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COVID-19 Federal Responses: Monday, June 14, 2021

COVID-19 Federal Responses: Monday, June 14, 2021
  • HHS issued new guidance that sets new deadlines for Provider Relief Fund money received after June 30, 2020. It also includes information about how to report information to HHS on how the funding was used.
  • Results from the Phase 3 trial of Novavax’s COVID-19 vaccine show it is 90% effective against symptomatic COVID-19 infection. Novavax plans to apply for authorization in the third quarter, and hopes to produce 100 million doses per month by the end of that quarter.
  • The Food and Drug Administration (FDA) announced yesterday a Class 1 recall of a coronavirus rapid antigen test produced by Innova Medical Group, alleging that the company behind the product was selling the tests without regulatory approval and was using falsified data to inflate the tests’ performance.
  • Several hospitals are requiring their staff to get vaccinated against COVID-19.
  • The FDA has instructed Johnson & Johnson to discard about 60 million COVID-19 vaccines made at the troubled Emergent BioSolutions’ factory.

White House and Federal Agencies

  • HHS issued new guidance that gives providers new flexibility to spend part of their Provider Relief Fund (PRF) grant money after June 30. Providers need to spend PRF money they received before June 30, 2020 by June 30, 2021. The guidance sets new deadlines for PRF money received after that date. It also includes information about how to report information to HHS on how the funding was used.
  • President Joe Biden said the U.S. may be able to provide 1 billion doses of coronavirus vaccine to the world by 2023. This would be in addition to the 500 million he promised by the end of 2022.

Economy, Vaccines, Testing and Treatment

  • The CDC will hold an emergency meeting on June 18 to discuss reports of heart inflammation that may be associated with the COVID-19 vaccines. Though rare overall, the cases appear to be most prevalent in adults under the age of 30.
  • Results from the Phase 3 trial of Novavax’s COVID-19 vaccine show it is 90% effective against symptomatic COVID-19 infection. Novavax plans to apply for authorization in the third quarter, and hopes to produce 100 million doses per month by the end of that quarter.
  • The Department of Health and Human Services (HHS) announced it is distributing $424.7 million in funding to rural health clinics for COVID-19 testing and mitigation.
  • The Group of Seven Summit (G-7) held its first face-to-face summit in two years in southwest England. The leaders made commitments on a range of topics, including sharing coronavirus vaccines.
    • Leaders attending the G-7 summit also issued a call for a new study into the origins of COVID-19.
  • The Food and Drug Administration (FDA) announced yesterday a Class 1 recall of a coronavirus rapid antigen test produced by Innova Medical Group, alleging that the company behind the product was selling the tests without regulatory approval and was using falsified data to inflate the tests’ performance.
  • Several hospitals are requiring their staff to get vaccinated against COVID-19.
  • The FDA has instructed Johnson & Johnson to discard about 60 million COVID-19 vaccines made at the troubled Emergent BioSolutions’ factory.

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