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Florida Woman Says COVID Shots Made Her Sick, but Federal Law Protects Vaccine Makers
The Daytona Beach News-Journal reported:
A Port Orange woman and eight others say they were harmed by COVID-19 vaccinations and have filed a federal lawsuit against the U.S. Department of Health and Human Services, seeking to break the immunity granted to vaccine makers.
Moms for America, an Ohio-based nonprofit, was joined by Michelle Utter of Port Orange and eight other individuals in suing the government in a case filed last week in the Middle District of Florida in Tampa. They argue a provision of a federal law protecting vaccine manufacturers from damage claims is unconstitutional and should be struck down.
After receiving the first shot of the two-part vaccination on Dec. 22, 2020, Utter became ill for two weeks, with inflammation throughout her body, restless leg syndrome and flu-like symptoms, the suit states. She was hesitant, but took the second dose three weeks later, which the lawsuit described as “a tragic mistake.
She was ultimately diagnosed with CIDP, a neurological disorder caused by damage to the myelin sheath, the protective covering that surrounds nerve fibers, due to an autoimmune response, the suit states.
She has had other complications, as well, and has been regularly receiving intravenous immunoglobulin (IVIG), which manages immunodeficiency and other conditions including micro-clotting in her blood. “Tests show that her body still produces the COVID-19 spike protein, a vaccine artifact,” the suit states.
CDC Looks to Expand Capacity to Test for H5N1 Bird Flu in People
As the H5N1 bird flu outbreak in dairy cows enters its fourth month, the Centers for Disease Control and Prevention is taking steps to ramp up the nation’s capacity to test for the virus in people.
In a call with reporters Tuesday, Nirav Shah, the CDC’s principal deputy director, emphasized that the risk to the general public remains low at this time. But given that the virus is showing no signs of slowing its push deeper into the U.S. cattle population — threatening to create lasting risks to dairy workers and giving it more chances to evolve in ways that make it better at spreading to and among humans — the agency is looking to increase the number and types of tests that can effectively detect H5N1 infections in people.
Currently, the CDC’s bird flu test is the only one the Food and Drug Administration has authorized for use. Shah said the agency has distributed 750,000 of these tests to local public health labs and is expecting 1.2 million more to come online in the next two to three months.
But should the virus begin to spread easily among humans, testing needs may quickly outpace existing public health laboratory capacity. Which is why the CDC is also working with commercial labs to build additional tests. So far, the agency has given eight companies licenses for its tests, Shah said. Three additional licenses are pending and another four companies are in the process of applying for licenses.
NIH Announces Launch of Clinical Trial for Nasal COVID Vaccine
The National Institutes of Health (NIH) yesterday announced the launch of a phase 1 trial of a nasal vaccine against COVID-19, which also marks the first National Institute for Allergy and Infectious Diseases (NIAID) trial conducted as part of the government’s Project NextGen — an effort designed to advance the development of next-generation vaccines against the disease.
The investigational vaccine, called MPV/S-2P, uses a murine pneumonia vector (MPV) to deliver a version of the SARS-CoV-2 spike protein. The NIH said MPV has an affinity for epithelial cells that line the respiratory tract and may be useful for delivering the vaccine to body sites where natural coronavirus infection begins. In preclinical nonhuman primate studies, the vaccine prompted a robust systemic immune response as well as mucosal immunity, which plays a greater role in controlling respiratory virus replication.
Researchers will enroll 60 adults ages 18 to 64 who have received at least three doses of mRNA COVID vaccine, who will be divided into three groups receiving progressively higher doses of the nasal vaccine. They will be followed up for about 1 year as investigators track participants’ immune responses in the blood and nose. Study sites are Baylor College of Medicine in Houston; Hope Clinic at Emory University in Decatur, Georgia; and New York University, Long Island.
GSK Buys COVID, Influenza Vaccines From Retrenching CureVac
British drugmaker GSK (GSK.L) on Wednesday bought partner CureVac out of their alliance on influenza and COVID-19 vaccine development, boosting its messenger RNA credentials and extending the German biotech company’s financial lifeline.
GSK, one of the world’s largest vaccine manufacturers, will take control of CureVac’s leading experimental vaccines to fight infections, including seasonal flu and bird flu.
It will pay CureVac 400 million euros ($430 million) upfront and up to 1.05 billion euros contingent on achievements. CureVac shares surged on the news, trading 24% higher to reach a three-week high at 0739 GMT.
Under the partnership that began in 2020 during the COVID-19 pandemic, the companies have worked together to develop mRNA vaccines for infectious diseases.
Israeli Scientists Get Funding to Help Eradicate Polio
Ben-Gurion University of the Negev has received a $1.3 million grant from the Bill & Melinda Gates Foundation to develop and validate a novel and safe approach for measuring immune responses to polioviruses.
This research is being led by Prof. Tomer Hertz of the Department of Microbiology, Immunology and Genetics and the National Institute for Biotechnology in the Negev.
Since 2018, Hertz has been developing antigen arrays capable of predicting immune responses of patients vaccinated against polioviruses, influenza viruses or viruses from the flavivirus family (including, among others, Zika and the viruses that cause dengue and yellow fever).
FDA Approves New Drug to Treat Alzheimer’s
U.S. News & World Report reported:
A new drug to treat Alzheimer’s disease was approved by the U.S. Food and Drug Administration on Tuesday.
In clinical trials, donanemab (Kisunla) modestly slowed the pace of thinking declines among patients in the early stages of the memory-robbing disease. But it also carried significant safety risks, including swelling and bleeding in the brain.
Prescription Drug Prices Have Surged Almost 40% Over the Past Decade
The cost of prescription drugs in the U.S. has surged nearly 40% over the past decade, easily outstripping the pace of inflation, according to a new study.
Findings published by GoodRx, a drug savings company, show that the list price for prescription drugs has climbed about 37% since 2014. Although price increases have slowed this year, costs continue to pose a “significant burden” to many consumers.
Biden Joins Sanders’ Campaign Targeting Novo Nordisk, Eli Lilly’s Diabetes and Obesity Drug Prices
In recent months, frequent pharma critic Sen. Bernie Sanders has been ratcheting up a campaign against Novo Nordisk over the price of its popular diabetes and weight loss medicines. Now, the senator has big-time backup in his fight.
In a new USA Today op-ed piece, President Joe Biden and Sen. Sanders blasted Novo Nordisk for “charging the American people unconscionably high prices” for its popular GLP-1 medicines Ozempic and Wegovy. They noted that the drugs cost several times more in the U.S. than in many other developed nations, a point Sanders has raised repeatedly during his recent crusade against Novo Nordisk.
“Each country has its own healthcare system and making isolated and limited comparisons ignores this fundamental concern,” Novo’s spokesperson added. “What remains constant is the indisputable value and cost savings Novo Nordisk medicines bring to patients, healthcare systems and society.”
Besides Novo, the two politicians said Eli Lilly is charging “unconscionably high prices for Mounjaro, a drug with similar health effects as Ozempic.” Lilly’s drug costs about $1,100 monthly in the U.S., according to the op-ed.
