-- Takeda submits application for TAK-019/NVX-CoV2373, the first protein-based 
COVID-19 vaccine candidate for NDA, to Japan's Ministry of Health, Labour and 
Welfare (MHLW)

-- Interim data from Phase 1/2 trial in Japan demonstrate robust immune 
response and favorable tolerability with no serious adverse events

Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing 
and commercializing next-generation vaccines for serious infectious diseases, 
today announced the submission of a New Drug Application (NDA) to the Ministry 
of Health, Labour and Welfare (MHLW) in Japan for its COVID-19 vaccine by its 
partner Takeda Pharmaceutical Company Limited (Takeda). Novavax' recombinant 
nanoparticle COVID-19 vaccine with Matrix-M(TM) adjuvant, known as TAK-019 in 
Japan and NVX-CoV2373 outside Japan, is the first protein-based COVID-19 
vaccine to be submitted under an NDA in Japan.

Logo - https://mma.prnewswire.com/media/1506866/Novavax_High_Res_Logo.jpg

With the support of the MHLW, the companies are working to establish the 
capability to manufacture TAK-019 at Takeda's facilities in Japan and aim to 
begin distribution in early 2022, pending regulatory approval.

"Today's submission marks further progress in our quest to ensure broad global 
access to our protein-based COVID-19 vaccine," said Stanley C. Erck, President 
and Chief Executive Officer of Novavax. "Our partnership with Takeda reflects 
our shared commitment to tireless collaboration to deliver a COVID-19 vaccine, 
built on a well-understood vaccine platform."

The NDA submission includes an interim analysis from Takeda's ongoing Phase 1/2 
immunogenicity and safety clinical trial of NVX-CoV2373/TAK-019 in Japan, in 
which the vaccine demonstrated a robust immune response and was well tolerated 
with no serious adverse events. Takeda submitted all available chemistry, 
manufacturing and controls (CMC), non-clinical and clinical data as of December 
2021. Additional CMC data will be subsequently submitted to the Japan 
Pharmaceuticals and Medical Devices Agency (PMDA) during the NDA review period.

The application also includes safety and efficacy data from Novavax' two 
pivotal Phase 3 trials: PREVENT-19, which included 30,000 participants in the 
U.S. and Mexico and demonstrated 100% protection against moderate and severe 
disease, 93.2% efficacy against the predominantly circulating variants of 
concern and variants of interest, and 90.4% efficacy overall; and a trial of 
15,000 participants 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. In both trials, NVX-CoV2373 demonstrated a reassuring safety 
and tolerability profile.

In addition to the submission of the NDA to MHLW in Japan, Novavax and Serum 
Institute of India Pvt. Ltd. (SII) recently received Emergency Use 
Authorization (EUA) for the vaccine in Indonesia( 
https://c212.net/c/link/?t=0&l=en&o=3392093-1&h=3594107833&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D3367039-1%26h%3D230028734%26u%3Dhttps%253A%252F%252Fc212.net%252Fc%252Flink%252F%253Ft%253D0%2526l%253Den%2526o%253D3362763-1%2526h%253D3423756820%2526u%253Dhttps%25253A%25252F%25252Fir.novavax.com%25252F2021-11-01-Novavax-and-Serum-Institute-of-India-Receive-Emergency-Use-Authorization-for-COVID-19-Vaccine-in-Indonesia%2526a%253DIndonesia%26a%3DIndonesia&a=Indonesia 
) and the Philippines( 
https://c212.net/c/link/?t=0&l=en&o=3392093-1&h=3176837156&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D3367039-1%26h%3D3201419400%26u%3Dhttps%253A%252F%252Fc212.net%252Fc%252Flink%252F%253Ft%253D0%2526l%253Den%2526o%253D3362763-1%2526h%253D2975356756%2526u%253Dhttps%25253A%25252F%25252Fir.novavax.com%25252F2021-11-17-Novavax-and-Serum-Institute-of-India-Receive-Emergency-Use-Authorization-for-COVID-19-Vaccine-in-the-Philippines%2526a%253DPhilippines%26a%3DPhilippines&a=Philippines 
), and the companies have filed for EUA in India and for Emergency Use Listing 
(EUL) with the World Health Organization( 
https://c212.net/c/link/?t=0&l=en&o=3392093-1&h=1573279911&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D3367039-1%26h%3D2000528552%26u%3Dhttps%253A%252F%252Fc212.net%252Fc%252Flink%252F%253Ft%253D0%2526l%253Den%2526o%253D3362763-1%2526h%253D1111037274%2526u%253Dhttps%25253A%25252F%25252Fir.novavax.com%25252F2021-09-23-Novavax-and-Serum-Institute-of-India-Announce-Submission-to-World-Health-Organization-for-Emergency-Use-Listing-of-Novavax-COVID-19-Vaccine%2526a%253DWorld%252BHealth%252BOrganization%26a%3DWorld%2BHealth%2BOrganization&a=World+Health+Organization 
) (WHO). Novavax also announced regulatory filings for its vaccine in the 
United Kingdom( 
https://c212.net/c/link/?t=0&l=en&o=3392093-1&h=1179269650&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D3367039-1%26h%3D3193774664%26u%3Dhttps%253A%252F%252Fc212.net%252Fc%252Flink%252F%253Ft%253D0%2526l%253Den%2526o%253D3362763-1%2526h%253D4271304883%2526u%253Dhttps%25253A%25252F%25252Fir.novavax.com%25252F2021-10-27-Novavax-Files-for-Authorization-of-its-COVID-19-Vaccine-in-the-United-Kingdom%2526a%253DUnited%252BKingdom%26a%3DUnited%2BKingdom&a=United+Kingdom 
), Australia( 
https://c212.net/c/link/?t=0&l=en&o=3392093-1&h=2328085324&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D3367039-1%26h%3D1509999465%26u%3Dhttps%253A%252F%252Fc212.net%252Fc%252Flink%252F%253Ft%253D0%2526l%253Den%2526o%253D3362763-1%2526h%253D2847977980%2526u%253Dhttps%25253A%25252F%25252Fir.novavax.com%25252F2021-10-29-Novavax-Files-for-Provisional-Approval-of-its-COVID-19-Vaccine-in-Australia%2526a%253DAustralia%26a%3DAustralia&a=Australia 
), New Zealand( 
https://c212.net/c/link/?t=0&l=en&o=3392093-1&h=3888937572&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D3367039-1%26h%3D2449088172%26u%3Dhttps%253A%252F%252Fc212.net%252Fc%252Flink%252F%253Ft%253D0%2526l%253Den%2526o%253D3362763-1%2526h%253D2146291065%2526u%253Dhttps%25253A%25252F%25252Fir.novavax.com%25252F2021-11-03-Novavax-Files-COVID-19-Vaccine-for-Provisional-Approval-in-New-Zealand%2526a%253DNew%252BZealand%26a%3DNew%2BZealand&a=New+Zealand 
), Canada( 
https://c212.net/c/link/?t=0&l=en&o=3392093-1&h=2081871061&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D3367039-1%26h%3D4223724015%26u%3Dhttps%253A%252F%252Fc212.net%252Fc%252Flink%252F%253Ft%253D0%2526l%253Den%2526o%253D3362763-1%2526h%253D2249194863%2526u%253Dhttps%25253A%25252F%25252Fir.novavax.com%25252F2021-11-01-Novavax-Files-for-COVID-19-Vaccine-Authorization-with-Health-Canada-and-Completes-Submission-for-Rolling-Review-to-European-Medicines-Agency%2526a%253DCanada%26a%3DCanada&a=Canada 
), Singapore( 
https://c212.net/c/link/?t=0&l=en&o=3392093-1&h=2870727507&u=https%3A%2F%2Fir.novavax.com%2F2021-11-24-Novavax-Files-for-Interim-Authorization-of-COVID-19-Vaccine-in-Singapore&a=Singapore 
), United Arab Emirates( 
https://c212.net/c/link/?t=0&l=en&o=3392093-1&h=1758428223&u=https%3A%2F%2Fir.novavax.com%2F2021-12-13-Novavax-Files-for-Emergency-Use-of-COVID-19-Vaccine-in-the-United-Arab-Emirates&a=United+Arab+Emirates 
), and the European Union( 
https://c212.net/c/link/?t=0&l=en&o=3392093-1&h=1549963081&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D3367039-1%26h%3D2030819781%26u%3Dhttps%253A%252F%252Fir.novavax.com%252F2021-11-17-Novavax-Confirms-European-Medicines-Agency-Review-of-COVID-19-Vaccine-Filing-for-Conditional-Marketing-Authorization%26a%3DEuropean%2BUnion%25C2%25A0&a=European+Union 
) and with the WHO. Additionally, Novavax and SK bioscience announced a 
Biologics License Application (BLA) submission to MFDS in South Korea( 
https://c212.net/c/link/?t=0&l=en&o=3392093-1&h=2320701571&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D3367039-1%26h%3D3035390095%26u%3Dhttps%253A%252F%252Fc212.net%252Fc%252Flink%252F%253Ft%253D0%2526l%253Den%2526o%253D3362763-1%2526h%253D4072734029%2526u%253Dhttps%25253A%25252F%25252Fir.novavax.com%25252F2021-11-15-Novavax-Announces-Submission-of-Biologics-License-Application-in-South-Korea-for-Approval-of-NVX-CoV2373%2526a%253DSouth%252BKorea%26a%3DSouth%2BKorea&a=South+Korea 
). Novavax expects to submit its complete CMC data package to the U.S. FDA by 
the end of the year.

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.

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 mcg antigen and 50 mcg Matrix-M adjuvant) given intramuscularly 21 days 
apart. The vaccine is stored at 2 degrees - 8 degrees Celsius, enabling the use 
of existing vaccine supply and cold chain channels.

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, received Emergency Use Authorization in Indonesia and the 
Philippines and has been submitted for regulatory authorization in multiple 
markets globally. NanoFlu(TM), the company's quadrivalent influenza 
nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 
clinical trial in older adults. Novavax is currently evaluating a COVID-NanoFlu 
combination vaccine in a Phase 1/2 clinical trial, which combines the company's 
NVX-CoV2373 and NanoFlu vaccine candidates. These vaccine candidates 
incorporate Novavax' proprietary saponin-based Matrix-M™ 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, 
LinkedIn, Instagram and Facebook.

Forward-Looking Statements
Statements herein relating to the future of Novavax, its operating plans and 
prospects, its partnerships, the ongoing development of NVX-CoV2373, the scope, 
timing and outcome of future regulatory filings and actions, the capability to 
manufacture TAK-019 at Takeda's facilities in Japan and aim to begin 
distribution in early 2022, Novavax' quest to ensure broad global access of its 
protein-based COVID-19 vaccine, Novavax' plans to deliver a COVID-19 vaccine to 
people around the globe, Novavax' plan to supplement the CMC data submitted to 
the PMDA with additional CMC data, and Novavax' plans to submit a complete CMC 
data package to the U.S. FDA by the end of the year 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 Lindsey, +1 202-709-7521
media@novavax.com

SOURCE: Novavax, Inc.