U.S. Government to Fund up to $500 Million for Studies on Oral, Nasal COVID Vaccines
The U.S. Department of Health and Human Services (HHS) said on Thursday it will provide up to $500 million for mid-stage trials evaluating vaccines administered as a nasal spray or pill to protect against symptomatic COVID-19.
The funding is part of Project NextGen, a $5 billion initiative led by the Biomedical Advanced Research and Development Authority (BARDA), to advance a pipeline of new, innovative vaccines and therapeutics providing broader and more durable protection against COVID-19 infection.
The project is awarding up to $453 million to Vaxart (VXRT.O) for a study that will evaluate its oral COVID vaccine. The company’s shares more than doubled to $1.78 after market. It is also awarding privately held Castlevax and Cyanvac around $34 million and $40 million, respectively, to develop their intranasal vaccine candidates.
Each trial will enroll 10,000 volunteers and compare the efficacy and safety of the investigational vaccines to FDA-licensed vaccines.
“Currently approved COVID-19 vaccines are administered intramuscularly and, while extremely effective, are limited in their capacity to induce a robust immune response in mucosal areas such as the mouth, nose and gut, where the SARS-CoV-2 virus first enters the body,” the HHS said.
CDC Warns Access to ADHD Meds May Be Disrupted After Arrests of Healthcare Startup Executives
People taking medications for ADHD, or attention-deficit hyperactivity disorder, may face disruptions in accessing treatment after the arrests of two executives of a telehealth company that distributed such drugs to adults across the United States.
On Thursday, the U.S. Centers for Disease Control and Prevention issued an official health advisory warning about a “potential disrupted access to care among individuals taking prescription stimulant medications and possible increased risks for injury and overdose.”
Around the same time, the US Department of Justice announced a federal healthcare fraud indictment against two executives from the digital health company Done Global, whose website describes it as “making high-quality psychiatric chronic care management more accessible and affordable for patients.”
FDA Tells Vaccine Makers to Target New COVID Variant for Fall
U.S. News & World Report reported:
COVID vaccine makers will be advised to update their shots to target the KP.2 variant, an offshoot of the JN.1 variant that spread widely last winter, the U.S. Food and Drug Administration announced Thursday.
It’s a turnaround for the agency: The new recommendation follows an FDA advisory panel vote last week that unanimously recommended COVID vaccines target the older JN.1 variant this fall.
Although the FDA said it first advised vaccine makers to target JN.1, the most current data, along with a recent rise in COVID cases, suggests the preferred variant for the updated vaccines to target is now the KP.2 strain, the FDA said.
JN.1 has largely fallen out of circulation in the United States, according to the U.S. Centers for Disease Control and Prevention. KP.2 now accounts for 22.5% of new COVID cases in this country while KP.3, a sister variant, is fueling 25% of new cases.
Pfizer Expects 8 Blockbuster Cancer Drugs to Come From Each of 4 Focus Areas: Exec
During a recent investor event dedicated to the newly expanded oncology business, Pfizer unveiled a goal to have eight blockbuster cancer drugs by 2030 but fell short of naming specific products.
Pfizer’s internal calculation suggests that “on paper” more than eight cancer drugs could become blockbusters, but the New York pharma decided that eight is what it can stand by now, Varma added.
Pfizer is betting big on oncology with the $43 billion acquisition of antibody-drug conjugate specialist Seagen last year. The heavy investment runs in parallel with some multiyear, multi-billion-dollar cost-cutting schemes as once high-flying sales from COVID products fell back to earth.
Fewer People May Need Statins to Prevent Heart Disease, New Study Suggests
A new way of determining heart disease risk may result in millions fewer people getting prescriptions for statins, according to new research. Heart doctors warned, however, that more information is needed and patients shouldn’t stop taking their medications.
Statins, such as Lipitor, Crestor and Zocor, are widely used to protect against high levels of LDL cholesterol, one of the causes of cardiovascular disease. Doctors prescribe the daily pills based on 2013 guidelines from the American Heart Association and the American College of Cardiology, which estimate risk based on a patient’s age, diabetes, blood pressure and other factors.
Using PREVENT to calculate the 10-year risk for developing heart disease, the researchers determined that some 40% fewer people would have met the criteria for a statin prescription.
In other words, as many as 4 million people in the U.S. who currently take statins for primary prevention — meaning they have not had a cardiovascular event such as a stroke or heart attack — may not need them, said Anderson, lead author of the new study.
Immunization Rates Fall Among Australia’s Vulnerable as Experts Blame Pandemic Misinformation and Practical Barriers
Immunization rates are lagging in Australia’s most vulnerable populations — the very young and old — with experts blaming practical barriers as well as the misinformation and vaccine hesitancy that took off during the COVID-19 pandemic.
In 2020 Australia achieved a record-high rate of 95.09% of five-year-olds fully immunized against infectious diseases, even surpassing the government’s target of 95%, which provides “herd immunity.”
However, the latest government data shows Australian children have fallen below that target, with only 93.93% of five-year-olds having had all vaccines recommended for their age, 91.24% of two-year-olds and 93.16% of one-year-olds.
A new study of more than 3,000 Australian parents published in the Medical Journal of Australia found misinformation and vaccine hesitancy increased during the pandemic compared with the views of research participants in 2017.
