Novavax vaccine’s emergency use authorization application has been submitted to FDA recently. Novavax is hoping to bring it to the Finish Line in 2022.
Novavax Vaccine (STR/NurPhoto via Getty Images)
Novavax is entering the New Year with final plans for an emergency use authorization application filing to the U.S. Food and Drug Administration (FDA) for its COVID-19 vaccine, NVX-CoV2373.
On Friday, Maryland-based Novavax announced it completed the submission of its final data package to the FDA. Information contained includes the complete chemistry, manufacturing and controls module for the experimental vaccine.
NVX-CoV2373 (Novavax Vaccine) is a recombinant nanoparticle protein-based COVID-19 vaccine that harnesses the power of Novavax’s Matrix-M adjuvant. While no hard date was announced for its planned filing, Novavax said it plans to seek EUA within one month. The company, which has partnered with the Serum Institute of India, one of the largest vaccines makers in the world, has already won EUA in India for NVX-CoV2373.
Stanley C. Erck, president, and chief executive officer of Novavax, said the company is committed to delivering its protein-based vaccine to people in the United States. Erck noted that the nation continues to battle with emerging variants, such as Omicron and Delta, which means there is a continuing need for wider vaccination in order to slow the spread of the virus, which is surging with hundreds of thousands of new infections reported each day.
Novavax had hoped its vaccine would be out the door earlier than this, but the company ran into several issues with manufacturing and delays in its studies. In March 2021, the company said it expected to file its EUA application in the second quarter of the year.
What is Unique About Novavax Vaccine?
Unlike the three vaccines currently available in the U.S., NVX-CoV2373 is a protein-based vaccine. It generates an antigen to the virus, which was derived from the coronavirus spike (S) protein. The vaccine, which uses Novavax’s recombinant nanoparticle technology, has been combined with the Matrix-M adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. The Novavax vaccine can be stored in regular refrigerators, making transportation and distribution much easier than the mRNA vaccines that call for specialized freezers. The shelf life of the Novavax vaccine is about nine months.
The company is seeking EUA based on data from two pivotal Phase III studies. In the PREVENT-19 trial, which was tested on 25,452 participants in the U.S. and Mexico, Novavax Vaccine achieved 90.4% efficacy overall. Full results of this study were published in the New England Journal of Medicine. A second late-stage study conducted in the U.K. with 14,039 participants, achieved overall efficacy of 89.7%. Results from that study were also published in NEJM.
Like the other COVID-19 vaccines, NVX-CoV2373 is a two-shot regimen. The vaccine is delivered in two doses given three weeks apart.
With its EUA in India and hoped-for EUA in the United States and South Korea, Novavax recently expanded its manufacturing agreement with SK bioscience, a vaccine business subsidiary of Korea-based SK Group. The company also has additional manufacturing partnerships that will support commercialization and distribution of NVX-CoV2373 (Novavax Vaccine) worldwide.
