Novavax COVID-19 vaccine

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

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]

Novavax COVID-19 vaccine

Vaccine description
Target	SARS-CoV-2
Vaccine type	Subunit
Clinical data
Trade names	Covovax,^[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	AU: B1^[2]^[11]^[12]^[13]
Routes of administration	Intramuscular
ATC code	J07BN04 (WHO)
Legal status
Legal status	AU: S4 (Prescription only)^[2]^[11]^[12]^[14]^[15]^[16] CA: ℞-only / Schedule D^[17]^[18]^[19]^[20] UK: POM (Prescription only)^[3] US: ℞-only with standing order;^[21] Unapproved (Emergency Use Authorization) for those aged 12+^[22]^[23]^[24]^[25] EU: Rx-only^[4] Full list of Novavax vaccine authorizations
Identifiers
DrugBank	DB15810
UNII	UK9AK2IN1P
KEGG	D12336

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%)^[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%)^[32]	Not reported	51% (−1 to 76%)^[33]	96% (74–99%)^[a]
	Hospitalization	Not reported	Not reported	100%^[b]^[32]	Not reported	Not reported	100%^[b]^[a]

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]

Clinical trials

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]

Legal status

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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Further reading

• Corum J, Zimmer C (30 December 2020). "How the Novavax Vaccine Works". The New York Times.

External links