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January 15, 2021

Health Law Weekly

COVID-19 Updates and Developments (Week of January 11)

  • January 15, 2021

President-Elect Biden unveiled January 14 a sweeping $1.9 billion relief package that includes funding for COVID-19 vaccination, testing, and other containment efforts; direct aid to individuals and families; and other measures to shore up the nation’s economy.

The American Rescue Plan would devote $400 billion to help combat the COVID-19 pandemic, including $160 billion for vaccinations, scaling up testing, and expanding capacity to fight the virus.

Biden said he planned to lay out the incoming administration’s vaccination plan on January 15, including a $20 billion investment in a national vaccination program, with a goal of achieving “100 million shots by the end of our first 100 million days.”

The relief package provides $50 billion to ramp up testing, including funds for rapid tests, expanding lab capacity, and helping schools and local governments implement regular testing protocols. The proposal also would fund 100,000 additional public health workers, provide $30 billion to ensure sufficient supplies and protective gear, and invest an additional $10 billion in expanding domestic manufacturing for pandemic supplies.

Other proposals include providing $1,400 in direct assistance to individuals; extending unemployment benefits, which are scheduled to expire in March, to workers at $400/per week; and providing $350 billion in funding to state and local governments.

The American Rescue Plan is the first in the incoming administration's anticipated two-prong approach to stemming the pandemic and helping the economy. Biden plans to reveal the second step—the Build Back Better Recovery Plan—next month before a Joint Session of Congress. Biden said that plan will focus on infrastructure and manufacturing, innovation, research and development, and clean energy.

Department of Health and Human Services (HHS)

January 12—HHS and the Department of Defense announced the purchase of 1.25 million additional treatment courses of Regeneron Pharmaceuticals Inc.’s investigational monoclonal antibody therapeutic for delivery in the first half of 2021. The latest agreement begins the total purchase of the monoclonal antibody, which is used to treat hospitalized, high-risk COVID-19 patients, to 1.5 million treatment courses. The Food and Drug Administration issued an emergency use authorization to Regeneron for its investigational monoclonal antibodies therapy—casirivimab and imdevimab—in November 2020. According to the FDA, a clinical trial showed administering the two antibodies together by intravenous infusion reduced COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo.

January 11—Health care providers and patients now have access to a web-based COVID-19 outpatient treatment locator to help them find potential locations for treatment with monoclonal antibody therapeutics, HHS announced. HHS is hoping the outpatient treatment locator will help point patients and providers to outpatient treatment options and ease the number of people who require hospitalization for COVID-19. The locator only shows facilities that are open to the general public. Twenty-two states and territorial health departments have opted in to have information for facilities within their jurisdictions listed through the locator, HHS said.

Other Developments

January 13—Johnson & Johnson’s (J&J's) single-dose investigational COVID-19 vaccine candidate (JNJ-78436735) provided an immune response that lasted for at least 71 days, according to early results from a clinical study, the company announced. Interim Phase 1/2a data were published January 13 in the New England Journal of Medicine. J&J released a preview of the interim data in September 2020. According to the company, the interim analysis of the data showed neutralizing antibodies against COVID-19 were detected in over 90% of study participants 29 days after vaccination, and in 100% of participants aged 18-55 at day 57. “These neutralizing antibodies remained stable through Day 71, currently the latest timepoint available in this ongoing study, in all participants aged 18-55 years,” the company said.