New Zealand's Medsafe Grants Provisional Approval for Novavax' COVID-19 Vaccine

Author: Novavax, Inc. / 2023-07-24 00:04 / Source: Novavax, Inc.

New Zealand's Medsafe Grants Provisional Approval for Novavax' COVID-19 Vaccine

Nuvaxovid™ is the first protein-based COVID-19 vaccine to receive provisional approval for distribution in New Zealand

GAITHERSBURG,Md.,Feb. 4,2022 -- Novavax,Inc. (Nasdaq: NVAX),a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases,today announced that New Zealand's Medsafe has granted provisional approval of NVX-CoV2373,Novavax' COVID-19 vaccine (adjuvanted),for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 in individuals 18 years of age and older. The vaccine will be supplied to New Zealand under the brand name Nuvaxovid™.

"The provisional approval of Nuvaxovid by Medsafe will enable Novavax to deliver the first protein-based COVID-19 vaccine to New Zealand," said Stanley C. Erck,President and Chief Executive Officer,Novavax. "We thank Medsafe for its thorough review and,as the pandemic continues to evolve,we remain committed to supporting New Zealand and the world in the fight against COVID-19."

The provisional approval by Medsafe is based on evaluation of the quality,safety,and efficacy data submitted for review. This includes two pivotal Phase 3 clinical trials: PREVENT-19 enrolled approximately 30,000 participants in the U.S. andMexico,the results of which were published inThe New England Journal of Medicine(NEJM); and a trial with almost 15,000 participants in the U.K.,the results of which were also published inNEJM. In both trials,NVX-CoV2373 demonstrated efficacy and a reassuring safety and tolerability profile. Serious and severe adverse events were low in number and balanced between vaccine and placebo groups. The most common adverse reactions observed during clinical studies (frequency category of very common ≥1/10) were headache,nausea or vomiting,myalgia,arthralgia,injection site tenderness/pain,fatigue,and malaise. Novavax will continue to collect and analyze real-world data,including the monitoring of safety and the evaluation of variants,as the vaccine is distributed.

Novavax and the New Zealand Government previously announcedan advance purchase agreement (APA) for 10.7 million doses of Novavax' COVID-19 vaccine.This provisional approval leverages Novavax' manufacturing partnership with Serum Institute ofIndia(SII),the world's largest vaccine manufacturer by volume,which will supply initial doses to New Zealand. The provisional approval will later be supplemented with data from additional manufacturing sites in Novavax' global supply chain.

Novavax receivedconditional marketing authorizationfor NVX-CoV2373 in theEuropean Union,emergency use listing (EUL) from theWorld Health Organization(WHO),and was granted provisional registration by the Therapeutic Goods Administration in Australia,among others. The vaccine is also currently under review by multiple regulatory agencies worldwide,including the U.S. Food and Drug Administration (FDA).

For more information on Nuvaxovid,including the approved New Zealand Datasheet and approved Consumer Medicine Information and Important Safety Information,or to request additional information,please visit the following websites:

Novavax global authorization website

COVID-19 Vaccine Status of Applications

Information for Prescribers/Consumers Search

The brand name Nuvaxovid™ has not yet been authorized for use in the U.S. by the FDA. Novavax' sponsor in Australia and New Zealand is Biocelect Pty. Ltd.

Provisional Approval of Nuvaxovid™ in New Zealand

Medsafe has granted provisional approval of Nuvaxovid™ COVID-19 Vaccine (adjuvanted) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older.

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. 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.

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 fetus.

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 (frequency category of very common ≥1/10) were headache,and malaise.

For additional safety information,please visit www.NovavaxCovidVaccine.com for the full New Zealand Datasheet and New Zealand Consumer Medicine Information. Information regarding adverse event reporting instructions can also be found at www.NovavaxCovidVaccine.com.

Information on this vaccine is also available on the New Zealand Medsafe website at www.medsafe.govt.nz.

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™ 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°- 8° 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,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%. The key secondary endpoint is 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).

A trial conducted in the U.K. with 14,039 participants was designed as a randomized,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.

About Matrix-M™ Adjuvant

Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and generally 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 authorization from multiple regulatory authorities globally,including Conditional Marketing Authorization from the European Commission and Emergency Use Listing from the World Health Organization. The vaccine is also under review by multiple regulatory agencies worldwide. NanoFlu™,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,visitwww.novavax.comand connect with us on LinkedIn.

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,including Novavax' plans to supplement the provisional approval with data from the additional manufacturing sites in Novavax' global supply chain,the potential impact 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 delivery 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 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.

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