• Regulatory NewsRegulatory News

    VRBPAC recommends addition of Omicron-component to future boosters

    A panel of experts recommended the inclusion of an Omicron component in future COVID-19 vaccine boosters in the United States. Public health officials suspect another surge in COVID-19 cases this fall and are considering boosters with an updated strain composition in hopes that vaccine targeting a more recent strain of the virus will be more effective.   FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) met on 28 June to discuss whether the a...
  • Regulatory NewsRegulatory News

    FDA extends temporary halt in inspections driven by omicron

    The US Food and Drug Administration (FDA) has extended its temporary pause on non-mission-critical domestic surveillance inspections through 4 February 2022, an agency spokesperson told Focus on Wednesday.   FDA previously announced it would halt certain inspectional activities out of concern for its employees and those of the companies it regulates amid the wave of COVID-19 infections driven by the omicron variant. At the time, the agency said it would continue to c...