Vaccine description | |
---|---|
Target | SARS-CoV-2 |
Vaccine type | Subunit |
Clinical data | |
Trade names | Covovax, [1] Nuvaxovid [2] [3] [4] |
Other names | |
AHFS/ Drugs.com | Monograph |
License data | |
Pregnancy category | |
Routes of administration | Intramuscular |
ATC code | |
Legal status | |
Legal status |
|
Identifiers | |
DrugBank | |
UNII | |
KEGG |
Part of a series on the |
COVID-19 pandemic |
---|
|
COVID-19 portal |
The Novavax COVID-19 vaccine, sold under the brand names Nuvaxovid and Covovax, [1] among others, is a subunit COVID-19 vaccine developed by Novavax and the Coalition for Epidemic Preparedness Innovations (CEPI). [29]
The Novavax COVID‑19 vaccine is indicated for active immunization to prevent COVID‑19 caused by SARS-CoV-2. [4]
This section needs to be updated.(December 2023) |
A vaccine is generally considered effective if the estimate is ≥50% with a >30% lower limit of the 95% confidence interval. [30] Efficacy is closely related to effectiveness, which is generally expected to slowly decrease over time. [31]
In December 2021, Novavax reported that its phase III trial showed the vaccine achieved its primary endpoint of preventing infection at least seven days after the second dose. [32] Overall efficacy against different SARS-CoV-2s was 90.4% and efficacy against moderate-to-severe disease was 100%. [33] [32] Trials were conducted before the emergence of the SARS-CoV-2 Omicron variant, which has sharply reduced the effectiveness of authorized vaccines in preventing infections. [34]
Doses | Severity of illness | Omicron | Delta | Alpha | Gamma | Beta | Others circulating previously |
---|---|---|---|---|---|---|---|
1 | Symptomatic | Not reported | Not reported | 83% (74–90%) [a] | Not reported | Not reported | 83% (74–90%) [a] |
Hospitalization | Not reported | Not reported | Not reported | Not reported | Not reported | Not reported | |
2 | Symptomatic | Not reported | Not reported | 86% (71–94%) [35] | Not reported | 51% (−1 to 76%) [36] | 96% (74–99%) [a] |
Hospitalization | Not reported | Not reported | 100% [b] [35] | Not reported | Not reported | 100% [b] [a] |
The most common side effects include fever, headache, nausea, muscle and joint pain, tenderness and pain at the injection site, tiredness, and feeling unwell. [4]
Additional possible side effects include anaphylaxis (severe allergic reaction), paresthesia (unusual feeling in the skin, such as tingling or a crawling sensation) and hypoesthesia (decreased feeling or sensitivity, especially in the skin), and pericarditis (inflammation of lining around the heart). [37]
On 27 January 2023, Australia's Therapeutic Goods Administration indicated it will add tinnitus to its label. [38]
The vaccine requires two doses [39] and is stable at 2 to 8 °C (36 to 46 °F) refrigerated temperatures. [40]
NVX-CoV2373 has been described as both a protein subunit vaccine [41] [42] and a virus-like particle vaccine, [43] [44] though the producers call it a "recombinant nanoparticle vaccine". [45]
The vaccine is produced by creating an engineered baculovirus containing a gene for a modified SARS-CoV-2 spike protein. [46] The spike protein was modified by incorporating two proline amino acids in order to stabilize the pre-fusion form of the protein; this same 2P modification is being used in several other COVID‑19 vaccines. [47] The baculovirus is made to infect a culture of Sf9 moth cells, which then create the spike protein and display it on their cell membranes. The spike proteins are harvested and assembled onto a synthetic lipid nanoparticle about 50 nanometers across, each displaying up to 14 spike proteins. [41] [42] [45]
The formulation includes a saponin-based adjuvant [41] [42] [45] named Matrix-M.
In February 2021, Novavax partnered with Takeda to manufacture the vaccine in Japan, where its COVID‑19 vaccine candidate is known as TAK-019. [48]
Novavax signed an agreement with Serum Institute of India for mass scale production for developing and low-income countries. [49] In 2020 it was reported, that the vaccine would be manufactured in Spain [50] and in November 2021 it was reported to be produced in Poland by the Mabion company. [51] As of 2021, antigens were made at Novavax's factory Novavax CZ in the Czech Republic; [52] Novavax CZ was also marketing authorisation holder of its EU authorization. [4]
In May 2021, Serum Institute of India said that it started the production of the Novavax COVID‑19 vaccine candidate branded as Covovax in India after receiving permission from the Indian government. [53]
In January 2020, Novavax announced development of a vaccine candidate, codenamed NVX-CoV2373, to establish immunity to SARS-CoV-2. [54] Novavax's work is in competition for vaccine development among dozens of other companies. [55]
In March 2020, Novavax announced a collaboration with Emergent BioSolutions for preclinical and early-stage human research on the vaccine candidate. [56] Under the partnership, Emergent BioSolutions was supposed to manufacture the vaccine at large scale at their Baltimore facility. [57] However, following production issues with the Johnson & Johnson and Oxford–AstraZeneca vaccines at its Baltimore plant and to decrease the burden on the plant, Novavax subsequently partnered with a different manufacturer in a new agreement overseen by the U.S. government. [58]
Trials have also taken place in the United Kingdom. [59] [60] The first human safety studies of the candidate, codenamed NVX-CoV2373, started in May 2020 in Australia. [61] [62]
In July 2020, the company announced it might receive US$1.6 billion from Operation Warp Speed to expedite development of its coronavirus vaccine candidate by 2021 – if clinical trials show the vaccine to be effective. [63] [64] A spokesperson for Novavax stated that the $1.6 billion was coming from a "collaboration" between the Department of Health and Human Services and Department of Defense. [63] [64]
In May 2020, Australia's first human trials of a candidate COVID‑19 vaccine, Novavax's NVX-CoV2373, began in Melbourne. It involved about 130 volunteers aged between 18-59. [65]
In September 2020, Novavax started for a phase III trial with 15,000 in the UK. [66] [67]
In December 2020 Novavax started the PREVENT-19 (NCT04611802) phase III trial in the US and Mexico, funded by NIAID and BARDA. [68] [69]
In May 2021, Novavax initiated a pediatric expansion for the phase III clinical trial, with 3,000 adolescents 12–17 years of age in up to 75 sites in the United States. [70]
In January 2021, Novavax reported that preliminary results from the United Kingdom trial showed that its vaccine candidate was more than 89% effective. [71] [40]
In June 2021, a primary Novavax-funded study found that the vaccine has an overall efficacy of 83.4% two weeks after the first dose and 89.7% one week after the second dose. [35] A post hoc analysis showed an efficacy of 86.3% against the B.1.1.7 (Alpha) variant and 96.4% against "non-B.1.1.7 strains", the majority of which were the "prototype strains" (original strain). [35] [72]
In January 2021, Novavax reported that interim results from a trial in South Africa showed a lower effectiveness rate against the Beta variant (lineage B.1.351), at around 50–60%. [39] [73]
In a study reported in March and May 2021, the efficacy of the Novavax vaccine (NVX-CoV2373) was tested in a preliminary randomized, placebo-controlled study involving 2684 participants who were negative for COVID at baseline testing. The Beta variant was the predominant variant to occur, with post-hoc analysis indicating a cross-protective vaccine efficacy of Novavax against Beta of 51.0% for HIV-negative participants. [46] [74] [75]
In June 2021, Novavax announced overall 90.4% efficacy in the phase III US & Mexico trial that involved nearly 30,000 people aged 18 years of age and older. [76] From the total 77 COVID-19 cases found in the trial participants, 14 occurred in the vaccine group, while 63 occurred in the placebo group. [77]
About 216,000 doses of the Novavax COVID-19 vaccine were administered in the EU/EEA from authorization to 26 June 2022. [37]
|
In February 2021, the European Medicines Agency (EMA) started a rolling review of the Novavax COVID-19 vaccine (NVX‑CoV2373). [5] In November 2021, the EMA received application for conditional marketing authorization. [78] In December 2021, the European Commission granted a conditional marketing authorization across the EU, following a recommendation from the EMA, for it to be sold under the brand name Nuvaxovid. [79] [4] [80] [81]
As of November 2021, it has been authorized for use in Indonesia, [82] the Philippines, [83] as of December in India, [84] as of January 2022 in South Korea, [85] [86] Australia, [87] [88] as of February 2022 in the United Kingdom, [89] Canada, [90] Taiwan, [91] and Singapore. [92] [93] As of December 2021 it was validated by the World Health Organization. [94]
In June 2022, the FDA's advisory committee voted 21-0 with one abstention to recommend authorization of Novavax's vaccine for use in adults in the United States. [95] [96] In July 2022, the FDA authorized NVX-CoV2373 for emergency use as a primary immunization (not booster) in adults. [97] [24] making it the fourth COVID‑19 vaccine authorized in the US. [34] In July 2022, the US Centers for Disease Control and Prevention (CDC) recommended the Novavax COVID‑19 vaccine as a two-dose primary series for adults age 18 and older, thus endorsing the recommendation from the Advisory Committee on Immunization Practices (ACIP) regarding this vaccine. [98] [99] In August 2022, the FDA granted Emergency Use Authorization for the Novavax COVID‑19 vaccine in people aged 12–17 years. [27] In August 2022, the CDC recommended the Novavax COVID‑19 vaccine for adolescents aged 12–17 years. [100]
In October 2023, the FDA amended the emergency use authorization of the Novavax COVID-19 Vaccine, Adjuvanted for use in individuals 12 years of age and older to include the Novavax COVID-19 Vaccine, Adjuvanted (2023–2024 Formula) and removed the authorization for the Novavax COVID-19 Vaccine, Adjuvanted (Original monovalent). [101] [102]
WHO recommends that successful vaccines should show an estimated risk reduction of at least one-half, with sufficient precision to conclude that the true vaccine efficacy is greater than 30%. This means that the 95% CI for the trial result should exclude efficacy less than 30%. Current US Food and Drug Administration guidance includes this lower limit of 30% as a criterion for vaccine licensure.
Vaccine description | |
---|---|
Target | SARS-CoV-2 |
Vaccine type | Subunit |
Clinical data | |
Trade names | Covovax, [1] Nuvaxovid [2] [3] [4] |
Other names | |
AHFS/ Drugs.com | Monograph |
License data | |
Pregnancy category | |
Routes of administration | Intramuscular |
ATC code | |
Legal status | |
Legal status |
|
Identifiers | |
DrugBank | |
UNII | |
KEGG |
Part of a series on the |
COVID-19 pandemic |
---|
|
COVID-19 portal |
The Novavax COVID-19 vaccine, sold under the brand names Nuvaxovid and Covovax, [1] among others, is a subunit COVID-19 vaccine developed by Novavax and the Coalition for Epidemic Preparedness Innovations (CEPI). [29]
The Novavax COVID‑19 vaccine is indicated for active immunization to prevent COVID‑19 caused by SARS-CoV-2. [4]
This section needs to be updated.(December 2023) |
A vaccine is generally considered effective if the estimate is ≥50% with a >30% lower limit of the 95% confidence interval. [30] Efficacy is closely related to effectiveness, which is generally expected to slowly decrease over time. [31]
In December 2021, Novavax reported that its phase III trial showed the vaccine achieved its primary endpoint of preventing infection at least seven days after the second dose. [32] Overall efficacy against different SARS-CoV-2s was 90.4% and efficacy against moderate-to-severe disease was 100%. [33] [32] Trials were conducted before the emergence of the SARS-CoV-2 Omicron variant, which has sharply reduced the effectiveness of authorized vaccines in preventing infections. [34]
Doses | Severity of illness | Omicron | Delta | Alpha | Gamma | Beta | Others circulating previously |
---|---|---|---|---|---|---|---|
1 | Symptomatic | Not reported | Not reported | 83% (74–90%) [a] | Not reported | Not reported | 83% (74–90%) [a] |
Hospitalization | Not reported | Not reported | Not reported | Not reported | Not reported | Not reported | |
2 | Symptomatic | Not reported | Not reported | 86% (71–94%) [35] | Not reported | 51% (−1 to 76%) [36] | 96% (74–99%) [a] |
Hospitalization | Not reported | Not reported | 100% [b] [35] | Not reported | Not reported | 100% [b] [a] |
The most common side effects include fever, headache, nausea, muscle and joint pain, tenderness and pain at the injection site, tiredness, and feeling unwell. [4]
Additional possible side effects include anaphylaxis (severe allergic reaction), paresthesia (unusual feeling in the skin, such as tingling or a crawling sensation) and hypoesthesia (decreased feeling or sensitivity, especially in the skin), and pericarditis (inflammation of lining around the heart). [37]
On 27 January 2023, Australia's Therapeutic Goods Administration indicated it will add tinnitus to its label. [38]
The vaccine requires two doses [39] and is stable at 2 to 8 °C (36 to 46 °F) refrigerated temperatures. [40]
NVX-CoV2373 has been described as both a protein subunit vaccine [41] [42] and a virus-like particle vaccine, [43] [44] though the producers call it a "recombinant nanoparticle vaccine". [45]
The vaccine is produced by creating an engineered baculovirus containing a gene for a modified SARS-CoV-2 spike protein. [46] The spike protein was modified by incorporating two proline amino acids in order to stabilize the pre-fusion form of the protein; this same 2P modification is being used in several other COVID‑19 vaccines. [47] The baculovirus is made to infect a culture of Sf9 moth cells, which then create the spike protein and display it on their cell membranes. The spike proteins are harvested and assembled onto a synthetic lipid nanoparticle about 50 nanometers across, each displaying up to 14 spike proteins. [41] [42] [45]
The formulation includes a saponin-based adjuvant [41] [42] [45] named Matrix-M.
In February 2021, Novavax partnered with Takeda to manufacture the vaccine in Japan, where its COVID‑19 vaccine candidate is known as TAK-019. [48]
Novavax signed an agreement with Serum Institute of India for mass scale production for developing and low-income countries. [49] In 2020 it was reported, that the vaccine would be manufactured in Spain [50] and in November 2021 it was reported to be produced in Poland by the Mabion company. [51] As of 2021, antigens were made at Novavax's factory Novavax CZ in the Czech Republic; [52] Novavax CZ was also marketing authorisation holder of its EU authorization. [4]
In May 2021, Serum Institute of India said that it started the production of the Novavax COVID‑19 vaccine candidate branded as Covovax in India after receiving permission from the Indian government. [53]
In January 2020, Novavax announced development of a vaccine candidate, codenamed NVX-CoV2373, to establish immunity to SARS-CoV-2. [54] Novavax's work is in competition for vaccine development among dozens of other companies. [55]
In March 2020, Novavax announced a collaboration with Emergent BioSolutions for preclinical and early-stage human research on the vaccine candidate. [56] Under the partnership, Emergent BioSolutions was supposed to manufacture the vaccine at large scale at their Baltimore facility. [57] However, following production issues with the Johnson & Johnson and Oxford–AstraZeneca vaccines at its Baltimore plant and to decrease the burden on the plant, Novavax subsequently partnered with a different manufacturer in a new agreement overseen by the U.S. government. [58]
Trials have also taken place in the United Kingdom. [59] [60] The first human safety studies of the candidate, codenamed NVX-CoV2373, started in May 2020 in Australia. [61] [62]
In July 2020, the company announced it might receive US$1.6 billion from Operation Warp Speed to expedite development of its coronavirus vaccine candidate by 2021 – if clinical trials show the vaccine to be effective. [63] [64] A spokesperson for Novavax stated that the $1.6 billion was coming from a "collaboration" between the Department of Health and Human Services and Department of Defense. [63] [64]
In May 2020, Australia's first human trials of a candidate COVID‑19 vaccine, Novavax's NVX-CoV2373, began in Melbourne. It involved about 130 volunteers aged between 18-59. [65]
In September 2020, Novavax started for a phase III trial with 15,000 in the UK. [66] [67]
In December 2020 Novavax started the PREVENT-19 (NCT04611802) phase III trial in the US and Mexico, funded by NIAID and BARDA. [68] [69]
In May 2021, Novavax initiated a pediatric expansion for the phase III clinical trial, with 3,000 adolescents 12–17 years of age in up to 75 sites in the United States. [70]
In January 2021, Novavax reported that preliminary results from the United Kingdom trial showed that its vaccine candidate was more than 89% effective. [71] [40]
In June 2021, a primary Novavax-funded study found that the vaccine has an overall efficacy of 83.4% two weeks after the first dose and 89.7% one week after the second dose. [35] A post hoc analysis showed an efficacy of 86.3% against the B.1.1.7 (Alpha) variant and 96.4% against "non-B.1.1.7 strains", the majority of which were the "prototype strains" (original strain). [35] [72]
In January 2021, Novavax reported that interim results from a trial in South Africa showed a lower effectiveness rate against the Beta variant (lineage B.1.351), at around 50–60%. [39] [73]
In a study reported in March and May 2021, the efficacy of the Novavax vaccine (NVX-CoV2373) was tested in a preliminary randomized, placebo-controlled study involving 2684 participants who were negative for COVID at baseline testing. The Beta variant was the predominant variant to occur, with post-hoc analysis indicating a cross-protective vaccine efficacy of Novavax against Beta of 51.0% for HIV-negative participants. [46] [74] [75]
In June 2021, Novavax announced overall 90.4% efficacy in the phase III US & Mexico trial that involved nearly 30,000 people aged 18 years of age and older. [76] From the total 77 COVID-19 cases found in the trial participants, 14 occurred in the vaccine group, while 63 occurred in the placebo group. [77]
About 216,000 doses of the Novavax COVID-19 vaccine were administered in the EU/EEA from authorization to 26 June 2022. [37]
|
In February 2021, the European Medicines Agency (EMA) started a rolling review of the Novavax COVID-19 vaccine (NVX‑CoV2373). [5] In November 2021, the EMA received application for conditional marketing authorization. [78] In December 2021, the European Commission granted a conditional marketing authorization across the EU, following a recommendation from the EMA, for it to be sold under the brand name Nuvaxovid. [79] [4] [80] [81]
As of November 2021, it has been authorized for use in Indonesia, [82] the Philippines, [83] as of December in India, [84] as of January 2022 in South Korea, [85] [86] Australia, [87] [88] as of February 2022 in the United Kingdom, [89] Canada, [90] Taiwan, [91] and Singapore. [92] [93] As of December 2021 it was validated by the World Health Organization. [94]
In June 2022, the FDA's advisory committee voted 21-0 with one abstention to recommend authorization of Novavax's vaccine for use in adults in the United States. [95] [96] In July 2022, the FDA authorized NVX-CoV2373 for emergency use as a primary immunization (not booster) in adults. [97] [24] making it the fourth COVID‑19 vaccine authorized in the US. [34] In July 2022, the US Centers for Disease Control and Prevention (CDC) recommended the Novavax COVID‑19 vaccine as a two-dose primary series for adults age 18 and older, thus endorsing the recommendation from the Advisory Committee on Immunization Practices (ACIP) regarding this vaccine. [98] [99] In August 2022, the FDA granted Emergency Use Authorization for the Novavax COVID‑19 vaccine in people aged 12–17 years. [27] In August 2022, the CDC recommended the Novavax COVID‑19 vaccine for adolescents aged 12–17 years. [100]
In October 2023, the FDA amended the emergency use authorization of the Novavax COVID-19 Vaccine, Adjuvanted for use in individuals 12 years of age and older to include the Novavax COVID-19 Vaccine, Adjuvanted (2023–2024 Formula) and removed the authorization for the Novavax COVID-19 Vaccine, Adjuvanted (Original monovalent). [101] [102]
WHO recommends that successful vaccines should show an estimated risk reduction of at least one-half, with sufficient precision to conclude that the true vaccine efficacy is greater than 30%. This means that the 95% CI for the trial result should exclude efficacy less than 30%. Current US Food and Drug Administration guidance includes this lower limit of 30% as a criterion for vaccine licensure.