Novavax submits emergency use application to WHO

NOVAX and the Serum Institute of India submitted relevant regulatory documents to the World Health Organization for the application to include the Novavax recombinant nanoparticle protein new coronary pneumonia vaccine on the emergency use list

Gaithersburg, Maryland, September 24, 2021/PRNewswire/ - Biotechnology company Novavax, Inc.
(NASDAQ: NVAX), a biotechnology company dedicated to the development and commercialization of next-generation vaccines for severe infectious diseases, cooperates with it Partner Serum Institute of India Private Limited (SII) announced today that the two companies have submitted relevant regulatory documents to the World Health Organization (WHO) to apply for Novavax recombinant nanoparticle protein new coronary pneumonia vaccine candidates using Matrix-M™ adjuvant.
Enter the emergency use list (EUL)
.

The documents submitted to the WHO are based on the previous regulatory documents submitted by the two companies to the Director of Medicines of India (DCGI)

Stanley C.
Erck, President and CEO of Novavax, said: "Today's submission of an application for the emergency use of the protein new crown vaccine to the WHO is an important step on the road to accelerate the delivery and fairer distribution of vaccines to countries in urgent need of vaccines around the world
.

This is another major milestone in Novavax's transformation into a global commercial vaccine company, which strengthens the value of global cooperation and the need to adopt multiple methods to help control the epidemic

The WHO grant of EUL is a prerequisite for the export of vaccines to many countries participating in the new crown vaccine guarantee mechanism, and the establishment of the mechanism is to distribute and distribute vaccines fairly to participating countries and economies
.

In addition to submitting documents for inclusion in the WHO emergency use list, SII and Novavax have submitted all modules required by the regulatory agencies of India, Indonesia and the Philippines to initiate vaccine review last month, including preclinical, clinical, and chemical, manufacturing and control data.

About NVX-CoV2373

NVX-CoV2373 is being evaluated in two key Phase 3 trials: a trial conducted in the UK showed that the vaccine is 96.
4% effective against the original strain and effective against the alpha (B.
1.
1.
7) variant strain It was 86.
3%, and the overall effectiveness was 89.
7%; PREVENT-19 trials conducted in the United States and Mexico showed that the vaccine has a protection rate of 100% against moderate to severe cases, and the overall effectiveness is 90.
4%
.

The vaccine was generally well tolerated and produced a reliable antibody response

NVX-CoV2373 is a protein-based vaccine candidate, modified from the genetic sequence of the first strain of SARS-CoV-2 (the disease-causing virus of new coronary pneumonia)
.

NVX-CoV2373 is created using Novavax recombinant nanoparticle technology, which can produce antigens derived from coronavirus spike protein, and is also formulated with Novavax based on saponin patented Matrix-M™ adjuvant to enhance immune response and stimulate high levels of neutralizing antibodies

Novavax's new crown vaccine is packaged in a ten-dose vial as a ready-to-use liquid formulation
.

The vaccination protocol requires two intramuscular injections with an interval of 21 days, 0.

About Matrix-M™ adjuvant

Novavax's patented saponin-based Matrix-M™ adjuvant can stimulate antigen-presenting cells to enter the injection site, enhance the antigen presentation of local lymph nodes, and thereby enhance the immune response.
It has shown a strong and well-tolerated effect
.

About Novavax

Novavax, Inc.
(NASDAQ: NVAX) is a biotechnology company that promotes the improvement of global health through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases
.

The company's proprietary recombination technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles to meet the urgent global medical needs

Forward-looking statements

In this article, all statements concerning Novavax's future, operational plans and prospects, the continuous development of NVX-CoV2373 and other Novavax vaccine candidates, the timing of future regulatory filings and actions, and the possible role of Novavax in helping to control the new crown epidemic are all Forward-looking statements
.

Novavax hereby reminds that the foregoing forward-looking statements are subject to numerous risks and uncertainties, which may cause actual results to differ materially from those expressed or implied by such statements