Immunizations with Nuvaxovid™ to begin in coming days
Gaithersburg-Based Novavax has started shipping its Nuvaxovid Covid-19 vaccine to European countries, according to a press release from earlier this week.
Novavax and the European Commission have an advance purchase agreement for up to 100 million doses of Nuvaxovid with the option for an additional 100 million doses (up to 200 million doses total).
Nuvaxovid “provides a differentiated option to bolster vaccination rates across Europe,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “Nuvaxovid has demonstrated efficacy, a reassuring safety and tolerability profile, and is built on a well-understood protein-based vaccine platform used for other vaccines for decades.”
Full press release below:
GAITHERSBURG, Md., Feb. 23, 2022 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced the first doses of Nuvaxovid™ COVID-19 Vaccine (recombinant, adjuvanted) have begun shipping to European Union (EU) member states. Nuvaxovid, also known as NVX-CoV2373, is the first protein-based COVID-19 vaccine authorized for use in Europe.
Local test and release procedures were completed and Nuvaxovid doses are shipping from Novavax’ Netherlands distribution center to EU member states beginning this week. The first wave of shipments includes several countries, such as Germany, France and Austria. Shipments to additional EU member states are expected to quickly follow.
“Today’s announcement paves the way for vaccination with Nuvaxovid to begin in Europe within the coming days. The Novavax COVID-19 vaccine provides a differentiated option to bolster vaccination rates across Europe,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “Nuvaxovid has demonstrated efficacy, a reassuring safety and tolerability profile, and is built on a well-understood protein-based vaccine platform used for other vaccines for decades.”
The European Commission (EC) granted conditional marketing authorization (CMA) for Nuvaxovid for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. The authorization followed the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommendation to authorize the vaccine and is applicable in all 27 EU member states. Novavax expects to submit its regulatory filing for a pediatric indication in adolescents aged 12 through 17-years to global regulatory authorities, including EMA, during the first quarter of 2022.
Novavax and the EC have an advance purchase agreement for up to 100 million doses of Nuvaxovid with the option for an additional 100 million doses (up to 200 million doses total). Through the second quarter, Novavax has received a commitment for orders from the EC totaling 69 million doses. The initial doses were manufactured by Novavax’ partner, the Serum Institute of India, the world’s largest vaccine manufacturer by volume. Information about dose administration will be available through each member state.
For more information on Nuvaxovid, including the European approved Product Information, European approved Consumer Medicines Information and Important Safety Information, or to request additional information, please visit the following websites:
The brand name Nuvaxovid™ has not yet been authorized for use in the U.S. by the FDA.
Authorized Use of Nuvaxovid™ in the European Union
European Commission has granted conditional marketing authorization for Nuvaxovid™ COVID-19 Vaccine (recombinant, 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
- Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation, or stress–related reactions may occur in association with vaccination as a 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
- Give Nuvaxovid 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
- The duration of protection afforded by the vaccine is unknown as it is still being determined by ongoing clinical trials
- 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, 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™ 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 Matrix-M™ 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 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™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.
Per Novavax:
GAITHERSBURG, Md., Jan. 31, 2022 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that it has submitted a request to the U.S Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) for NVX-CoV2373, its protein-based COVID-19 vaccine candidate for immunization of individuals 18 year of age and older against SARS-CoV-2.
The request for EUA is based on the totality of pre-clinical, clinical and manufacturing-related (CMC) data provided to the agency, including results of two large pivotal clinical trials that demonstrated an overall efficacy of approximately 90 percent and a reassuring safety profile.
“We’re extremely proud of the work of our teams and we look forward to FDA’s review of our EUA request. We believe our vaccine offers a differentiated option built on a well-understood protein-based vaccine platform that can be an alternative to the portfolio of available vaccines to help fight the COVID-19 pandemic,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “I’d like to also extend our thanks for the support of the U.S. Department of Health and Human Services and the U.S. Department of Defense for their partnership leading up to today’s milestone of EUA request submission.”
Novavax conducted two pivotal Phase 3 clinical trials: PREVENT-19 which enrolled approximately 30,000 participants in the U.S. and Mexico and published results in the New England Journal of Medicine (NEJM) and a trial with almost 15,000 participants in the U.K. which was also published in NEJM. In both trials, the vaccine demonstrated efficacy with a reassuring safety 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 in authorized markets. As part of the PREVENT-19 trial, a booster study is ongoing to evaluate the safety and effectiveness of a third does of the vaccine, as well as a study in adolescents aged 12-17.
NVX-CoV2373 has been granted conditional authorization by multiple regulatory agencies worldwide, including the European Commission, and emergency use listing (EUL) from the World Health Organization (WHO), with additional filings currently under review.
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, 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.
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 (NIAID), part of the National Institutes of Health (NIH) at HHS. BARDA is providing up to $1.75 billion under a Department of Defense agreement.
The Novavax vaccine would be the first protein-based alternative available in Israel
Novavax, Inc. (Nasdaq: NVAX), a biotechnology company based in Gaithersburg dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, and Israel’s Ministry of Health today announced an agreement for the purchase of NVX-CoV2373, the company’s recombinant nanoparticle protein-based COVID-19 vaccine candidate with Matrix-M™ adjuvant.
“Israel has been at the forefront of the fight against COVID-19 and has demonstrated strong leadership throughout the pandemic,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “We thank the Israeli Ministry of Health for their commitment to providing a protein-based COVID-19 vaccine option, based on well-understood technology, to the people of Israel.”
Under the advance purchase agreement, Novavax will provide an initial 5 million doses of its protein-based vaccine with an option for Israel to purchase an additional 5 million doses. Novavax will work with the Ministry of Health to obtain the necessary authorizations and finalize plans for distribution in Israel pending regulatory approval.
Novavax is conducting two pivotal ongoing Phase 3 clinical trials: PREVENT-19 which enrolled approximately 30,000 participants in the U.S. and Mexico, the results of which were published in the New England Journal of Medicine (NEJM); and a trial with almost 15,000 participants in the U.K. which was also published in NEJM. In both trials, the vaccine demonstrated high efficacy with a reassuring safety 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 received conditional marketing authorization for NVX-CoV2373 in the European Union and emergency use listing (EUL) from the World Health Organization (WHO), among others. The vaccine is also currently under review by multiple regulatory agencies worldwide. The company submitted its complete chemistry, manufacturing and controls (CMC) data package to the U.S. Food and Drug Administration (FDA) at the end of 2021 and expects to submit a request for EUA for the vaccine in the U.S. after one month in accordance with guidance from the FDA regarding submission of all EUA vaccines.
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, 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.
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.
Two weeks ago, Gaithersburg-based Novavax received approval for its Covid-19 Vaccine from the South Korean food and drug administration and filed for emergency use authorization in South Africa. In late December it received emergency authorization in India, and earlier this week Novavax announced its Australian approval.
Additional information can be found in the press release below:
GAITHERSBURG, Md., Jan. 19, 2022 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that Australia’s Therapeutic Goods Administration (TGA) has granted approval for provisional registration 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 Australia under the brand name Nuvaxovid™.
“The grant of provisional registration of Nuvaxovid by the TGA reflects Novavax’ increasing momentum around the globe and represents the first-protein based COVID-19 vaccine authorized for use in Australia,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “While the world continues to grapple with the ever-changing nature of the virus, we look forward to delivering our vaccine to the people of Australia. We would also like to extend our gratitude to the Australian clinical trial participants who contributed so significantly to the development of our vaccine.”
Australia has played a pivotal role in Novavax’ Phase 1 and Phase 2 clinical trials supporting the development of Nuvaxovid. Additionally, a booster trial for Nuvaxovid and a Phase 1/2 trial for a combination seasonal influenza and COVID-19 vaccine are currently underway in Australia. Overall, nearly 1,500 Australians have participated in Novavax COVID-19 and combination vaccine clinical trials.
Click here to view multimedia content that accompanies this press release.
The approval for provisional registration by the TGA is based on the totality of preclinical, manufacturing and clinical trial data submitted for review. This includes two pivotal Phase 3 clinical trials: PREVENT-19 enrolled approximately 30,000 participants in the U.S. and Mexico, the results of which were published in The 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 in NEJM. In both trials, NVX-CoV2373 demonstrated high 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 Commonwealth of Australia announced an advance purchase agreement (APA) for 51 million doses of Novavax’ COVID-19 vaccine in January 2021, with the option for an additional 10 million doses (up to 61 million doses total). The approval for provisional registration leverages Novavax’ manufacturing partnership with Serum Institute of India (SII), the world’s largest vaccine manufacturer by volume, which will supply initial doses to Australia. It will later be supplemented with data from additional manufacturing sites in Novavax’ global supply chain.
Novavax received conditional marketing authorization (CMA) for NVX-CoV2373 in the European Union and emergency use listing (EUL) from the World Health Organization (WHO). The Novavax/SII vaccine (brand name, Covovax™) recently received emergency use authorization (EUA) in India, Indonesia and the Philippines, as well as EUL from the WHO. The Novavax/SK bioscience vaccine was granted approval in South Korea by the Ministry of Food and Drug Safety (MFDS). The vaccine is also currently under review by multiple regulatory agencies worldwide. The company submitted its complete chemistry, manufacturing and controls (CMC) data package to the U.S. Food and Drug Administration (FDA) at the end of 2021 and expects to submit a request for EUA for the vaccine in the U.S. after one month in accordance with guidance from the FDA regarding submission of all EUA vaccines.
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:
The brand name Nuvaxovid™ has not yet been authorized for use in the U.S. by the FDA. Novavax’ sponsor in Australia is Biocelect Pty. Ltd.
Provisional Registration of Nuvaxovid™ in Australia
The Therapeutic Goods Administration (TGA) has granted approval for provisional registration 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 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 (frequency category of very common ≥1/10) were headache, nausea or vomiting, myalgia, arthralgia, injection site tenderness/pain, fatigue, and malaise.
For additional safety information, please visit www.NovavaxCovidVaccine.com for the full Australian Product Information (PI) and Australian Consumer Medicine Information (CMI). Information regarding adverse event reporting instructions can also be found at www.NovavaxCovidVaccine.com.
Information on this vaccine is also available on the Australia Therapeutic Goods Administration website: www.tga.gov.au.
GAITHERSBURG, Md., Dec. 31, 2021 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that it has completed submission of the final data package, including the complete chemistry, manufacturing and controls module, to fulfill the prerequisites for emergency use authorization (EUA) application request to the U.S. Food and Drug Administration (FDA) for NVX-CoV2373, the company’s recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M™ adjuvant. Novavax expects to submit a request for EUA for the vaccine in the U.S. in one month in accordance with guidance from the FDA regarding submission of all EUA vaccines.
“Novavax is committed to delivering our protein-based vaccine in the United States, where the COVID-19 pandemic continues to evolve with the emergence of new variants, ongoing need to ensure primary vaccination for the eligible population, and need for boosting,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “We thank the U.S. Government for its ongoing support of our COVID-19 vaccine program, as well as our clinical trial participants and those who have supported the development and manufacturing of our vaccine.”
Novavax has filed the complete CMC data package, which leverages Novavax’ manufacturing partnership with the Serum Institute of India Pvt. Ltd. (SII), the world’s largest vaccine manufacturer by volume, with the FDA. The company expects to later supplement the submission with data from additional manufacturing sites across Novavax’ global supply chain.
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. The current assigned shelf life of the vaccine is 9 months.
Novavax has established partnerships for the manufacture, commercialization and distribution of NVX-CoV2373 worldwide.
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, with 25,452 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 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, 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.
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 (NIAID), part of the National Institutes of Health (NIH) at HHS. BARDA is providing up to $1.75 billion under a Department of Defense agreement.
About Matrix-M™ 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.
Gaithersburg’s Novavax has received emergency use authorization in India just one week after the European Union authorized the use of Novavax Inc.’s Covid-19 vaccine for adults.
On December 23, Novavax announced that early data showed its vaccine protects against the Omicron variant of Covid-19 and in early November the company announced it had received emergency authorization in Indonesia.
In an early December meeting, the City of Gaithersburg unanimously approved Novavax’s development plan.
Per Shulman Rogers, Novavax secured two sites in the City of Gaithersburg and obtained zoning approvals for a 180,000 square feet Global Headquarters and manufacturing facility delivering late summer at 700 Quince Orchard, and an additional 600,000+ square feet integrated campus next door at 14 Firstfield Road for expansion of its manufacturing and research and development capacity.
Last year, the State of Maryland announced it would assist with project costs related to the expansion. The Maryland Department of Commerce approved a $2 million conditional loan contingent on job creation and capital investment. In addition, the state approved a $200,000 Partnership for Workforce Quality training grant, and the company was deemed eligible for several tax credits, including the Job Creation Tax Credit and More Jobs for Marylanders.
Full press release in the emergency authorization in I dis can be seen below.
GAITHERSBURG, Md. and PUNE, India, Dec. 28, 2021 /PRNewswire/ — 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, today announced that the Drugs Controller General of India (DCGI) has granted emergency use authorization (EUA) for Novavax’ recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M™ adjuvant. The vaccine will be manufactured and marketed in India by SII under the brand name Covovax™.
“No one is safe until everyone is safe, and today’s authorization marks a vital step for India, where additional vaccine options and millions of doses are needed in the country’s ongoing efforts to control the pandemic,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “Novavax and SII will not rest in our partnership to deliver our vaccine to those in India and across the globe, as we work to protect the health of people everywhere.”
Because the vaccine is stored with standard refrigeration at 2° to 8° Celsius, it may be transported and stored using existing vaccine supply chain, potentially increasing access in hard-to-reach areas.
“The approval of Covovax in India marks a 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, based on Phase 3 clinical data demonstrating more than 90% efficacy and a favorable safety profile, to our nation.”
The Novavax/SII vaccine recently received EUA in Indonesia and the Philippines, as well as Emergency Use Listing (EUL) with the World Health Organization (WHO). Novavax was also granted Conditional Marketing Authorization by the European Commission and EUL with the WHO for its vaccine, which will be marketed by Novavax as NuvaxovidTM. Novavax has also announced regulatory filings for its vaccine in multiple countries worldwide, while partners SK bioscience and Takeda have submitted regulatory filings in South Korea and Japan, respectively. Novavax expects to submit the complete package to the U.S. FDA by the end of the year.
– Two-dose primary regimen of NVX-CoV2373 demonstrated cross-reactive immune responses against Omicron (B.1.1.529) and other variants
– Third dose produced increased immune responses comparable to or exceeding levels associated with protection in Phase 3 clinical trials, with a 9.3-fold IgG rise and a 19.9-fold ACE2 inhibition increase after booster dose
– Immune responses in adolescents were 2- to 4-fold higher than adults against broad array of variants of interest and variants of concern
– Development of Omicron-specific vaccine on track for initiation of GMP manufacturing in early January
– Company to host investor conference call today from 4:30 – 5:00 pm ET
GAITHERSBURG, Md., Dec. 22, 2021 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced initial data evaluating the immune response of its COVID-19 vaccine, NVX-CoV2373, against the Omicron variant as well as additional data from its ongoing Phase 2 boost study. New results demonstrate broad cross-reactivity against Omicron and other circulating variants from a primary 2-dose regimen, with responses that increased following a third dose at six months.
Immune responses included the following:
- Anti-spike IgG titers after Dose 3 increased 5.4-fold (prototype) to 9.3-fold (Omicron) from peak responses seen after 2-dose primary vaccination.
- This represents a 61.1-fold (prototype) and a 73.5-fold (Omicron) increase from prior to the Dose 3 boost.
- ACE2-inhibition titers increased 6-fold (prototype) to 19.9-fold (Omicron) compared to peak responses following 2-dose primary series, representing a 54.4-fold (prototype), a 24.4-fold (Delta) and a 36.3-fold (Omicron) increase from prior to the booster.
- Wild-type neutralization responses were observed after 2 doses for prototype, Delta and Omicron. Significant increases were observed after boosting, with titers for Delta and Omicron comparable to levels associated with protection in U.S. and Mexico and U.K. Phase 3 studies.
- After 2 doses, Omicron wild-type neutralization was <4-fold lower than prototype, suggesting that both a booster dose as well as an Omicron-specific vaccine may be beneficial.
Further, data from the pediatric expansion of Novavax’ PREVENT-19 Phase 3 trial in the U.S. and Mexico showed robust immune responses in adolescents, including increased IgG and receptor inhibition titers against a wide array of variants, including Omicron, following a 2-dose series. Responses in adolescents were 2- to 4-fold higher than adults against all evaluated variants.
“In the midst of an evolving pandemic, NVX-CoV2373 showed strong immune responses against Omicron and other circulating variants. We are encouraged that boosted responses against all variants were comparable to those associated with high vaccine efficacy in our Phase 3 clinical trials, suggesting that NVX-CoV2373 can play an important role in the ongoing fight against new variants,” said Gregory M. Glenn, President of Research and Development, Novavax. “Given the continued evolution of the coronavirus, the development of an Omicron vaccine could be necessary. Novavax has cloned, expressed and characterized the Omicron spike protein vaccine and will soon enter the GMP-phase of production. We expect to begin clinical studies in the first quarter of 2022.”
As part of an ongoing study, a single booster dose of 5 µg SARS-CoV-2 rS with 50 µg Matrix-M™ adjuvant was administered to healthy adult participants approximately six months after their primary 2-dose vaccination series. Multiple assays were used to evaluate immune responses against SARS-CoV-2 twenty-eight days following the booster dose.
Safety reporting of reactogenicity events showed an increasing trend across all 3 doses of NVX-CoV2373, reflecting the increased immunogenicity seen with a third dose. Following the booster, local and systemic reactions were generally short-lived with a median duration of approximately 2 days. The incidence of Grade 3 or higher events remained relatively low. Medically attended adverse events (MAAEs), potentially immune-mediated medical conditions (PIMMCs), and severe adverse events (SAEs) occurred infrequently following the booster dose and were balanced between vaccine and placebo groups.
The major findings, detailed in ‘Immunogenicity and Safety Following a Homologous Booster Dose of a SARS-CoV-2 recombinant spike protein vaccine (NVX-CoV2373): A Phase 2 Randomized Placebo-Controlled Trial,’ will be submitted for peer-review publication and are expected to be available online at https://www.medrxiv.org/ in the coming days.
Conference Call
Novavax will host a conference call for investors today at 4:30 p.m. ET. The dial-in numbers for the conference call are (877) 870-4263 (Domestic) or (412) 317-0790 (International). Participants will be prompted to request to join the Novavax, Inc. call. A replay of the conference call will be available starting at 7:30 p.m. ET on December 22, 2021 until 11:59 p.m. ET on December 31, 2021. To access the replay by telephone, dial (877) 344-7529 (Domestic) or (412) 317-0088 (International) and use passcode 6207101.A webcast of the conference call can also be accessed on the Novavax website at novavax.com/events. A replay of the webcast will be available on the Novavax website until March 22, 2022.
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. The current assigned shelf life of the vaccine is 9 months.
Novavax has established partnerships for the manufacture, commercialization and distribution of NVX-CoV2373 worldwide.
About the NVX-CoV2373 Phase 3 trials
NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials.A trial conducted in the U.K. with 14,039 participants 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 the New England Journal of Medicine (NEJM).
PREVENT-19, a trial in the U.S. and Mexico, with 25,452 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 in both studies. 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 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 Conditional Marketing Authorization from the European Commission, Emergency Use Listing from the World Health Organization, Emergency Use Authorization in Indonesia and the Philippines, and has been submitted for regulatory authorization in multiple markets globally. 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, 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, including Novavax’ plans to submit a complete CMC data package to the U.S. FDA by the end of the year, 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 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.
Yesterday, the European Union authorized the use of Novavax Inc.’s Covid-19 vaccine for adults. This makes Gaithersburg-based Novavax’s two-dose vaccine the fifth of its kind to be approved in the European Union.
More information below from the Novavax press release:
- Nuvaxovid™ COVID-19 Vaccine (recombinant, adjuvanted) is the first protein-based COVID-19 vaccine authorized for use in Europe
- Novavax and the European Commission previously announced an advance purchase agreement for up to 200 million doses through 2023
- Authorization follows positive recommendation by European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP)
GAITHERSBURG, Md., Dec. 20, 2021/PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that the European Commission (EC) has granted Novavax conditional marketing authorization (CMA) for Nuvaxovid™ COVID-19 Vaccine (recombinant, adjuvanted) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. The authorization follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommendation today to authorize the vaccine (also known as NVX-CoV2373) and is applicable in all 27 European Union (E.U.) member states.
“We welcome today’s European Commission decision reflecting the first authorization of a protein-based COVID-19 vaccine for the people of the E.U.,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “We thank the European Medicines Agency, the Committee for Medicinal Products for Human Use reviewers and the European Commission for their thorough assessment as we look forward to playing a critical role in helping to address the continued threat of COVID-19. We also thank the thousands of clinical trial participants, our partners and Novavax employees worldwide who have contributed to this historic milestone.”
The EMA opinion and related EC decision is based on the totality of preclinical, manufacturing and clinical trial data submitted for review. This includes two pivotal Phase 3 clinical trials: PREVENT-19 which included 30,000 participants in the U.S. and Mexico, the results of which were published in The New England Journal of Medicine (NEJM); and a trial with 15,000 participants in the U.K., the results of which were also published in NEJM. In both trials, NVX-CoV2373 demonstrated high efficacy and an acceptable safety and tolerability profile. 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 EC announced an advance purchase agreement (APA) for up to 200 million doses of Novavax’ COVID-19 vaccine in August 2021. Initial doses are expected to arrive in Europe in January. Novavax is working with EMA and its partners to expedite local release testing.
This authorization leverages Novavax’ manufacturing partnership with Serum Institute of India (SII), the world’s largest vaccine manufacturer by volume, which will supply initial doses for the E.U. It will later be supplemented with data from additional manufacturing sites in Novavax’ global supply chain.
Novavax and SII recently received emergency use authorization (EUA) in Indonesia and the Philippines, where it will be commercialized by SII under the trade name Covovax™. The companies also received emergency use listing for Covovax from the World Health Organization. The vaccine is also currently under review by multiple regulatory agencies worldwide, and the company expects to submit its complete chemistry, manufacturing and controls (CMC) data package to the U.S. Food and Drug Administration (FDA) by the end of the year.
Authorized Use of Nuvaxovid™ in the European Union
European Commission has granted conditional marketing authorization for Nuvaxovid™ COVID-19 Vaccine (recombinant, 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
- Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation, or stress–related reactions may occur in association with vaccination as a 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
- Give Nuvaxovid 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
- The duration of protection afforded by the vaccine is unknown as it is still being determined by ongoing clinical trials
- 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, nausea or vomiting, myalgia, arthralgia, injection site tenderness/pain, fatigue and malaise
The Gaithersburg City Council approved unanimously approved Novavax’s development plan at Monday’s meeting.
Per Shulman Rogers, Novavax secured two sites in the City of Gaithersburg and obtained zoning approvals for a 180,000 square feet Global Headquarters and manufacturing facility delivering late summer at 700 Quince Orchard, and an additional 600,000+ square feet integrated campus next door at 14 Firstfield Road for expansion of its manufacturing and research and development capacity.
Last year, the State of Maryland announced it would assist with project costs related to the expansion. The Maryland Department of Commerce approved a $2 million conditional loan contingent on job creation and capital investment. In addition, the state approved a $200,000 Partnership for Workforce Quality training grant, and the company was deemed eligible for several tax credits, including the Job Creation Tax Credit and More Jobs for Marylanders.
Montgomery County approved a $500,000 grant, contingent on job creation and capital investment, and the City of Gaithersburg is anticipated to approve a grant of up to $50,000 from its Economic Development Opportunity Fund.
Over 400 jobs are expected by December 2024.
Novavax, a Gaithersburg-based 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, today announced that the National Agency of Drug and Food Control of the Republic of Indonesia, or Badan Peng was Obat dan Makanan (Badan POM), has granted emergency use authorization (EUA) for Novavax’ recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M™ adjuvant. It will be manufactured by SII in India and marketed by SII in Indonesia under the brand name COVOVAX™.
“The first authorization of Novavax’ COVID-19 vaccine exemplifies our commitment to equitable global access and will fill a vital need for Indonesia, which despite being the fourth most populous nation on earth, continues to work to procure sufficient vaccine for its population,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “This also marks the first regulatory authorization worldwide of a protein-based COVID-19 vaccine based on Phase 3 clinical data demonstrating efficacy and a favorable safety profile. This is a landmark moment for Novavax and our partner, Serum Institute of India, and it is the first of many authorizations that Novavax expects in the coming weeks and months for our vaccine globally.”
Because the vaccine is stored at 2° to 8° Celsius, the use of existing vaccine supply channels with more traditional cold chain capabilities is possible, potentially increasing access in hard-to-reach areas and vaccination rates across the nation. Initial shipments into Indonesia are expected to begin imminently.
“Access to supply of a safe and highly effective vaccine, coupled with the ease of its distribution, should be a critical enabler to help Indonesiacontrol the current coronavirus outbreak,” said Adar Poonawalla, Chief Executive Officer, Serum Institute of India. “We continue to work with urgency to ensure the first protein-based COVID-19 vaccine option in Indonesia is available for all awaiting its arrival.”
Novavax and SII have already filed for authorization of Novavax’ COVID-19 vaccine in India and the Philippines, as well as for Emergency Use Listing (EUL) with the World Health Organization (WHO). Novavax recently also completed rolling submissions for authorization of the Novavax vaccine with regulatory agencies in the United Kingdom, European Union, Canada and Australia. Novavax expects to submit additional regulatory filings for its vaccine around the world as well as an additional supplemental filing for its vaccine for EUL with the WHO, shortly. Novavax expects to submit its complete package to the U.S. FDA by the end of the year.
Indonesia is a member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S), a non-binding co-operative arrangement between more than 50 regulatory authorities, including those in the U.S., United Kingdom, European Union, Australia and Canada, in the field of Good Manufacturing Practice (GMP) of medicinal products for human or veterinary use. PIC/S aims at harmonizing inspection procedures worldwide through the development of common standards in the field of GMP and at facilitating cooperation and networking between competent authorities, regional and international organizations, thus increasing mutual confidence.
For additional information on COVOVAX, including the Summary of Product Characteristics, Prescribing Information and Important Safety Information, please visit: Indonesia National Agency of Drug and Food Control (Badan POM). This information will be posted in the coming days.
Authorized Use of Novavax’ Covid-19 Vaccine in Indonesia
Badan POM has issued Emergency Use Authorization (EUA) for Covovax /Recombinant Spike Protein of SARS-CoV-2 Virus 5 mcg to induce immunity against SARS-CoV-2 to prevent COVID-19 for adults 18 years old and above.
Important Safety Information
COVOVAX is contraindicated in persons who have hypersensitivity to the active substance or to any of the excipients of this vaccine.
About the NVX-CoV2373 Phase 3 Trials
NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials: the PREVENT-19 trial in the U.S. and Mexico that demonstrated 100% protection against moderate and severe disease and 90.4% efficacy overall. It was generally well-tolerated and elicited a robust antibody response. It is also being evaluated in a trial 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.
NVX-CoV2373, Novavax’ Covid-19 vaccine, 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™ 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 microgram antigen and 50 microgram 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.
About Matrix-M™ 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.
- Filing marks first protein-based COVID-19 vaccine submitted to MHRA for authorization
- All modules required for regulatory review, including CMC data, are now complete
- Submission based on Phase 3 data from ~45K patients demonstrating high efficacy and well-tolerated safety, including against variants
- Submissions to additional global regulatory authorities including EU, Canada and Australia expected soon
GAITHERSBURG, Md., Oct. 27, 2021/PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced the completion of its rolling regulatory submission to the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) for authorization of its COVID-19 vaccine candidate. The company’s application for Conditional Marketing Authorization (CMA) marks the first submission for authorization of a protein-based COVID-19 vaccine in the United Kingdom.
“This submission brings Novavax significantly closer to delivering millions of doses of the first protein-based COVID-19 vaccine, built on a proven, well-understood vaccine platform that demonstrated high efficacy against multiple strains of the coronavirus,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “We look forward to MHRA’s review and will be prepared to deliver vaccine doses following what we anticipate will be a positive decision. We thank the clinical trial participants and trial sites in the United Kingdom, as well as the U.K. Vaccines Taskforce, for their support and vital contributions to this program.”
Novavax has now completed the submission of all modules required by MHRA for the regulatory review of NVX-CoV2373, the company’s recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M™ adjuvant. This includes preclinical, clinical, and chemistry, manufacturing and controls (CMC) data. Clinical data from a pivotal Phase 3 trial of 15,000 volunteers in the U.K. was submitted to MHRA earlier this year in which NVX-CoV2373 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, as well as a favorable safety and tolerability profile. The submission also includes data from PREVENT-19, a 30,000-person trial in the U.S. and Mexico, which demonstrated 100% protection against moderate and severe disease and 90.4% efficacy overall. NVX-CoV2373 was generally well-tolerated and elicited a robust antibody response.
Novavax expects to complete additional regulatory filings in key markets, including Europe, Canada, Australia, New Zealand, the World Health Organization and other markets around the world shortly following the U.K. submission. In the U.S., Novavax expects to submit the complete package to the FDA by the end of the year. The company continues to work closely with governments, regulatory authorities and non-governmental organizations (NGOs) in its commitment to ensuring equitable global access to its COVID-19 vaccine.
“The submission to MHRA leverages our manufacturing partnership with the Serum Institute of India, the world’s largest supplier of COVID-19 vaccines,” said Rick Crowley, Executive Vice President, Chief Operations Officer, Novavax. “In the near future, we expect to supplement this filing with supply from our global supply chain.”
