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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.
