Novavax gets FDA nod; fourth vaccine to receive approval for mass-production in US

The Food and Drug Administration (FDA) vaccine experts backed the protein-based vaccine- Novavax as the United States's fourth COVID-19 shot for adults. The committee voted 21-to-0, with one abstention. It is expected that the committee would make a final call on whether to issue emergency authorization for the anti-COVID shots. Though the vaccine has already been approved in 41 countries including, Australia, Canada, and parts of Europe, clearance by the United States drug authority is a key hurdle for the vaccine manufacturer. 

As per the FDA panel, they voted that the benefits of two primary Novavax doses outweigh its risks, but added they have still a lot of questions about the vaccine. "This vaccine does indeed fill some unmet needs," such as an option for people with allergies to competing shots, said Dr Michael Nelson of the University of Virginia. Meanwhile, FDA's vaccine chief Dr Peter Marks said another choice in the country may draw at least some vaccine holdouts -- whatever their reason -- to consider rolling up their sleeves.

"We do have a problem with vaccine uptake that is very serious in the United States," Marks said. "Anything we can do to get people more comfortable to accept these potentially life-saving products is something that we feel we are compelled to do," he added. However, an FDA decision isn’t expected immediately. According to the Centers for Disease Control and Prevention, around three-quarters of Americans have already taken the COVID vaccine, while 27 million are yet to receive even the first dose of the vaccine.

What is Novavax?

Novavax or NVX-CoV2373 is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. According to the manufacturer, the vaccine was created using Novavax's recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax's patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate nor can it cause COVID-19.

Novavax usage

The Novavax COVID-19 vaccine is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 mcg antigen and 50 mcg Matrix-M adjuvants) given intramuscularly 21 days apart. The vaccine is stored at 2°- 8° Celsius, enabling the use of existing vaccine supply and cold chain channels. 

Image: PTI/Representative