Novavax COVID-19 vaccine

Novavax COVID-19 vaccine, codenamed NVX-CoV2373, and also called SARS-CoV-2 rS (recombinant spike) protein nanoparticle with Matrix-M1 adjuvant, is a COVID-19 vaccine candidate developed by Novavax and Coalition for Epidemic Preparedness Innovations (CEPI). It requires two doses[1] and is stable at 2 to 8 °C (36 to 46 °F)(refrigerated).[2]

Novavax COVID-19 vaccine

Vaccine description
Target disease	COVID-19
Type	Subunit vaccine
Clinical data
Other names	NVX-CoV2373
Routes of administration	Intramuscular
Identifiers
DrugBank	DB15810

Description

NVX-CoV2373 has been described as both a protein subunit vaccine[3][4][5] and a virus-like particle vaccine,[6][7] though the producers call it a "recombinant nanoparticle vaccine".[8]

The vaccine is produced by creating an engineered baculovirus containing a gene for a modified SARS-CoV-2 spike protein. The baculovirus then infects a culture of Sf9 moth cells, which create the spike protein and display it on their cell membranes. The spike proteins are then harvested and assembled into a virus-like particle containing a synthetic lipid nanoparticle about 50 nanometers across, each displaying up to 14 spike proteins.[3][4][8]

The formulation includes a saponin-based adjuvant.[3][4][8]

Development

In January 2020, Novavax announced development of a vaccine candidate, codenamed NVX-CoV2373, to establish immunity to SARS-CoV-2.[9] Novavax's work is in competition for vaccine development among dozens of other companies.[10]

In March 2020, Novavax announced a collaboration with Emergent BioSolutions for preclinical and early-stage human research on the vaccine candidate.[11] Under the partnership, Emergent BioSolutions will manufacture the vaccine at large scale at their Baltimore facility.[12] Trials have also taken place in the United Kingdom, and subject to regulatory approval, at least 60 million doses will be manufactured by Fujifilm Diosynth Biotechnologies in Billingham for purchase by the UK government.[13][14] They also signed an agreement with Serum Institute of India for mass scale production for developing and low-income countries.[15] It has also been reported, that the vaccine will be manufactured in Spain.[16] The first human safety studies of the candidate, codenamed NVX-CoV2373, started in May 2020 in Australia.[17] [18]

In July, the company announced it might receive $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.[19][20] 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,[19][20] 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.[21]

In December 2020, Novavax started the PREVENT-19 (NCT04611802) Phase III trial in the US and Mexico.[22][23]

On 28 January 2021, Novavax reported that preliminary results from the United Kingdom trial showed that its vaccine candidate was more than 89% effective.[24][2] However, interim results from a trial in South Africa showed a lower effectiveness rate against the 501.V2 variant of the virus, at around 50-60%.[1][25]

On 2 February 2021, the 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 in Montreal, Canada, once it's approved for use by Health Canada, making it the first COVID-19 vaccine to be produced domestically.[26]

References

1. Wadman M, Jon C (28 January 2021). "Novavax vaccine delivers 89% efficacy against COVID-19 in UK—but is less potent in South Africa". Science. doi:10.1126/science.abg8101.
2. "New Covid vaccine shows 89% efficacy in UK trials". BBC News. 28 January 2021. Retrieved 28 January 2021.
3. Wadman M (November 2020). "The long shot". Science. 370 (6517): 649–653. doi:10.1126/science.370.6517.649. PMID 33154120.
4. Wadman M (28 December 2020). "Novavax launches pivotal U.S. trial of dark horse COVID-19 vaccine after manufacturing delays". Science. doi:10.1126/science.abg3441.
5. Parekh N (24 July 2020). "Novavax: A SARS-CoV-2 Protein Factory to Beat COVID-19". Archived from the original on 22 November 2020. Retrieved 24 July 2020.
6. Chung YH, Beiss V, Fiering SN, Steinmetz NF (October 2020). "COVID-19 Vaccine Frontrunners and Their Nanotechnology Design". ACS Nano. 14 (10): 12522–12537. doi:10.1021/acsnano.0c07197. PMC 7553041. PMID 33034449.
7. Medhi R, Srinoi P, Ngo N, Tran HV, Lee TR (25 September 2020). "Nanoparticle-Based Strategies to Combat COVID-19". ACS Applied Nano Materials. 3 (9): 8557–8580. doi:10.1021/acsanm.0c01978. PMC 7482545.
8. "Urgent global health needs addressed by Novavax". Novavax. Retrieved 30 January 2021.
9. Gilgore S (26 February 2020). "Novavax is working to advance a potential coronavirus vaccine. So are competitors". Washington Business Journal. Archived from the original on 16 March 2020. Retrieved 6 March 2020.
10. "COVID-19 vaccine tracker (click on 'Vaccines' tab)". Milken Institute. 11 May 2020. Archived from the original on 6 June 2020. Retrieved 12 May 2020. Lay summary.
11. Gilgore S (10 March 2020). "Novavax's coronavirus vaccine program is getting some help from Emergent BioSolutions". Washington Business Journal. Archived from the original on 9 April 2020. Retrieved 10 March 2020.
12. McCartney R. "Maryland plays an outsized role in worldwide hunt for a coronavirus vaccine". Washington Post. Archived from the original on 7 May 2020. Retrieved 8 May 2020.
13. Boseley S, Davis N (28 January 2021). "Novavax Covid vaccine shown to be nearly 90% effective in UK trial". The Guardian. Retrieved 29 January 2021.
14. Brown M (14 August 2020). "60m doses of new covid-19 vaccine could be made in Billingham - and be ready for mid-2021". TeesideLive. Reach. Retrieved 29 January 2021.
15. "Novavax signs COVID-19 vaccine supply deal with India's Serum Institute". Reuters. 5 August 2020.
16. "Spain, again chosen to produce the vaccine to combat COVID-19". This is the Real Spain. 18 September 2020.
17. Sagonowsky E (11 May 2020). "Novavax scores $384M deal, CEPI's largest ever, to fund coronavirus vaccine work". FiercePharma. Archived from the original on 16 May 2020. Retrieved 12 May 2020.
18. "Novavax starts clinical trial of its coronavirus vaccine candidate". CNBC. 25 May 2020. Archived from the original on 26 May 2020. Retrieved 26 May 2020.
19. Thomas K (7 July 2020). "U.S. Will Pay $1.6 Billion to Novavax for Coronavirus Vaccine". The New York Times. Archived from the original on 7 July 2020. Retrieved 7 July 2020.
20. Steenhuysen J (7 July 2020). "U.S. government awards Novavax $1.6 billion for coronavirus vaccine". Reuters. Archived from the original on 14 September 2020. Retrieved 15 September 2020.
21. Thomas K, Zimmer C (24 September 2020). "Novavax Enters Final Stage of Coronavirus Vaccine Trials". The New York Times. ISSN 0362-4331. Archived from the original on 28 September 2020. Retrieved 28 September 2020.
22. 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
23. "Phase 3 trial of Novavax investigational COVID-19 vaccine opens". National Institutes of Health (NIH). 28 December 2020. Retrieved 28 December 2020.
24. Lovelace B (28 January 2020). "Novavax says Covid vaccine is more than 89% effective". CNBC.
25. Facher L, Joseph A (28 January 2021). "Novavax says its Covid-19 vaccine is 90% effective in late-stage trial". Stat. Retrieved 29 January 2021.
26. "Canada signs deal to produce Novavax COVID-19 vaccine at Montreal plant". CP24. 2 February 2021. Retrieved 2 February 2021.