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September 25, 2020

Health Law Weekly

COVID-19 Updates and Developments (Week of September 21)

  • September 25, 2020

Agency Action

Department of Health and Human Services (HHS)

September 23—The Centers for Disease Control and Prevention (CDC) will send $200 million to 64 jurisdictions across the country to help them prepare for the COVID-19 vaccine, HHS announced. CDC is awarding the funding through the existing Immunizations and Vaccines for Children cooperative agreement. HHS said the new funding can be used to develop and update plans for distributing and administrating vaccines once they are available.

Centers for Medicare & Medicaid Services (CMS)

September 23—CMS reported significant declines in rates for vaccinations and primary and preventative services among children in Medicaid and the Children’s Health Insurance Program (CHIP) during the COVID-19 public health emergency. From March to May, there were 22% fewer (1.7 million) vaccinations received by beneficiaries up to age two, 44% fewer (3.2 million) child screening services to assess physical and cognitive development; and 69% fewer (7.6 million) dental services. CMS said it released the preliminary data as a call to action for heading off gaps in care for children that may have long term consequences.

National Institutes of Health (NIH)

September 22—Two NIH-funded clinical trials evaluating convalescent plasma as treatment for hospitalized patients with COVID-19 are expanding their enrollment, the agency announced. The two trials each expect to enroll about 1,000 hospitalized patients across the country at academic and community-based hospitals. Patients will be randomly assigned to receive the treatment or a placebo. Preliminary data indicates that convalescent plasma, which is blood plasma taken from patients who have recovered from COVID-19, may improve outcomes for severely ill and hospitalized patients with the virus, the agency said. “The evidence on convalescent plasma as a treatment for severe cases of COVID-19 is promising but incomplete. We need to carry out rigorous randomized control clinical trials to determine how this therapy can improve outcomes,” said NIH Director Francis S. Collins, M.D., Ph.D.

Other Developments

September 23—Johnson & Johnson announced that its COVID-19 vaccine candidate, JNJ-78436735, which is being developed by its Janssen Pharmaceutical unit, is entering a global Phase 3 clinical trial. The vaccine will be administered to 60 volunteers across three continents to study the safety and efficacy of a single dose versus placebo in preventing COVID-19, the company said in a statement. J&J anticipates the first batches of a COVID-19 vaccine will be available for emergency use authorization in early 2021, if proven to be safe and effective.

September 21—As required by the CARES Act, the Government Accountability Office (GAO) issued its third bimonthly report on the federal government’s ongoing response to the COVID-19 pandemic. The report notes that “[t]imely and concerted federal leadership will be required” as the nation continues to face public health risks and economic difficulties, particularly as flu season ramps up. The report outlines lessons learned and issues that Congress and the administration still need to address, including collecting reliable data to drive decision making; establishing mechanisms for accountability and transparency; and protecting against ongoing cyber threats to patient information, intellectual property, public health data, and intelligence. The report offers specific recommendations for improving the federal response to the pandemic, including that HHS document and share a national plan for distributing and administering COVID-19 vaccine; take additional steps to ensure accurate and complete data collection; and expedite the implementation of previous GAO recommendations for cybersecurity threats.