Federal law prohibits employers and others from requiring vaccination with a Covid-19 vaccine distributed under an EUA


The same section of the Federal Food, Drug, and Cosmetic Act that authorizes the FDA to grant emergency use authorization also requires the secretary of Health and Human Services to “ensure that individuals to whom the product is administered are informed … of the option to accept or refuse administration of the product.”

Likewise, the FDA’s guidance on emergency use authorization of medical products requires the FDA to “ensure that recipients are informed to the extent practicable given the applicable circumstances … That they have the option to accept or refuse the EUA product …”

Author(s): Aaron Siri

Publication Date: 23 February 2021

Publication Site: Stat News

Myths of Vaccine Manufacturing

Link: https://blogs.sciencemag.org/pipeline/archives/2021/02/02/myths-of-vaccine-manufacturing


The first thing to understand is that these are not, of course, traditional vaccines. That’s why they came on so quickly. mRNA as a vaccine technology has been worked on for some twenty to twenty-five years now, from what I can see, and (as I never tire of mentioning) we’re very fortunate that it had worked out (and quite recently) several of its outstanding problems just before this pandemic hit. Five years ago we simply could not have gone from sequence to vaccine inside of a year. And I mean that “we” to mean both “we the biopharma industry” and “we the human race”.

At this point, let me briefly dispose of an even less well-founded take that’s been going around as well. I’ve seen a number of people say something like “We had the vaccine back in February! It only took until the end of the year to roll it out because of the FDA!” The main thing I’ll say about that idea is that no one who actually works on vaccines, in any capacity, has any time for that statement. Not all vaccine ideas work – we’re already seeing that with the current coronavirus, and if you’d like to talk to some folks about that, then I suggest you call up GlaxoSmithKline and Sanofi and ask them what happened to their initial candidate, and while you’re at it, call up Merck and ask them what happened to their two. Note that I have just named three of the largest, most experienced drug companies on the planet, all of whom have come up short. So no, we did not “have the vaccine” in February.

Author(s): Derek Lowe

Publication Date: 1 February 2021

Publication Site: Science Magazine