• 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...
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    FDA panel split on approach to COVID-19 vaccines for younger children

    Members of the US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) disagreed as to whether the agency should grant emergency use authorizations (EUAs) for COVID-19 vaccines for children at a 10 June meeting.   Some said that EUAs were necessary to get the pediatric population vaccinated quickly to achieve herd immunity as the country emerges from the pandemic and that these vaccines should be available soon as th...
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    EMA bumps up Moderna vaccine review

    As it faces increasing pressure to authorize vaccines to prevent COVID-19, the European Medicines Agency (EMA) on Thursday said it would speed up its assessment of Moderna’s mRNA COVID-19 vaccine by nearly a week after receiving the last outstanding data it needed to decide on the application.   The agency had initially scheduled an extraordinary meeting of its Committee for Medicinal Products for Human Use (CHMP) to conclude its assessment of Moderna’s conditional mar...