News

COVID vaccine boosters called into question by FDA chief: ‘Void of data’
Dr. Marty Makary, chief of the FDA, has expressed doubts about the agency approving the COVID-19 vaccine for winter, stating ...
MedPage Today1d
FDA Scrutiny of Novavax COVID Shot Sparks Uncertainty About Other Vaccines
The Trump administration's effort to impose new requirements on Novavax's COVID-19 vaccine -- the nation's only traditional ...
FDA scrutiny of Novavax COVID-19 vaccine sparks uncertainty about other shots
There’s new uncertainty about updated COVID-19 shots this fall after the Trump administration’s handling of a shot from ...
STAT12h
8 possible indicators of how RFK Jr.’s HHS will handle vaccine policy
Here are eight possible indicators of how health secretary Robert F. Kennedy Jr. may handle U.S. vaccine policy in coming ...
FDA may ask Novavax to conduct additional trials of its Covid-19 vaccine to receive full approval
The US Food and Drug Administration has discussed with vaccine-maker Novavax the need for an additional trial of its Covid-19 ...
BioPharma Dive2d
Novavax says vaccine application still ‘approvable,’ despite FDA delay
Comments over the weekend by FDA chief Martin Makary suggest the agency views Novavax’s updated COVID shot as a “new product” ...
Pulmonology Advisor8h
Novavax COVID Vaccine Moves Closer to Full FDA Approval
Novavax's protein-only vaccine is once again expected to move from emergency approval to full approval status following a pause.
Novavax shares soar after FDA request raises hope for COVID vaccine approval
Novavax said on Wednesday U.S. regulators asked the company to produce more data on its COVID-19 vaccine if it gets full ...
pharmaphorum2d
Does the Novavax delay augur a COVID vaccine policy change?
In addition, HHS Secretary Robert F. Kennedy Jr addressed the delay in Novavax's approval in a CBS interview earlier this ...
FDA Asks Vaccine Maker to Complete New Clinical Trial for Delayed Covid-19 Shot
A new randomized study could cost Novavax tens of millions of dollars, vaccine experts say ...
Mercury News1d
FDA scrutiny of Novavax COVID-19 vaccine sparks uncertainty about other shots
WASHINGTON (AP) — The Trump administration’s effort to impose new requirements on Novavax’s COVID-19 vaccine — the nation’s only traditional protein-based option for the coronavirus ...
Hartford Courant2d
FDA scrutiny of Novavax COVID-19 vaccine sparks uncertainty about other shots
If that’s the new policy, “you’d always be doing clinical trials and you’d never have a vaccine that was up to date.” The Novavax vaccine, which originally showed effectiveness in a ...