• Regulatory NewsRegulatory News

    FDA calls for inclusion of Omicron BA.4/5 in future boosters

    Heeding the advice of its expert advisory committee, the US Food and Drug Administration (FDA) on Thursday recommended the inclusion of an Omicron BA.4/5 spike protein component in modified COVID-19 vaccine boosters for the upcoming fall and winter seasons.   The recommendation follows a 19-2 vote in favor of adding an Omicron-specific component to future boosters by FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) earlier this week. (RELATED:...
  • 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...
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    FDA okays Moderna, J&J, 'mix and match' boosters

    The US Food and Drug Administration has authorized booster doses of both the Moderna COVID-19 vaccine and the vaccine made by Janssen, the vaccines arm of Johnson & Johnson. The agency has also taken a “mix and match” approach, authorizing heterologous booster doses for all populations eligible for boosters under today's expansion of the emergency use authorizations for COVID-19 vaccines.   A booster is recommended for all recipients of the one-dose Janssen vaccine, an...
  • Regulatory NewsRegulatory News

    FDA to convene VRBPAC on vaccines for younger children plus Moderna, J&J boosters

    Amid the nationwide rollout of booster shots of the Pfizer-BioNTech COVID-19 vaccine, the US Food and Drug Administration (FDA) on Friday announced it will convene its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to discuss potential booster doses for the other two US-authorized COVID-19 vaccines developed by Moderna and Johnson & Johnson (J&J) later this month.   The committee will also meet on 26 October to discuss Pfizer's anticipated request...