Novavax COVID-19 Vaccine Faces Unexpected Roadblock as FDA Delays Approval Despite Meeting Requirements

By Madelaine Panganiban

Updated: Apr 03 2025, 19:45 PM EDT

Novavax COVID-19 Vaccine Faces Unexpected Roadblock as FDA Delays Approval — A healthcare worker prepares a dose of Nuvaxovid vaccine from Novavax in Utrecht on March 15, 2022. Unlike mRNA vaccines, Nuvaxovid does not need to be stored in ultra-low temperatures, giving it a logistical advantage in difficult-to-access regions. JEROEN JUMELET/ANP/AFP via Getty Images/Getty Images

The Novavax COVID-19 vaccine has hit an unexpected roadblock as the US Food and Drug Administration (FDA) has delayed its full approval, even though the company met all the required criteria.

Novavax had been expecting a decision by April 1, but the FDA has asked for additional data, delaying the approval process.

Novavax's protein-based COVID-19 vaccine has been available under emergency use authorization since 2022.

It was on track to become the third COVID-19 vaccine to receive full approval, following those from Pfizer/BioNTech and Moderna, CNN said.

Full approval would allow the vaccine to be used beyond the emergency declaration and provide more reassurance for those hesitant about COVID-19 vaccination.

Novavax expressed its frustration in a statement, saying it had responded to all of the FDA's information requests by April 1 and believed its vaccine was ready for approval.

The company's filing emphasized that the vaccine's Phase 3 clinical trials showed it is both safe and effective in preventing COVID-19. "We are confident our well-tolerated vaccine represents an important alternative to mRNA COVID-19 vaccines for the U.S.," Novavax said.

🇺🇸USA: FDA delays full approval of Novavax Covid-19 vaccine even though it was on track for clearance.

Source: https://t.co/LNOxB1oi9R pic.twitter.com/GixlMAJMiU
— Denis - The COVID info guy - (@BigBadDenis) April 2, 2025

FDA Delays Full Approval of Novavax Vaccine, Requests More Data

Despite the delay, Novavax has not yet received an official decision from the FDA. The company remains hopeful that its vaccine will eventually be granted full approval.

In the meantime, the vaccine remains available under emergency use authorization for individuals aged 12 and older.

The delay comes amidst significant changes in US health agencies, particularly under the leadership of President Donald Trump's administration.

According to MedicalExpress, Health and Human Services Secretary Robert F. Kennedy Jr., who has been known for his anti-vaccine stance, has recently sparked controversy with misleading statements regarding vaccines.

This shift in leadership has led to disruptions, including the restructuring of several health agencies, resulting in mass layoffs.

The FDA has not provided specific reasons for the delay. However, sources indicate that the agency is asking for more data to ensure the vaccine's safety and efficacy.

The FDA's independent review process is said to be focused solely on scientific evaluation, and not influenced by political pressures.

For now, Novavax continues to await the FDA's final decision, which has left many wondering about the future of its vaccine.