PR91059

Novavax and Serum Institute of India Announce Submission to Regulatory Agencies in India, Indonesia, Philippines for Emergency Use Authorization of Novavax' Recombinant Nanoparticle COVID-19 Vaccine

GAITHERSBURG, Md., Aug. 6, 2021 /PRNewswire=KYODO JBN/--

- Novavax and Serum Institute of India file regulatory submissions to the Drugs

Controller General of India and to regulatory agencies in Indonesia and

Philippines for Novavax' recombinant nanoparticle COVID-19 vaccine

- Filing for World Health Organization Emergency Use Listing expected in August

2021

Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing

next-generation vaccines for serious infectious diseases, with its partner,

Serum Institute of India Pvt. Ltd. (SII), today announced that the companies

have filed regulatory submissions for emergency use authorization of Novavax'

recombinant nanoparticle protein-based COVID-19 vaccine candidate with

Matrix-M(TM) adjuvant. The submissions were made to the Drugs Controller

General of India (DCGI) and regulatory agencies in Indonesia and the

Philippines.

"Today's submission of our recombinant nanoparticle COVID-19 vaccine, the first

protein-based option filed with any regulatory agency, represents a major

milestone in Novavax' transformation into a commercial global vaccine company,"

said Stanley C. Erck, President and Chief Executive Officer, Novavax. "This

important step toward access to millions of doses of a safe and effective

vaccine for countries with an urgent need to control the pandemic was made

possible through our strategic partnership with Serum Institute of India, and

it demonstrates the power of global collaboration."

SII and Novavax have now completed the submission of all modules required by

regulatory agencies in India, Indonesia and the Philippines for the initiation

of review of the vaccine, including preclinical, clinical, and chemistry,

manufacturing and controls data. A Good Manufacturing Practice joint site

inspection of SII was successfully completed by DCGI in May 2021.

A submission to the World Health Organization (WHO) for emergency use listing

(EUL) based on the DCGI submission is expected to be filed in August. The grant

of EUL by the WHO is a prerequisite for exports to numerous countries

participating in the COVAX Facility, which was established to allocate and

distribute vaccines equitably to participating countries and economies.

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 microgram antigen and 50 microgram Matrix-M adjuvant) given intramuscularly

21 days apart. The vaccine is stored at 2-8 degrees Celsius, enabling the use

of existing vaccine supply and cold chain channels.

SII is manufacturing, and developing, and is responsible for commercializing

the vaccine in India. Novavax and SII have cumulative commitments to provide

more than 1.1 billion doses to the COVAX Facility.

About NVX-CoV2373

NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic

sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19

disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle

technology to generate antigen derived from the coronavirus spike (S) protein

and is formulated with Novavax' patented saponin-based Matrix-M(TM) 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. In preclinical studies, NVX-CoV2373

induced antibodies that blocked the binding of spike protein to cellular

receptors and provided protection from infection and disease. It was generally

well-tolerated and elicited robust antibody response in Phase 1/2 clinical

testing.

NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials: a trial in the

U.K. that demonstrated efficacy of 96.4% against the original virus strain,

86.3% against the Alpha (B.1.1.7) variant and 89.7% efficacy overall; and the

PREVENT-19 trial in the U.S. and Mexico that demonstrated 100% protection

against moderate and severe disease and 90.4% efficacy overall. It is also

being tested in two ongoing Phase 2 studies that began in August 2020: A Phase

2b trial in South Africa that demonstrated 55% efficacy overall in HIV-negative

participants and 48.6% efficacy against a newly emerging escape variant first

described in South Africa, and a Phase 1/2 continuation in the U.S. and

Australia.

NVX-CoV2373 is stored and stable at 2-8 degrees C, allowing the use of existing

vaccine supply chain channels for its distribution. It is packaged in a

ready-to-use liquid formulation in 10-dose vials.

About Matrix-M(TM) Adjuvant

Novavax' patented saponin-based Matrix-M(TM) adjuvant has demonstrated a potent

and well-tolerated effect by stimulating the entry of antigen-presenting cells

into the injection site and enhancing antigen presentation in local lymph

nodes, boosting immune response.

About Novavax

Novavax, Inc. (Nasdaq: NVAX) is a biotechnology company that promotes improved

health globally through the discovery, development and commercialization of

innovative vaccines to prevent serious infectious diseases. The company's

proprietary recombinant technology platform combines the power and speed of

genetic engineering to efficiently produce highly immunogenic nanoparticles

designed to address urgent global health needs. Novavax is conducting

late-stage clinical trials for NVX-CoV2373, its vaccine candidate against

SARS-CoV-2, the virus that causes COVID-19. NanoFlu(TM), its quadrivalent

influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase

3 clinical trial in older adults and will be advanced for regulatory

submission. Both vaccine candidates incorporate Novavax' proprietary

saponin-based Matrix-M(TM) adjuvant to enhance the immune response and

stimulate high levels of neutralizing antibodies.

For more information, visit www.novavax.com and connect with us on Twitter (https://c212.net/c/link/?t=0&l=en&o=3251534-1&h=4134015854&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D3158017-1%26h%3D500821283%26u%3Dhttps%253A%252F%252Ftwitter.com%252FNovavax%26a%3DTwitter&a=Twitter) and LinkedIn (https://c212.net/c/link/?t=0&l=en&o=3251534-1&h=3791277229&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D3158017-1%26h%3D3702938248%26u%3Dhttps%253A%252F%252Fwww.linkedin.com%252Fcompany%252Fnovavax%252F%26a%3DLinkedIn&a=LinkedIn).

Forward-Looking Statements

Statements herein relating to the future of Novavax, its operating plans and

prospects, the ongoing development of NVX-CoV2373 and other Novavax vaccine

product candidates, timing of future regulatory filings and actions, and the

role that Novavax may play in helping control the COVID-19 pandemic are

forward-looking statements. Novavax cautions that these forward-looking

statements are subject to numerous risks and uncertainties that could cause

actual results to differ materially from those expressed or implied by such

statements. These risks and uncertainties include challenges satisfying, alone

or together with partners, various safety, efficacy, and product

characterization requirements, including those related to process qualification

and assay validation, necessary to satisfy applicable regulatory authorities;

difficulty obtaining scarce raw materials and supplies; resource constraints,

including human capital and manufacturing capacity, on the ability of Novavax

to pursue planned regulatory pathways; challenges meeting contractual

requirements under agreements with multiple commercial, governmental, and other

entities; and those other risk factors identified in the "Risk Factors" and

"Management's Discussion and Analysis of Financial Condition and Results of

Operations" sections of Novavax' Annual Report on Form 10-K for the year ended

December 31, 2020 and subsequent Quarterly Reports on Form 10-Q, as filed with

the Securities and Exchange Commission (SEC). We caution investors not to place

considerable reliance on forward-looking statements contained in this press

release. You are encouraged to read our filings with the SEC, available at

www.sec.gov and www.novavax.com, for a discussion of these and other risks and

uncertainties. The forward-looking statements in this press release speak only

as of the date of this document, and we undertake no obligation to update or

revise any of the statements. Our business is subject to substantial risks and

uncertainties, including those referenced above. Investors, potential

investors, and others should give careful consideration to these risks and

uncertainties.

Contacts:

Investors

Novavax, Inc.  

Erika Schultz

+1-240-268-2022

ir@novavax.com

Solebury Trout

Alexandra Roy

+1-617-221-9197

aroy@soleburytrout.com

Media

Alison Chartan

+1-240-720-7804

Laura Keenan

+1-202-709-7521  

media@novavax.com

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SOURCE: Novavax, Inc.