About Covid-19
Second coronavirus booster shots for people under 50 on hold amid drive to speed up new vaccine “Second booster shots of the coronavirus vaccine for people younger than 50 are on hold as the Biden administration tries to accelerate a fall vaccination campaign using reformulated shots that target the now-dominant omicron subvariants, according to federal health officials.
Officials are hoping vaccine makers — Moderna and Pfizer and its German partner, BioNTech — are able to make the updated shots available as soon as early to mid-September instead of later in the fall, said three officials who spoke on the condition of anonymity because they were not authorized to talk about the issue.”
CDC stops reporting coronavirus cases on cruise ships “A notice posted on the CDC website for cruise travel said the program ended Monday. A sortable color-coded chart and spreadsheet that detailed the level of spread on ships is no longer viewable on the webpage, the agency confirmed.
‘CDC has determined that the cruise industry has access to the necessary tools (e.g., cruise-specific recommendations and guidance, vaccinations, testing instruments, treatment modalities, and non-pharmaceutical interventions) to prevent and mitigate COVID-19 on board,’ CDC spokeswoman Kristen Nordlund said in an email.”
Judge tosses lawsuit challenging FBI’s coronavirus testing policy “A federal judge in Virginia on Thursday dismissed a lawsuit from a group of employees at the FBI and other national security and defense agencies who argued it was “unlawful and unconstitutional” to require unvaccinated staff get tested weekly for the coronavirus.
U.S. District Judge Leonie M. Brinkema agreed with Justice Department lawyers that the federal employees who sued must instead pursue administrative grievances, through a process established by the Civil Service Reform Act…
Brinkema tossed the lawsuit on procedural grounds but also made comments from the bench addressing the merits of the case.
‘This is an effort by the agencies involved to keep the workforce safe,’ Brinkema said.”
About health insurance
CBO letter to Mike Crapo, Ranking Member Committee on Finance U.S. Senate regarding making permanent the enhanced premium tax credit structure provided in section 9661 of the American Rescue Plan Act of 2021 (ARPA) “Under the May 2022 baseline, CBO and JCT estimate that if the enhancements became permanent, federal deficits would increase by $247.9 billion over the 2023-2032 period…
CBO and JCT expect that, on average, the enhanced subsidies would attract 4.8 million new enrollees to the marketplaces in each year over the 2023-2032 period relative to current law…
CBO and JCT expect that if the enhancement became permanent,
2.2 million fewer people would be without health insurance, on average, in each year over the 2023-2032 period, relative to current law.”
CMS releases home- and community-based quality [HCB Service] measure set “CMS said the release of this voluntary measure set is also a critical step to promoting health equity among the millions of older adults and people with disabilities who need long-term care because of disabling conditions and chronic illnesses…
Nationally, more than 7 million people receive HCBS under Medicaid, and Medicaid-funded HCBS accounts for $125 billion annually in state and federal spending.”
About pharma
CVS prods prescriptions that can induce abortion “In states where medication abortion, an FDA-approved regimen that can induce an abortion within the first 10 weeks of pregnancy, is illegal, CVS is instructing its pharmacists to first confirm prescriptions for some drugs aren't intended for an abortion.”
USD 11 million in illicit medicines seized in global INTERPOL operation “The global trade in illicit pharmaceuticals is a vast and lucrative crime area – valued at USD 4.4 billion – which attracts the involvement of organized crime groups around the world.
Over just one week (23-30 June), 94 INTERPOL member countries representing every continent launched a coordinated crackdown on illicit online pharmacies in Operation Pangea XV.
Globally, law enforcement made more than 7,800 seizures of illicit and misbranded medicines and healthcare products, totaling more than 3 million individual units.
During the week, law enforcement:
Investigated more than 4,000 web links, mainly from social media platforms and messaging apps
Shut down or removed more than 4,000 web links containing adverts for illicit products
Inspected nearly 3,000 packages and 280 postal hubs at airports, borders and mail distribution or cargo mail centres
Opened more than 600 new investigations and issued more than 200 search warrants
While results are still coming in from countries, enforcement actions have already disrupted the activities of at least 36 organized crime groups.”
Drugmakers are slow to prove medicines that got a fast track to market really work “NPR analyzed 30 years of FDA and National Institutes of Health data and found that 42% of currently outstanding confirmatory studies, or 50 of them, either took more than a year to begin following accelerated approval or hadn't started at all. Nineteen of those required studies still haven't started three years or more after accelerated approval. Four of them haven't started more than ten years later.”
Read the entire article. Clearly, a change in process is needed.
About the public’s health
WHO declares monkeypox a global health emergency as infections soar “The decision to label the outbreak a Public Health Emergency of International Concern, the highest level of alert the WHO can issue, is expected to marshal new funding and to pressure governments into action. More than 16,500 cases have been reported in 75 countries.”
New studies offer theory on cause of unusual hepatitis cases in kids “Two new and as-yet-unpublished studies from scientists in the United Kingdom theorize that children who have developed the hepatitis cases may have been co-infected with two different viruses and had a genetic predisposition to have an over-exuberant immune response when that happened.
Previously the leading hypothesis was that adenovirus 41, which had been found in a number of the infected children, was causing the liver damage…
But the new studies report finding the presence of something called adeno-associated virus 2 — AAV2 for short — in the blood and in liver tissues from a number of affected children. They also found the children were infected with adenoviruses or herpes viruses.”
About health technology
Unique Device Identification System (UDI System) “On July 22, 2022, the FDA posted the final guidance: Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain Devices. This final guidance describes the FDA's compliance policy regarding Global Unique Device Identification Database (GUDID) submission requirements for certain Class I devices considered consumer health products.”
Comparing Racial Differences in Emphysema Prevalence Among Adults With Normal Spirometry: A Secondary Data Analysis of the CARDIA Lung Study “Emphysema is often present before spirometry findings become abnormal, particularly among Black men. Reliance on spirometry alone to differentiate lung health from lung disease may result in the underrecognition of impaired respiratory health and exacerbate racial disparities.”