The United States Department of Health and Human Services has expanded its avian flu pandemic preparedness partnership with CSL Seqirus, lining up the vaccine specialist tocompletethe fill-finish process for the shots.
Execution of this stage will increase the arsenal of vaccines acquired by the Biomedical Advanced Research and Development Authority (BARDA) under its National Pre-Pandemic Influenza Vaccine Stockpile (NPIVS) program.
It is the fourth award from BARDA to CSL Seqirus related to preparations for a potential outbreak of avian influenza (HPAI) virus, which has been detected in wild birds and livestock throughout the U.S.
With this agreement, CSL Seqirus will deliver 4.8 million vaccine doses that are matched to the current H5N1 strain of the virus.
On Thursday, the CDC reported on the spread of H5N1 in dairy cattle and two cases of humans contracting the virus.
“The CDC maintains the risk to public health as low. We are closely monitoring the situation because we are acutely aware of the threat that influenza virus strains like H5N1 can pose and take seriously our role in preparedness efforts alongside our government and public health partners,” Marc Lacey, CSL Seqirus, Global Executive Director for Pandemic, said in a release.
CSL will provide the vaccines from its massive manufacturing site in Holly Springs, N.C. which was built through a public-private partnership between the company and BARDA 15 years ago.
The facility can deliver up to 150 million doses within six months of the declaration of a pandemic, CSL Seqirus said, with a second phase of manufacturing enabling more vaccines as needed.
Two years ago, CSL Seqirus gained a “ready to respond” designation, meaning that in the case of a pandemic, it would immediately shift from its usual production of seasonal flu shots to the manufacture of those for the emergency.
Of the potential $2 billion award amount from the government to CSL Seqirus, BARDA has obligated $1.1 billion to the company, with $139 million of that paid for, according to USASpending.com.
In October 2022, CSL Seqirus scored a $30 million contract from BARDA to conduct a phase 2 trial of its avian flu candidate. In August of last year, BARDA awarded a $46.3 million contract to the company for one bulk lot of HPAI vaccines.
An FDA panel voted 11-0 Monday to recommend the use of Eli Lilly's(LLY) early-stage Alzheimer's treatment, known as donanemab.
The monoclonal antibody drug, delivered through an IV monthly for up to 18 months, would be the second Alzheimer's drug on the market if the FDA moves ahead to approve. The FDA's decision does not have to align with the panel's vote.
During the panel hearing Monday, experts discussed the safety of the product, as there were a number of deaths reported during the trial, and recommended use only within certain subgroups as a result.
The trial studied the drug's ability to address beta-amyloid plaque buildup associated with dementia and the ability to slow progress of the disease in patients between the ages of 60 and 85. Lilly's results showed a 35% reduction in progress of the disease in 18 months.
The only other drug on the market currently is Eisai and Biogen's (BIIB) Leqembi, which showed a 27% decline in progression of the disease in patients who used it for 18 months.
There were also adverse events reported in 21% of patients. This had been a concern for doctors regarding Leqembi's predecessor which had a disastrous rollout and was eventually taken off the market.
Leqembi has struggled to take off due to burdensome Medicare rules for use — including expensive brain scans — as well as skepticism about its benefits from doctors. Medicare is also concerned about the cost, estimating $3.5 billion will be spent on Alzheimer's drugs in 2025.
Eisai and Biogen have also asked the FDA to approve an injectable version of the drug, which would make it easier for patients to access.
Eisai also announced Sunday it had filed for extended use of the IV version of Leqembi after the initial 18-month treatment period to ensure continued support against progression of the disease. The FDA accepted the request on Monday and has until January 2025 to make a decision.
The timeline for Lilly's donanemab approval, initially expected by the end of the first quarter of this year, has been delayed. The FDA has not updated its anticipated action date to approve or reject the drug.
U.S. District Judge Karen Marstonin Philadelphia is set to preside over litigation involving the popular diabetes and weight-loss drugs Ozempic,Wegovy, and Mounjaro.
The Judicial Panel on Multidistrict Litigation appointed Marston to manage over 10,000 personal injury lawsuits.
U.S. District Judge Gene E.K. Pratter, who had previously been handling the case, had died.
Marston, a former federal prosecutor appointed by Donald Trump in 2019, is expected to move swiftly.
ACalifornia federal judge has reportedly allowed litigation to proceed against Abbott Laboratories (NYSE:ABT) regarding its Glucerna shakes and nutritional powders.
The lawsuit claims these products, marketed as suitable for people with diabetes, contain harmful ingredients.
U.S. District Judge P. Casey Pitts in San Jose largely denied Abbott’s motion to dismiss the proposed class action, stating that consumers had provided sufficient evidence to support their claims that Glucerna, which is labeled as “scientifically designed for people with diabetes,” contains sucralose and other additives that some studies indicate could have adverse health effects.
Judge Pitts did grant Abbott’s motion to dismiss the consumers’ request for an injunction that would require Abbott to amend the labeling on Glucerna products.
He reasoned that consumers concerned about these additives could check the ingredients list to see if the products contain sucralose.
Steven Prescott, a California resident, initiated the lawsuit in August. Prescott alleges that the Glucerna product labels misled consumers by claiming they could help regulate blood sugar in diabetics and individuals with similar conditions.
He contends that the products contain sucralose, a sugar substitute approved by the FDA for use in food, which can deregulate blood sugar, kill insulin-releasing cells in the pancreas, and cause cells to become resistant to insulin.
Reuters noted that Abbott has maintained that the Glucerna product labels are not misleading, asserting that the products are intended as snacks or meal replacements that help regulate blood sugar compared to high glycemic carbohydrates.
The company also criticized the studies Prescott cited, arguing they do not substantiate a link between sucralose and the alleged health problems.
In its dismissal motion, Abbott pointed to the side label on Glucerna shakes, which states the product is designed to “help minimize blood sugar spikes” compared to high glycemic carbohydrates.
However, Judge Pitts noted that at this stage, it is not clear that consumers would understand the side label to limit the front-label claims as much as Abbott suggests.
President Biden's executive order to curb the illegal alien invasion was nothing more than optically pleasing headlines before the September presidential debates. Just days after the order was signed, US Customs and Border Protection agents in the southern California sector received a memo instructing them to release single adults from all but six countries.
Fox News' Bill Melugin obtained an internal CBP memo sent to agents in the San Diego sector following Biden's executive order last Tuesday. The memo instructed them to release single adults from over 100 eastern hemisphere countries, except for six (Uzbekistan, Russia, Tajikistan, Georgia, Moldova, Kyrgyzstan) deemed "mandatory referral" countries. This means despite the president's promise of stopping the invasion between border checkpoints, the majority, including Chinese, Middle Eastern, and African adults, are still being released into the US.
Here's more from Melugin:
NEW: @FoxNews has obtained an internal Border Patrol memo sent to agents in San Diego sector after President Biden's executive order took effect, instructing them to release single adults from all but six countries in the eastern hemisphere & classifying them as "hard" or "very hard" to remove.
Specifically, the memo instructs agents to process all single adults from 100+ countries in the eastern hemisphere as NTA/OR, which means "Notice to Appear/Release on Own Recognizance", except for six countries which are deemed "mandatory referral" countries (Uzbekistan, Russia, Tajikistan, Georgia, Moldova, Kyrgyzstan).
President Biden & DHS promised consequences & removal for those who cross illegally between ports of entry after the executive order took effect - but the overwhelming majority of illegal crossers in San Diego sector, including the Chinese, Middle Eastern, & African adults we've been showing, are still being released into the US with future court dates, as our coverage has shown repeatedly with Border Patrol mass releases at a trolley station in San Diego.
In a background call with reporters, DHS officials acknowledged the difficulty of removing illegal immigrants from eastern hemisphere countries, as some governments won't cooperate with US repatriation flights/travel documents & won't take their citizens back
DHS officials said they are engaged with these countries and are trying to enhance cooperation.
Bottom line in the short term: Mass catch & release continues for illegal immigrants in San Diego sector, who continue pouring in from all around the globe.
H/T to @Anna_Giaritelli , who was the first reporter to scoop this memo.
Melugin continued.
Mass releases are ongoing, even after the order.
"Voter importation," Elon Musk wrote on X, responding to Melugin's post.
Last week, Biden tried to convince the nation that his executive action would actually do something to stop the illegal invasion, yet it was merely a lie as the flood of migrants will continue. One reason to lie to the American people is that Biden's polling data has been crushed by the crime and chaos spreading across cities as migrants pour in by the tens of thousands, and in some cases, hundreds of thousands.
Common sense returns to Virginia as California Governor Gavin Newsom Struggles to defend inane policy. Let’s start with Newsom and gasoline prices.
In a Wall Street Journal Op-Ed, Newsom says “What people pay at the pump isn’t simple supply and demand but the result of a highly concentrated and opaque market.“
Here are the facts. Price spikes—like the $6.42 a gallon in June 2022 that sparked our new price-gouging law—happened when California taxes and fees remained unchanged, and crude prices had actually decreased. What drove up prices were increases in industry profits.
California’s new law provides us with tools to investigate profit spiking by Big Oil, helping us to prevent supply disruptions and take legal action when necessary. Another potential tool to encourage the oil industry to do right by Californians is a price-gouging penalty that will be developed through a public process.
What people pay at the pump isn’t simple supply and demand but the result of a highly concentrated and opaque market that lets a handful of mega-profitable oil companies upcharge tens of millions of people. In California, four companies control 90% of the gasoline refining capacity.
Factors such as refinery maintenance and lack of planning have been shown to reduce supply and increase refinery margins by upward of 200% at a time. California has also found that traders on the open “spot market” drive up prices, benefiting oil companies.
OK, why is the market in California concentrated and opaque?
California has the most regulations of any state
Refiners tired of California nonsense have left the state
California seasonal blend requirements have costs. But there’s not just one summer blend. Refineries make more than 14 kinds due to different state regulations.
“Coming into the year, there’s only gonna be three refineries in the Bay Area,” said Texas-based Andrew Lipow, an oil industry analyst and consultant. “When you have only three and one shuts down, it makes, to say the least, it would make things exciting and not necessarily in a good way.”
“Yes, we’ll be as vulnerable or more to disruptions just because there’s less alternative sources to diversity that production amongst. I think we’ll have too much diesel and not enough gasoline,” said UC Davis economics professor Jim Bushell.
Not enough gasoline in a state mostly using gasoline cars means higher priced gasoline.
California Issues Major New Emergency Rules
Totally oblivious to what’s going on, please ponder Newsom’s solution to high gas prices and refiners leaving the state.
Effective May 20, 2024, refiners and all importers of transportation fuels into California must follow the newest regulations from the California Energy Commission (CEC) — the Gross Gasoline Refining Margin and Marine Import Reporting Regulations. These impose substantial reporting obligations on imports of transportations fuels destined for California. Importers subject to these obligations are all entities that import transportation fuels, including refiners, traders, and brokers, and that are importers of record under federal customs law or are otherwise owners of cargo before arrival. Refiners, firms that produce liquid hydrocarbons or fuel ethanol, and firms that sell these products to retailers and resellers are also required to submit new monthly reports on their gross gasoline refining margins and detailed information on expenses and wholesale gasoline sales.
Following a pre-rulemaking workshop in April, CEC submitted this latest regulation to the Office of Administrative Law (OAL) on May 9, kicking off a limited five-day public comment period. OAL ultimately approved the regulation on May 20, and it became effective immediately for a period of two years. Most significantly, the regulation requires that any importer of record or owner of “reportable cargo,” which includes finished gasolines, gasoline blending components, diesel fuels, and aviation fuels, file the new California Marine Import Report prior to arrival at a California port.
The latest regulation is a product of the March 2023 California Gas Price Gouging and Transparency Law (SBX1-2), which provides CEC with unprecedented authority to promulgate regulations that will increase state regulatory control over the transportation fuels market. These regulations will have a significant impact on a wide swath of market participants — including market participants beyond refiners and importers of gasoline.
What Newsom Deserves
What Newsom and his supporters deserve is for all California refiners to leave the state.
However, if the refiners all did leave, innocent bystanders who don’t support Newsom’s madness would also suffer in the debacle.
Considering that it takes many years to build a new refinery and that Gov. Gavin Newsom championed California’s law to prohibit the sale of new gas-powered vehicles after 2035, why would anyone invest in new refining capacity to produce California’s unique blends? Mr. Newsom and his fellow travelers are on a mission to force Californians to stop driving gas-powered vehicles, so he should be thrilled at high gasoline prices.
Gov. Gavin Newsom wants to spread his anti-fossil fuel gospel far beyond California, but last week he lost a follower. Virginia canceled its plan to adopt West Coast vehicle standards, offering drivers freedom instead of climate dogma.
Gov. Glenn Youngkin said his state won’t phase out sales of gas-powered vehicles, despite a 2021 law that might have set Virginia on course to ban them by 2035, as California will. “The idea that government should tell people what kind of car they can or can’t purchase is fundamentally wrong,” he said.
He’s changing policy set by Democratic Gov. Ralph Northam, who signed a bill letting Virginia impose regulations set by the California Air Resources Board (CARB). The Biden Administration opened the door by letting the Golden State set stricter rules than those set by the Environmental Protection Agency, and Virginia was one of several states to follow California.
In 2022 Mr. Newsom pushed CARB to impose even stricter rules, mandating that zero-emissions cars make up 35% of new auto-maker sales by 2026 and 100% by 2035. Democrats in Virginia say they are bound to go along once the new rules take effect next year. So much for individual state sovereignty.
Mr. Youngkin has the public on his side. A December poll found that 57% of Virginians want to repeal the vehicle mandates, compared with 30% who prefer to keep them in place. Ditching the mandates will give consumers a choice of EVs or gas-powered cars, which will help low-income buyers in particular. As for Mr. Newsom, check back in a decade to see where his forced EV march has led the Golden State.
Virginia Has Had Enough
Expect a challenge from the climate fearmongers, but it won’t go anywhere. The bill signed by Democratic Gov. Ralph Northam lets (but does not require) Virginia to follow California nonsense.
No matter what idiots decide, 35 percent of new car sales in 2026 will not be EVs.
Assuming Trump is elected, he will seek to reverse ruling that lets California set stricter rules than those set by the Environmental Protection Agency.
And expect those increasingly ridiculous EPA rules themselves to be watered down.
Prepare to pay another $1 per gallon in California with higher prices in Nevada and Arizona too.
Despite refiners losing money, Newsom seeks new taxes causing a complaint from Nevada.
If I was a refiner, I would leave that hell hole and let California fend for itself.
California already pays $1.48 more than the national average. Governor Newsom wants you to believe gouging is more likely in California than anyplace else in the nation.
As of April, 2024, the World Resources Institute reports “While around 50 oil refineries were in operation across California a few decades ago, 11 refineries operate in California today.”
Newsom’s proposal will impose more still costs on gasoline refiners, perhaps to the point more leave the state.
It’s on purpose.
Virginia now says no thanks to the path California is on.
Modernaon Mondayunveiled Phase III datafor its investigational combination vaccine mRNA-1083, which demonstrated a superior immune response against COVID-19 and influenza compared to licensed vaccines.
In patients aged 65 years and older, mRNA-1083 triggered significantly higher immune responses than two co-administered licensed vaccines, which are routinely recommended—Fluzone HD, an enhanced flu vaccine, and Moderna’s COVID-19 shot Spikevax. The investigational vaccine induced a stronger response against SARS-CoV-2 and the H1N1, H3N2 and B/Victoria influenza strains.
Moderna’s experimental combo shot also elicited significantly better immune responses against these viruses in adults aged 50 through 64. In this younger age group, mRNA-1083 was compared with the co-administration of Spikevax and the standard-dose flu vaccine Fluarix.
The late-stage study found mRNA-1083 to be non-inferior to licensed comparators in both age groups against the B/Yamagata influenza strain, which has increasingly disappeared from circulation, according to Moderna.
In terms of safety, most of the adverse events associated with mRNA-1083 were grade 1 or 2 in severity. The most common side effects included headaches, fatigue and injection site pain.
“Combination vaccines have the potential to reduce the burden of respiratory viruses on health systems and pharmacies, as well as offer people more convenient vaccination options that could improve compliance and provide stronger protection from seasonal illnesses,” Moderna CEO Stéphane Bancel said in a statement.
With Monday’s readout, Moderna has become “the only company with a positive Phase III flu and COVID combination vaccine,” Bancel said. The pharma will present complete Phase III data and analyses at an upcoming medical congress and will work with regulators to determine the next steps for mRNA-1083.
MRNA-1083 combines two of Moderna’s investigational mRNA vaccines. The first is the flu vaccine candidate mRNA-1010, which encodes for the hemagglutinin glycoproteins of the H1N1, H3N2, B/Victoria and B/Yamagata influenza strains.
In February 2023, Moderna posted interim Phase III data for mRNA-1010, which was able to elicit better seroconversion rates for the H3N2 and H1N1 strains. However, the investigational shot did not meet its non-inferiority bar for seroconversion for the B/Victoria- and B/Yamagata-lineage strains.
The second component of mRNA-1083 is mRNA-1283, a next-generation COVID-19 vaccine candidate. In March 2024, Moderna announced that mRNA-1283 met its primary endpoint in a Phase III trial, eliciting a stronger immune response against SARS-CoV-2 compared with the pharma’s licensed COVID-19 vaccine. This advantage was consistent for both the Omicron BA.4/BA.5 and wildtype strains and was pronounced in older adults over 65 years of age.
