Novavax COVID-19 vaccine

Last updated

Novavax COVID-19 vaccine
Vaccine description
Target SARS-CoV-2
Vaccine type Subunit
Clinical data
Trade names Nuvaxovid, Covovax [1]
Other namesNVX-CoV2373 [2]
TAK-019 [3]
SARS-CoV-2 rS with Matrix-M1 adjuvant [4]
License data
Routes of
administration
Intramuscular
ATC code
  • None
Legal status
Legal status
Identifiers
DrugBank
UNII

The Novavax COVID-19 vaccine, sold under the brand name Nuvaxovid among others, is a subunit COVID-19 vaccine developed by Novavax and the Coalition for Epidemic Preparedness Innovations (CEPI), that is undergoing trials in India under the brand name Covovax. [1] [5] It requires two doses [6] and is stable at 2 to 8 °C (36 to 46 °F) refrigerated temperatures. [7]

Contents

Medical uses

The vaccine is given in two doses administered 21 days apart. [8] It is stable at refrigerated temperatures of 2 to 8 °C (36 to 46 °F). [7]

Efficacy

A vaccine is generally considered effective if the estimate is ≥50% with a >30% lower limit of the 95% confidence interval. [9] Efficacy is closely related to effectiveness, which is generally expected to slowly decrease over time. [10]

Efficacy by variant
Doses Severity of illness Delta Alpha Gamma Beta Others circulating previously
1 Symptomatic Not reported83% (7490%) [lower-alpha 1] Not reportedNot reported83% (7490%) [lower-alpha 1]
Hospitalization Not reportedNot reportedNot reportedNot reportedNot reported
2 Symptomatic Not reported86% (7194%) [11] Not reported51% (−1 to 76%) [12] 96% (7499%) [lower-alpha 1]
Hospitalization Not reported100% [lower-alpha 2] [11] Not reportedNot reported100% [lower-alpha 2] [lower-alpha 1]

UK trial

On 28 January 2021, Novavax reported that preliminary results from the United Kingdom trial showed that its vaccine candidate was more than 89% effective. [13] [7] However, 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%. [6] [14]

On 12 March 2021, Novavax announced their vaccine candidate was 96.4% effective in preventing the original strain of COVID-19 and 86% effective against the Alpha variant.[ citation needed ]

On 30 June 2021, a study in The New England Journal of Medicine funded by Novavax, showed that the vaccine had an overall efficacy of 83.4% two weeks after the first dose and 89.7% one week after the second dose. 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" , majority of which were the "prototype strains" (original strain). [11] [15]

South Africa trial

On 28 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%. [6] [14]

On 12 March 2021, Novavax announced their vaccine candidate proved 55% effective against the Beta variant in people without HIV/AIDS. It was also 100% effective at preventing severe illness. [16] [ clarification needed ]

US and Mexico trial

On 14 June 2021, Novavax announced overall 90.4% efficacy in the Phase 3 U.S. & Mexico trial that involved nearly 30,000 people ages 18 years and older. [17] 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. [18]

Technology

NVX-CoV2373 has been described as both a protein subunit vaccine [19] [20] [21] and a virus-like particle vaccine, [22] [23] though the producers call it a "recombinant nanoparticle vaccine". [24]

The vaccine is produced by creating an engineered baculovirus containing a gene for a modified SARS-CoV-2 spike protein. 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. [25] 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. [19] [20] [24]

The formulation includes a saponin-based adjuvant. [19] [20] [24]

Czechia's health minister, Adam Vojtěch, expressed hope that, since it is not a mRNA vaccine, the Novavax vaccine might persuade some reluctant individuals to get vaccinated, given the high rate of disinformation regarding mRNA vaccines. [26]

History

In January 2020, Novavax announced development of a vaccine candidate, codenamed NVX-CoV2373, to establish immunity to SARS-CoV-2. [27] Novavax's work is in competition for vaccine development among dozens of other companies. [28]

In March 2020, Novavax announced a collaboration with Emergent BioSolutions for preclinical and early-stage human research on the vaccine candidate. [29] Under the partnership, Emergent BioSolutions was supposed to manufacture the vaccine at large scale at their Baltimore facility. [30] 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. [31]

Trials have also taken place in the United Kingdom. [32] [33] The first human safety studies of the candidate, codenamed NVX-CoV2373, started in May 2020 in Australia. [34] [35]

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. [36] [37] 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, [36] [37] where Gen. Gustave F. Perna has been selected as COO for Warp Speed. In late September, Novavax entered the final stages of testing its coronavirus vaccine in the UK. Another large trial was announced to start by October in the US. [38]

Clinical trials

Phase I and II

On 26 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. [39]

Phase III

On 24 September 2020, Novavax started for a phase III trial with 15,000 in the UK. [40] [41]

In December, Novavax started the PREVENT-19 (NCT04611802) phase III trial in the US and Mexico, funded by NIAID and BARDA. [42] [43]

On 3 May 2021, Novavax initiated a pediatric expansion for the phase III clinical trial, with 3,000 adolescents 12–17 years old. [44]

Manufacturing

On 24 February 2021, Novavax partnered with Takeda Pharmaceutical Company to manufacture the vaccine in Japan, where its COVID-19 vaccine candidate is known as TAK-019. [45]

Novavax signed an agreement with Serum Institute of India for mass scale production for developing and low-income countries. [46] It has also been reported, that the vaccine will be manufactured in Spain [47] and in Poland by the Mabion company. [48]

On 26 May 2021, Serum Institute of India said that it has started the production of the Novavax COVID-19 vaccine candidate (branded as Covovax in India) after receiving permission from the Indian government. [49]

Authorization

  Full authorization
  Emergency authorization

In February 2021, the European Medicines Agency (EMA) started a rolling review of the Novavax COVID-19 vaccine (NVX‑CoV2373). [2] In November 2021 EMA received application for conditional marketing authorisation. [50]

On 1 November 2021, Novavax was authorized in Indonesia. [51]

On 17 November 2021, Novavax was authorized in the Philippines. [52]

The company has applied for authorization in the United Kingdom, Australia, Canada, and New Zealand. [53]

Purchases

The Australian Government placed 51 million doses of the vaccine on order in January 2021, subject to its approval by the Therapeutic Goods Administration (TGA). [54]

On 2 February 2021, Canadian Prime Minister Justin Trudeau announced that Canada has signed a tentative agreement for Novavax to produce millions of doses of its COVID-19 vaccine at a National Research Council facility in Montreal once it is approved for use by Health Canada, making it the first COVID-19 vaccine to be produced domestically in that country. [55] During the initial vaccination stages of the COVID-19 pandemic Canada's program was hampered due to relying solely on vaccines imported from Europe, India, and later the United States.[ citation needed ]

On 16 March 2021, Philippine vaccine czar Carlito Galvez Jr. announced a purchase agreement for the Novavax vaccine of 30 million doses for the national vaccination program that shall be produced by the Serum Institute of India, being the first Southeast Asian country to procure the said vaccine. [56]

On 29 March 2021, the UK government announced that their order for 60 million doses of the Novavax vaccine, which will be manufactured in the UK by FUJIFILM Diosynth Biotechnologies, will also be filled and finished in the UK by GlaxoSmithKline. [57]

On 24 June 2021, Singapore's Health Minister Ong Ye Kung announced an advance purchase agreement signed for supplies of Novavax vaccine with promising results shown, which may arrive by December 2021. [58]

On 4 August 2021, the European Commission and Novavax announced the approval of the Commission for an advance purchase agreement of 100 million doses, plus 100 million others as option, arriving from December 2021 at the earliest, pending the EMA's approval of the vaccine. The application for approval has been under a rolling review at the time of the contract. [59] [60]

On 7 September 2021, the Japanese government announced it would purchase 150 million doses of the Novavax vaccine from Takeda, marketed as TAK-019. [61] [62]

Notes

  1. 1 2 3 4 28 September 2020 to January 2021, United Kingdom. [11] According to Nextstrain, during this period, the Alpha variant completely replaced the previously dominant lineage B.1.282 by the end of October.
  2. 1 2 No cases detected.

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