PR88849

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

-- Crossover allows participants to continue in trials and remain blinded

-- Ensures that all trial participants receive active vaccine

-- South Africa and UK crossover arms initiated; US/Mexico PREVENT-19 crossover

planned

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

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

initiation of crossover arms in two ongoing clinical trials of NVX-CoV2373, the

company's COVID-19 vaccine candidate. Crossover ensures the administration of

active vaccine to all participants in the trials and has begun for Novavax'

Phase 2b trial in South Africa and its pivotal Phase 3 trial in the United

Kingdom.

Under Novavax' updated clinical trial protocols[1], all participants in the UK

and US Phase 3 trials will be offered the opportunity to receive an additional

round of injections. Participants who elect to do so will receive an additional

two-dose regimen of either vaccine (for those who originally received placebo)

or placebo (for those who originally received vaccine). Participants in the

South Africa Phase 2b trial will receive either active vaccine for those who

initially received placebo, or a booster dose of active vaccine for those who

initially received active vaccine. Participants across all three trials will

remain blinded to their courses of treatment to preserve the ability to assess

efficacy in each trial, and all will be followed for up to two years to monitor

the safety and durability of protection the vaccine. In the trials taking place

in South Africa and the United Kingdom, half of the participants initially

received the active vaccine while two-thirds of participants in PREVENT-19, the

trial being conducted in the US and Mexico, initially received active vaccine.

"The crossover arms ensure that all participants have access to an active

vaccine candidate while allowing Novavax to continue to monitor the safety and

efficacy of our vaccine over the long term," said Filip Dubovsky, M.D., Chief

Medical Officer, Novavax. "We are grateful to the volunteers who stepped

forward to take part in our clinical trials, without whom we would be unable to

develop, study and ultimately deliver what we hope will be a significant tool

in the fight against COVID-19."

The company is also planning a crossover in the PREVENT-19 study, for which the

company expects to read out initial clinical data during the second quarter. In

addition, the company is planning to expand the trial to include pediatric and

adolescent arms, which are also expected to begin in the second quarter.

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 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 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 degrees - 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)

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=3119096-1&h=3399801961&u=https%3A%2F%2Ftwitter.com%2Fnovavax&a=Twitter

) and LinkedIn (

https://c212.net/c/link/?t=0&l=en&o=3119096-1&h=2015760856&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

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.

____________________

1 Clinical trial protocols (

https://c212.net/c/link/?t=0&l=en&o=3119096-1&h=1559927069&u=https%3A%2F%2Fwww.novavax.com%2Fresources%23protocols&a=protocols

) may be found in the Resources section of the Novavax website and will be

updated as appropriate.

Contacts:

Investors

Novavax, Inc.

Erika Schultz | +1-240-268-2022

ir@novavax.com

Solebury Trout

Jennifer Porcelli | +1-617-974-8659

jporcelli@soleburytrout.com

Media

Laura Keenan | +1-410-419-5755

Amy Speak | +1-617-420-2461

media@novavax.com

SOURCE Novavax, Inc.