Today's News and Commentary

About Covid-19

 Americans can now order four more free at-home Covid-19 tests: “Americans can now order a second set of free at-home Covid-19 rapid antigen tests from the federal government. 
Covidtests.gov, the website to sign up for the free tests, launched in January, when people could order a maximum of four tests per household. Households that took part in that first round can now order an additional four.
Households that missed the first round of test giveaways can order up to eight tests through the website or by calling 1-800-232-0233.”

WHO says COVID boosters needed, reversing previous call: “An expert group convened by the World Health Organization said Tuesday it “strongly supports urgent and broad access” to booster doses of COVID-19 vaccine amid the global spread of omicron, capping a reversal of the U.N. agency’s repeated insistence last year that boosters weren't necessary for healthy people and contributed to vaccine inequity.”

Pfizer to Submit Data to FDA on Fourth Covid Shot Soon, CEO Says:”Pfizer CEO Albert Bourla said the company will soon submit data to US regulators on a fourth dose of its COVID-19 vaccine Comirnaty…
Meanwhile, findings from a study of a three-dose regimen of the company's vaccine for children under the age of 5 are also expected next month, he added.”

COVID-19 Focused Inspection Initiative in Healthcare: From OSHA: “This memorandum provides instructions and guidance to Federal OSHA Area Offices for a highly focused, short-term inspection initiative directed at hospitals and skilled nursing care facilities that treat or handle COVID-19 patients…
The intent of this initiative is to magnify OSHA’s presence in high-hazard healthcare facilities over a three-month period (March 9, 2022 to June 9, 2022), to encourage employers in these industry sectors to take the necessary steps to protect their workers against the hazards of COVID-19...
Criteria for Conducting Focused Healthcare Inspections…

  1. Follow-up inspection of any prior inspection where a COVID-19-related citation or hazard alert letter (HAL) was issued;

  2. Follow-up or monitoring inspections for randomly selected closed COVID-19 unprogrammed activity (UPA), to include COVID-19 complaints and Rapid Response Investigations (RRIs); or

  3. Monitoring inspections for randomly selected, remote-only COVID-19 inspections where COVID-19-related citations were previously issued.”

About pharma

 FDA Offers Grants for Biosimilar Research: “The FDA’s Center for Drug Evaluation and Research announced plans to fund up to five biosimilar research efforts and has committed $5 million toward the projects in fiscal 2022.
The funding will target projects for innovations in biosimilar and interchangeable products, as part of the FDA’s commitments under the Biosimilar User Fee Amendments (BsUFA).”

About the public’s health

Global community comes together in support of 100 Days Mission and pledges over $1.5 billion for CEPI’s pandemic-busting plan: “The global community [yesterday] came together to commit to the 100 Days Mission – the ambition to have safe and effective vaccines within 100 days of an epidemic or pandemic threat being identified – and pledged $1.535 billion to the Coalition for Epidemic Preparedness Innovations (CEPI) to help kick start the organization’s ambitious plan to tackle epidemics and pandemics, potentially saving millions of lives and trillions of dollars in lost economic output.”

 The Loophole That’s Fueling a Return to Teenage Vaping: “The Food and Drug Administration’s crackdown on flavored e-cigarettes in 2020 was meant to be a comprehensive, aggressive strategy to curtail the epidemic of teenage vaping.
But two years later, sales of disposable, flavored e-cigarettes have soared. Some companies have moved just beyond the reach of the F.D.A. by swapping out one key ingredient. They have circumvented federal oversight of tobacco plant-derived nicotine by using an unregulated synthetic version…
Lawmakers on Tuesday proposed language that they want inserted in the Congressional omnibus budget bill that would give the F.D.A. authority to regulate synthetic nicotine, although it is unclear if the issue will be included in the final bill.”

About healthcare IT

 Considering the Patient Perspective When Prescribing Medical Wearables: “KEY FINDINGS

  • 1 in 5 patients says their wearable device is hard to use.

  • The majority of patients who are manually inputting data (87%) have recorded inaccurate data on their wearable devices.

  • Of these, 85% said the error occurred because the user interface was hard to understand.

  • Despite challenges, patients still see the benefits of wearables: 49% of patients cited the biggest benefit of their wearable as a better understanding of their own health.”

Congress set to add 151 days of telehealth coverage: “Congress is set to grant a five-month extension to telehealth flexibilities, created during the pandemic, as part of the 2022 omnibus spending bill made public March 9.
The $1.5 trillion omnibus legislation, which would set spending levels for defense and nondefense spending for fiscal 2022, would also extend the telehealth federal public health emergency, which is set to expire in April, until Sept. 14.”