Novavax COVID-19 vaccine

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).[26]

"Covovax" redirects here. Not to be confused with COVAX or Covaxin.

Novavax COVID-19 vaccine
Vaccine description
TargetSARS-CoV-2
Vaccine typeSubunit
Clinical data
Trade namesCovovax,[1] Nuvaxovid[2][3][4]
Other names
  • NVX-CoV2373[5]
  • TAK-019[6]
  • SARS-CoV-2 rS[7][8]
  • COVID-19 Vaccine (recombinant protein)[9]
  • NVX-CoV2601[10]
Pregnancy
category
Routes of
administration		Intramuscular
ATC code
Legal status
Legal status
Identifiers
DrugBank
UNII
KEGG
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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.[27] Efficacy is closely related to effectiveness, which is generally expected to slowly decrease over time.[28]

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.[29] Overall efficacy against different SARS-CoV-2s was 90.4% and efficacy against moderate-to-severe disease was 100%.[30][29] 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.[31]

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%)[32] Not reported 51% (−1 to 76%)[33] 96% (74–99%)[lower-alpha 1]
Hospitalization Not reported Not reported 100%[lower-alpha 2][32] Not reported Not reported 100%[lower-alpha 2][lower-alpha 1]

Side effects

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).[34]

On 27 January 2023, Australia's Therapeutic Goods Administration indicated it will add tinnitus to its label.[35]

Handling and administration

The vaccine requires two doses[36] and is stable at 2 to 8 °C (36 to 46 °F) refrigerated temperatures.[37]

Technology

NVX-CoV2373 has been described as both a protein subunit vaccine[38][39] and a virus-like particle vaccine,[40][41] though the producers call it a "recombinant nanoparticle vaccine".[42]

The vaccine is produced by creating an engineered baculovirus containing a gene for a modified SARS-CoV-2 spike protein.[43] 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.[44] 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.[38][39][42]

The formulation includes a saponin-based adjuvant[38][39][42] named Matrix-M.

Manufacturing

In February 2021, Novavax partnered with Takeda 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] In 2020 it was reported, that the vaccine would be manufactured in Spain[47] and in November 2021 it was reported to be produced in Poland by the Mabion company.[48] As of 2021, antigens were made at Novavax's factory Novavax CZ in the Czech Republic;[49] 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.[50]

History

In January 2020, Novavax announced development of a vaccine candidate, codenamed NVX-CoV2373, to establish immunity to SARS-CoV-2.[51] Novavax's work is in competition for vaccine development among dozens of other companies.[52]

In March 2020, Novavax announced a collaboration with Emergent BioSolutions for preclinical and early-stage human research on the vaccine candidate.[53] Under the partnership, Emergent BioSolutions was supposed to manufacture the vaccine at large scale at their Baltimore facility.[54] 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.[55]

Trials have also taken place in the United Kingdom.[56][57] The first human safety studies of the candidate, codenamed NVX-CoV2373, started in May 2020 in Australia.[58][59]

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.[60][61] 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.[60][61]

Phase I and II

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.[62]

Phase III

In September 2020, Novavax started for a phase III trial with 15,000 in the UK.[63][64]

In December 2020 Novavax started the PREVENT-19 (NCT04611802) phase III trial in the US and Mexico, funded by NIAID and BARDA.[65][66]

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.[67]

UK trial

In January 2021, Novavax reported that preliminary results from the United Kingdom trial showed that its vaccine candidate was more than 89% effective.[68][37]

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.[32] 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).[32][69]

South Africa trial

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%.[36][70]

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.[43][71][72]

US and Mexico trial

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.[73] 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.[74]

Administration

About 216,000 doses of the Novavax COVID-19 vaccine were administered in the EU/EEA from authorization to 26 June 2022.[34]

  Full authorization
  Emergency authorization
  Allowed for travel
  Eligible COVAX recipient
See also: List of COVID-19 vaccine authorizations § Novavax

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.[75] 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.[76][4][77][78]

As of November 2021, it has been authorized for use in Indonesia,[79] the Philippines,[80] as of December in India,[81] as of January 2022 in South Korea,[82][83] Australia,[84][85] as of February 2022 in the United Kingdom,[86] Canada,[87] Taiwan,[88] and Singapore.[89][90] As of December 2021 it was validated by the World Health Organization.[91]

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.[92][93] In July 2022, the FDA authorized NVX-CoV2373 for emergency use as a primary immunization (not booster) in adults.[94][22] making it the fourth COVID‑19 vaccine authorized in the US.[31] 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.[95][96] In August 2022, the FDA granted Emergency Use Authorization for the Novavax COVID‑19 vaccine in people aged 12–17 years.[25] In August 2022, the CDC recommended the Novavax COVID‑19 vaccine for adolescents aged 12–17 years.[97]

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).[98][99]

Notes
  1. 28 September 2020 to January 2021, United Kingdom.[32] According to Nextstrain, during this period, the Alpha variant completely replaced the previously dominant lineage B.1.282 by the end of October.
  2. No cases detected.

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