneron Cocktail Given to Trump
A man in Britain who was infected with COVID-19 for 411 days was finally cured after receiving the same cocktail of drugs given to former President Donald Trump, doctors in London said. His is one of the longest-known cases of COVID in the world, after another patient who was infected for 505 days, according to the team at the London hospital that treated him.
The 59-year-old, who had a weakened immune system due to an earlier kidney transplant, first tested positive for COVID in December 2020. Even though his symptoms resolved, he continued testing positive intermittently until January 2022.
By that point the patient had received three doses of a COVID vaccine. Doctors then analyzed the genetics of the strain of the virus he was infected with and discovered it was a variation of the original variant from Wuhan, which had been extremely common in the U.K. during the end of 2020, and that he was suffering from a persistent infection.
Doctors said they gave him the Regeneron mixture of neutralizing monoclonal antibodies that are known to be effective against early COVID variants, and he was then able to clear the virus.
Pfizer’s Paxlovid Antiviral Lowered Long-COVID Risk in Study
Pfizer Inc.’s blockbuster Paxlovid antiviral that lowers rates of illness and death in people infected with the coronavirus also cuts the risk of some symptoms of disabling long COVID, a study found.
Taking the oral medication within five days of testing positive for a SARS-CoV-2 infection was linked to a 26% lower risk of lingering post-viral complications, researchers with the Veterans Affairs St. Louis Health Care System said in the study.
That equates to 2.3 fewer cases of long COVID within three months of infection for every 100 patients treated, according to the findings released Saturday on the medRxiv server ahead of publication in a peer-reviewed journal.
Europe OKs 1st One-Dose Drug to Protect Babies Against RSV
The European Commission has authorized the world’s first one-dose drug against a respiratory virus that sickens millions of babies and children globally every year.
In a statement Friday, drugmakers Sanofi and AstraZeneca said the European Commission had given the green light to nirsevimab, a laboratory-developed antibody designed to protect infants during their first exposure to RSV, or respiratory syncytial virus, a highly contagious common infection that infects nearly all babies by age 2.
At the moment, babies at high risk of the disease can be given monthly shots to protect them during RSV season.
In September, the European Medicines Agency recommended that nirsevimab, sold as Beyfortus, be authorized based on advanced research that showed the drug reduced the chances that babies with RSV needed medical attention and appeared to be safe, compared to infants who got a dummy treatment. The drug is given in a single injection.
Rutgers Recruiting Children Under 5 for Pfizer COVID Bivalent Vaccine Clinical Trial + More
Rutgers Recruiting Participants for Pfizer COVID Pediatric Bivalent Vaccine Clinical Trial
Rutgers has been selected as a clinical trial site for the global Pfizer-BioNTech research study to evaluate the safety and efficacy of the bivalent COVID-19 vaccines in children under age 5.
Although the U.S. Food and Drug Administration and Centers for Disease Control and Prevention have given early-use authorization for the bivalent COVID-19 vaccine, children under 5 are still only eligible for the monovalent vaccine.
Partnering with Pfizer/BioNTech, the Pediatric Clinical Research Center at Rutgers Robert Wood Johnson Medical School will begin to study the bivalent vaccine in children less than 5 years old. The trial will include a substudy of children under 2 who have never received a COVID-19 vaccine and a substudy of children under 5 who have received doses of COVID vaccines.
This is the fourth time Rutgers has served as a COVID-19 vaccine clinical trial site for pharmaceutical companies. In 2021, it conducted trials for Moderna and Johnson & Johnson, and in 2022, it conducted pediatric vaccine trials for Pfizer/BioNTech.
Alcohol Deaths Spiked Among Middle-Aged Adults, Especially Women, During Pandemic
Excessive drinking is increasingly killing middle-aged adults — a trend that had been brewing for nearly two decades before it ramped up at an alarming pace when the coronavirus pandemic began.
Alcohol-related deaths rose by 26% from 2019 to 2020, a new report published Friday by the Centers for Disease Control and Prevention finds. The increase was even sharper among women ages 35 to 44, going up by 42% from 2019 to 2020.
When the pandemic hit, many people greatly increased their drinking. The new research “unmasks the fact that we have a vulnerable population that was also living through the COVID-19 pandemic,” said Dr. Kristopher Kast, the clinical director of the Addiction Consult Service at Vanderbilt University Medical Center in Nashville, Tennessee.
“With that increased rate” of drinking, Kast said, “we saw this increase in mortality.”
‘Giving People a Voice’: New Platform Hopes to Shed Light on Post-Vaccine Injuries
Rather than get bogged down in the never-ending debate on vaccine science, Matt Jordan set out to simply give people a voice when he launched Jab Injuries Global. The platform, which has garnered 113,000 followers on its Australian Instagram account in just 10 months, has big plans globally, with local accounts in the United States, United Kingdom, and New Zealand beginning to gain traction.
“We are offering a service. I’ve got a team of about 12 writers, and we sit on the phone with people for about one-and-a-half to two hours. We type out their whole story from beginning to end in as much detail as possible so that the community can go through and see what’s really happening,” Jordan told The Epoch Times.
“We’re not really sharing science, news, data or any of our own opinions. We’ve allowed the people to speak about their experiences and their stories. I think we’ve got 300 now,” he said.
The platform comes as debate continues on the efficacy of vaccines and processes that governed their worldwide rollout during the pandemic years. The Instagram pages include testimonials from individuals reporting side effects, including pericarditis and seizures.
‘That’s a Tactic!’: Megyn Kelly’s Podcast Gets Heated as She Questions Virologist Dodging COVID Lab-Leak Theory Questions
Megyn Kelly’s podcast got heated on Thursday as she questioned virologist Dr. Robert Garry about the Wuhan lab-leak theory, asking him several times to stop dodging her questions.
During Sirius XM’s “The Megyn Kelly Show” podcast, the host spoke with Garry, a Tulane virologist, about the “furin cleavage site” in the virus, and how he allegedly changed his mind in just 48 hours regarding its origin from that of a lab leak in Wuhan, China, to something that started in nature.
Kelly then noted that we know, thanks to uncovered emails, that Garry originally thought COVID was likely leaked from the Wuhan lab, stating that he said, “I just can’t figure out how this gets accomplished in nature.”
After his conversations with Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, as well as the then-Director of the National Institutes of Health Dr. Francis Collins, he changed his mind. Kelly said that Garry completely “reversed” himself, claiming just two days later that “it can’t possibly be lab leak, it is nature.”
U.S. Faces Pandemic Crossroads With COVID Deaths Still Too High and New Omicron Variants Emerging, Fauci Says
White House chief medical advisor Dr. Anthony Fauci on Thursday said the U.S. is at a crossroads in the COVID-19 pandemic as new Omicron subvariants are gaining ground across the country.
Fauci, in a radio interview Thursday, said the pandemic has clearly eased since last winter, but deaths, which average more than 2,600 per week, remain far too high. At the same time, the new Omicron variants are knocking out key tools used to protect the most vulnerable.
Natural infection from the BA.5 subvariant or vaccination with the new boosters should provide protection against these subvariants for healthy people, Fauci said. But U.S. health officials are concerned the subvariants will basically knock out antibody treatments such as Evusheld that play a key role in protecting people with severely compromised immune systems, he said.
The Omicron subvariants BQ.1 and BQ.1.1 are of greatest concern. They are resistant to Evusheld and are increasing in the U.S. every week. BQ.1 and BQ.1.1 represent 27% of infections combined while Omicron BA.5 has declined to 50%, according to the Centers for Disease Control and Prevention.
Pfizer/BioNTech Say Updated COVID Booster Generates ‘Substantially Higher’ Protection Against Omicron Subvariants Than Original Vaccine
Pfizer and BioNTech said Friday that the immune responses against Omicron BA.4/BA.5 subvariants were “substantially higher” in people who got its new bivalent booster compared with people who received the companies’ original COVID-19 vaccine.
The bivalent booster that targets the original coronavirus strain and the Omicron BA.4 and BA.5 subvariants became available in the U.S. in early September. Pfizer and BioNTech said in a news release that the bivalent booster generated about four times higher levels of neutralizing antibody against the Omicron BA.4/BA.5 variants in people older than 55, compared with the original vaccine. The data has not been peer-reviewed or published.
The companies’ new data comes after two small studies that measured immune responses about three to five weeks after the updated booster dose; both found that the updated COVID-19 booster shots appear to work about as well against the BA.4 and BA.5 Omicron subvariants as the original boosters they replaced. The studies were released as preprints and have not been peer-reviewed or published.
Scholz’s China Visit Secures BioNTech/Pfizer Vaccine Access for Expats
People in China will soon be offered the BioNTech/Pfizer COVID-19 vaccine — but only if they are not Chinese. German Chancellor Olaf Scholz announced the deal today during a visit to China accompanied by a cohort of business leaders from his country, including BioNTech chief Uğur Şahin.
Scholz agreed with Chinese President Xi Jinping and outgoing Prime Minister Li Keqiang that the countries will work more closely in the fight against the coronavirus, he said.
“This also includes an approval of the BioNTech vaccine for expats in China,” he said during a press conference in Beijing.
The chancellor did not specify if he was referring to German ex-pats only, or all expats in the country. But one influential financial news outlet, Caixin, reported that the BioNTech vaccine would only be available to “German ex-pats” in China.
Why You May Soon Have to Pay for That COVID Test
The federal government is poised to stop paying for COVID-19 vaccines, tests and treatments in the coming months, shifting the costs onto the public.
Experts say most Americans are not aware that this will happen and will be in for a major case of sticker shock. They warn without additional protections or funding, the transition to commercialized treatments and preventive services will lead to health barriers.
Instead of free access to tests and treatments like Paxlovid, insurance companies and manufacturers will set the price.
The days of free, easily accessible COVID-19 tests will also likely end. Private insurance may not cover over-the-counter tests anymore, and patients may need a prescription first for a PCR test.
Pfizer, BioNTech Start COVID-Flu Combination Vaccine Study + More
Pfizer, BioNTech Start COVID-Flu Combination Vaccine Study
U.S. drugmaker Pfizer Inc. (PFE.N) and its German partner BioNTech SE have started an early-stage study to evaluate a combination vaccine targeting COVID-19 and influenza, the companies said on Thursday.
The single-dose vaccine candidate is a combination of Pfizer’s mRNA-based flu shot and the companies’ Omicron-tailored COVID-19 booster shot.
The early-stage study, which is being sponsored by BioNTech, aims to evaluate the combination shot’s safety, tolerability and immunogenicity, or the ability to generate an immune response.
Rivals Moderna Inc. (MRNA.O) and Novavax Inc. (NVAX.O) are also developing combination vaccines targeting both COVID-19 and influenza.
Sweden Pauses COVID Vaccine Nuvaxovid for Under 30s Due to Increased Risk of Myocarditis and Pericarditis
Sweden’s Public Health Agency has recommended that the protein-based COVID-19 vaccine Nuvaxovid should not be given to people 30 years of age and younger due to increased risk of myocarditis and pericarditis. The decision is said to be temporary and was applied from Nov. 2, 2022.
“The background to the decision is signals of an increased risk of heart muscle inflammation (myocarditis) and pericarditis,” a statement read.
“Data from Australia point to an increased incidence, especially in younger people, in connection with vaccination with Nuvaxovid.” It added: “The recommendation is made for precautionary reasons and applies until there is more information from the ongoing studies. The vaccine can continue to be given as a primary vaccination or booster dose to individuals aged 31 and older.”
The current vaccine for vaccination of people under the age of 31 is Comirnaty, from Pfizer/BioNTech — which was recently recommended to have heavy menstrual bleeding added to the product information as a side effect.
GOP Majority’s to-Do List Includes COVID Response, Origins — and Fauci
Congressional Republicans are floating sweeping investigations into the Biden administration’s COVID-19 spending and are looking to tighten the purse strings on agency funding should they hold majorities after next week’s midterms.
Republicans are frustrated with what they see as the administration’s unaccountable coronavirus spending and are looking to shine a spotlight on where the trillions of dollars doled out by the White House have gone.
Republicans in both chambers are also eager to launch investigations into Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases who is set to retire from the government this year.
Republicans have not been shy about launching probes into the U.S. response to the coronavirus pandemic, focusing on the origins of the virus and whether the federal government — and by extension, Fauci — helped fund controversial research that might have played a role in its creation.
Moderna, Not U.S. Gov’t, Must Defend COVID Vaccine Patent Case for Now
Moderna Inc. must face a patent infringement lawsuit over its COVID-19 vaccines, a federal judge in Delaware ruled Wednesday, finding that the biotech company has not shown that the U.S. government should have been sued instead.
U.S. District Judge Mitchell Goldberg said he was not yet convinced that the lawsuit by Arbutus Biopharma Corp and Genevant Sciences GmbH should have been brought against the government instead of Cambridge, Massachusetts-based Moderna.
Genevant said in a statement that it was pleased the court “rejected Moderna’s attempt to shift liability for its actions to U.S. taxpayers.” A spokesperson for Moderna said the company looks forward to “proving not only that Arbutus and Genevant sued the wrong party in the wrong court, but also, at the appropriate time, that there was no patent infringement here.”
Moderna and Pfizer‘s COVID-19 vaccines have been subject to several patent lawsuits this year from companies that say they pioneered key technologies related to the shots. Moderna sued Pfizer for patent infringement in August.
COVID: Pandemic Disruption Linked to 30,000 Excess Heart Disease Deaths, Charity Reports
Record-long waiting lists, ambulance delays and inaccessible care have driven a surge in excess deaths involving heart disease in England, an analysis by the British Heart Foundation has found.
Between March 2020 and August 2022 there were more than 30,000 excess deaths involving coronary heart disease, an average of 230 a week above the expected death rate. In addition, many people have not been able to access care for conditions such as high blood pressure, which could raise the risk of a future heart attack or stroke, the foundation’s report said.
It highlighted NHS England data showing that two million fewer people were recorded as having controlled hypertension in 2021 than in the previous year and that this could lead to an extra 11,190 myocardial infarctions and 16,702 additional strokes over three years.
COVID Infection Disrupts the Gut’s Microbiome
U.S. News & World Report reported:
COVID-19 is known to mess with a person’s lungs and can have long-term effects on the brain. Now doctors have found another way COVID harms your health — through your gut.
A COVID infection can reduce the number of bacterial species in the gut, creating an opportunity for dangerous antibiotic-resistant bacteria to thrive, according to a new study in the journal Nature Communications.
The study is the first to show that COVID alone damages the gut microbiome, researchers said. Before now, doctors had suspected that the use of antibiotics to treat COVID had been damaging gut bacteria.
Moderna Misses on 3Q, Shaves 2022 Vaccine Expectations
Supply problems have again forced Moderna to delay some COVID-19 vaccine deliveries, a move that surprised Wall Street and contributed to a disappointing third quarter.
The vaccine developer said Thursday that short-term issues prompted it to shift some deliveries initially planned for this year into 2023. It now expects 2022 revenue from advance purchase agreements to be as much as $3 billion lower than what it had forecast in August.
CEO Stephane Bancel told analysts on a call to discuss the quarter that the company was dealing with complex manufacturing issues. They included switching from 10-dose vials to five doses, the launch of a new booster and providing two different boosters globally.
On Thursday, the company said it now expects between $18 billion and $19 billion in revenue from advance purchase agreements this year. That’s down from the approximately $21 billion it forecast in August.
Australia Inks Next-Gen mRNA Technology Deal With U.S.
Commonwealth Serum Laboratories (CSL), an Australian biotechnology company and the world’s second-biggest flu vaccine manufacturer, has agreed to pay $312 million ($US200 million) to use groundbreaking mRNA vaccine technology from a U.S. company.
The vaccine manufacturer announced on Nov. 2 that it had licensed the new technology with Arcturus Therapeutics, an American mRNA medicines biotechnology company.
Arcturus’s mRNA vaccines use “self-amplifying” technology which studies have shown creates copies of themselves within the body so that they would require much smaller doses than the multiple doses required with current mRNA vaccines.
HHS Renews Public Health Emergency for Monkeypox Outbreak
The Department of Health and Human Services (HHS) on Wednesday renewed the national public health emergency for the monkeypox outbreak, with officials stating that the virus is still very present in the U.S. even as cases continue to drop.
The public health emergency for monkeypox was first signed on August 4. Public health emergencies from HHS end after 90 days unless they are renewed.
‘Considerable’ Monkeypox Transmission Happens Before Symptoms, Study Suggests
Monkeypox can spread before symptoms appear, British researchers said on Wednesday, providing the first evidence indicating the virus can be transmitted this way.
It was previously thought that monkeypox was almost entirely spread by people who were already sick, although pre-symptomatic transmission had not been ruled out and some routine screening had picked up cases without symptoms.
To find out more about how monkeypox was transmitted in Britain, a team from the U.K. Health Security Agency used routine surveillance and contact tracing data for 2,746 people in the country who tested positive between May and August.
Using two statistical models, they found that the median serial interval was shorter than the median incubation period. This indicated that “considerable” transmission happened before the appearance or detection of symptoms has taken place, the researchers wrote in the paper published in the British Medical Journal.