November 5, 2021 Edition
On Tuesday, the U.S. Centers for Disease Control and Prevention (CDC) cleared the way for children 5 to 11 years old to be vaccinated against COVID-19 with the Pfizer-BioNTech pediatric vaccine. Following last week’s emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA), the CDC’s Advisory Committee on Immunization Practices (ACIP) issued its recommendation on a unanimous 14-0 vote after reviewing clinical trial data and receiving presentations from the vaccine manufacturer and CDC officials.
CDC Director Rochelle Walensky, shortly after the ACIP decision, formally endorsed the recommendation, expanding vaccine recommendations to approximately 28 million children in the United States.
The Western States Scientific Safety Review Workgroup on Tuesday evening then conducted a review of the federal process and data, determining the Pfizer-BioNTech vaccine is safe and effective for children 5-11 years old. The Workgroup issued its recommendation to the Governors of California, Nevada, Oregon, and Washington on Wednesday morning, allowing vaccine providers to begin administering doses among children 5-11.
Following the Workgroup’s recommendation, California Health and Human Services Agency (CalHHS) Secretary Dr. Mark Ghaly and California Department of Public Health (CDPH) Director and State Public Health Officer Dr. Tomás Aragón issued a joint statement reiterating the vaccines’ safety and encouraging eligible residents to receive their dose.
As noted by the Governor’s Office, over 500 entities throughout California have begun receiving shipments of pediatric vaccines, and the state will continue its efforts to leverage existing infrastructure and partnerships to deliver vaccines to this newly eligible population.
Additional information from the Governor’s Office is available here. The full CDC announcement is available here.
This week, the Biden-Harris Administration announced two significant regulatory rules aimed at increasing vaccination rates throughout the country, protecting workers, preventing hospitalization and death, and strengthening the economy.
These rules include:
- Vaccination Requirement for Employers with 100 or More Employees – The Department of Labor (DOL) Occupational Safety and Health Administration (OSHA) is issuing a COVID-19 Vaccination and Testing Emergency Temporary Standard (ETS) to require employers with 100 or more employees to:
- Be Vaccinated or Test Regularly by January 4 – Employers must ensure their employees have received the necessary doses to be fully vaccinated by January 4, 2022. After this date, employers must require any employees who are not fully vaccinated to produce a verified negative test to their employer on at least a weekly basis. Any employee who receives a positive COVID-19 test or is diagnosed with COVID-19 must be removed from the workplace. The Biden-Harris Administration notes that the ETS does not require employers to provide or pay for tests, though employers may be required to pay for testing due to other laws or collective bargaining agreements.
- Pay Employees for Time to Get Vaccinated – Employers will be required to provide paid-time for their employees to receive their vaccine and, if needed, sick leave to recover from side effects experienced from the vaccine that prevent them from working.
- Require Unvaccinated Employees to be Masked – Employers must also ensure that unvaccinated employees wear a face mask at all times in the workplace.
- Reporting and Compliance – Employers will be subject to other reporting and recordkeeping requirements, as detailed by OSHA. While the testing requirement for unvaccinated workers will begin after January 4, employers must be in compliance with all other requirements detailed in the ETS by December 5.
- Vaccination Requirement for Health Care Workers – The U.S. Centers for Medicare and Medicaid Services (CMS) announced details of its requirements for facilities participating in Medicare and Medicaid, covering more than 17 million workers at approximately 76,000 health care facilities. CMS is requiring workers at these facilities to be fully vaccinated by January 4, and the rule applies to employees regardless of whether their positions are clinical and non-clinical.
- Requirement Deadline Alignment – To simplify compliance with the requirements, the Biden-Harris Administration is aligning the requirement for federal contractors to be fully vaccinated with the OSHA and CMS deadline of January 4, 2022. The OSHA ETS will not be applied to workplaces subject to the federal contractor requirement or the CMS rule, ensuring that employers will not have to track multiple vaccination requirements for the same employees.
Additional information from the White House is available here.
The California Department of Health Care Services (DHCS), in partnership with the Office of the California Surgeon General (CA-OSG), announced this week that the state’s ACEs Aware Initiative has screened more than 500,000 children and adults in California for adverse childhood experiences (ACEs) and trained more than 20,500 clinicians in conducting the screenings.
Research from DHCS and OSH indicate that 62 percent of Californians screened have experienced at least one ACE, and emerging data has shown that the COVID-19 pandemic is leading to significant increases in ACEs exposure for children and youth. DHCS and OSG note that Governor Gavin Newsom signed into law SB 428, requiring all health insurance plan contracts that provide for pediatric services and preventive care to include coverage for ACEs screenings.
Further, DHCS and OSG announced ACEs Aware will be moving to a new organizational home within the University of California. The newly created UCLA/UCSF ACEs Aware Family Resilience Network (UCAAN) will leverage interdisciplinary resources of the two universities to develop, promote, and sustain evidence-based methods to screen patients for ACEs and advance evidence-based treatments for toxic stress.
Additional information from DHCS is available here.
This week, an Orange County Superior Court judge issued a tentative ruling in a lawsuit between several jurisdictions and opioid manufacturers.
The lawsuit, brought by Los Angeles, Orange, and Santa Clara counties and the City of Oakland, claimed pharmaceutical companies Johnson & Johnson, Allergan, Endo International, and Teva Pharmaceutical Industries contributed to the state’s opioid epidemic by downplaying the risks of opioid addiction, overdose, and death to health care providers and patients. The jurisdictions sought more than $50 billion to cover costs of abating the public nuisance caused by the opioid epidemic, plus penalties. The award from the suit would have supported ongoing opioid use disorder prevention and treatment programs in the plaintiff jurisdictions.
However, Judge Peter Wilson was not convinced of the pharmaceutical companies’ wrongdoing, noting in his ruling, “There is simply no evidence to show that the rise in prescriptions was not the result of medically appropriate provision of pain medication to patients in need. Any adverse downstream consequences flowing from medically appropriate prescriptions cannot constitute an actionable public nuisance.”
All parties involved, including Judge Wilson, have acknowledged the state and country’s ongoing opioid crisis. Monday’s tentative ruling in Orange County marks the first trial win for pharmaceutical companies in more than 3,000 lawsuits filed by states and local governments throughout the U.S.
Plaintiffs in the case are anticipated to appeal to “ensure no opioid manufacturer can engage in reckless corporate practices that compromise public health in the state for their own profit.”
The full tentative ruling is available here.
The National Association of County and City Health Officials (NACCHO) recently announced it has begun accepting applications for its 2022 Model and Innovative Practice Awards. Every year, NACCHO’s Model Practices Program nationally honors and recognizes outstanding local public health practice and shares them through the Model Practices Database. Model Practices are awarded to local health departments across the country for implementing programs that demonstrate exemplary and replicable outcomes in response to an identified public health need.
This year, NACCHO is continuing to recognize local public health innovation in response to the COVID-19 pandemic with the Innovative Practice Award. The 2022 Innovative Practice Award will focus on practices that were developed in response to emerging and exacerbated health inequities due to COVID-19 and demonstrate effective community partnerships and collaboration, adaptability and quality improvement, and remarkable innovation.
Applications for both awards are due December 31, 2021. Additional information from NACCHO is available here.