PR95125

Novavax and Serum Institute of India Announce First Emergency Use Authorization of Novavax' COVID-19 Vaccine in Adolescents (greater than, or equal to)12 to <18 in India

GAITHERSBURG, Md. and PUNE, India, March 23, 2022 /PRNewswire=KYODO JBN/ --

-- First authorization of Novavax' COVID-19 vaccine in adolescent population

received

-- Covovax(TM) (SARS-CoV-2 rS Protein (COVID-19) recombinant spike protein

Nanoparticle Vaccine) is the first protein-based COVID-19 vaccine authorized

for adolescents (greater than, or equal to)12 to <18 in India

-- Authorization highlights immunogenicity and reassuring safety profile of

Covovax in Phase 2/3 study of Indian adolescents aged (greater than, or equal

to) 12 to <18 and data from an ongoing Phase 3 pediatric expansion trial of

NVX-CoV2373 in adolescents aged (greater than, or equal to)12 to <18 in the U.S.

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

and commercializing next-generation vaccines for serious infectious diseases,

and Serum Institute of India Pvt. Ltd. (SII), the world's largest vaccine

manufacturer by volume, announced that the Drugs Controller General of India

(DCGI) has granted emergency use authorization (EUA) for Novavax' protein-based

COVID-19 vaccine for adolescents aged (greater than, or equal to)12 to <18

years in India. The vaccine, also known as NVX-CoV2373, is manufactured and

marketed in India by SII under the brand name Covovax(TM) and is the first

protein-based vaccine authorized for use in this age group in India.

"We're proud of this first approval in adolescents given the efficacy and

safety that our data show in this population, and that our COVID-19 vaccine

will provide an alternative protein-based vaccine option for individuals 12

years of age and older in India," said Stanley C. Erck, President and Chief

Executive Officer, Novavax. "We hope that this authorization of our COVID-19

vaccine in adolescents is the first of many worldwide so that families have an

additional choice built on a well-understood platform used in other vaccines

for decades."

A Phase 2/3, observer-blinded, randomized, controlled study in a total of 460

Indian adolescents aged (greater than, or equal to)12 to <18 years was

conducted to evaluate the safety and immunogenicity of Covovax. The study

demonstrated that Covovax was well-tolerated with a reassuring safety profile.

Furthermore, the data indicated that Covovax is immunogenic in adolescents aged

(greater than, or equal to)12 to <18 years. The authorization in India also

references the ongoing PREVENT-19 pivotal Phase 3 pediatric expansion trial of

NVX-CoV2373 in adolescents in the U.S. aged (greater than, or equal to)12 to

<18, results (https://c212.net/c/link/?t=0&l=en&o=3481047-1&h=118859063&u=https%3A%2F%2Fir.novavax.com%2F2022-02-10-Novavax-Announces-Positive-Results-of-COVID-19-Vaccine-in-Pediatric-Population-of-PREVENT-19-Phase-3-Clinical-Trial&a=results) of which were shared in February.

"The approval of Covovax for adolescents 12 and older in India marks another

significant milestone in strengthening our immunization efforts across India

and LMICs," said Adar Poonawalla, Chief Executive Officer, Serum Institute of

India. "We are proud to deliver a protein-based COVID-19 vaccine with a

favorable safety profile to the adolescents of our nation."

Covovax is the fourth vaccine to receive EUA from the DCGI for use among

adolescents 12 and older. The safety and efficacy of Covovax in adolescents

aged less than 12 years have not yet been established; however, studies

evaluating the safety and immunogenicity of Covovax for the age groups of

(greater than, or equal to)7 to <12 and (greater than, or equal to)2 to <7 years in India are

underway.

DCGI initially granted EUA for Covovax for adults 18 years old and above in

December (https://c212.net/c/link/?t=0&l=en&o=3481047-1&h=1374865207&u=https%3A%2F%2Fir.novavax.com%2F2021-12-28-Novavax-and-Serum-Institute-of-India-Receive-Emergency-Use-Authorization-for-COVID-19-Vaccine-in-India&a=December). In addition, Covovax has received Emergency Use Listing (EUL) from the World

Health Organization, as well as EUA in Indonesia, the Philippines, and

Bangladesh. For additional information on Covovax, please visit the following

websites:

-- Serum Institute of India (https://c212.net/c/link/?t=0&l=en&o=3481047-1&h=1922873189&u=https%3A%2F%2Fwww.seruminstitute.com%2FCOVOVAX.php&a=Serum+Institute+of+India)

-- Central Drugs Standard Control Organization (https://c212.net/c/link/?t=0&l=en&o=3481047-1&h=4206181535&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D3399869-1%26h%3D2212331164%26u%3Dhttps%253A%252F%252Fcdsco.gov.in%252Fopencms%252Fopencms%252Fen%252FHome%252F%26a%3DCentral%2BDrugs%2BStandard%2BControl%2BOrganization%2B(India)&a=Central+Drugs+Standard+Control+Organization)

Authorized Use of Novavax' COVID-19 Vaccine in India

The Drugs Controller General of India (DCGI) has issued a permission for

restricted use in emergency situation for Covovax for active immunization to

prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older.

Authorization in the U.S.

NVX-CoV2373 has not yet been authorized for use in the U.S. by the U.S. FDA.

Important Safety Information

   -- NVX-CoV2373 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 NVX-CoV2373.

   -- 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.

   -- NVX-CoV2373 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 NVX-CoV2373 may be lower in immunosuppressed individuals.

   -- Administration of NVX-CoV2373 in pregnancy should only be considered when

      the potential benefits outweigh any potential risks for the mother and

      foetus.

   -- The effects with NVX-CoV2373 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 NVX-CoV2373 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.

About NVX-CoV2373

NVX-CoV2373 is a protein-based vaccine 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(Deg.)- 8(Deg.) Celsius, enabling the use of

existing vaccine supply and cold chain channels. Use of the vaccine should be

in accordance with official recommendations.

Novavax has established partnerships for the manufacture, commercialization and

distribution of NVX-CoV2373 worldwide. Existing authorizations leverage

Novavax' manufacturing partnership with Serum Institute of India (SII), the

world's largest vaccine manufacturer by volume. They will later be supplemented

with data from additional manufacturing sites throughout Novavax' global supply

chain.

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=3481047-1&h=4064552863&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D3440781-1%26h%3D467849857%26u%3Dhttps%253A%252F%252Fwww.nejm.org%252Fdoi%252Ffull%252F10.1056%252FNEJMoa2116185%253Fquery%253Dfeatured_home%26a%3DNew%2BEngland%2BJournal%2Bof%2BMedicine&a=New+England+Journal+of+Medicine) .

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=3481047-1&h=298748608&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D3440781-1%26h%3D3617137863%26u%3Dhttps%253A%252F%252Fwww.nejm.org%252Fdoi%252Ffull%252F10.1056%252FNEJMoa2107659%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 Twitter

(https://c212.net/c/link/?t=0&l=en&o=3481047-1&h=3124045176&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D3399869-1%26h%3D2040794221%26u%3Dhttps%253A%252F%252Fc212.net%252Fc%252Flink%252F%253Ft%253D0%2526l%253Den%2526o%253D3260461-1%2526h%253D1316526774%2526u%253Dhttps%25253A%25252F%25252Fc212.net%25252Fc%25252Flink%25252F%25253Ft%25253D0%252526l%25253Den%252526o%25253D3158017-1%252526h%25253D500821283%252526u%25253Dhttps%2525253A%2525252F%2525252Ftwitter.com%2525252FNovavax%252526a%25253DTwitter%2526a%253DTwitter%26a%3DTwitter&a=Twitter), LinkedIn (https://c212.net/c/link/?t=0&l=en&o=3481047-1&h=1948372359&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D3399869-1%26h%3D27315898%26u%3Dhttps%253A%252F%252Fc212.net%252Fc%252Flink%252F%253Ft%253D0%2526l%253Den%2526o%253D3260461-1%2526h%253D1508558197%2526u%253Dhttps%25253A%25252F%25252Fc212.net%25252Fc%25252Flink%25252F%25253Ft%25253D0%252526l%25253Den%252526o%25253D3158017-1%252526h%25253D3702938248%252526u%25253Dhttps%2525253A%2525252F%2525252Fwww.linkedin.com%2525252Fcompany%2525252Fnovavax%2525252F%252526a%25253DLinkedIn%2526a%253DLinkedIn%26a%3DLinkedIn&a=LinkedIn), Instagram (https://c212.net/c/link/?t=0&l=en&o=3481047-1&h=613462772&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D3399869-1%26h%3D2634683834%26u%3Dhttps%253A%252F%252Fc212.net%252Fc%252Flink%252F%253Ft%253D0%2526l%253Den%2526o%253D3367039-1%2526h%253D3348182013%2526u%253Dhttps%25253A%25252F%25252Fwww.instagram.com%25252Fnovavax%25252F%2526a%253DInstagram%26a%3DInstagram&a=Instagram) and Facebook (https://c212.net/c/link/?t=0&l=en&o=3481047-1&h=843636805&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D3399869-1%26h%3D1555903536%26u%3Dhttps%253A%252F%252Fwww.facebook.com%252FNovavax%252F%26a%3DFacebook&a=Facebook).

About Serum Institute of India Pvt. Ltd.

Driven by the philanthropic philosophy of affordable vaccines, Serum Institute

of India Pvt, Ltd. is the world's largest vaccine manufacturer by number of

doses produced and sold globally (more than 1.5 billion doses), supplying the

world's least expensive and WHO-accredited vaccines to as many as 170

countries. It was founded in 1966 with the aim of manufacturing lifesaving

immunobiological drugs including vaccines worldwide. With a strong commitment

towards global health, the institute's objective has been proliferated by

bringing down the prices of newer vaccines such as Diphtheria, Tetanus,

Pertussis, Hib, BCG, r-Hepatitis B, Measles, Mumps and Rubella vaccines. SII is

credited with bringing world-class technology to India, through its

state-of-the-art equipped multifunctional production facility in Manjari, Pune;

association with Zipline and government agencies to transform emergency

medicine and critical care along with spearheading the race of vaccine

development against the COVID-19 pandemic.

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, including Novavax' plans to supplement existing

authorizations with data from the additional manufacturing sites in Novavax'

global supply chain, additional worldwide authorizations of NVX-CoV2373 for

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

addressing vaccine access, controlling the pandemic and protecting populations,

and the efficacy, safety and intended utilization 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

Novavax, Inc.

Erika Schultz | 240-268-2022

ir@novavax.com

Solebury Trout

Alexandra Roy | 617-221-9197

aroy@soleburytrout.com

Media

Ali Chartan | 240-720-7804

Laura Keenan Lindsey | 202-709-7521

media@novavax.com

Serum Institute of India

Mayank Sen | +91-986-797-4055

mayank.sen@seruminstitute.com

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SOURCE: Novavax, Inc.