FDA Panel Recommends Novavax To Be Fourth Authorized COVID-19 Vaccine in America

After receiving praise from the FDA Vaccines and Related Biological Products Advisory Committee based on its most recent Phase 3 clinical trial, Novavax is taking a step forward in its commercialization as the panel recommended Novavax for Emergency Use Authorization (EUA). If Novavax does receive the official authorization nod, it would be the fourth authorized vaccine in the US and the second non-mRNA vaccine available. Despite the committee’s concerns revolving around heart health, Novavax argues that because the safety profile is so tolerable and the efficacy rates are so high, its vaccine deserves a spot among the rest to serve the American people. 

What the FDA Advisory Committee Had to Say About Novavax

The FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) based most of their comments on Novavax’s PREVENT-19 Phase 3 clinical trial results. The PREVENT-19 study enrolled about 30,000 patients in the US and Mexico. Those who received two doses of Novavax’s NVX-CoV2373 vaccine showed a 90.4% efficacy rate. 

According to a paper published in The New England Journal of Medicine, the Phase 3 study took place in the first half of 2021, when 19,714 received the Novavax vaccine and 9,868 received a placebo. Of the 77 COVID-19 cases noted among the participants, 14 were among vaccine recipients, and 63 were among those that received a placebo. 

The FDA briefing reiterates most of the positive findings and says that VRBPAC will discuss whether or not it thinks NVX-CoV2373’s potential benefits outweigh the risks for use in individuals 18 or older. VRBPAC emphasized in the benefit/risk section of the briefing that the low number of immunocompromised adults in the trial did not allow for an accurate assessment of the vaccine in that group of people. It also emphasized that the EUA request did include individuals 17 and younger.

Novavax expressed its excitement in its press release, drawing attention to the potential of being America’s first authorized protein-based COVID-19 vaccine.

“The advisory committee’s positive recommendation acknowledges the strength of our data and the importance of a protein-based COVID-19 vaccine developed using an innovative approach to traditional vaccine technology,” President and Chief Executive Officer of Novavax, Stanley C. Erck, said, “We look forward to collaborating with the FDA as it makes its final decision.” 

Related Article: Learning From the COVID-19 Pandemic With Moderna CEO, Stéphane Bancel

Harnessing Protein-based COVID-19 Vaccines

If Novavax receives EUA, NVX-CoV2373 will be the fourth authorized vaccine in the US, alongside the two mRNA competitors, Moderna and Pfizer BioNTech, and the viral vector option provided by Johnson and Johnson. Novavax stands out from the rest because it is designed as a protein-based vaccine to protect against COVID-19. 

Protein-based vaccines entered the COVID-19 vaccine discussion early on in the pandemic, but due to restrictions in the manufacturing process, protein-based vaccines were destined to take longer to develop than their competitors. 

Rather than human tissue, insect cells are often the starting point for manufacturing protein-based vaccines. In Novavax’s case, it genetically modifies moth cells to create a protein that simulates the COVID-19 infection without making the person sick so they can still develop antibodies against COVID-19. Novavax mixes the final protein with an adjuvant, an additional aspect of the vaccine that provides a more effective immune response. 

Several other companies have developed and continue working to develop protein-based COVID-19 vaccines like Medigen, Clover, and Sanofi. Of the protein-based vaccines developed, Novavax outperforms the rest and continues to shine in authorized countries worldwide. Areas that already authorized Novavax’s use include the European Union, Canada, Australia, and New Zealand. 

Novavax has a large presence in Asia as well. Japan and South Korea fully approved the vaccine while Indonesia, Thailand, Singapore, and Bangladesh authorized the use of the vaccine. Novavax recently applied for EUA in Taiwan as well and is pending approval.  

Heart Health Concerns With Novavax

VRBPAC’s briefing appeared mostly positive about the potential EUA of NVX-CoV2373, but it did highlight a concern about the risk of people developing myocarditis and pericarditis after vaccine administration. Myocarditis is inflammation of the heart muscle, and pericarditis is inflammation of the heart’s outer lining.

Despite the FDA panel’s statements, Novavax says that the risk of myocarditis and pericarditis might not be associated with its vaccine at all. Novavax stated that among all of its clinical studies, which have involved over 50,000 participants, the rate of myocarditis was balanced between those who received the vaccine and those who received the placebo. Though Novavax will continue to monitor the association, it believes that based on available data, there is insufficient evidence to establish a relationship between NVX-CoV2373 and myocarditis and pericarditis. 

Myocarditis is not only a concern for Novavax but the two mRNA vaccine options as well. In November of last year, the CDC published that it continues to monitor associations between mRNA vaccination and myocarditis and pericarditis. The notice states that most cases happen within a week of the second dose but that most patients recover quickly after medical care. 

An additional COVID-19 vaccine option is exciting news for Americans who may be reluctant to get an mRNA vaccine or Johnson and Johnson’s vaccine and its risk of blood clots. Novavax will wait with bated breath for VRBPAC’s official decision on the EUA. Until then, the countries where it is authorized will continue to administer the protein-based vaccine to help mitigate severe cases and prevent the spread of COVID-19.

Author

Reed Slater