- More therapeutics but no surge in vaccine for Michigan, Biden administration says (reuters.com)Michigan Governor Says COVID-19 Infections Could Be Dropping (usnews.com)
The White House said on Monday it was prepared to send additional therapeutic treatments to the state of Michigan, which is experiencing a worrying number of COVID-19 cases, but declined to promise more vaccine as the state has sought...White House coronavirus adviser Andy Slavitt told reporters the U.S. government would work to ensure that states such as Michigan were ordering the full amount of vaccine that was available to them but said that shifting distribution was not in line with the administration’s public health strategy...READ MORE
- Pfizer and BioNTech request regulatory agencies expand emergency use of their COVID-19 vaccine to adolescents (worldpharmanews.com)
Pfizer Inc. and BioNTech SE...requested amendments to the U.S. Emergency Use Authorization of the Pfizer-BioNTech vaccine (BNT162b2) to expand the use in adolescents 12 to 15 years of age. The companies plan to request similar rulings by other regulatory authorities worldwide in coming days. These requests are based on data from the pivotal Phase 3 trial in adolescents 12 to 15 years of age with or without prior evidence of SARS-CoV-2 infection, which demonstrated 100 percent efficacy and robust antibody response after vaccination with the COVID-19 Vaccine...READ MORE
- Senate committee advances bill to create ‘988’ mental health hotline, set plan for allocating opioid settlement funds (thenevadaindependent.com)
A legislative committee unanimously passed a bill that would create a state fund to house proceeds from opioid settlements, such as those against prominent pharmaceutical companies accused of helping fuel the opioid crisis...The bill would establish the “Nevada Fund for Healthy Communities,” which would hold the proceeds of state litigation against opioid manufacturers, distributors, sellers and marketers — including the $45 million Nevada is set to receive from the settlement of a lawsuit against consulting firm McKinsey & Company, which provided services for opioid manufacturers...READ MORE
- Nevada gets $30 million from CDC to help ensure maximum vaccination of the population (thenevadaindependent.com)
Nevada was awarded $30.2 million from the Centers for Disease Control to beef up the state’s COVID-19 vaccine program, including a push to vaccinate communities of color...“Millions of Americans are getting vaccinated every day, but we need to ensure that we are reaching those in the communities hit hardest by this pandemic,” CDC Director Rochelle Walensky said... “This investment will support state and local health departments and community-based organizations as they work on the frontlines to increase vaccine access, acceptance, and uptake.”...READ MORE
- CDC, FDA Recommend Pausing J&J COVID-19 Vaccine Rollout Over Blood Clots (biospace.com)J&J says delaying rollout of COVID-19 vaccine in Europe (reuters.com)U.S. FDA to scrutinize vaccine design behind COVID-19 shots linked to blood clots (reuters.com)
The U.S. Centers for Disease Control and Prevention and the U.S. Food and Drug Administration have identified six cases in the U.S. of a “rare and severe” type of blood clot, which seems to be linked to the COVID-19 vaccine by Johnson & Johnson...That is six cases out of more than 6.8 million doses that have been given in the U.S...The blood clots are cerebral venous sinus thrombosis, which were observed in combination with low levels of blood platelets. All cases were in women between 18 and 48 years of age. The symptoms occurred six to 13 days after vaccination...READ MORE
- FibroGen admits to messing with roxadustat safety data, upending hopes for the AZ-partnered anemia drug (fiercepharma.com)
...FibroGen admitted to presenting roxadustat data manipulated to make the anemia drug look safer than it is...The...announcement sent FibroGen shares tumbling and prompted analysts to reassess the potential first-in-class therapy ahead of an FDA decision...The company changed parameters used to analyze heart safety data for roxadustat in patients with anemia from chronic kidney disease...The false criteria yielded more flattering data...READ MORE
- Australia calls for release of 3.1 million vaccine doses, if EU not blocking exports (reuters.com)Australia to continue AstraZeneca vaccine rollout, review EU findings (reuters.com)
Australia said on Wednesday it will ask the European Union to release more than 3 million doses of AstraZeneca PLC's COVID-19 vaccine, testing Brussels claim it is not blocking shipments, as the country struggles to vaccinate its population...The European Union...denied blocking vaccine shipments to Australia, which has fallen dramatically behind in its scheduled vaccination programme...READ MORE
- J&J scores backing from Chamber of Commerce, PhRMA and more in Supreme Court appeal of $2.1B talc verdict (fiercepharma.com)
Johnson & Johnson has ginned up major support in its quest to challenge a $2.1 billion verdict over claims that its talc-based powders cause cancer...The U.S. Chamber of Commerce and other business groups...pressed the Supreme Court to review the verdict, taking aim at the merging of 22 plaintiffs' cases and the damages J&J was subsequently asked to shell out...In a 2018 trial, a Missouri jury ordered Johnson & Johnson to pay $4.69 billion after hearing the combined claims of 22 women who alleged the company’s talc powder caused their ovarian cancer...the Missouri Court of Appeals for the Eastern District knocked the verdict down to $2.1 billion...READ MORE
- A third of COVID survivors suffer neurological or mental disorders: study (reuters.com)
One in three COVID-19 survivors in a study of more than 230,000 mostly American patients were diagnosed with a brain or psychiatric disorder within six months, suggesting the pandemic could lead to a wave of mental and neurological problems...Researchers who conducted the analysis said it was not clear how the virus was linked to psychiatric conditions such as anxiety and depression, but that these were the most common diagnoses...“Although the individual risks for most disorders are small, the effect across the whole population may be substantial,”...READ MORE
- Big Las Vegas vaccine clinics bustle, but many more doses available (reviewjournal.com)
In stark contrast to earlier this year, Clark County has plenty of COVID-19 vaccine this week, as well as staff to administer it and space in which to do so. Local public health officials now face a different challenge...“Now we need people to come and get vaccinated,” JoAnn Rupiper, chief administrative nurse for the Southern Nevada Health District, said...READ MORE