COVID-19 Vaccines: HHS Advisory Committee Urges ‘Great Caution’ On Use Of EUA
Biologics license application is preferred route to market, but if emergency authorization is given it should happen with full transparency and be communicated in a clear manner to strengthen public confidence, National Vaccine Advisory Committee says.
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Although UK labeling for the Pfizer/BioNTech vaccine recommends against use in women who are pregnant or breastfeeding, the US FDA’s labeling under an emergency use authorization is not expected to follow suit; agency says developmental and reproductive toxicity studies for some early candidates are nearing completion, but data will not available for EUA decision-making.
US FDA plans to leverage large safety surveillance databases to make up for the fact that a vaccine authorized for emergency use likely would have only one-quarter to one-half as much safety data follow-up as a typical vaccine licensed under a BLA, says CBER director Peter Marks.
US FDA will be cautious about development of a COVID-19 vaccine for children, Commissioner Hahn says at the Financial Times US Pharma And Biotech Summit.