Novavax COVID-19 vaccine

Novavax COVID-19 vaccine
Vaccine description
TargetSARS-CoV-2
Vaccine typeSubunit
Clinical data
Trade namesCovovax,[1] Nuvaxovid[2][3][4]
Other namesNVX-CoV2373[5]
TAK-019[6]
SARS-CoV-2 rS with Matrix-M1 adjuvant[7]
Pregnancy
category
Routes of
administration		Intramuscular
ATC code
Legal status
Legal status
Identifiers
DrugBank
UNII

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).[9] Full results from Nuvaxovid's pivotal phase III trial were published in December 2021.[10]

The vaccine requires two doses[11] and is stable at 2 to 8 °C (36 to 46 °F) refrigerated temperatures.[12] The most common side effects include headache, nausea or vomiting, muscle and joint pain, tenderness and pain at the injection site, tiredness and feeling unwell.[4]

Medical uses

The Novavax COVID-19 vaccine is indicated for active immunization to prevent COVID-19 caused by SARS-CoV-2.[4]

Efficacy

A vaccine is generally considered effective if the estimate is ≥50% with a >30% lower limit of the 95% confidence interval.[13] Efficacy is closely related to effectiveness, which is generally expected to slowly decrease over time.[14]

Novavax reported in December 2021, that its phase III trial showed the vaccine achieved its primary endpoint of preventing infection at least seven days after the second dose.[15] Overall efficacy was 90.4% and efficacy against moderate-to-severe disease was 100%.[10][15]

Efficacy by variant
Doses Severity of illness Omicron Delta Alpha Gamma Beta Others circulating previously
1 Symptomatic Not reported Not reported 83% (74–90%)[lower-alpha 1] Not reported Not reported 83% (74–90%)[lower-alpha 1]
Hospitalization Not reported Not reported Not reported Not reported Not reported Not reported
2 Symptomatic Not reported Not reported 86% (71–94%)[16] Not reported 51% (−1 to 76%)[17] 96% (74–99%)[lower-alpha 1]
Hospitalization Not reported Not reported 100%[lower-alpha 2][16] Not reported Not reported 100%[lower-alpha 2][lower-alpha 1]

Technology

NVX-CoV2373 has been described as both a protein subunit vaccine[18][19][20] and a virus-like particle vaccine,[21][22] though the producers call it a "recombinant nanoparticle vaccine".[23]

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.[24] 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.[18][19][23]

The formulation includes a saponin-based adjuvant.[18][19][23]

Manufacturing

On 24 February 2021, Novavax partnered with Takeda to manufacture the vaccine in Japan, where its COVID-19 vaccine candidate is known as TAK-019.[25]

Novavax signed an agreement with Serum Institute of India for mass scale production for developing and low-income countries.[26] It has also been reported, that the vaccine will be manufactured in Spain[27] and in Poland by the Mabion company.[28] Antigens are made at Novavax’s factory Novavax CZ in the Czech Republic,[29] Novavax CZ is also marketing authorisation holder of EU authorization.[4]

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.[30]

History

In January 2020, Novavax announced development of a vaccine candidate, codenamed NVX-CoV2373, to establish immunity to SARS-CoV-2.[31] Novavax's work is in competition for vaccine development among dozens of other companies.[32]

In March 2020, Novavax announced a collaboration with Emergent BioSolutions for preclinical and early-stage human research on the vaccine candidate.[33] Under the partnership, Emergent BioSolutions was supposed to manufacture the vaccine at large scale at their Baltimore facility.[34] 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.[35]

Trials have also taken place in the United Kingdom.[36][37] The first human safety studies of the candidate, codenamed NVX-CoV2373, started in May 2020 in Australia.[38][39]

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.[40][41] 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,[40][41] where General 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.[42]

Clinical trials

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.[43][12] 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%.[11][44]

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.

On 30 June 2021, a primary Novavax-funded study published in The New England Journal of Medicine, showed 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.[16] 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).[16][45]

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%.[11][44]

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.[46]

US and Mexico trial

On 14 June 2021, Novavax announced overall 90.4% efficacy in the Phase III U.S. & Mexico trial that involved nearly 30,000 people aged 18 years of age and older.[47] 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.[48]

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.[49]

Phase III

On 24 September 2020, Novavax started for a phase III trial with 15,000 in the UK.[50][51]

In December, Novavax started the PREVENT-19 (NCT04611802) phase III trial in the US and Mexico, funded by NIAID and BARDA.[52][53]

On 3 May 2021, Novavax initiated a pediatric expansion for the phase III clinical trial, with 3,000 adolescents 12–17 years of age.[54]

Society and culture

  Full authorization
  Emergency authorization
  Allowed for travel
  Eligible COVAX recipient

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.[55] On 20 December 2021, the European Commission granted a conditional marketing authorization across the EU, following a recommendation from the European Medicines Agency (EMA), for it to be sold under the brand name Nuvaxovid.[56][4][57][58]

On 1 November 2021, the Novavax COVID-19 vaccine, produced in India and sold under the brand name Covovax, was authorized in Indonesia.[59]

On 17 November 2021, the Novavax COVID-19 vaccine, produced in India and sold under the brand name Covovax, was authorized in the Philippines.[60]

On 17 December 2021, the World Health Organization (WHO) validated the vaccine for emergency use.[61]

On 28 December 2021, India approved the vaccine for emergency use.[62]

On 12 January 2022, South Korea authorized the vaccine, conditional on Novavax, Inc.'s submission of the results of the final clinical trial for the vaccine.[63][64]

On 20 January 2022, Australia approved Nuvaxovid (Novavax) for use in people aged 18 years of age and older.[65]

On 3 February 2022, the United Kingdom approved the vaccine[66] for people aged 18 years of age and older as a first and second dose.[67][3]

On 17 February 2022, Canada authorized Novavax's Nuvaxovid COVID-19 vaccine for the prevention of COVID-19 in adults 18 years of age and older.[68]

Notes

  1. 1 2 3 4 28 September 2020 to January 2021, United Kingdom.[16] 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.

References

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  3. 1 2 3 "Regulatory approval of COVID-19 vaccine Nuvaxovid". Medicines and Healthcare products Regulatory Agency (MHRA). 3 February 2022. Retrieved 3 February 2022.
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  52. ↑ Clinical trial number NCT04611802 for "A Study Looking at the Efficacy, Immune Response, and Safety of a COVID-19 Vaccine in Adults at Risk for SARS-CoV-2" at ClinicalTrials.gov
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  55. ↑ "EMA receives application for conditional marketing authorisation of Novavax's COVID-19 vaccine, Nuvaxovid". European Medicines Agency (EMA). 17 November 2021.{{cite web}}: CS1 maint: url-status (link)
  56. ↑ "EMA recommends Nuvaxovid for authorisation in the EU" (Press release). European Medicines Agency (EMA). 20 December 2021.{{cite press release}}: CS1 maint: url-status (link)
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