Country for PR: United States
Contributor: PR Newswire New York
Monday, June 13 2022 - 21:00
Novavax COVID-19 Vaccine Nuvaxovid(TM) Provisionally Registered in Australia as a Booster in Individuals Aged 18 and Over
GAITHERSBURG, Md., June 13, 2022 /PRNewswire-AsiaNet/ --

- In Australia, Nuvaxovid(TM) is the first protein-based COVID-19 vaccine 
registered for use as a booster regardless of previous vaccine history

Novavax, Inc. (NASDAQ: NVAX), a biotechnology company dedicated to developing 
and commercializing next-generation vaccines for serious infectious diseases, 
today announced that the Australian Therapeutic Goods Administration (TGA) has 
granted provisional registration of Nuvaxovid(TM) (NVX-CoV2373) COVID-19 
vaccine as a booster in individuals aged 18 and over.

"Today's provisional registration for Nuvaxovid as a booster in Australia is an 
important step in ensuring broad global access to diversified vaccine options," 
said Stanley C. Erck, President and Chief Executive Officer, Novavax. "As 
COVID-19 continues to persist and evolve, we are pleased to be able to offer 
the first protein-based COVID-19 vaccine registered for use as both a primary 
series and now booster regardless of previous vaccine history."

The provisional registration was based on data from Novavax' Phase 2 trial ( 
) conducted in Australia, from a separate Phase 2 trial conducted in South 
Africa, and from the UK-sponsored COV-BOOST trial. As part of the Phase 2 
trials, a single booster dose of Nuvaxovid was administered to healthy adult 
participants approximately six months after their primary two-dose vaccination 
series of Nuvaxovid. The third dose produced increased immune responses 
comparable to or exceeding levels associated with protection in Phase 3 
clinical trials. In the COV-BOOST trial, Nuvaxovid induced a robust antibody 
response when used as a heterologous third booster dose.

In the Novavax-sponsored trials, following the booster, local and systemic 
reactions were generally short-lived with a median duration of approximately 
two days. The incidence of Grade 3 or higher events remained relatively low. 
Safety reporting of reactogenicity events showed an increasing incidence across 
all three doses of Nuvaxovid, reflecting the increased immunogenicity seen with 
a third dose. Medically attended adverse events, potentially immune-mediated 
medical conditions, and severe adverse events occurred infrequently following 
the booster dose and were balanced between vaccine and placebo groups.

The TGA granted provisional registration in January 2022 ( 
) for use of Nuvaxovid in individuals aged 18 and over. Novavax filed for 
expanded provisional registration in Australia for use in adolescents aged 12 
through 17 in May 2022 ( 

Novavax' sponsor in Australia is Biocelect Pty. Ltd.

Authorization in the U.S.
The Novavax COVID-19 vaccine (NVX-CoV2373) has not yet been authorized for use 
in the U.S. and the trade name Nuvaxovid(TM) 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 seven 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 more information on Nuvaxovid, including the Australian approved Product 
Information, Australian approved Consumer Medicines Information and Important 
Safety Information, or to request additional information please visit the 
following websites:

    -- Australian TGA website ( 
    -- Novavax global authorization website ( 

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. The 
vaccine 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.

The 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. 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, the world's 
largest vaccine manufacturer by volume. They will later be supplemented with 
data from additional manufacturing sites throughout Novavax' global supply 

About the NVX-CoV2373 Phase 3 Trials
NVX-CoV2373 continues being evaluated in two pivotal Phase 3 trials.

PREVENT-19 (the PRE-fusion protein subunit Vaccine Efficacy Novavax Trial 
| COVID-19) is a 2:1 randomized, placebo-controlled, observer-blinded trial to 
evaluate the efficacy, safety and immunogenicity of NVX-CoV2373 with Matrix-M 
adjuvant in 29,960 participants 18 years of age and over in 119 locations in 
the U.S. and Mexico. The primary endpoint for PREVENT-19 was the first 
occurrence of PCR-confirmed symptomatic (mild, moderate or severe) COVID-19 
with onset at least seven 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 greater than 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. In the trial, NVX-CoV2373 achieved 90.4% efficacy overall. 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) ( 

The pediatric expansion of PREVENT-19 is a 2:1 randomized, placebo-controlled, 
observer-blinded trial to evaluate the safety, effectiveness, and efficacy of 
NVX-CoV2373 with Matrix-M adjuvant in 2,247 adolescent participants 12 to 17 
years of age in 73 locations in the U.S., compared with placebo. In the 
pediatric trial, NVX-CoV2373 achieved its primary effectiveness endpoint 
(non-inferiority of the neutralizing antibody response compared to young adult 
participants 18 through 25 years of age from PREVENT-19) and demonstrated 80% 
efficacy overall at a time when the Delta variant of concern was the 
predominant circulating strain in the U.S. Additionally, immune responses 
were about two-to-three-fold higher in adolescents than in adults against all 
variants studied.

PREVENT-19 is being conducted with support from the U.S. government, including 
the Department of Defense, the Biomedical Advanced Research and Development 
Authority (BARDA), part of the Office of the Assistant Secretary for 
Preparedness and Response at the U.S. Department of Health and Human Services 
(HHS), and the National Institute of Allergy and Infectious Diseases, part of 
the National Institutes of Health at HHS. BARDA is providing up to $1.75 
billion under a Department of Defense agreement (# MCDC2011-001).

Additionally, a trial conducted in the U.K. with 14,039 participants aged 18 
years and over 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 seven 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 ( 

About Matrix-M(TM) Adjuvant
Novavax' patented saponin-based Matrix-M 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 currently under review by multiple 
regulatory agencies worldwide and will soon be under review in the U.S. for use 
in adults, adolescents and as a booster. In addition to its COVID-19 vaccine, 
Novavax is also currently evaluating a COVID-seasonal influenza combination 
vaccine candidate in a Phase 1/2 clinical trial, which combines NVX-CoV2373 and 
NanoFlu*, its quadrivalent influenza investigational vaccine candidate, and is 
also evaluating an Omicron strain-based vaccine (NVX-CoV2515) as well as a 
bivalent Omicron-based / original strain-based vaccine. These vaccine 
candidates incorporate Novavax' proprietary saponin-based Matrix-M adjuvant to 
enhance the immune response and stimulate high levels of neutralizing 

For more information, visit ;and connect with us on 
LinkedIn ( ).

*NanoFlu identifies a recombinant hemagglutinin (HA) protein nanoparticle 
influenza vaccine candidate produced by Novavax. This investigational candidate 
was evaluated during a controlled phase 3 trial conducted during the 2019-2020 
influenza season. 

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, a COVID-seasonal influenza investigational vaccine 
candidate, the scope, timing and outcome of future regulatory filings and 
actions, including Novavax' upcoming FDA Advisory Committee meeting and 
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 evolving COVID-19 
pandemic, the potential impact and reach of Novavax and NVX-CoV2373 in 
addressing vaccine access, controlling the pandemic and protecting populations, 
including the potential for a booster dose of NVX-CoV2373 to provide protection 
against COVID-19 (including variants), the potential reach of NVX-CoV2373, the 
efficacy, safety and intended utilization of NVX-CoV2373, and expected 
administration 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 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 and, 
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.

Alex Delacroix | 240-268-2022

Ali Chartan | 240-720-7804

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SOURCE  Novavax, Inc.