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Several biopharma players are racing to deliver COVID-19 vaccines, and now Johnson & Johnson is revving up its plans for late-stage trials earlier than originally expected—and it's aiming far above the FDA's 50% efficacy bar for approval...Johnson & Johnson chief scientific officer Paul Stoffels said the company has seen “strong” preclinical data, and it's now ready to kick off human testing...A phase 1/2a study in more than 1,000 adults ages 18 to 55 will start by enrolling in Belgium next week and open to U.S. participants the week after...READ MORE

New technology to disinfect N95 masks worn by health care workers is now in Nevada, but a major nurses union is questioning the effectiveness of the process...The Battelle Critical Care Decontamination System has been used to clean more than 1,700 of the N95 masks since early May. It uses vaporized hydrogen peroxide to kill the novel coronavirus, which causes the respiratory disease COVID-19...The new sanitization process is intended to make that equipment last even longer if necessary...Battelle says the system can clean a mask for up to 20 reuses, but National Nurses United, the country’s largest union of registered nurses, has repeatedly called for the process to be halted immediately...Union president Zenei Cortez wrote in a statement that union members reported their decontaminated masks came back deformed and their straps had lost elasticity. The masks’ ability to filter out dangerous particles depends on their snug facial fit...Similar concerns were also raised by a local hospital worker and member of the Nevada chapter of Service Employees International Union...READ MORE

State officials presented to the Senate...$233 million in proposed cuts from the health care budget that will slash key programs for low-income Nevadans and significantly pare back mental health services to ease a budget crisis caused by the ongoing coronavirus pandemic...Many of the proposed cuts will roll back initiatives spearheaded by lawmakers and the Department of Health and Human Services over the last few legislative sessions in an effort to improve health care in the state, which ranks among the worst in the nation...The recommended reductions to the Department of Health and Human Services budget will, if approved, make up nearly 20 percent of the $1.2 billion shortfall projected by the governor’s office and more than 42 percent of the proposed $549 million in agency rate reductions...READ MORE

The Trump administration has formally notified the United Nations of its withdrawal from the World Health Organization, although the pullout won’t take effect until next year, meaning it could be rescinded under a new administration or if circumstances change...The withdrawal notification makes good on President Donald Trump’s vow in late May to terminate U.S. participation in the WHO, which he has harshly criticized for its response to the coronavirus pandemic and accused of bowing to Chinese influence...The move was immediately assailed by health officials and critics of the administration, including numerous Democrats who said it would cost the U.S. influence in the global arena...READ MORE

In the global race to make a coronavirus vaccine, a state-owned Chinese company is boasting that its employees, including top executives, received experimental shots even before the government approved testing in people...“Giving a helping hand in forging the sword of victory,” reads an online post from SinoPharm with pictures of company leaders it says helped “pre-test” its vaccine...Whether it’s viewed as heroic sacrifice or a violation of international ethical norms, the claim underscores the enormous stakes as China competes with U.S. and British companies to be the first with a vaccine to help end the pandemic — a feat that would be both a scientific and political triumph...READ MORE

Leaders of a rural Nevada church are asking the U.S. Supreme Court to suspend the state’s 50-person cap on religious gatherings while an appellate court considers their claim that COVID-19 restrictions treating casinos and others more leniently violate their constitutional right to freely exercise their beliefs...Gov. Steve Sisolak’s June 4 directive allowing casinos, restaurants, bowling alleys and amusement parks to reopen at 50% of capacity while maintaining a hard cap for church services “simply turns the First Amendment on its head,” lawyers for Calvary Chapel Dayton Valley wrote in the request to the high court for an emergency injunction...“The Free Exercise Clause protects the exercise of religion. No constitutional provision protects the right to gamble at casinos, eat at restaurants, or frolic at indoor amusement parks,” they said...READ MORE

A group of pharmacies and pharmacy organizations urged the Centers for Medicare & Medicaid Services to formally recognize and promote medical at home pharmacy services for long-term care —particularly in the wake of the coronavirus disease 2019 (COVID-19) pandemic...“With medical at home pharmacy services being needed now more than ever due to the coronavirus public health emergency, long-term care pharmacy stakeholders are urging the Centers for Medicare & Medicaid Services to formally recognize and promote these services to help improve value-based patient care, increase savings, and ensure pharmacy providers are fairly and properly reimbursed,”...READ MORE

Britain, the United States and Canada accused Russian hackers on Thursday of trying to steal information from researchers seeking a coronavirus vaccine, warning scientists and pharmaceutical companies to be alert for suspicious activity...Intelligence agencies in the three nations alleged that the hacking group APT29, also known as Cozy Bear and said to be part of the Russian intelligence services, is attacking academic and pharmaceutical research institutions involved in COVID-19 vaccine development...“It is completely unacceptable that the Russian Intelligence Services are targeting those working to combat the coronavirus pandemic,″ British Foreign Secretary Dominic Raab said in a statement, accusing Moscow of pursuing “selfish interests with reckless behavior.”...READ MORE

To eradicate SARS-CoV-2, the virus that causes COVID-19 illness, we'll need a vaccine that's 70% effective—and 70% of the population will need to receive it, an FDA vaccine official said...That's a higher bar than the FDA set last week. To pass muster at the agency, a COVID-19 vaccine will need to be at least 50% more effective than placebo, according to new FDA guidelines...But the agency felt a 50% efficacy requirement was a “reasonable place” and about comparable to a flu vaccine on a good year, said Peter Marks, director of the Center for Biologics Evaluation and Research...READ MORE

South Korea has asked Gilead Sciences Inc’s to supply enough of its anti-viral drug remdesivir to treat more than 5,000 COVID-19 patients in preparation for a potential second wave of infections...remdesivir is in high demand, but there are concerns about its availability after Gilead allocated nearly all of its supply to the United States over the next three months..In a letter sent to Gilead on June 3, South Korea had requested doses for 360 patients who are in urgent need of the drug, and for enough to have ready for an additional 5,000 patients in the event of a second wave of infections...READ MORE