FDA's Quiet Update on Novavax Vaccine Sparks Concern
The Food and Drug Administration (FDA) has discreetly updated the Emergency Use Authorization (EUA) for the Novavax COVID-19 vaccine. This move is puzzling, given that the Centers for Disease Control and Prevention (CDC) officially declared the end of the Public Health Emergency nearly five months prior. The decision has ignited debates about the FDA's jurisdiction to issue an EUA in the absence of a declared public health emergency.
On October 3, the FDA's website indicated an amendment to the EUA for the Novavax COVID-19 Vaccine, Adjuvanted, introducing the 2023-2024 formula. This new version incorporates the spike protein from the SARS-CoV-2 Omicron variant lineage XBB.1.5. Notably, the original version of this vaccine is no longer authorized for use in the U.S.
The revised vaccine is approved for individuals 12 years and older. For those already vaccinated, a single dose of the updated vaccine is advised two months post the last dose. Unvaccinated individuals are recommended two doses, three weeks apart. Additional doses for immunocompromised individuals are at the healthcare provider's discretion.
This update aligns with the Biden administration's decision to restart the distribution of "at-home" COVID test kits. After pausing the taxpayer-funded distribution in June 2023, families can now avail up to four free tests per member.
However, the FDA's subtle EUA update for the Novavax vaccine has stirred discussions among health experts. Concerns have arisen due to the reported increase in excess mortality and the discovery of unusual white fibrous clots in half of the cadavers, as highlighted by travel embalmer Richard Hirschman. Additionally, Pfizer & Moderna COVID-19 mRNA Vaccines have been linked to a significant rise in young people's deaths over the past three years.
Despite these alarming reports, the federal government persists in its COVID-19 response through extensive testing and EUA vaccine approvals. The FDA's decision to grant an EUA without a current emergency, as per the CDC's stance, has left many perplexed.
An FDA.gov letter discloses that the Secretary of the Department of Health and Human Services (HHS) believes there's a potential or existing public health emergency impacting national security or U.S. citizens abroad.
The FDA's discreet EUA update for the Novavax vaccine underscores the need for transparency and accountability in our public health agencies, especially as concerns and data continue to emerge.