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FDA: Where is Novavax? Why Haven’t You Authorized? Who are You Protecting?

What do Europe, the United Kingdom, Canada, and the World Health Organization have in common? They have all authorized or approved the Novavax COVID-19 vaccine while the U.S. Food and Drug Administration (FDA) continues to sit on a submission by the American company.

This starts to seem a bit strange. On December 31 Novavax completed the submission of the final data package to the FDA including the complete chemistry, manufacturing, and controls module to fulfill the prerequisites for emergency use authorization (EUA) application.

  • What’s happened since then at the purported Gold Standard agency? Not much in relation to the Novavax vaccine, at least not publicly.

In the meantime, the Novavax vaccine (NVX-CoV2373) has been authorized on an emergency basis in the world’s major markets including European (European Medicines Agency), approved by the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) as well as Canada and even the World Health Organization’s Emergency Use Listing (EUL). Even Japan’s health authorities procured 150 million doses from Novavax recently.

  • Health Canada granted authorization for the recombinant protein, adjuvanted vaccine branded as Nuvaxovid COVID-19 Vaccine for active immunization to prevent COVID-19 last month. Novavax has been authorized in several other nations as well, including major markets.

TrialSite reported that a version of the product was produced in India for Indonesia as well as for the Philippines.

On December 20 the European Medicines Agency recommended that the Novavax product the European Medicines recommended use of the product.

Most recently the company requested access with EMA for the teen cohort. The United Kingdom’s MHRA approved the vaccine on February 3, 2022. See the press release.

Even the World Health Organization (WHO) included Novavax on the global health agencies emergency use listing (EUL). See the press release.

Where is the FDA?

What about the U.S. FDA? Why has EMA, MHRA, Health Canada, and other agencies such as the WHO authorized this vaccine from an American company and not the FDA? TrialSite receives mail all the time from viewers who would eagerly accept this vaccine? Why isn’t the FDA accelerating for choice like their colleagues in Europe? Why can’t the American consumer have competition for COVID-19 vaccines?

Some across America start to think that the medical establishment, including regulators, are too cozy with a couple of the vaccine producers, namely the mRNA makers of Pfizer-BioNTech and Moderna.

  • While the pivotal Phase 3 studies were good enough to support emergency approvals in Canada, the UK, Europe, and World Health Organization, why in the world wouldn’t the FDA move as well? It’s time for the American public to knock on that regulator’s door.

Source: TrialSite Staff