<
https://www.thebulwark.com/p/this-is-what-destroying-the-vaccine-market-looks-like-moderna-flu-prasad-fda>
"THE VACCINE MAKER MODERNA decided this past week to tell the world about bad
news it had received from the federal government.
A potentially groundbreaking vaccine for seasonal flu that the
Massachusetts-based company had developed would not be getting approval from
regulators. In fact, it wasn’t even getting formal consideration, Moderna
announced in a Tuesday press release, because officials were refusing to accept
the application.
This is not the type of development you would normally expect a pharmaceutical
company to broadcast. But that’s because there’s nothing normal about the way
the federal government is behaving in this saga—or, for that matter, how the
government has been behaving ever since President Donald Trump put
anti-vaccination crusader Robert F. Kennedy Jr. in charge of America’s public
health.
Moderna’s flu shot, which uses mRNA technology made famous during the COVID-19
pandemic, is the product of a lengthy research and development process that
goes back years. Along the way, Moderna scientists consulted directly with
officials at the Food and Drug Administration, the agency inside of Kennedy’s
department (Health and Human Services) that is responsible for reviewing and
approving vaccines.
Such consultation is normal. And a major focus of the discussion between the
company and the regulators was how Moderna should test the new shot to
demonstrate its safety and effectiveness. There was some back and forth—again,
pretty routine—but ultimately the FDA agreed that Moderna’s design for a trial
was “acceptable,” according to communication Moderna cited in its press
release.
Moderna proceeded with the testing, got promising results and submitted its
application. It had good reason to believe it would receive consideration and,
in due time, outright approval. Instead, on February 3, Moderna got what’s
known as a “refuse to file” letter from the FDA, in which the agency said the
company had not put the new vaccine to a sufficiently demanding test.
This was not a decision to reject the Moderna vaccine. It was a refusal even to
think about approving it. The FDA rarely takes such a step, and when it does
it’s usually because an application is missing a whole component or includes
suspect data. Nobody is suggesting Moderna’s application has those kinds of
issues."
Via Kenny Chaffin.
Cheers,
*** Xanni ***
--
mailto:xanni@xanadu.net Andrew Pam
http://xanadu.com.au/ Chief Scientist, Xanadu
https://glasswings.com.au/ Partner, Glass Wings
https://sericyb.com.au/ Manager, Serious Cybernetics
