October 22, 2021 Edition

State Health Officials Issue Statement Reaffirming COVID-19 Approach in Schools

On Wednesday, California Health and Human Services (CalHHS) Secretary Dr. Mark Ghaly and California Department of Public Health Director and State Public Health Officer Dr. Tomás Aragón issued a joint statement reaffirming the state’s approach to preventing COVID-19 in schools and protecting students’ health by continuing the state’s successful masking requirements in K-12 settings.

The joint statement cautions against relaxing masking requirements in schools and calls for ongoing vigilance against COVID-19. The state will continue to maintain universal indoor mask mandates in K-12 schools and will continue to monitor conditions through the winter. According to Drs. Ghaly and Aragón, the state’s current strategy “represents the best path for schools to protect children and school staff, ensuring that classrooms remain safe spaces for learning, and children are provided every opportunity to be successful.”

The full statement from the state health officials is available here.

FDA, CDC Greenlight Moderna, Johnson & Johnson COVID-19 Boosters for Certain Populations

Following last week’s unanimous recommendation from the U.S. Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) relative to COVID-19 booster vaccines, both the FDA and the U.S. Centers for Disease Control and Prevention (CDC) this week officially approved the use of booster doses for specified populations.

On Wednesday, the FDA formally accepted the VRBPAC recommendations by amended the emergency use authorizations (EUAs) for both the Moderna and Johnson & Johnson COVID-19 vaccines. The FDA’s authorizations include:

  • A single booster dose of the Moderna COVID-19 vaccine may be administered at least six months after completion of the primary series to individuals:
    • 65 years of age and older
    • 18 through 64 years of age at high risk of severe COVID-19
    • 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2
  • A single booster dose of the Janssen (Johnson & Johnson) COVID-19 vaccine may be administered at least two months after completion of the single-dose primary regimen to individuals 18 years of age and older
  • The use of each of the available COVID-19 vaccines as a heterologous (“mix-and-match”) booster dose in eligible individuals following the completion of primary vaccination with a different available COVID-19 vaccine
  • To clarify that a single booster dose of the Pfizer-BioNTech COVID-19 vaccine may be administered at least six months after the completion of the primary series to individuals 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2

On Thursday, the CDC Advisory Committee on Immunization Practices (ACIP) similarly took steps to recommend a booster shot of the COVID-19 vaccine in certain populations. CDC Director Dr. Rochelle Walensky endorsed the ACIP recommendations, enabling specified Americans to receive a COVID-19 vaccine booster, including a “mix-and-match” booster dose.

Additional information from the FDA is available here. Additional information from the CDC is available here.

UPDATE: On October 22, 2021, the Western States Scientific Safety Review Workgroup completed its review of data associated with the above boosters and aligned its recommendations with the FDA and CDC. More information is available here.

Biden-Harris Administration Outlines Plan for COVID-19 Vaccines for Children Ages 5-11

This week, the Biden-Harris Administration detailed the latest operational planning for COVID-19 vaccines for children ages 5-11. In anticipation of the U.S. Food and Drug Administration’s (FDA) scheduled review on October 26 and the U.S. Centers for Disease Control and Prevention’s (CDC) scheduled review on November 2-3, the Biden-Harris Administration plans to quickly distribute vaccine supply if an authorization is granted by the FDA and CDC.

The Administration’s plan will mobilize public and private sectors to ensure convenient and equitable availability of vaccines throughout the country, including:

  • Securing Vaccine Supply: The Administration has procured enough vaccine to support vaccination of the country’s 28 million children ages 5-11. If authorized, the Pfizer-BioNTech COVID-19 vaccine will be a specific dose and formula for this age group, including packaging in smaller configurations of 10-dose vials in cartons of 10 vials each. Product will be delivered in a newly updated shipper, and the vaccine can be stored for up to 10 weeks at standard refrigeration temperatures and six months at ultralow temperatures.
  • Standing Up Vaccine Sites at Familiar Settings: The Administration is working to ensure the availability of vaccine at accessible and convenient locations. This includes:
    • Over 25,000 pediatricians’ offices and other primary care sites
    • Over 100 children’s hospitals and health systems nationwide
    • Tens of thousands of pharmacies participating in the federal government’s pharmacy program
    • Hundreds of school- and community-based clinics
    • Hundreds of community health centers and rural health clinics
  • Supporting Education and Engagement to Build Trust: The U.S. Department of Health and Human Services (HHS) will launch a national public education campaign to reach parents and guardians with accurate and culturally responsive information about COVID-19 vaccines and the risks that the COVID-19 virus poses to children. This campaign will feature partnerships with trusted messengers, schools, state and local health departments, and national and community organizations to build public trust.

Additional information from the Biden-Harris Administration is available here.

State Auditor Issues High-Risk Reports on Federal COVID-19 Funding to CDE, BSCC

This week, California State Auditor Elaine Howle issued two reports relative to state agency and departmental oversight of federal COVID-19 funds awarded to the California Department of Education (CDE) and the Board of State and Community Corrections (BSCC). The reports are part of the state’s high-risk audit program, as determined by Howle. These reports are detailed below:

CDE Oversight of Federal COVID-19 Funds

The State Auditor reviewed CDE’s oversight of the Elementary and Secondary School Emergency Relief Fund (ESSER) and the Governor’s Emergency Education Relief Fund (GEER), which provided more than $24 billion to help mitigate the effects of the pandemic and enable the safe reopening of schools statewide. Local educational agencies (LEAs) must spend their first allocations of ESSER and GEER funds by January 2023 and subsequent allocations by January 2024 and January 2025. Any unspent funds after these deadlines will revert to the federal government.

According to Auditor Howle, CDE does not have the information necessary to oversee LEAs’ use of funds to meet educational and safety needs of students because LEAs are not consistently reporting spending data to the state. Further, Howle determined CDE has not taken a “strong leadership role” in ensuring that LEAs are effectively and promptly using ESSER and GEER funds. As of June 30, 2021, nearly 90 LEAs had spent less than 20 percent of their initial ESSER allocations and more than 140 had spent less than 20 percent of their initial GEER allocations.

The Auditor’s Office projects that LEAs will collectively have nearly $160 million in unspent initial ESSER and GEER allocations, which would be reverted to the federal government. Howle additionally notes that CDE has monitored less than one percent of the LEAs that received additional funds during FY 2020-21.

The Auditor sets forth a series of recommendations for CDE and LEAs to ensure the full utilization of federal funds. CDE is recommended to continue tracking the number of LEAs that fail to submit quarterly spending reports and to seek additional resources and staffing to ensure all LEAs submit required reports. CDE is also recommended to regularly assess LEAs’ spending data to identify LEAs in jeopardy of losing funding and strengthen its oversight activities of LEAs that have received ESSER and GEER funds.

CDE agreed with some of Auditor Howle’s recommendations, though it disagreed with recommendations aimed at strengthening monitoring efforts.

The full report on federal funding received by CDE is available here.

BSCC Emergency Supplemental Funds

Auditor Howle additionally conducted a review of the BSCC’s management of the federal Coronavirus Emergency Supplemental Funding (CESF) intended to prevent, prepare for, and respond to the pandemic in correctional settings. BSCC received $59 million in federal funding to be allocated to state, county, city, and tribal agencies.

According to Auditor Howle, BSCC significantly reduced the amount of CESF funds that were available to assist local governments, specifically counties, impacted by the pandemic. BSCC did not use a formula, as promised to the U.S. Department of Justice, to allocate $22 million of the $59 million received to the California Department of Corrections and Rehabilitation (CDCR). BSCC did not require CDCR to justify its specific needs or associated costs in responding to COVID-19. BSCC used a population-based formula for allocating remaining CESF funds instead of identifying jurisdictions most impacted by COVID-19, and “it unnecessarily delayed providing CESF funds to counties and deprived them of these funds during the height of the pandemic.” Howle additionally determined BSCC’s grant requirements were overly burdensome and more stringent than federal requirements, deterring some counties from applying for any of the funds.

Auditor Howle set forth a series of recommendations for BSCC to ensure that it efficiently and effectively administers state and federal grants, including any future emergency funds it might receive. BSCC is recommended to revise its grant policies and procedures by December 2021 and immediately develop and implement a plan to monitor the use of CESF funds.

BSCC acknowledged it takes “audit report findings and recommendations seriously,” but disagreed with the Auditor’s findings and criticized some of the Auditor’s methodologies. BSCC also generally disagreed with the recommendation to revise its grant policies and procedures and did not address other recommendations provided by the Auditor’s Office.

The full report on federal funding received by BSCC is available here.

NACCHO Requests DOJ Assistance in Protecting Health Department Personnel

The National Association of County and City Health Officials (NACCHO) this week sent a letter to U.S. Attorney General Merrick Garland requesting that his recent federal directive to protect school personnel be expanded to include health department officials and staff. Pointing to the increasing threats and violence being faced by many local health department personnel relative to the COVID-19 pandemic response, NACCHO urges the Department of Justice (DOJ) to direct federal authorities to meet with local, state, tribal, and territorial law enforcement entities to address the risks of harassment, intimidation, and threats of violence against health department staff.

The full NACCHO letter is available here.

CDPH, UCSD Health to Hold CA Notify Virtual Symposium on November 4

The California Department of Public Health (CDPH) and the University of California, San Diego (UCSD) Health Center for Health Innovation will host a virtual symposium entitled, “CA Notify One-Year Later: Exposure Notifications at the Crossroads of Technology and Public Health” on Thursday, November 4 from 11:30 am to 2:00 pm.

The event will feature a conversation with public health experts, clinicians, scientists, engineers, and entrepreneurs to discuss lessons learned over the past year and future possibilities for deploying exposure notification systems to meet public health challenges.

One year ago, CDPH, UCSD Health, Google, Apple, and the California Department of Technology (CDT) built and launched CA Notify, a smartphone-based exposure notification system to help mitigate the spread of COVID-19 in California.

Additional information, including event registration, is available here.

Newsom Expands Drought Emergency Statewide

On Tuesday, Governor Gavin Newsom issued a proclamation adding jurisdictions to the drought state of emergency and requiring local water suppliers to implement water shortage contingency plans. The Governor’s proclamation adds eight counties not previously included in drought state of emergency issued earlier this summer: Imperial, Los Angeles, Orange, Riverside, San Bernardino, San Diego, San Francisco, and Ventura.

With the addition of these counties, the Governor’s proclamation covers the entire state of California and provides state government agencies additional flexibilities to ban wasteful water practices and take other conservation actions. Recall, Governor Newsom also issued an executive order in July calling on all California residents to voluntarily reduce water use by 15 percent compared to 2020.

Additional information on the Governor’s drought-related action is available here.

State Proposes New Setback Regulations for Oil Drilling Operations, Aims to Protect Public Health

This week, the California Department of Conservation’s Geologic Energy Management (CalGEM) issued a proposed regulation that would prohibit new oil wells and facilities within a 3,200-foot exclusion area, or setback, from homes, schools, hospitals, nursing homes, and other sensitive locations. The proposed regulation would also require pollution control measures for existing wells and facilities within the same 3,200-foot setback area.

According to the Newsom Administration, the proposed regulation is intended to protect public health. A 15-member public health expert panel selected by the University of California, Berkeley and Physicians, Scientists, and Engineers (PSE) for Healthy Energy helped inform the state’s proposed regulation. The panel determined that when oil and gas developments are within 3,200 feet, there is a strong connection to higher rates of adverse birth outcomes, respiratory diseases, and other health impacts.

CalGEM has now begun its 60-day public comment period on the proposed regulation. Once completed, CalGEM will conduct a full analysis of the rule to then be submitted to the Office of Administrative Law (OAL) for further review and refinement, if needed.

Additional information, including on the public comment period, is available here.

Federal Government Unveils Plan to Address PFAS Pollution

This week, the Biden-Harris Administration rolled out a plan to accelerate efforts to protect Americans from per- and polyfluoroalkyl substances (PFAS), which can cause severe health issues and persist in the environment once released. The efforts by the federal government are intended to safeguard public health and the environment by preventing PFAS from being released into the air, drinking systems, and food supplies.

The actions, spanning eight federal agencies, consist of:

  • EPA PFAS Roadmap: The Environmental Protection Agency (EPA) launched a comprehensive three-year strategy to control PFAS at its sources, hold polluters accountable, ensure science-based decision-making, and address impacts on disadvantaged communities.
  • DOD PFAS Cleanup: The Department of Defense (DOD) is conducting PFAS cleanup assessments at nearly 700 DOD installations and National Guard locations where PFAS was used or may have been released. The initial assessments are anticipated to be completed by the end of 2023.
  • FDA Food Supply Testing: The U.S. Food and Drug Administration (FDA) over the next three years will proactively engage with and continue to support states when suspected areas of PFAS contamination may impact food. The FDA will expand its PFAS analysis method and will announce additional testing results from the general food supply and targeted testing of seafood.
  • USDA Food System Research: The U.S. Department of Agriculture (USDA) Agricultural Research Service is investigating the causes and implications of PFAS in the country’s food system. USDA will also continue extramural research on environmental contaminants including PFAS and impacts on animal and human health.
  • DHS PFAS Remediation: The Department of Homeland Security (DHS) conducted the first-ever inventory of PFAS use and prior releases from its facilities. A recent policy directive establishes procedures for notification, investigation, and remediation activities.
  • HHS Scientific Review: The U.S. Department of Health and Human Services (HHS) continues to review rapidly evolving science on human health and PFAS, including through a study by the U.S. Centers for Disease Control and Prevention (CDC) and Agency for Toxic Substances and Disease Registry (ATSDR).
  • Scientific Agency Innovation: A series of federal agencies are conducting research on the use of firefighting foam containing PFAS in emergencies and using technologies to reduce PFAS discharges in testing of firefighting equipment. Other agencies are working to develop innovative protective equipment for emergency responders.
  • Council on Environmental Quality Activities: The White House Council on Environmental Quality (CEQ) will facilitate the coordination of PFAS response activities across the government and help develop new policy strategies to support research, remediation, and removal of PFAS in communities throughout the country.

Additional information from the White House is available here.

CDC Reestablishes Advisory Committee to the Director

This week, the U.S. Centers for Disease Control and Prevention (CDC) announced it has reestablished the Advisory Committee to the Director of the Centers for Disease Control and Prevention (ACD). The committee, authorized by federal law, is intended to advise the CDC Director, the Secretary of the Department of Health and Human Services (HHS), and the Assistant Secretary for Health on policy and broad strategies to enable CDC to fulfill its mission of protecting the country’s health.

The ACD will recommend ways to prioritize CDC’s activities, improve results, and address health disparities, among other areas. Committee members include people with expertise in areas pertinent to the CDC mission, including public health, health equity, medical education, industry, health care delivery, health policy, preventive medicine, allied fields, and communication.

The ACD was originally established in 1962 but was terminated in 2019. ACD meetings are typically held twice a year and are open to the public. The ACD will have 14 members, including the char, David Warren Fleming, MD, from the University of Washington School of Public Health.

Additional information is available here.

New Smokeless Oral Tobacco Products Cleared by FDA

On Tuesday, the U.S. Food and Drug Administration (FDA) announced it has authorized the marketing of four new oral tobacco products manufactured by U.S. Smokeless Tobacco Company, LLC under the brand name of Verve. The products were reviewed under the agency’s premarket tobacco product application (PMTA) process in which the agency must determine whether the marketing of the products would be consistent with the statutory standard, “appropriate for the protection of the public health.”

The Verve products are oral tobacco products that contain nicotine derived from tobacco, but they do not contain cut, ground, powdered, or leaf tobacco. The products are chewed and discarded and intended for adult tobacco users.

According to the FDA, research has shown a low likelihood that youth, nonsmokers, or former smokers would initiate or reinitiate tobacco use with the Verve products. Further, current users of Verve products and users who completely switch to Verve products are generally exposed to fewer harmful and potentially harmful constituents compared to cigarettes and other smokeless tobacco products.

Under the FDA’s decision, the four tobacco products can now be legally sold and distributed in the U.S. Notably, the FDA notes that their review does not mean the products are safe or “FDA approved,” as there are no safe tobacco products.

Additional information from the FDA is available here.

FDA Proposes Rule on Over-the-Counter Hearing Aids

The U.S. Food and Drug Administration (FDA) this week unveiled a proposed rule intended to improve access to and reduce the costs of hearing aid technology for Americans. The federal agency proposes to establish a new category of over-the-counter (OTC) hearing aids, allowing hearing aids in this category to be sold directly to consumers in stores or online without a medical exam or a fitting by an audiologist.

According to the FDA, the proposed rule is designed to help increase competition in the market while ensuring the safety and effectiveness of OTC and prescription hearing aids. The proposed rule has been published in the Federal Register for public comment which closes in early 2022.

Additional information is available here.