On Wednesday, the Centers for Disease Controls and Prevention (CDC) confirmed the first case of the Omicron COVID-19 variant in the U.S. Regarding the new variant, President Biden said there was “cause for concern, not a cause for panic.” The World Health Organization designated Omicron as a variant posing a “very high” global risk. Today, the Biden Administration outlined plans to combat the new Omicron variant this winter. These actions include: launching a new public education campaign encouraging the booster shot nationwide, protecting workplaces to keep business open, strengthening health protocols for international travel, and continuing the vaccination of children. Of note, the plan makes more than 60 winter COVID emergency response teams available to states, including 20 teams to support clinical staffing, 10 teams to provide disaster medical support, 20 antibody teams to help administer lifesaving treatments, and 15 CDC expert teams to aid in outbreak investigations.
The CDC strengthened its recommendation for the booster shot, saying individuals 18 years and older should get a booster shot 6 months after their Pfizer or Moderna vaccine and 2 months after their Johnson & Johnson vaccine. CDC Director Dr. Rochelle Walensky noted the emergence of the Omicron variant “further emphasizes the importance of vaccination boosters and prevention efforts needed to protect against COVID-19.”
On Tuesday, independent advisers to the FDA narrowly endorsed Merck’s oral COVID treatment pill. The Antimicrobial Drugs Advisory Committee voted to recommend emergency authorization of the pill by a vote of 13 to 10. Molnupiravir, the antiviral drug designed to treat high-risk adults with mild to moderate symptoms of COVID-19 has unanswered questions about the drug’s efficacy and safety concerns. Dr. Michael Green, a member of the advisory committee, called the vote “a very difficult decision” citing a lack of therapies to treat COVID as a reason swaying his vote in favor of the emergency application.
The Centers for Medicare and Medicaid Services (CMS) is temporarily blocked from enforcing its vaccine mandate for healthcare workers after a Louisiana federal court ruled on Tuesday. In a move slowing the Biden Administration’s plans of bringing Americans back to the workplace, the court blocked the enforcement of a vaccine mandate nationwide for healthcare workers. A federal district court in Missouri had previously blocked the mandate.
Capitol Hill
On November 19, the House passed the $1.85 trillion Build Back Better (BBB) Act (H.R. 5376) by a vote of 220-213. The Senate is currently working on amending the House-passed version of the bill and Senate consideration of the bill may slip to January 2022. The House-passed version of the legislation includes funding for pandemic preparedness, including: $1.4 billion in funding for CDC laboratory activities and support for the renovation, improvement, expansion, and modernization of state and local public health laboratory infrastructure; $1.3 billion in funding to the HHS Assistant Secretary for Preparedness and Response to prepare for, and respond to, public health emergencies; and $300 million for improving infrastructure at the FDA. The bill also includes $7 billion in funding to support core public health infrastructure activities to strengthen the public health system through grants to state and local health departments, and expanding and improving activities of the CDC; $2 billion in funding to award grants and enter into cooperative agreements for capital projects to health centers and federally qualified health centers; $2 billion in funding for the National Health Service Corps; and $500 million in funding for the Nurse Corps.
On November 22, House Oversight Select Subcommittee on the Coronavirus Crisis Chair James Clyburn (D-SC) sent a letter to Dr. Stephen Hahn, the former Commissioner of the FDA from 2019-2021 and member of the White House Coronavirus Task Force, requesting a transcribed interview and documents related to his role in the Trump Administration’s pandemic response.
On November 22, Chair Clyburn sent letters to two FinTech companies (Blue Acorn PPP, LLC & Womply, Inc.) following reports that these two companies may be linked to a disproportionate number of Paycheck Protection Program (PPP) loans made to fraudulent or ineligible applicants.
On November 23, the chairs of the Congressional Progressive, Black, Hispanic, and Asian Pacific American Caucuses jointly sent a letter to Treasury Secretary Janet Yellen urging the Treasury Department to support House Democrats’ recent approval of a new issuance of “urgently needed financial assistance through the International Monetary Fund (IMF). The Special Drawing Rights (SDRs) would help hundreds of millions of people in developing countries still suffering from the ongoing effects of the global COVID-19 pandemic.”
On November 23, House Energy and Commerce Committee Ranking Member Cathy McMorris Rodgers (R-WA) and House Oversight and Reform Committee Ranking Member James Comer (R-KY) sent a letter to Acting Director of the White House Office of Management and Budget (OMB) Shalanda Young “demanding more information on the Administration’s compliance with the President’s sweeping vaccine mandates for Federal employees.” Ninety-two percent of the more than 3.5 million federal government employees received at least one COVID-19 vaccination dose as of November 23, with another roughly 4.5 percent of federal employees considered to be in compliance with the mandate because they have a pending or approved exception request for vaccination. OMB said in a statement that the 3.5 percent of federal employees (i.e., 123,000 employees) who have not been in compliance with the mandate will face a period of education and counseling, with further enforcement actions put off until January 2022.
On December 1, Chair Clyburn sent a letter to the CEO of Telegram, Inc., requesting documents and information related to the use of the company’s large social media platform for disseminating information used to commit fraud against pandemic relief programs, including the PPP, Economic Injury Disaster Loan (EIDL) program, unemployment insurance, and the Restaurant Revitalization Fund (RRF).
Administration
President Biden will outline the Administration’s winter strategy for COVID at 2pm ET today. According to several sources including the White House, the strategy will include a new push for booster shots, family vaccination clinics, safe schools, insurance reimbursement for at-home coronavirus tests, and restrictions on international travelers. On Monday the President said the strategy would not include lockdowns.
The Biden Administration filed a motion urging a federal appeals court to unblock the OSHA public health rule requiring businesses with 100 or more employees to require vaccination or regular testing and masking. The Federal Fifth Circuit Court of Appeals in Cincinnati previously found the mandate to be “staggeringly overbroad” and noted “the Mandate is a one-size-fits-all sledgehammer that makes hardly any attempt to account for differences in workplaces…”
The FDA said the agency is actively working with our federal partners, international regulators, and medical product companies to quickly address any potential impacts of the new Omicron variant on the tools to fight the pandemic. “The agency is working as quickly as possible to evaluate the potential impact of this variant on the currently available diagnostics, therapeutics and vaccines. We are closely monitoring the situation and are committed to communicating with the public as we learn more.”
Treasury began reallocating available rental assistance funds from grantees that have unused funds. “Treasury anticipates that a substantial portion of the first round of reallocation will happen voluntarily – in a collaborative process among grantees and
Treasury. The rapid pace of improvement in ERA programs — including the overwhelming share of funds estimated to be spent or obligated by year-end —means that Treasury expects only a limited amount will be available for reallocation.”
SBA announced updated guidance for COVID Economic Injury Disaster Loan (EIDL) program applicants. Applications for loans and targeted advance will be accepted until December 31 and will be processed until all EIDL funds are exhausted.
HHS began distributing $7.5 billion in ARPA Rural payments to providers and suppliers who serve rural Medicaid, Children's Health Insurance Program (CHIP), and Medicare beneficiaries.
USDA announced $32 million in grants to meat and poultry slaughter and processing facilities to support expanded capacity and efficiency. Secretary Tom Vilsack said, “Today’s investment supports local and regional meat and poultry processors as they recover from the pandemic and also work to expand capacity.” Vilsack said the move will help meet consumer and producer demand along the supply chain.
USDA also today announced an $86 million investment to improve equitable access to jobs, business opportunities, education, housing and health care for people who live and work in rural areas.
On November 18, the FCC Wireline Competition Bureau issued a Public Notice seeking comment on the rules and administration of the Affordable Connectivity Program (ACP). The Infrastructure Investment and Jobs Act provides $14.2 billion for the longer-term Affordable Connectivity Program, which will replace the Emergency Benefit Broadband Program.
The US Department of Education announced $20 million in grants to Tribal Educational Agencies to meet the urgent needs of students in response to the coronavirus pandemic.
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NYC officials said they do not plan to immediately reimpose an indoor mask requirement due to the Omicron coronavirus variant but are “strongly” recommending people wear masks indoors in public places. Dave Chokshi, Commissioner of the NYC Department of Health and Mental Hygiene, said the delta variant currently accounts for 98 percent of all sequenced cases in the city right now.
A federal court this week temporarily halted the Biden Administration’s COVID-19 vaccine mandate for health workers at hospitals that receive federal funding. The ruling by a Missouri-based federal judge applies to health care employees in the 10 states that sued to block the Administration’s November 5 rule (Alaska, Arkansas, Iowa, Kansas, Missouri, Nebraska, New Hampshire, North Dakota, South Dakota, and Wyoming).
Vaccine News
The CEO of Moderna said it will take months for the company to develop and ship a vaccine that targets the new COVID-19 Omicron variant. Stephane Bancel stated that it will take some time to develop a vaccine that is specifically meant to protect against the Omicron variant, the company could have a higher, 100-microgram dose, of its booster shot ready much earlier. Additionally, he said that once the company learns about the new variant and vaccine efficacy it may consider allocating higher doses of existing shots and could request authorization for a fourth dose for elderly individuals.
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Webinars, Events and Resources |
ARPA Usage Series with Esri and NACo: Transportation and Transit
NACo
December 6, 1:00 PM ET
ARPA Usage Series with Esri and NACo: Broadband
NACo
December 8, 1:00 PM ET
Planning for Economic Recovery
ICMA
January 13, 1:00 PM ET
CRS Reports of Interest:
GAO Reports of Interest:
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