AsiaNet 89399

GAITHERSBURG, Md., May 7, 2021 /PRNewswire=KYODO JBN/ --

-- Novavax to deliver 350 million doses beginning Q3 2021

-- 1.1 billion doses of Novavax vaccine to be available to countries

participating in COVAX

-- Serum Institute of India to provide balance of doses for LMICs

-- Underscores commitment to global equitable access to Novavax vaccine

GAITHERSBURG, Md., May 7, 2021 /PRNewswire-AsiaNet/ --

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

next-generation vaccines for serious infectious diseases, today announced that

it has finalized an advance purchase agreement (APA) with Gavi, the Vaccine

Alliance (Gavi) for supply of its recombinant protein-based COVID-19 vaccine

candidate to the COVAX Facility. Under the APA, Novavax is expected to

manufacture and distribute 350 million doses of NVX-CoV2373 to countries

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

distribute vaccines equitably to participating countries and economies. Under a

separate purchase agreement with Gavi, the Serum Institute of India (Serum

Institute) is expected to manufacture and deliver the balance of the 1.1

billion doses of Novavax' vaccine.

"This is a tremendous opportunity to partner with global organizations focused

on accelerating equitable access to safe and effective COVID-19 vaccines,

particularly in countries where vaccination rates are currently low," said

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

arrangement is the culmination of a collaboration among CEPI, Gavi, Serum

Institute and Novavax, who are partnering in our urgent mission to deliver

significant amounts of vaccines to all countries, regardless of income level.

Novavax thanks CEPI for its longstanding support and tireless work with Gavi as

the curators of the COVAX Facility."

Under the APA, Novavax expects to deliver doses with antigen and adjuvant

manufactured at facilities directly funded by the investments Novavax received

from the Coalition for Epidemic Preparedness Innovations (CEPI). CEPI invested

nearly $400 million in Novavax in the spring of 2020 to advance preclinical and

early clinical development, manufacturing scale-up, technology transfer, and

manufacturing capacity reservation for NVX-CoV2373.

"CEPI's investments to accelerate the clinical development and manufacturing of

this vaccine candidate have been critical to enabling equitable access to the

vaccine through COVAX," said Dr. Richard Hatchett, CEO of CEPI. "With this

agreement in place, the Novavax vaccine candidate will play a vital role in our

mission to protect those most at risk from COVID-19, wherever they are in the

world."

"Today's agreement with Novavax marks a major step towards COVAX's objective of

building the world's largest and most diverse portfolio of COVID-19 vaccines,

and a major step towards our goal of delivering 2 billion doses of safe and

effective vaccines in 2021," said Dr Seth Berkley, CEO of Gavi. "Novavax'

commitment not only to support COVAX directly, but also through technology

transfer via other manufacturers, shines a light on the end-to-end nature of

COVAX and the kind of collaboration needed to bring this pandemic under

control."

Together, Novavax and Serum Institute expect to initiate delivery of the

cumulative 1.1 billion doses in the third quarter of 2021, pending receipt of

appropriate regulatory authorizations. Under the APA, Novavax will receive an

upfront payment from Gavi later this month and an additional payment after it

secures Emergency Use Listing for its vaccine by the WHO. In addition, Novavax

has agreed to provide additional doses in the event that Serum Institute cannot

materially deliver expected vaccine doses to the COVAX Facility.

Vaccine dose allocation will be determined by Gavi across the AMC-eligible and

self-financing participants under a tiered pricing schedule.

"CEPI's early support served as a catapult for Novavax to create a global

supply network that we expect could provide a significant percent of the

world's vaccine supply via COVAX," Erck continued. "We look forward to the

ongoing collaboration with Serum Institute to deliver on our manufacturing

capacity and to working with WHO to secure authorization as rapidly as possible

for NVX-CoV2373."

About the COVAX Facility

The COVAX Facility is a global risk-sharing mechanism for pooled procurement

and equitable distribution of COVID-19 vaccines that currently includes more

than 190 participating economies, designed and administered by Gavi, the

Vaccine Alliance. It is part of COVAX, co-led by CEPI, Gavi and the World

Health Organization (WHO), which are working in partnership with developed and

developing country vaccine manufacturers, UNICEF, PAHO, the World Bank, civil

society organizations and others to guarantee fair and equitable access to the

vaccine.

About NVX-CoV2373

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

sequence 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 adjuvanted with Novavax'

patented saponin-based Matrix-M(TM) 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 100% protection against severe disease, efficacy of

96.4% against the original virus strain and 89.7% overall, and the PREVENT-19

trial in the U.S. and Mexico that began in December 2020. 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 100% protection against severe disease

and 48.6% efficacy against a newly emerging escape variant, and a Phase 1/2

continuation in the U.S. and Australia.

NVX-CoV2373 is stored and stable at 2°- 8°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)

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://twitter.com/novavax ) and LinkedIn (

https://c212.net/c/link/?t=0&l=en&o=3154807-1&h=1132737244&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fnovavax&a=LinkedIn

).

Novavax Forward Looking Statements

Statements herein relating to the future of Novavax and the ongoing development

of its vaccine and adjuvant products are forward-looking statements. Novavax

cautions that these forward-looking statements are subject to numerous risks

and uncertainties, which could cause actual results to differ materially from

those expressed or implied by such statements. These risks and uncertainties

include those identified under the heading "Risk Factors" in the Novavax Annual

Report on Form 10-K for the year ended December 31, 2020, 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, 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

Novavax Media

Laura Keenan | +1-202-709-7521

media@novavax.com

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SOURCE: Novavax, Inc.