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# Makary Says Novavax BLA Decision is Forthcoming
- URL: https://www.fdaweb.com/makary-says-novavax-bla-decision-is-forthcoming/
- Published: 2025-05-09T12:00:00.000Z
- Updated: 2026-09-14T15:11:27.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5159155

Appearing on [MSNBC 5/9](https://www.msnbc.com/morning-joe/watch/-show-me-the-data-fda-commissioner-reacts-to-question-about-covid-vaccine-for-young-americans-239253573811?ref=fdaweb.com), FDA commissioner **Marty Makary** said discussions are continuing with Novavax on its BLA to convert a 2022 emergency use authorization to a full approval for its Covid-19 vaccine. The agency missed a user fee target date last month, which the company said was related to a post-approval commitment for clinical trial data ([see earlier story](https://www.fdaweb.com/novavax-hhs-clarify-on-post-approval-covid-study/)).

“We’d like to see some clinical trial data, either before or after, and so we are in discussions, and we’re going to see a mutually satisfactory middle ground, and that announcement should be forthcoming,” Makary said in the interview. He said “Americans want to know if they should take a Covid booster. They want to know when they have a comorbid condition, if they should take it. They want to know if their 12-year-old healthy girl should be getting a sixth Covid jab this fall… We have a void of science. It’s been about four years since we’ve had a randomized control trial. So the companies have been creating new vaccines each year and getting a rubber stamp from the FDA.”

Asked whether FDA and the Trump administration still believe in the efficacy of the Covid-19 vaccines, Makary responded: “Show me the data where a young, healthy teenager should be taking a Covid shot right now.” Without the data, opinions have filled that void, Makary said, adding that the administration is committed to gold standard science and common sense.