Medicine:Novavax COVID-19 vaccine

From HandWiki
Short description: Vaccine against COVID-19
Novavax COVID-19 vaccine
Vaccine description
Target diseaseSARS-CoV-2
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]
AHFS/Drugs.comMonograph
License data
Pregnancy
category
Routes of
administration		Intramuscular
ATC code
Legal status
Legal status
Identifiers
DrugBank
UNII
KEGG

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).[23]

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.[24] Efficacy is closely related to effectiveness, which is generally expected to slowly decrease over time.[25]

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.[26] Overall efficacy against different SARS-CoV-2s was 90.4% and efficacy against moderate-to-severe disease was 100%.[27][26] 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.[28]

Efficacy by variant
Doses Severity of illness Omicron Delta Alpha Gamma Beta Others circulating previously
1 Symptomatic Not reported Not reported Template:Estimate[lower-alpha 1] Not reported Not reported Template:Estimate[lower-alpha 1]
Hospitalization Not reported Not reported Not reported Not reported Not reported Not reported
2 Symptomatic Not reported Not reported Template:Estimate[29] Not reported Template:Estimate[lower-alpha 1]
Hospitalization Not reported Not reported Template:Estimate[lower-alpha 2][29] Not reported Not reported Template:Estimate[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).[30]

On 27 January 2023, Australia's Therapeutic Goods Administration indicated it will add tinnitus to its label.[31]

Handling and administration

The vaccine requires two doses[32] and is stable at 2 to 8 °C (36 to 46 °F) refrigerated temperatures.[33]

Technology

NVX-CoV2373 has been described as both a protein subunit vaccine[34][35] and a virus-like particle vaccine,[36][37] though the producers call it a "recombinant nanoparticle vaccine".[38]

The vaccine is produced by creating an engineered baculovirus containing a gene for a modified SARS-CoV-2 spike protein.[39] 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.[40] 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.[34][35][38]

The formulation includes a saponin-based adjuvant[34][35][38] 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.[41]

Novavax signed an agreement with Serum Institute of India for mass scale production for developing and low-income countries.[42] In 2020 it was reported, that the vaccine would be manufactured in Spain[43] and in November 2021 it was reported to be produced in Poland by the Mabion company.[44] As of 2021, antigens were made at Novavax's factory Novavax CZ in the Czech Republic;[45] 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.[46]

History

In January 2020, Novavax announced development of a vaccine candidate, codenamed NVX-CoV2373, to establish immunity to SARS-CoV-2.[47] Novavax's work is in competition for vaccine development among dozens of other companies.[48]

In March 2020, Novavax announced a collaboration with Emergent BioSolutions for preclinical and early-stage human research on the vaccine candidate.[49] Under the partnership, Emergent BioSolutions was supposed to manufacture the vaccine at large scale at their Baltimore facility.[50] 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.[51]

Trials have also taken place in the United Kingdom.[52][53] The first human safety studies of the candidate, codenamed NVX-CoV2373, started in May 2020 in Australia.[54][55]

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.[56][57] 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.[56][57]

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.[58]

Phase III

In September 2020, Novavax started for a phase III trial with 15,000 in the UK.[59][60]

In December 2020 Novavax started the PREVENT-19 (NCT04611802) phase III trial in the US and Mexico, funded by NIAID and BARDA.[61][62]

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.[63]

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.[64][33]

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.[29] 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).[29][65]

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%.[32][66]

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.[39][67][68]

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.[69] 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.[70]

Administration

About 216,000 doses of the Novavax COVID-19 vaccine were administered in the EU/EEA from authorization to 26 June 2022.[30]

Legal status

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.[71] 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.[72][4][73][74]

As of November 2021, it has been authorized for use in Indonesia,[75] the Philippines,[76] as of December in India,[77] as of January 2022 in South Korea,[78][79] Australia,[80][81] as of February 2022 in the United Kingdom,[82] Canada,[83] Taiwan,[84] and Singapore.[85][86] As of December 2021 it was validated by the World Health Organization.[87]

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.[88][89] In July 2022, the FDA authorized NVX-CoV2373 for emergency use as a primary immunization (not booster) in adults.[90][18] making it the fourth COVID‑19 vaccine authorized in the US.[28] 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.[91][92] In August 2022, the FDA granted Emergency Use Authorization for the Novavax COVID‑19 vaccine in people aged 12–17 years.[21] In August 2022, the CDC recommended the Novavax COVID‑19 vaccine for adolescents aged 12–17 years.[93]

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).[94][95]

Notes

  1. ↑ 1.0 1.1 1.2 1.3 28 September 2020 to January 2021, United Kingdom.[29] According to Nextstrain, during this period, the Alpha variant completely replaced the previously dominant lineage B.1.282 by the end of October.
  2. ↑ 2.0 2.1 No cases detected.

References

  1. ↑ 1.0 1.1 "WHO issues emergency use listing to Novavax-Serum Institute's COVID-19 vaccine". Reuters. 17 December 2021. https://www.reuters.com/business/healthcare-pharmaceuticals/who-issues-emergency-use-listing-novavax-serum-institutes-covid-19-vaccine-2021-12-17/. 
  2. ↑ 2.0 2.1 2.2 "Nuvaxovid APMDS". Therapeutic Goods Administration (TGA). 20 January 2022. https://www.tga.gov.au/resources/auspmd/nuvaxovid. 
  3. ↑ 3.0 3.1 "Regulatory approval of COVID-19 vaccine Nuvaxovid". Medicines and Healthcare products Regulatory Agency (MHRA). 3 February 2022. https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-nuvaxovid. 
  4. ↑ 4.0 4.1 4.2 4.3 4.4 4.5 "Nuvaxovid EPAR". European Medicines Agency (EMA). 17 December 2021. https://www.ema.europa.eu/en/medicines/human/EPAR/nuvaxovid.  Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  5. ↑ 5.0 5.1 "EMA starts rolling review of Novavax's COVID-19 vaccine (NVX-CoV2373)" (Press release). European Medicines Agency (EMA). 3 February 2021. Archived from the original on 2 July 2021. Retrieved 30 June 2021.
  6. ↑ "Novavax and Takeda Finalize License Agreement for Novavax' COVID-19 Vaccine Candidate in Japan; Takeda Initiates Phase 1/2 Trial in Japan" (Press release). GlobeNewswire. 26 February 2021. Archived from the original on 2 June 2021. Retrieved 29 May 2021.
  7. ↑ "EMEA-002941-PIP01-20". European Medicines Agency (EMA). 16 March 2021. https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002941-pip01-20. 
  8. ↑ "SARS-CoV-2 rS (NVX-CoV-2373) vaccine for prevention of COVID-19". Aust Prescr 45 (2): 62. April 2022. doi:10.18773/austprescr.2022.012. PMID 35592366. PMC 9081941. https://www.nps.org.au/australian-prescriber/articles/sars-cov-2-rs-nvx-cov-2373-vaccine-for-prevention-of-covid-19. Retrieved 14 May 2022. 
  9. ↑ "Updates to the Prescribing Medicines in Pregnancy database". 21 December 2022. https://www.tga.gov.au/resources/resource/guidance/updates-prescribing-medicines-pregnancy-database. 
  10. ↑ "Novavax 2023-2024 COVID-19 Vaccine Now Authorized and Recommended for Use in the U.S. - Oct 3, 2023". Novavax (Press release). 3 October 2023. Archived from the original on 4 October 2023. Retrieved 4 October 2023.
  11. ↑ 11.0 11.1 "TGA eBS - Product and Consumer Medicine Information Licence". https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2022-PI-01041-1. 
  12. ↑ 12.0 12.1 "AusPAR: SARS-CoV-2 rS with Matrix-M adjuvant". 21 January 2022. https://www.tga.gov.au/auspar/auspar-sars-cov-2-rs-matrix-m-adjuvant. 
  13. ↑ "Updates to the Prescribing Medicines in Pregnancy database". 12 May 2022. https://www.tga.gov.au/resources/resource/guidance/updates-prescribing-medicines-pregnancy-database. 
  14. ↑ "AusPAR: SARS-CoV-2 rS vaccine with Matrix-M1 adjuvant". 27 June 2022. https://www.tga.gov.au/auspar/auspar-sars-cov-2-rs-vaccine-matrix-m1-adjuvant-0. 
  15. ↑ "AusPAR: SARS-CoV-2 rS vaccine with Matrix-M1 adjuvant". 24 June 2022. https://www.tga.gov.au/auspar/auspar-sars-cov-2-rs-vaccine-matrix-m1-adjuvant. 
  16. ↑ "Novavax) (Biocelect Pty Ltd) Labelling Exemption 2022". 21 June 2022. https://www.tga.gov.au/therapeutic-goods-poisons-standard-covid-19-vaccine-novavax-biocelect-pty-ltd-labelling-exemption-2022. 
  17. ↑ "Novavax COVID-19 Vaccine: Standing Orders for Administering Vaccine to Persons 12 Years of Age and Older". Centers for Disease Control and Prevention. 22 August 2022. https://www.cdc.gov/vaccines/covid-19/info-by-product/novavax/downloads/novavax-standing-orders.pdf. 
  18. ↑ 18.0 18.1 "Coronavirus (COVID-19) Update: FDA Authorizes Emergency Use of Novavax COVID-19 Vaccine, Adjuvanted" (Press release). U.S. Food and Drug Administration. 13 July 2022. Archived from the original on 15 July 2022. Retrieved 15 July 2022.
  19. ↑ "Novavax COVID-19 Vaccine". 13 July 2022. https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/novavax-covid-19-vaccine-adjuvanted. 
  20. ↑ Novavax, Inc. (13 July 2022). "Novavax HCP Fact Sheet 07132022". https://www.fda.gov/media/159897/download. 
  21. ↑ 21.0 21.1 "FDA Roundup: August 19, 2022". U.S. Food and Drug Administration (Press release). 19 August 2022. Archived from the original on 21 August 2022. Retrieved 20 August 2022.
  22. ↑ "Novavax COVID-19 Vaccine, Adjuvanted- nvx-cov2373 injection, suspension". 11 October 2023. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5b237fbc-d58a-4ca0-a56b-f9425d14dab5. 
  23. ↑ "Hope to launch Covovax by September, says Serum Institute CEO". mint. 27 March 2021. https://www.livemint.com/companies/news/hope-to-launch-covovax-by-september-says-serum-institute-ceo-11616834205232.html. 
  24. ↑ "COVID-19 vaccine trials should seek worthwhile efficacy". The Lancet 396 (10253): 741–743. 12 September 2020. doi:10.1016/S0140-6736(20)31821-3. ISSN 0140-6736. PMID 32861315. "WHO recommends that successful vaccines should show an estimated risk reduction of at least one-half, with sufficient precision to conclude that the true vaccine efficacy is greater than 30%. This means that the 95% CI for the trial result should exclude efficacy less than 30%. Current US Food and Drug Administration guidance includes this lower limit of 30% as a criterion for vaccine licensure.". 
  25. ↑ "Neutralizing antibody levels are highly predictive of immune protection from symptomatic SARS-CoV-2 infection". Nature Medicine 27 (7): 1205–1211. May 2021. doi:10.1038/s41591-021-01377-8. ISSN 1546-170X. PMID 34002089. 
  26. ↑ 26.0 26.1 "Efficacy and Safety of NVX-CoV2373 in Adults in the United States and Mexico". New England Journal of Medicine 386 (6): 531–543. December 2021. doi:10.1056/NEJMoa2116185. PMID 34910859. 
  27. ↑ "What Happened to the Novavax Vaccine?". 1 January 2022. https://www.medpagetoday.com/special-reports/exclusives/96461. 
  28. ↑ 28.0 28.1 "A fourth Covid vaccine is cleared for use in the United States". The New York Times. 19 July 2022. ISSN 0362-4331. https://www.nytimes.com/2022/07/19/health/cdc-novavax-covid-vaccine.html. 
  29. ↑ 29.0 29.1 29.2 29.3 29.4 "Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine". The New England Journal of Medicine 385 (13): 1172–1183. June 2021. doi:10.1056/NEJMoa2107659. PMID 34192426. 
  30. ↑ 30.0 30.1 "COVID-19 vaccines safety update". European Medicines Agency. 3 August 2022. https://www.ema.europa.eu/documents/covid-19-vaccine-safety-update/covid-19-vaccines-safety-update-14-july-2022_en.pdf.  Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  31. ↑ Therapeutic Goods Administration (27 January 2023). "COVID-19 vaccine safety report - 27-01-2023". https://www.tga.gov.au/news/covid-19-vaccine-safety-reports/covid-19-vaccine-safety-report-27-01-2023. 
  32. ↑ 32.0 32.1 "Novavax vaccine delivers 89% efficacy against COVID-19 in UK – but is less potent in South Africa". Science. 28 January 2021. doi:10.1126/science.abg8101. 
  33. ↑ 33.0 33.1 "New Covid vaccine shows 89% efficacy in UK trials". BBC News. 28 January 2021. https://www.bbc.com/news/uk-55850352. 
  34. ↑ 34.0 34.1 34.2 "The long shot". Science 370 (6517): 649–653. November 2020. doi:10.1126/science.370.6517.649. PMID 33154120. Bibcode: 2020Sci...370..649W. 
  35. ↑ 35.0 35.1 35.2 "Novavax launches pivotal U.S. trial of dark horse COVID-19 vaccine after manufacturing delays". Science. 28 December 2020. doi:10.1126/science.abg3441. 
  36. ↑ "COVID-19 Vaccine Frontrunners and Their Nanotechnology Design". ACS Nano 14 (10): 12522–12537. October 2020. doi:10.1021/acsnano.0c07197. PMID 33034449. 
  37. ↑ "Selective Naked-Eye Detection of SARS-CoV-2 Mediated by N Gene Targeted Antisense Oligonucleotide Capped Plasmonic Nanoparticles". ACS Nano 14 (6): 7617–7627. June 2020. doi:10.1021/acsanm.0c01978. PMID 32437124. 
  38. ↑ 38.0 38.1 38.2 "Urgent global health needs addressed by Novavax". Novavax. https://www.novavax.com/our-unique-technology. 
  39. ↑ 39.0 39.1 "Whole Inactivated Virus and Protein-Based COVID-19 Vaccines". Annual Review of Medicine 73 (1): 55–64. January 2022. doi:10.1146/annurev-med-042420-113212. PMID 34637324. 
  40. ↑ "Researchers Are Hatching a Low-Cost Coronavirus Vaccine". The New York Times. 5 April 2021. ISSN 0362-4331. https://www.nytimes.com/2021/04/05/health/hexapro-mclellan-vaccine.html. 
  41. ↑ "Takeda Provides Updates on Phase 1/2 Clinical Trials of Novavax' and Moderna's COVID-19 Vaccine Candidates in Japan" (Press release). Takeda. 24 February 2021. Archived from the original on 24 February 2021. Retrieved 11 March 2021.
  42. ↑ "Novavax signs COVID-19 vaccine supply deal with India's Serum Institute". Reuters. 5 August 2020. https://www.reuters.com/article/us-health-coronavirus-novavax/novavax-signs-covid-19-vaccine-supply-deal-with-indias-serum-institute-idINKCN25139A. 
  43. ↑ "Spain, again chosen to produce the vaccine to combat COVID-19". This is the Real Spain. Secretariat of State for Global Spain, Spanish Ministry of Foreign Affairs. 18 September 2020. https://www.thisistherealspain.com/en/latest-news/spain-again-chosen-to-produce-the-vaccine-to-combat-covid-19/. 
  44. ↑ "Novavax Deal With Mabion Boosts Poland's Nascent Biotech Scene". Bloomberg. 25 March 2021. https://www.bloomberg.com/news/articles/2021-03-03/novavax-deal-with-mabion-boosts-poland-s-nascent-biotech-scene. 
  45. ↑ "EU approves Novavax shot as fifth COVID vaccine". https://www.aljazeera.com/news/2021/12/20/eu-approves-novavax-shot-as-fifth-covid-vaccine. 
  46. ↑ "SII begins manufacturing, stockpiling 2nd Covid vaccine Covovax after Modi govt nod". ThePrint. 26 May 2021. https://theprint.in/health/sii-begins-manufacturing-stockpiling-2nd-covid-vaccine-covovax-after-modi-govt-nod/665600/. 
  47. ↑ "Novavax is working to advance a potential coronavirus vaccine. So are competitors.". Washington Business Journal. 26 February 2020. https://www.bizjournals.com/washington/news/2020/02/26/novavax-is-moving-forward-with-a.html. 
  48. ↑ "COVID-19 vaccine tracker (click on 'Vaccines' tab)". Milken Institute. 11 May 2020. https://docs.google.com/spreadsheets/d/16DbPhF9OD0MHHtCR12of6yUcfiRzP_-XGkynEbnipds/htmlview?pru=AAABchldaXU*ZWdU7a75RG6u_cw8QpEBhw#. 
  49. ↑ "Novavax's coronavirus vaccine program is getting some help from Emergent BioSolutions". Washington Business Journal. 10 March 2020. https://www.bizjournals.com/washington/news/2020/03/10/novavax-s-coronavirus-vaccine-program-is-getting.html. 
  50. ↑ "Maryland plays an outsized role in worldwide hunt for a coronavirus vaccine". The Washington Post. 4 May 2020. https://www.washingtonpost.com/local/maryland-plays-an-outsized-role-in-worldwide-hunt-for-a-coronavirus-vaccine/2020/05/03/3b6f2cb8-8bd5-11ea-8ac1-bfb250876b7a_story.html. 
  51. ↑ "Top Official Warned That Covid Vaccine Plant Had to Be 'Monitored Closely'". The New York Times. 7 April 2021. https://www.nytimes.com/2021/04/07/us/emergent-biosolutions-coronavirus-vaccine.html. 
  52. ↑ "Novavax Covid vaccine shown to be nearly 90% effective in UK trial". The Guardian. 28 January 2021. https://www.theguardian.com/society/2021/jan/28/novavax-covid-vaccine-shown-to-be-nearly-90-effective-in-uk-trial. 
  53. ↑ "60m doses of new covid-19 vaccine could be made in Billingham – and be ready for mid-2021". 14 August 2020. https://www.gazettelive.co.uk/news/teesside-news/60m-doses-new-covid-19-18767512. 
  54. ↑ "Novavax scores $384M deal, CEPI's largest ever, to fund coronavirus vaccine work". FiercePharma. 11 May 2020. https://www.fiercepharma.com/vaccines/novavax-scores-cepi-s-largest-award-up-to-384m-to-support-covid-19-vaccine-work. 
  55. ↑ "Novavax starts clinical trial of its coronavirus vaccine candidate". CNBC. 25 May 2020. https://www.cnbc.com/2020/05/25/novavax-starts-phase-1-clinical-trial-of-coronavirus-vaccine-candidate.html. 
  56. ↑ 56.0 56.1 "U.S. Will Pay $1.6 Billion to Novavax for Coronavirus Vaccine". The New York Times. 7 July 2020. https://www.nytimes.com/2020/07/07/health/novavax-coronavirus-vaccine-warp-speed.html. 
  57. ↑ 57.0 57.1 "U.S. government awards Novavax $1.6 billion for coronavirus vaccine". Reuters. 7 July 2020. https://www.reuters.com/article/us-health-coronavirus-novavax-idUSKBN248182. 
  58. ↑ "Human trials of potential coronavirus vaccine begin in Melbourne". Australian Broadcasting Corporation. 25 May 2020. https://www.abc.net.au/news/2020-05-26/coronavirus-vaccine-trial-begins-in-melbourne-brisbane/12286028. 
  59. ↑ "Novavax Initiates Phase 3 Efficacy Trial of COVID-19 Vaccine in the United Kingdom". Novavax. 24 September 2020. https://ir.novavax.com/2020-09-24-Novavax-Initiates-Phase-3-Efficacy-Trial-of-COVID-19-Vaccine-in-the-United-Kingdom. 
  60. ↑ "A Study Looking at the Effectiveness, Immune Response, and Safety of a COVID-19 Vaccine in Adults in the United Kingdom". United States National Library of Medicine. 12 October 2021. https://clinicaltrials.gov/ct2/show/NCT04583995. 
  61. ↑ 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
  62. ↑ "Phase 3 trial of Novavax investigational COVID-19 vaccine opens" (Press release). National Institutes of Health (NIH). 28 December 2020. Archived from the original on 19 January 2021. Retrieved 28 December 2020.
  63. ↑ "Novavax Initiates Pediatric Expansion for Phase 3 Clinical Trial of COVID-19 Vaccine" (Press release). Novavax. 3 May 2021. Archived from the original on 2 June 2021. Retrieved 30 May 2021.
  64. ↑ "Novavax says Covid vaccine is more than 89% effective". CNBC. 28 January 2020. https://www.cnbc.com/2021/01/28/covid-vaccine-novavax-says-covid-vaccine-is-more-than-89percent-effective.html. 
  65. ↑ "Novavax Publishes Results of United Kingdom Phase 3 Clinical Trial in New England Journal of Medicine, Demonstrating High Levels of Efficacy of COVID-19 Vaccine" (Press release). Novavax. 30 June 2021. Archived from the original on 30 June 2021. Retrieved 30 June 2021.
  66. ↑ "Novavax says its Covid-19 vaccine is 90% effective in late-stage trial". 28 January 2021. https://www.statnews.com/2021/01/28/novavax-says-its-covid-19-vaccine-is-90-effective-but-far-less-so-against-one-variant/. 
  67. ↑ "Efficacy of NVX-CoV2373 Covid-19 Vaccine against the B.1.351 Variant". The New England Journal of Medicine 384 (20): 1899–1909. May 2021. doi:10.1056/NEJMoa2103055. PMID 33951374. 
  68. ↑ Clinical trial number NCT04533399 for "A Phase 2A/B, Randomized,Observer-blinded, Placebo-controlled Study to Evaluate the Efficacy, Immunogenicity, and Safety of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) With Matrix-M1 Adjuvant in South African Adult Subjects Living Without HIV; and Safety and Immunogenicity in Adults Living With HIV" at ClinicalTrials.gov
  69. ↑ "Large study finds that vaccine maker Novavax's shot is about 90% effective". Los Angeles Times. 14 June 2021. https://www.latimes.com/world-nation/story/2021-06-14/novavax-large-study-finds-novavax-covid-19-shot-about-90-effective?sfmc_id=1352782. 
  70. ↑ "Novavax says Covid-19 vaccine shows 90.4% overall efficacy in US/Mexico Phase 3 trial". CNN. 14 June 2021. https://edition.cnn.com/2021/06/14/health/novavax-covid-19-vaccine-us-phase-3-trial-study/index.html. 
  71. ↑ "EMA receives application for conditional marketing authorisation of Novavax's COVID-19 vaccine, Nuvaxovid". European Medicines Agency (EMA). 17 November 2021. https://www.ema.europa.eu/en/news/ema-receives-application-conditional-marketing-authorisation-novavaxs-covid-19-vaccine-nuvaxovid. 
  72. ↑ "EMA recommends Nuvaxovid for authorisation in the EU" (Press release). European Medicines Agency (EMA). 20 December 2021. Archived from the original on 20 December 2021. Retrieved 20 December 2021.
  73. ↑ "Nuvaxovid". Union Register of medicinal products. European Commission. 6 July 2022. https://ec.europa.eu/health/documents/community-register/html/h1618.htm. 
  74. ↑ "Nuvaxovid : EPAR - Product information". European Medicines Agency. 5 July 2022. https://www.ema.europa.eu/en/documents/product-information/nuvaxovid-epar-product-information_en.pdf. 
  75. ↑ "Novavax COVID-19 vaccine receives first emergency use authorization". Reuters. 1 November 2021. https://www.reuters.com/business/healthcare-pharmaceuticals/novavax-covid-19-vaccine-receives-emergency-use-authorization-indonesia-2021-11-01/. 
  76. ↑ "Philippines approves emergency use of Novavax's COVID-19 vaccine". Reuters. 17 November 2021. https://www.reuters.com/business/healthcare-pharmaceuticals/philippines-approves-emergency-use-novavaxs-covid-19-vaccine-2021-11-17/. 
  77. ↑ "India Clears 2 New Vaccines And Merck's Covid Pill". NDTV.com. 28 December 2021. https://www.ndtv.com/india-news/coronavirus-2-more-vaccines-covovax-and-corbevax-and-anti-viral-drug-molnupiravir-cleared-in-india-2675170. 
  78. ↑ "South Korea approves Novavax coronavirus vaccine". The Washington Post. 12 January 2022. https://www.washingtonpost.com/world/2022/01/12/novavax-vaccine-south-korea-authorization-covid/. 
  79. ↑ "S.Korea authorises Novavax COVID-19 vaccine, imports Pfizer pills". Reuters. 12 January 2022. https://www.reuters.com/business/healthcare-pharmaceuticals/skorea-authorises-use-novavax-covid-19-vaccine-2022-01-12/. 
  80. ↑ "TGA provisionally approves Novavax (Biocelect Pty Ltd's) COVID-19 vaccine Nuvaxovid". Therapeutic Goods Administration (TGA) (Press release). 19 January 2022. Archived from the original on 28 January 2022. Retrieved 5 February 2022.
  81. ↑ "TGA approves provisional determination for Biocelect Pty Ltd for COVID-19 vaccine, Nuvaxovid". Therapeutic Goods Administration (TGA) (Press release). 10 March 2022. Archived from the original on 8 May 2022. Retrieved 7 May 2022.
  82. ↑ "Novavax Covid jab approved by UK drugs regulator". BBC News. 3 February 2022. https://www.bbc.com/news/health-60245736. 
  83. ↑ "Health Canada authorizes Novavax's Nuvaxovid COVID-19 vaccine" (Press release). Ottawa: Health Canada. 17 February 2022. Archived from the original on 17 February 2022. Retrieved 17 February 2022.
  84. ↑ "Novavax's COVID-19 shot authorized in Taiwan for adults". Reuters. 23 June 2022. https://www.reuters.com/business/healthcare-pharmaceuticals/novavaxs-covid-19-shot-authorized-taiwan-adults-2022-06-23/. 
  85. ↑ "Novavax Covid-19 vaccine approved for those aged 18 and above in Singapore". 14 February 2022. https://www.straitstimes.com/singapore/novavax-covid-19-vaccine-approved-for-those-aged-18-and-above-to-arrive-in-the-next-few-months. 
  86. ↑ "Novavax's Nuvaxovid COVID-19 vaccine granted interim authorisation in Singapore". 14 February 2022. https://www.channelnewsasia.com/singapore/novavax-nuvaxovid-covid-19-vaccine-interim-authorisation-singapore-hsa-2496476. 
  87. ↑ "WHO lists 9th COVID-19 vaccine for emergency use with aim to increase access to vaccination in lower-income countries" (Press release). World Health Organization (WHO). 17 December 2021. Archived from the original on 24 December 2021. Retrieved 17 December 2021.
  88. ↑ "FDA decision on Novavax's Covid shots could be delayed to review changes in manufacturing". 9 June 2022. https://www.cnbc.com/2022/06/09/fda-decision-on-novavaxs-covid-shots-could-be-delayed-.html. 
  89. ↑ "FDA advisory committee recommends Novavax vaccine for use in adults". Yahoo! Finance. 7 June 2022. https://finance.yahoo.com/news/fda-advisory-committee-recommends-novavax-vaccine-for-use-in-adults-194314939.html. 
  90. ↑ "FDA gives emergency use authorization to Novavax's Covid-19 vaccine". 13 July 2022. https://www.cnn.com/2022/07/13/health/novavax-covid-vaccine-fda-authorization/index.html. 
  91. ↑ "CDC Recommends Novavax's COVID-19 Vaccine for Adults" (Press release). Centers for Disease Control and Prevention. 19 July 2022. Archived from the original on 20 July 2022. Retrieved 21 July 2022.
  92. ↑ "CDC endorses more traditional Novavax COVID shot for adults". Associated Press. 19 July 2022. https://apnews.com/article/covid-science-health-centers-for-disease-control-and-prevention-29202c59952b4454079c36ce589eaa7b. 
  93. ↑ "CDC Recommends Novavax COVID-19 Vaccine for Adolescents" (Press release). US Centers for Disease Control and Prevention. 22 August 2022. Archived from the original on 3 September 2022. Retrieved 3 September 2022.
  94. ↑ "FDA Authorizes Updated Novavax COVID-19 Vaccine Formulated to Better Protect Against Currently Circulating Variants". U.S. Food and Drug Administration (FDA) (Press release). 3 October 2023. Archived from the original on 4 October 2023. Retrieved 4 October 2023. This article incorporates text from this source, which is in the public domain.
  95. ↑ "Novavax COVID-19 Vaccine, Adjuvanted". 3 October 2023. https://www.fda.gov/vaccines-blood-biologics/coronavirus-covid-19-cber-regulated-biologics/novavax-covid-19-vaccine-adjuvanted. 

Further reading

External links




Retrieved from "https://handwiki.org/wiki/index.php?title=Medicine:Novavax_COVID-19_vaccine&oldid=3271521"