Janssen Biotech Inc.
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AstraZeneca and Novavax have not filed EUAs for their vaccines, and they never might. The pathway remains viable in the short-term, but as BLAs are approved and supplies are no longer short, the window may close.
Emergency use authorization in 12-15 year-olds follows announcement of a June advisory committee meeting on pediatric data requirements, including the FDA’s criteria for younger children. Authorization for US adolescents has raised ethical questions about prioritizing this lower-risk group over hard-hit populations overseas.
US FDA’s Search For Class-Wide Vaccine Blood-Clot Effect Makes Scientific Sense, But Raises Questions
Several adenovirus vaccine developers say the products cannot be compared, potentially complicating the US FDA and CDC’s decision on ending the recommended pause in the use of Janssen’s vaccine.
Based on the historical time between Phase III results and filing announcements, AstraZeneca is way behind the pace. The firm will soon have waited longer to submit its EUA to the US FDA than the three already-authorized products waited combined.
- Drug Delivery