USA FDA Attacks Moderna's Flu Vaccine in Rare Public Rebuke

[Webster]

(The Guardian) 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.

Dorit Reiss, professor of law at UC Law San Francisco, said “personally humiliating a company is not a legitimate reason to refuse to review a submission”, and the refusal needs to “address substantive reasons”. Angela Rasmussen, an American virologist at the Vaccine and Infectious Disease Organization at the University of Saskatchewan, says “they’re just coming up with reasons to not approve mRNA anything, and they’re going to eventually do it to all these vaccines”.

Andrew Nixon, a spokesperson for the US Department of Health and Human Services, said the concerns that mRNA and other vaccines are being targeted by officials were “baseless”.

FDA refuses to consider Moderna flu shot in move experts claim is part of ‘anti-vaccine agenda’

 

[Lamb]

It's possible that the failure of the vaccine wasn't the mRNA portion, but the inactive ingredients such as PEG that they force into their medicines. As someone who had anaphylaxis twice from the Moderna Covid vaccine, I now suffer from a severe PEG allergy and so do thousands of others.