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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

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

FDA granted an emergency use authorization for the first machine learning–based COVID-19 nondiagnostic screening device. The Tiger Tech COVID Plus Monitor identifies certain biomarkers that may be indicative of SARS-CoV-2 infection. It can also detect hypercoagulable conditions, such as sepsis or cancer, or hyper-inflammatory states in asymptomatic individuals over the age of 5 years...FDA said the device, which is an armband embedded with light sensors and a small computer processor, is intended for use by trained personnel to help prevent exposure to and the spread of COVID-19...READ MORE

An FDA inspector-turned-whistleblower claims the agency soft-pedaled violations at a range of pharma manufacturing plants, including a Merck & Co. vaccine facility in Durham, North Carolina, where staff allegedly destroyed evidence of unsanitary practices. Those allegations have now been passed along to the White House… The whistleblower alleged that employees at Merck's plant were moving between cleanrooms and uncontrolled areas without properly ungowning, and that a biohazard bin contained employee uniforms soiled with blood, urine and feces. Employees were soiling their uniforms rather than taking restroom breaks, the whistleblower claimed, citing a confidential informant, because staffers would have otherwise needed to remove sterile gowning and leave manufacturing areas…READ MORE

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

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

Vaccine passports being developed to verify COVID-19 immunization status and allow inoculated people to more freely travel, shop and dine have become the latest flash point in America’s perpetual political wars, with Republicans portraying them as a heavy-handed intrusion into personal freedom and private health choices...They currently exist in only one state — a limited government partnership in New York with a private company — but that hasn’t stopped GOP lawmakers in a handful of states from rushing out legislative proposals to ban their use...READ MORE

The University of Oxford said...it had paused a small UK trial testing the COVID-19 vaccine it developed with AstraZeneca Plc in children and teenagers, as it waits for more data on rare blood clotting issues in adults who received the shot...The trial disruption is the latest blow to the vaccine, once hailed as a milestone in the fight against the pandemic, after several countries restricted its use in light of reports of medical issues after inoculations...READ MORE

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

Throughout the frantic response to the pandemic last year, drugmakers worldwide tested hundreds of potential treatments. Gilead’s antiviral remdesivir quickly rose to the top of treatment guidelines, and with the pandemic spiraling out of control, advocacy groups called on the U.S. government to step in and enforce patents against the company...But it turns out the government has no intellectual property covering remdesivir, the Government Accountability Office concluded in a new report...READ MORE