Agency says application rejected due to lack of ‘adequate and well controlled’ trial, but experts say ‘they’re just coming up with reasons’
A senior US Food and Drug Administration (FDA) official says Moderna’s clinical trial on a new, potentially more effective flu vaccine was a “brazen failure” and that the FDA is now calling it into question.
The FDA unexpectedly refused to consider Moderna’s application for a flu shot based on messenger RNA (mRNA) technology in a decision that experts say is already having a chilling effect on vaccine development.
Officials say the issue is the design of the study, in which control group participants over the age of 65 should have received a high-dose flu shot instead of a standard flu shot.
Outside experts say the reasons seem to go deeper. “It’s all pretext and obfuscation when the real agenda is rejecting conventional science and serving a predetermined anti-vaccine agenda,” said Richard Hughes IV, a partner with Epstein Becker Green and law professor at George Washington University.
Those companies, like Pfizer, do very little of their R&D. They spend money buying up companies to control the IP after most of the work is done. And that work is often funded by government grants. So American citizens have their tax money go towards research (which is great, I’m all for that) but for-profit companies come in at the end to carry the ball over the line, and make billions doing it (which we pay for too). Broken system.