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Janssen Biotech Inc.

http://www.janssenbiotech.com

Latest From Janssen Biotech Inc.

COVID-19 Vaccine Regulatory Strategy Evolving With The Pandemic

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.

Coronavirus COVID-19 Vaccines

Pfizer/BioNTech’s COVID-19 Vaccine Moves Into Adolescents; Adcomm To Weigh Broader Pediatric Issues

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.

Coronavirus COVID-19 Vaccines

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.

Coronavirus COVID-19 Vaccines

AstraZeneca’s COVID Vaccine US Filing Is Delayed – Really Delayed. Here Are Two Theories Why

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.

Coronavirus COVID-19 Vaccines
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