As your partner in health and safety, we are continuously monitoring regulatory updates that may affect your operations. See the NIH's latest COVID-19 updates and resources below.

No new updates.

Pregnancy Study During COVID-19

Researchers will analyze the medical records of up to 21,000 women to evaluate whether changes to healthcare delivery that were implemented as a result of the pandemic have led to higher rates of pregnancy-related complications and cesarean delivery.

https://www.nih.gov/news-events/news-releases/nih-funded-study-investigate-pregnancy-outcomes-resulting-covid-19-pandemic

Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV)

Released a statement describing the initiative referred to Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV). Which is a public-private initiative designed to coordinate at least 18 leading biopharmaceutical companies, multiple US Federal agencies, and the European Medicines Agency to developing an international strategy for an integrated research response to COVID-19. Four working groups have been established:

  • Preclinical group to standardized evaluation resources and methods
  • Therapeutics Clinical group to prioritize and accelerate clinical evaluation of therapeutic candidates
  • Clinical trial capacity to assemble and coordinate existing networks of clinical trials.
  • Vaccines group to accelerate and evaluate vaccine candidates

https://www.nih.gov/news-events/news-releases/nih-director-defeating-covid-19-requires-unprecedented-action-collaboration

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Investigational Vaccine Protects Monkeys Against COVID-19 Pneumonia

University of Oxford researchers developed first vaccine using existing methods but applying SARS-CoV-2 protein. The vaccine was tested with six rhesus monkeys provided adequate immune response to prevent illness when compared to 3 control monkeys that were not given the vaccine.

https://www.nih.gov/news-events/news-releases/investigational-chadox1-ncov-19-vaccine-protects-monkeys-against-covid-19-pneumonia

Coordinated Strategy to Accelerate Multiple COVID-19 Vaccine Candidates is Key, NIH Experts Say

Scientific leaders published in Science a likely path toward vaccine for COVID-19 that includes:

  • No single vaccine or vaccine platform is likely to meet the global need
  • Researchers need to learn more about how to ensure the vaccine actually protects against COVID-19
  • Significant manufacturing capacity will be required to produce the vaccine for worldwide consumption
  • Collaboration will be essential

https://www.nih.gov/news-events/news-releases/coordinated-strategy-accelerate-multiple-covid-19-vaccine-candidates-key-nih-experts-say

  

NIH Begins Clinical Trial of Hydroxychloroquine and Azithromycin to Treat COVID-19

Clinical Trial paring the malaria drug hydroxychloroquine and the antibiotic azithromycin to prevent hospitalization and death has begun. A Phase 2b trial will enroll 2000 adults with confirmed SARS-CoV-2 infection and fever, cough and/or shortness of breath. Participants will take either placebo or medication at home and report symptoms/hospitalizations to researches for the next 20 days. FDA cautions that use of hydroxychloroquine has rare risk of life-threatening heart rhythm problems and should only be used for COVID-19 patients in the clinical trial.

https://www.nih.gov/news-events/news-releases/nih-begins-clinical-trial-hydroxychloroquine-azithromycin-treat-covid-19

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NIH Study to Determine Incidence of COVID-19 in Children Begins

Remote surveys of 6,000 children in 2,000 families are designed to increase understanding of full extent of infection in the entire population, and how it manifests in children and spreads to family members.

https://www.nih.gov/news-events/news-releases/study-determine-incidence-novel-coronavirus-infection-us-children-begins

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NIH Released a Strategic Plan to Accelerate Research to Diagnose, Prevent, and Treat COVID-19

The plan has a four-pronged approach:

  • Understand the SARS-CoV-2 Virus and resulting COVID-19 illness including transmission surveillance and the role of asymptomatic individuals in viral spread.
  • Development of rapid diagnostics to identify new cases, as well as individuals who may have had an infection and recovered. (see “Diagnostics Innovation Initiative” below).
  • The testing of treatments for the illness by identifying and evaluating drugs already approved for other conditions.
  • Development of safe and effective vaccines to protect individuals from infection and future outbreaks.

https://www.nih.gov/news-events/news-releases/niaid-strategic-plan-details-covid-19-research-priorities

  

NIH Diagnostics Innovation Initiative

The Diagnostics Innovation Initiative is a call to all scientists and inventors with rapid testing technology to compete in the national COVID-19 testing challenge for a share of up to $500M over all phases of development. The goal is to rapidly develop at-home or point-of-care tests.

https://www.nih.gov/news-events/news-releases/nih-mobilizes-national-innovation-initiative-covid-19-diagnostics

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The NIH published interim guidelines for the medical management of COVID-19.

People seeking information about registered clinical trials for COVID-19 in the US can search ClinicalTrials.gov.

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