Pfizer and its partner BioNTech submitted an application to FDA to allow emergency use of its COVID-19 vaccine. Trials have shown the vaccine is 95 percent effective after two doses. The FDA announced that a panel of outside experts, the Vaccines and Related Biological Products Advisory Committee, will meet on December 10 to advise FDA on whether to approve the emergency use request. If the vaccine is approved, the US government has agreed to purchase 100 million doses of the vaccine, with an option to purchase an additional 500 million doses.
On Thursday, staffers for House Speaker Nancy Pelosi (D-CA), Senate Majority Leader Mitch McConnell (R-KY), Senate Minority Leader Chuck Schumer (D-NY), and House Minority Leader Kevin McCarthy (R-CA) met to discuss a spending deal as lawmakers work to meet the December 11 deadline. According to Politico Playbook, coronavirus relief was also discussed during the meeting. However, the discussion was not about a new relief package but rather, “the expiration of COVID relief-related items like pandemic unemployment assistance, student loan forbearance and the Paycheck Protection Program.”
On Monday, President-elect Joe Biden and Vice President-elect Kamala Harris met virtually with the US Conference of Mayors to discuss their shared priorities, including coronavirus relief. The meeting comes days after President-elect Biden and Vice President-elect Harris met with a bipartisan group of governors, as well as House Speaker Pelosi and Senate Minority Leader Schumer, to discuss pandemic response, among other issues. At the meeting with Speaker Pelosi and Leader Schumer, President-elect Biden also outlined his agenda for the first 100 days of his presidency, which he said includes taking aggressive action (e.g., expanded testing) to contain COVID-19 and providing resources for economic recovery.
President-elect Biden and his team now have authorization from the General Services Administration to begin the transition process, which will allow them to more robustly begin planning pandemic response and recovery efforts. Yohannes Abraham, the executive director of the Biden-Harris transition, said “transition officials will begin meeting with federal officials to discuss the pandemic response” in the days ahead.
Capitol Hill. Senate Finance Committee Chairman Chuck Grassley (R-IA) and Ranking Member Ron Wyden (D-OR) are criticizing the new Treasury Department guidance about the tax treatment of expenses related to the Paycheck Protection Program (PPP) loans, asking the Department to revisit its approach. Under the IRS guidance reported previously by TFG Coronavirus Update, if a business has not had its PPP loan forgiven at the end of the year but expects the loan to be forgiven in the future, the company cannot deduct expenses related to the loan if the business hasn’t yet filed for forgiveness. In their statement, Senators Grassley and Wyden said that the new guidance goes against the congressional intent that small businesses receiving PPP loans be able to take deductions for ordinary and necessary business expenses.
Administration. The White House Coronavirus Task Force is urging Americans to stay safe and mitigate the spread of the coronavirus during the upcoming holidays. The public health experts urged the general public to take basic precautions such as wearing masks, washing their hands, and limiting gatherings, particularly indoors. “Now more than ever we’re asking all Americans to redouble their efforts to be vigilant, to embrace masks, social distancing, hand washing, our advice about crowds, and really to support using the data to make decisions in their communities,” said CDC Director Robert Redfield.
Fed Chair Jerome Powell wrote a letter to Treasury Secretary Steven Mnuchin confirming the Fed will return unused CARES Act capital to the Treasury. Secretary Mnuchin proposed using the funds as part of a new relief package. However, according to Bloomberg Government, the funds may not yield any measurable savings due to congressional budget scoring conventions.
HHS published a Request for Information seeking comments from healthcare systems and clinicians on the impact of changes adopted in response to COVID-19. “Many… have rapidly reengineered their policies and programs to improve access, safety, quality, outcomes including mortality and morbidity, cost, and value for both COVID-19 and non-COVID-19 related medical conditions.” HHS intends to use comments to inform HHS priorities and programs moving forward.
HHS announced plans to allocate initial doses of Regeneron’s investigational monoclonal antibody therapeutic, casirivimab and imdevimab, for treatment of non-hospitalized patients with mild or moderate confirmed cases of COVID-19 at high risk of hospitalization.
DHS continued the temporary travel limitation on individuals from Canada and Mexico into the US; only “essential travel” is allowed.
The New York Times published a list of individual state travel restrictions related to COVID.
A new study released by Columbia University found as many as 310,000 cases of the virus are connected with proximity to meatpacking plants. Approximately 5,200 coronavirus deaths during this period were residents of counties with a large meatpacking plant in the vicinity, and that residents of those counties were 51 percent more likely to become infected and 37 percent more likely to die.
The Aspen Institute and Economic Strategy Group, along with JP Morgan, Brookings Institution, and many other industry and academic organizations, sent a letter to Congress urging the passage of legislation focused on core measures necessary to provide additional fiscal relief as quickly as possible and no later than the end of this calendar year. In addition to calling for funding to fight the virus, the letter also endorses an extension of federal government income relief to unemployed individuals, enhanced benefits to households who need food assistance, and measures to help people facing potential eviction and homelessness.
According to the American Academy of Pediatrics and Children’s Hospital Association, children represent about 11.5% of all reported coronavirus cases where a person’s age is noted. The groups said the seven-day period of November 5 to 12 was “by far the highest weekly increase” in children’s cases since the start of the pandemic.
Fifty-one percent of respondents to a Ipsos poll said they would take a first-generation vaccine immediately once it becomes available. According to the poll, the belief that a vaccine will be available over the next three months has also increased, with 47 percent stating in the affirmative compared to 32 percent just a week ago.
Two-thirds of voters believe President-elect Joe Biden should prioritize a coronavirus relief package in his first 100 days of taking office, according to a Politico tracking poll.
HHS and DOD announced a $11.6 million contract award to Puritan Medical Products Company, LLC, to expand domestic production capacity of Cue Sample Wands, the nasal swabs used exclusively with the COVID-19 cartridge-based molecular testing system developed and manufactured by Cue Health, Inc. The test generates results in about 20 minutes.
Siemens Healthineers was awarded a $12 million contract from HHS and DOD to support domestic production of two diagnostic tests for COVID-19. The funding is in addition to a $13 million HHS contract awarded November 2 to enable the company to develop the tests. Combined, the two contracts represent another $25 million investment by the federal government to expand the types of tests for COVID-19 and to ensure enough tests are available in the US.
In more vaccine news, Moderna has announced their vaccine is 94.5 percent effective, raising hopes for an eventual slowdown in COVID-19 transmission although questions remain about how long protection lasts and how long it will take to vaccinate enough Americans to stop the virus’ widescale spread. The massive Moderna clinical trial involves more than 30,000 U.S. participants. The vaccine developer is backed 100 percent with federal funding, according to a Moderna disclosure.
NACo published an article on how counties across the country are handling housing stabilization and homeless services to stem the ride of home losses as eviction moratoriums end.
Webinars, Events and Resources