June 29, 2022

Novavax Gets FDA Green Light; fourth vaccine to receive approval for mass production in the United States

Vaccine experts from the Food and Drug Administration (FDA) have endorsed the protein-based vaccine – Novavax as the fourth COVID-19 vaccine in the United States for adults. The committee voted 21 to 0, with one abstention. The committee is expected to make a final appeal on whether to issue emergency clearance for anti-COVID injections. Although the vaccine has already been approved in 41 countries, including Australia, Canada and parts of Europe, clearance by the US drug authority is a major hurdle for the vaccine maker.

According to the FDA panel, they voted that the benefits of two primary doses of Novavax outweigh its risks, but added that they still had many questions about the vaccine. “This vaccine does indeed fill some unmet need,” as an option for people allergic to competing injections, said Dr. Michael Nelson of the University of Virginia. Meanwhile, the FDA’s vaccine chief, Dr. Peter Marks, said another choice in the country could inspire at least some vaccine holders — whatever their reason — to consider rolling up their sleeves.

“We have a vaccination problem that is very serious in the United States,” Marks said. “Anything we can do to make it easier for people to accept these potentially life-saving products is something we feel compelled to do,” he added. However, an FDA decision is not expected immediately. According to the Centers for Disease Control and Prevention, about three-quarters of Americans have already taken the COVID vaccine, while 27 million have not yet received the first dose of the vaccine.

What is Novavax?

Novavax or NVX-CoV2373 is a protein-based vaccine designed 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 an antigen derived from the coronavirus spike (S) protein and is formulated with the patented Matrix-M adjuvant based on saponin from Novavax to improve the immune response and stimulate high levels of neutralization. antibody. NVX-CoV2373 contains a purified protein antigen and cannot replicate or cause COVID-19.

Use of Novavax

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

Image: PTI/Representative