FDA may ask Novavax to conduct additional trials of its Covid-19 vaccine to receive full approval

CNN - Apr 26th, 2025

The US Food and Drug Administration (FDA) has requested a new trial from vaccine-maker Novavax as part of a post-approval commitment before granting full approval for its Covid-19 vaccine. This development was revealed by a source familiar with the situation, highlighting that Novavax had expected approval by April 1, but the FDA postponed the decision pending additional data. Novavax confirmed its response to the FDA's Post Marketing Commitment (PMC) request and expressed optimism about the approval process, which would make it the third fully approved Covid-19 vaccine in the US. This is particularly significant given Novavax's use of traditional protein-based technology compared to the mRNA technology used by Pfizer/BioNTech and Moderna.

The delay in approval coincides with leadership changes at the FDA's Center for Biologics Evaluation and Research, where Dr. Scott Steele has been appointed acting director following Dr. Peter Marks' departure. Marks' resignation was linked to concerns over misinformation about vaccine safety, an issue exacerbated by anti-vaccine advocate Robert F. Kennedy Jr., who has made misleading claims about Covid-19 and measles vaccines. Full approval of the Novavax vaccine could enhance public confidence, especially amidst ongoing misinformation campaigns and vaccine hesitancy challenges. The FDA and the Department of Health and Human Services remain committed to ensuring that vaccines meet their rigorous safety standards.

Robert F. Kennedy Jr. Fda Vaccine Misinformation Dr. Peter Marks Novavax Covid 19 Vaccine Vaccine Approval Dr. Scott Steele

Story submitted by Fairstory

RATING

6.2

Moderately Fair

Read with skepticism

The article provides a timely and relevant update on the FDA's interactions with Novavax regarding the approval of its Covid-19 vaccine. It accurately reports the FDA's request for additional trials as a post-approval commitment and includes direct statements from Novavax. However, the credibility is undermined by an error regarding Robert F. Kennedy Jr.'s position and the reliance on an anonymous source. The story could benefit from more diverse perspectives and greater transparency about the FDA's decision-making process. Despite these shortcomings, the article remains accessible and informative for readers interested in vaccine-related news.

Accuracy

The story accurately reports on the FDA's interactions with Novavax regarding the Covid-19 vaccine's approval process. It correctly notes that the FDA has discussed the need for a post-approval trial, consistent with the standard practice of postmarketing commitments (PMCs). However, there is a significant inaccuracy regarding the position of Robert F. Kennedy Jr., who is incorrectly identified as the HHS Secretary, which undermines the story's credibility. The claim regarding the anticipated approval timeline and the FDA's request for additional data aligns with available information from Novavax and the FDA. The article's accuracy is supported by the inclusion of direct statements from Novavax, although the anonymous source from the FDA could be more transparent.

Balance

The article provides a balanced view by including perspectives from both Novavax and the FDA. It presents Novavax's response to the FDA's request and the agency's commitment to safety. However, the article lacks input from independent experts who could provide a more nuanced understanding of the implications of the FDA's request for additional trials. The narrative may slightly favor Novavax by emphasizing their confidence in the approvability of their application without offering critical analysis of the potential reasons for the FDA's delay.

Clarity

The article is generally clear and well-structured, with a logical flow of information. It effectively outlines the key points regarding the FDA's interaction with Novavax and the potential impact of full approval. However, the error regarding Robert F. Kennedy Jr.'s position introduces confusion. The language is straightforward, but the story could benefit from additional context to help readers understand the significance of the FDA's actions and the technical aspects of vaccine approval.

Source quality

The article relies on a mix of named and unnamed sources. Novavax's statements are directly quoted, lending credibility to their perspective. However, the use of an anonymous source for information about the FDA's internal discussions weakens the source quality. The credibility of the source is further questioned due to the error regarding Robert F. Kennedy Jr.'s position. The story would benefit from more authoritative sources, such as official statements from the FDA or insights from vaccine experts.

Transparency

The article provides some transparency by quoting Novavax's statement on the FDA's request for a postmarketing commitment. However, it lacks transparency regarding the anonymous source's identity and the basis for their claims. The article does not sufficiently explain the context of the FDA's decision-making process or the implications of the leadership change at the FDA. Greater transparency about the methodology and sources would enhance the article's credibility.