Vaccines

The Centers for Disease Control and Prevention’s vaccine advisory committee meets today to discuss authorizing the Pfizer-BioNTech vaccine in children aged 5 to 11 years.
The FDA informed Moderna that it would need more time to evaluate the company’s Emergency Use Authorization (EUA) submission for its COVID-19 vaccine for adolescents 12 to 17 years of age.
Inovio shares are down about 2% in premarket trading after cancellation reports of a DNA cancer vaccine collab with AstraZeneca.
FDA
The U.S. Food and Drug Administration granted Emergency Use Authorization (EUA) for the Pfizer-BioNTech vaccine for children ages 5 to 11.
In the face of Delta, the actual efficacy of the vaccines has come into question, while global cases and deaths from COVID-19 increased for the first time in two months, primarily in Europe.
FDA
Emergent BioSolutions, the manufacturer responsible for the doses in question, is reportedly just waiting for the U.S. FDA’s signal to start shipping the vaccines.
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On Tuesday morning, Provention Bio announced positive interim results from its Phase I PROVENT study of PRV-101.
In documents prepared for the meeting, the vaccine demonstrated 90.7% effectiveness for the children in this age group.
BioNTech plans to increase its manufacturing capacity in Africa over time through the supplementation of new manufacturing lines and construction of additional manufacturing sites.
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