Vaccines Archives

I Got Mine, How About You?

By Bob Pollock Jan 08, 2026 Biologics Vaccines

I usually get a flu shot around this time each year and, in recent years, an updated COVID vaccine. I sit at my computer, go on my local retail pharmacy’s website, and select a date for my immunizations in the not-too-distant future so I’ll have adequate protection during that flu season. In addition, I’m convinced […]

Dec

FDA’s Adcom Meeting for Moderna COVID Vaccine

By Bob Pollock Dec 17, 2020 Biologics COVID-19 Vaccines

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 […]

Dec

NEWS FLASH – COVID-19 Vaccine Vote from the Advisory Committee Meeting

By Bob Pollock Dec 11, 2020 Biologics EUA FDA Regulatory Affairs Vaccines

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. […]

Dec

Vaccine Advisory Committee to Consider Pfizer COVID-19 Product

By Bob Pollock Dec 09, 2020 Biologics FDA Regulatory Affairs Vaccines

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 […]

Dec

Administration Pressure on the FDA – What’s Taking So Long? Let Me Tell You Why!

By Bob Pollock Dec 01, 2020 Biologics FDA Regulatory Affairs Vaccines

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. […]

Nov

Complex Drugs and Complex Decisions Topped the Afternoon AAM sessions

By Bob Pollock Nov 11, 2020 FDA Generics Regulatory Affairs Vaccines

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 […]