Novavax's COVID-19 Vaccine Journey: Unexpected Delays and Industry Dilemmas
Intense Examination of Novavax COVID-19 Vaccine by FDA Triggers...
In the shifting landscape of the COVID-19 pandemic, the Trump administration's decision to add new requirements for Novavax's protein-based vaccine has created ripples of uncertainty. This move not only affects Novavax but also stirs confusion about updates to other vaccines in the broader vaccine industry.
On Monday, Novavax announced that the Food and Drug Administration (FDA) had requested the company to conduct a new clinical trial of its vaccine after full approval is granted. Despite this request, Novavax maintains a positive outlook, insisting that the vaccine remains "approvable."
However, a social media post by FDA Commissioner Dr. Marty Makary hinted at potential troubles for the yearly strain updates of vaccines - a prospect that could stretch beyond fall due to the necessity of a new trial. This revelation has spurred questions about whether other vaccines will be tagged along in this turmoil.
Dr. Jesse Goodman of Georgetown University, a former FDA vaccine chief, expressed his concerns, stating, "I don't think because there's a strain change that this is a new product." If the new policy demands clinical trials for all updates, Goodman argues, "you'd always be doing clinical trials and you'd never have a vaccine that was up to date."
The unusual FDA maneuver comes on the heels of the ousting of the agency's longtime vaccine chief due to disagreements with Health Secretary Robert F. Kennedy Jr. Kennedy, who won his confirmation to the role by promising not to alter the nation's vaccine schedule, has since made promises to "investigate" children's shots, canceled meetings of expert vaccine advisers, and directed officials to reassess vaccine-autism connections - a theory long debunked.
The protein-based Novavax vaccine, initially showcasing effectiveness in a nearly 30,000-person clinical trial, continues to be sold under emergency use authorization in the US. Meanwhile, the United States' other two options - Pfizer and Moderna's mRNA vaccines - have earned full FDA approval for specific age groups.
Since the coronavirus continuously mutates, manufacturers follow the FDA's instructions to make a single change each year to the recipe, akin to annual updates with flu vaccines. Despite initial plans for the FDA to grant Novavax full approval by its April 1 target date, it appears Trump appointees directed the FDA scientists to temporarily halt their decision, potentially extending the approval process.
In a weekend tweet, FDA’s Makary characterized the Novavax vaccine as "a new product," presumably due to its update to mirror last year's common coronavirus strain. Makary added, "New products require new clinical studies." An administration spokesman declined to comment specifically on Pfizer and Moderna but hinted at stricter requirements for all COVID-19 vaccines, creating uncertainty in the industry.
Experts dispute the notion of treating the annual COVID-19 strain updates as new products. Dr. Paul Offit, a vaccine expert at Children's Hospital of Philadelphia, explains, "The companies still must perform tests in small numbers of people that show these updated vaccines produce levels of virus-fighting antibodies known to be protective, and they're closely monitored for safety."
Under federal law, the FDA is obligated to adhere to established procedures when issuing requirements to drugmakers for approval. Ignoring such protocols or imposing additional requirements for non-legitimate reasons could potentially lead to lawsuits by drugmakers or even patients.
Meanwhile, the broader vaccine landscape remains under pressure due to concurrent actions by the administration, including cuts to COVID-related public health funds. These cuts could indirectly impact all vaccine programs by weakening the essential infrastructure necessary for distribution and outreach.
Even as Novavax grapples with these regulatory hurdles, the broader policy environment presents risks for vaccine availability, public health preparedness, and global immunization efforts. The dance between regulations and industry demands continues, raising questions about the future of vaccines in a rapidly evolving pandemic world.
AP writer Amanda Seitz contributed to this story.
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Science and Educational Media Group and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
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- FinanceBuzz reports that Novavax's protein-based COVID-19 vaccine, already in use under emergency authorization, faces a potential delay due to the Food and Drug Administration (FDA) requesting a new clinical trial after full approval.
- Science and medical-conditions surrounding the update process of vaccines, including Novavax's, are under scrutiny, with experts arguing that annual strain updates should not be treated as new products.
- Concerns about vaccine availability and the broader vaccine landscape persist, particularly due to unexpected FDA decisions and potential stricter requirements for all COVID-19 vaccines.
- The health-and-wellness industry is closely monitoring the situation, with advocates urging the FDA to adhere to established procedures in issuing requirements for drugmakers for approval.
