Article 73NGZ FDA reverses surprise rejection of Moderna's mRNA flu vaccine

FDA reverses surprise rejection of Moderna's mRNA flu vaccine

by
Beth Mole
from Ars Technica - All content on (#73NGZ)

The Food and Drug Administration has reversed its shocking refusal to consider Moderna's mRNA flu vaccine for approval.

The refusal was revealed last week in a sharply worded press release from Moderna. Subsequent reporting found that the decision was made by political appointee Vinay Prasad, the Trump administration's top vaccine regulator, who overruled a team of agency scientists and a top career official in rejecting Moderna's application.

In an announcement Wednesday morning, Moderna said the FDA has now agreed to review its vaccine after the company held a formal (Type A) meeting with the FDA and proposed a change to the regulatory pathways used in the application.

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