Today, December 17, 2020, the Vaccine and Related Biological Products Advisory Committee meeting discussed the Moderna vaccine. That vaccine is an mRNA vaccine, much the same as the Pfizer-BioNtech vaccine. To remind you, the mRNA vaccine: Does not replicate Does not enter or integrate into DNA And the Moderna vaccine does not contain any preservatives […]
Today was the FDA vaccine advisory committee meeting to provide feedback to the FDA regarding the Pfizer-BioNtech COVID-19 vaccine. I don’t think anyone will be surprised by the outcome, especially since the pre-meeting package written by the FDA was extremely favorable regarding the safety profile and the very high efficacy rates seen in the study. […]
Based on the FDA advanced posting of material regarding the advisory committee meeting tomorrow to consider an EUA for the Pfizer vaccine, it appears that there should be clear sailing. From the materials that I was able to review, there were very few serious adverse reactions, 95% efficacy rate, and low episodes of severe disease […]
I read an Axios report this morning (here) written by Jonathan Swan, indicating that FDA commissioner Stephen Hahn has been summoned to the West Wing by White House Chief of Staff Mark Meadows to explain “why he hasn’t moved faster to approve the Pfizer coronavirus vaccine“. This type of pressure has no place in science. […]
Some of the afternoon sessions at AAM shone the light on approaching development of complex drug products including drug/device, topicals, ophthalmic products, and orally inhaled products. Each session provided a treasure trove of information regarding the specific dosage forms and issues that the agency and industry has had to deal with. To cover it all […]
