The Pfizer-BioNTech COVID-19 vaccine (marketed as Comirnaty) was approved by the FDA for “emergency use” last year but has now received full approval for individuals aged 16 years and over. It remains under emergency use approval for children aged 12 to 15, and for a third dose in certain immunocompromised individuals.
According to Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, “hundreds of thousands” of pages of scientific data were reviewed as part of the evaluation, including data from around 20,000 vaccine and 20,000 placebo recipients. The FDA also evaluated post-authorization safety surveillance data; the prescribing information will include a warning about the risk of myocarditis and pericarditis in certain individuals.
In a statement (1), Marks said, “The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the US.”
The technology transfer for BrainStorm's NurOwn® autologous cell therapy at Catalent’s facility has been finalized. NurOwn will be manufactured at Catalent’s world-class 32,000 square-foot cell therapy manufacturing facility in Houston.
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References
- FDA (2021). Available at: https://bit.ly/3yKUEgB
