moderna
3 stories tagged "moderna"
Drugs & FDA
The FDA Approved Moderna's mRNA Flu Shot for Seniors Without Proving It Works in Them
In February the FDA's own vaccine chief refused to even review it. One week later the agency reversed course, and the trial data never changed.
Drugs & FDAThe FDA Said No to Moderna's mRNA Flu Shot in February. By August, the Two Men Who Said No Were Gone.
The FDA refused to even review Moderna's mRNA flu shot in February because it was never tested against the enhanced vaccines seniors are steered toward. The two officials who objected are gone, and the agency approved it anyway, for the oldest patients, on a promise to prove it works later.
Drugs & FDAModerna's mRNA flu shot got a 9-0 vote. The comparator question that killed its first filing did not go away.
An FDA panel voted 9-0 to back Moderna's first mRNA flu vaccine. Four months earlier, the same agency refused to even read the file over the comparator the trial used. The comparator did not change.