PR95539

GAITHERSBURG, Md., April 19, 2022 /PRNewswire=KYODO JBN/ --

    -- Nuvaxovid is the first protein-based COVID-19 vaccine approved for use

       in adults aged 18 and older in Japan

    -- Approval is first in the world for NVX-CoV2373 that includes both

       primary and booster vaccination

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

and commercializing next-generation vaccines for serious infectious diseases,

today announced that its partner, Takeda,  received manufacturing and marketing

approval from the Japan Ministry of Health, Labour and Welfare for its

Nuvaxovid(TM) Intramuscular Injection (Nuvaxovid), Novavax' novel recombinant

protein-based COVID-19 vaccine, for primary and booster immunization in

individuals aged 18 and older. Nuvaxovid (NVX-CoV2373 outside Japan and TAK-019

in Japan) is the first protein-based vaccine to be authorized for use in Japan.

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

with Takeda, we are pleased to be able to offer the first protein-based

COVID-19 vaccine to adults aged 18 and over in Japan. This approval is

significant because it includes both primary and booster vaccination. Our

partnership with Takeda demonstrates our ongoing commitment to offer another

option as public health officials consider the need for boosters and annual

revaccination."

The approval is based on Takeda's New Drug Application submission which

included positive interim results from a Phase 1/2 study conducted by Takeda in

Japan and several studies conducted by Novavax, including two pivotal Phase 3

clinical trials in the U.K. and U.S. and Mexico and Phase 1/2 studies in

Australia and the U.S. Additional safety and efficacy data were submitted for

booster immunization review, which included a Phase 2 study conducted by

Novavax in South Africa for a single vaccination given six months after primary

immunization.

Novavax licensed and transferred (

https://c212.net/c/link/?t=0&l=en&o=3508597-1&h=2390246494&u=https%3A%2F%2Fwww.takedavaccines.com%2Fnews%2Frelease%2Fnovavax-and-takeda-announce-collaboration-for--novavax-covid-19-vaccine-candidate-in-japan%2F&a=licensed+and+transferred

) its manufacturing technologies and is supplying the Matrix-M(TM) adjuvant to

enable Takeda to manufacture the vaccine at its Hikari facility. Takeda, the

Marketing Authorization Holder for Nuvaxovid in Japan, will begin distribution

of doses purchased by the Government of Japan as soon as possible.

Authorization in the U.S.

NVX-CoV2373 has not yet been authorized for use in the U.S. and the trade name

Nuvaxovid has not yet been approved by the U.S. Food and Drug Administration.

Important Safety Information

    -- Nuvaxovid is contraindicated in persons who have a hypersensitivity to

       the active substance, or to any of the excipients.

    -- Events of anaphylaxis have been reported with administration of COVID-19

       vaccines. Appropriate medical treatment and supervision should be

       available in case of an anaphylactic reaction following the

       administration of the vaccine. Close observation for at least 15 minutes

       is recommended and a second dose of the vaccine should not be given to

       those who have experienced anaphylaxis to the first dose of Nuvaxovid.

    -- Anxiety-related reactions, including vasovagal reactions (syncope),

       hyperventilation, or stress]related reactions may occur in association

       with vaccination as a psychogenic response to the needle injection. It

       is important that precautions are in place to avoid injury from fainting.

    -- Vaccination should be postponed in individuals suffering from an acute

       severe febrile illness or acute infection. The presence of a minor

       infection and/or low-grade fever should not delay vaccination.

    -- Nuvaxovid should be given with caution in individuals receiving

       anticoagulant therapy or those with thrombocytopenia or any coagulation

       disorder (such as haemophilia) because bleeding or bruising may occur

       following an intramuscular administration in these individuals.

    -- The efficacy of Nuvaxovid may be lower in immunosuppressed individuals.

    -- Administration of Nuvaxovid in pregnancy should only be considered when

       the potential benefits outweigh any potential risks for the mother and

       foetus.

    -- The effects with Nuvaxovid may temporarily affect the ability to drive

       or use machines.

    -- Individuals may not be fully protected until 7 days after their second

       dose. As with all vaccines, vaccination with Nuvaxovid may not protect

       all vaccine recipients.

    -- The most common adverse reactions observed during clinical studies were

       headache, nausea or vomiting, myalgia, arthralgia, injection site

       tenderness/pain, fatigue, and malaise.

For additional safety information, including the full Summary of Product

Characteristics with Package Leaflet, please visit www.NovavaxCovidVaccine.com.

About TAK-019 Clinical Trial

This placebo-controlled Phase 1/2 study in Japan evaluated the safety and

immunogenicity of two vaccinations of TAK-019 given 21 days apart. The first of

200 subjects aged 20 years and older was dosed in Japan on February 24, 2021,

and each participant was assigned to receive a placebo or a 0.5 ml dose of

TAK-019 at both vaccinations. Participants Subjects were followed for 12 months

after the second dose of investigational product.

About the NVX-CoV2373 Phase 3 trials

NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials.

PREVENT-19, a trial in the U.S. and Mexico that enrolled almost 30,000

participants aged 18 years and older, achieved 90.4% efficacy overall. It was

designed as a 2:1 randomized, placebo-controlled, observer-blinded study to

evaluate the efficacy, safety and immunogenicity of NVX-CoV2373. The primary

endpoint for PREVENT-19 was the first occurrence of PCR-confirmed symptomatic

(mild, moderate or severe) COVID-19 with onset at least 7 days after the second

dose in serologically negative (to SARS-CoV-2) adult participants at baseline.

The statistical success criterion included a lower bound of 95% CI >30%. A

secondary endpoint was the prevention of PCR-confirmed, symptomatic moderate or

severe COVID-19. Both endpoints were assessed at least seven days after the

second study vaccination in volunteers who had not been previously infected

with SARS-CoV-2. It was generally well-tolerated and elicited a robust antibody

response after the second dose in both studies. Full results of the trial were

published in the New England Journal of Medicine (NEJM) (

https://c212.net/c/link/?t=0&l=en&o=3508597-1&h=3454798804&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D3490095-1%26h%3D276014382%26u%3Dhttps%253A%252F%252Fc212.net%252Fc%252Flink%252F%253Ft%253D0%2526l%253Den%2526o%253D3440781-1%2526h%253D467849857%2526u%253Dhttps%25253A%25252F%25252Fwww.nejm.org%25252Fdoi%25252Ffull%25252F10.1056%25252FNEJMoa2116185%25253Fquery%25253Dfeatured_home%2526a%253DNew%252BEngland%252BJournal%252Bof%252BMedicine%26a%3DNew%2BEngland%2BJournal%2Bof%2BMedicine&a=New+England+Journal+of+Medicine+(NEJM)

).

A trial conducted in the U.K. with 14,039 participants aged 18 years and older

was designed as a randomized, placebo-controlled, observer-blinded study and

achieved overall efficacy of 89.7%. The primary endpoint was based on the first

occurrence of PCR-confirmed symptomatic (mild, moderate or severe) COVID-19

with onset at least 7 days after the second study vaccination in serologically

negative (to SARS-CoV-2) adult participants at baseline. Full results of the

trial were published in NEJM (

https://c212.net/c/link/?t=0&l=en&o=3508597-1&h=3044567830&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D3490095-1%26h%3D4093184113%26u%3Dhttps%253A%252F%252Fc212.net%252Fc%252Flink%252F%253Ft%253D0%2526l%253Den%2526o%253D3440781-1%2526h%253D3617137863%2526u%253Dhttps%25253A%25252F%25252Fwww.nejm.org%25252Fdoi%25252Ffull%25252F10.1056%25252FNEJMoa2107659%2526a%253DNEJM%26a%3DNEJM&a=NEJM

).

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 harnesses the power and speed of

genetic engineering to efficiently produce highly immunogenic nanoparticles

designed to address urgent global health needs. NVX-CoV2373, the company's

COVID-19 vaccine, has received conditional authorization from multiple

regulatory authorities globally, including the European Commission and the

World Health Organization. The vaccine is also under review by multiple

regulatory agencies worldwide. In addition to its COVID-19 vaccine, Novavax is

also currently evaluating a COVID-seasonal influenza combination vaccine in a

Phase 1/2 clinical trial, which combines NVX-CoV2373 and NanoFlu, its

quadrivalent influenza investigational vaccine candidate. These 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 LinkedIn (

https://www.linkedin.com/company/novavax/ ).

Forward-Looking Statements

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

prospects, its partnerships, the timing of clinical trial results, the ongoing

development of NVX-CoV2373 and NanoFlu, its COVID-seasonal influenza

investigational vaccine candidate, the scope, timing and outcome of future

regulatory filings and actions, additional worldwide authorizations of

NVX-CoV2373, the potential impact and reach of Novavax and NVX-CoV2373 in

addressing vaccine access, controlling the pandemic and protecting populations,

the efficacy, safety and intended utilization of NVX-CoV2373, and the expected

distribution of NVX-CoV2373 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,

without limitation, 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, 2021, 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

Erika Schultz | 240-268-2022

ir@novavax.com

Media

Ali Chartan | 240-720-7804

Laura Keenan Lindsey | 202-709-7521

media@novavax.com

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SOURCE Novavax, Inc.