Jump to content

Novavax COVID-19 vaccine

From Wikipedia, the free encyclopedia
(Redirected from Novavax COVID‑19 vaccine)
"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]
AHFS/Drugs.comMonograph
License data
Pregnancy
category
Routes of
administration		Intramuscular
ATC code
Legal status
Legal status
Identifiers
CAS Number
DrugBank
UNII
KEGG
Part of a series on the
COVID-19 pandemic
Scientifically accurate atomic model of the external structure of SARS-CoV-2. Each "ball" is an atom.
Scientifically accurate atomic model of the external structure of SARS-CoV-2. Each "ball" is an atom.
Timeline
2019
2020
2021
2022
2023
Locations
By country and territory
By conveyance
International response
National responses
Medical response
Vaccines
Current vaccines
Variants
Variants of concern
Other variants
Economic impact and recession
By country
By sport
Impacts
Long COVID
Society
Politics
virus icon COVID-19 portal

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.[32]

Updated versions of the vaccine have been developed to provide coverage against the Omicron variant, with different formulas for 2023–2024 (containing a recombinant spike protein from lineage XBB.1.5)[33] and 2024–2025 (containing recombinant spike protein from lineage JN.1).[30]

Medical uses

[edit]

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

Efficacy

[edit]

A vaccine is generally considered effective if the estimate is ≥50% with a >30% lower limit of the 95% confidence interval.[34] Efficacy is closely related to effectiveness, which is generally expected to slowly decrease over time.[35]

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.[36] Overall efficacy against different SARS-CoV-2s was 90.4% and efficacy against moderate-to-severe disease was 100%.[37][36]

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%)[38] Not reported 51% (−1 to 76%)[39] 96% (74–99%)[a]
Hospitalization Not reported Not reported 100%[b][38] Not reported Not reported 100%[b][a]

Side effects

[edit]

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).[40] It has also been reported that myocarditis (inflammation of heart muscle cells) as reported incidence from receiving the NVX-CoV2373 vaccine.[41][42]

Tinnitus is a possible side effect.[43]

Handling and administration

[edit]

The vaccine requires two doses[44] and is stable at 2 to 8 °C (36 to 46 °F) refrigerated temperatures.[45] The second dose can be administered three to eight weeks after the first dose.[46] The vaccine injection is administered intramuscularly. There are no drug interactions that may affect the vaccine's efficacy if administered with other vaccines at the same time.[46]

Pregnancy and breastfeeding

[edit]

The vaccine is a recombinant protein, not a live virus, therefore it will not replicate and spread to the infant.[47]

There are no studies conducted to trial the efficacy and safety of Novavax vaccine to people who are breastfeeding.[47]

Technology

[edit]

NVX-CoV2373 has been described as both a protein subunit vaccine[48][49] and a virus-like particle vaccine,[50][51] although the producers call it a "recombinant nanoparticle vaccine".[52]

The vaccine is produced by creating an engineered baculovirus containing a gene for a modified SARS-CoV-2 spike protein.[53] 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.[54] 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.[48][49][52]

The formulation includes a saponin-based adjuvant[48][49][52] named Matrix-M.

Matrix-M adjuvant source is purified from Quillaja Saponaria Molina Tree. Matrix-M adjuvant is combined with the spike protein from the SARS-CoV-2 antigen to induce immune response in body upon vaccination. The adjuvant primarily enhances local antibodies and immunity at the local site of injection and draining lymph nodes. The adjuvant demonstrates its protection against the virus by inducing innate immune system rapidly. At the local site of injection, the adjuvant recruits antigen presenting cells and attracts more T cells, such as CD4+ and CD8+ T cells.[41] After entry of the vaccine nanoparticle containing the recombinant spike protein of the virus, it binds to ACE2 (angiotensin-converting enzyme 2) receptor to allow endocytosis and viral replication. However, upon endocytosis these viral particles are digested by lysosome and presented to MHC class molecules. This will lead to attracting T cells (CD4+ and CD8+).[55] This chemokine activity is further enhanced by the presence of the adjuvant component to enhance immune response from the viral particle. The cascade of immune activation leads to immediate immune response to target the virus as well as creating memory B cells specific to the antigen that the virus have.[41] These memory B cells enhances our immune response by faster immune cell recognition of these subsequent viral exposure to the same antigen compared to the initial exposure.[55]

Manufacturing

[edit]

In February 2021, Novavax partnered with Takeda to manufacture the vaccine in Japan, where its COVID‑19 vaccine candidate is known as TAK-019.[56]

Novavax signed an agreement with Serum Institute of India for mass scale production for developing and low-income countries.[57] In 2020 it was reported, that the vaccine would be manufactured in Spain[58] and in November 2021 it was reported to be produced in Poland by the Mabion company.[59] As of 2021, antigens were made at Novavax's factory Novavax CZ in the Czech Republic;[60] 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.[61]

History

[edit]

In January 2020, Novavax announced development of a vaccine candidate, codenamed NVX-CoV2373, to establish immunity to SARS-CoV-2.[62] Novavax's work is in competition for vaccine development among dozens of other companies.[63]

In March 2020, Novavax announced a collaboration with Emergent BioSolutions for preclinical and early-stage human research on the vaccine candidate.[64] Under the partnership, Emergent BioSolutions was supposed to manufacture the vaccine at large scale at their Baltimore facility.[65] 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 US government.[66]

Trials have also taken place in the United Kingdom.[67][68] The first human safety studies of the candidate, codenamed NVX-CoV2373, started in May 2020 in Australia.[69][70]

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.[71][72] 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.[71][72]

In 2024, Novavax announced a deal with Sanofi in which Sanofi would take over commercialization responsibilities for NVX-CoV2373 in most countries starting in 2025.[73] The deal also allows them to use the vaccine and Matrix-M to develop new vaccine products.[74]

An adapted version of the vaccine with the brand name Nuvaxovid XBB.1.5 is available.[4] It contains a version of the protein from the Omicron XBB.1.5 subvariant of SARS-CoV-2.[4]

In October 2024, the CHMP gave a positive opinion to update the composition of Nuvaxovid, a vaccine to target the SARS-CoV-2 JN.1 variant of the virus that causes COVID-19 following the recommendations issued by EMA's Emergency Task Force to update COVID-19 vaccines for the 2024/2025 vaccination campaign.[75]

Clinical trials

[edit]

Phase I and II

[edit]

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.[76]

Phase III

[edit]

In September 2020, Novavax started a phase III trial with 15,000 participants in the UK.[77][78]

In December 2020, Novavax started the PREVENT-19 (NCT04611802) phase III trial in the US and Mexico, funded by NIAID and BARDA.[79][80]

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.[81]

Vial of vaccine from clinical trials at Thackray Museum of Medicine[82]

UK trial

[edit]

In January 2021, Novavax reported that preliminary results from the United Kingdom trial showed that its vaccine candidate was more than 89% effective.[83][45]

The Thackray Museum of Medicine in Leeds hosted the largest cohort of volunteers. Trials of the Novavax vaccine were conducted on 5,000 people there during 2021.[84]

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.[38] 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).[38][85]

South Africa trial

[edit]

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%.[44][86]

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.[53][87][88]

US and Mexico trial

[edit]

In June 2021, Novavax announced overall 90.4% efficacy in the phase III US and Mexico trial that involved nearly 30,000 people aged 18 years of age and older.[89] 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.[90]

Administration

[edit]

About 216,000 doses of the Novavax COVID-19 vaccine were administered in the EU/EEA from authorization to 26 June 2022.[40]

[edit]
  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.[91] 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.[92][4][93][94]

As of November 2021, it has been authorized for use in Indonesia,[95] the Philippines,[96] as of December in India,[97] as of January 2022 in South Korea,[98][99] Australia,[100][101] as of February 2022 in the United Kingdom,[102] Canada,[103] Taiwan,[104] and Singapore.[105][106] As of December 2021 it was validated by the World Health Organization.[107]

During June 2022 a US Food and Drug Administration (FDA) advisory committee voted 21-0 with one abstention to recommend authorization of Novavax's vaccine for use in adults.[108][109] In July 2022, the FDA authorized NVX-CoV2373 for emergency use as a primary immunization (not booster) in adults.[110][24] making it the fourth COVID‑19 vaccine authorized in the US.[111] 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.[112][113] In August 2022, the FDA granted Emergency Use Authorization for the Novavax COVID‑19 vaccine in people aged 12–17 years.[27] In August 2022, the CDC recommended the Novavax COVID‑19 vaccine for adolescents aged 12–17 years.[114]

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).[33][29]

In January 2024, it was authorized in Brazil.[115][116]

In August 2024, the FDA granted emergency use authorization for an updated version of the Novavax COVID-19 that includes a monovalent (single) component that corresponds to the Omicron variant JN.1 strain of SARS-CoV-2.[117] The Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) is no longer authorized for use.[117] The FDA granted the emergency use authorization of the Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) to Novavax Inc. of Gaithersburg, Maryland.[117]

In October 2024, the CHMP gave a positive opinion to update the composition of Nuvaxovid, a vaccine to target the SARS-CoV-2 JN.1 variant of the virus that causes COVID-19 following the recommendations issued by EMA's Emergency Task Force to update COVID-19 vaccines for the 2024/2025 vaccination campaign.[75]

Notes

[edit]
  1. ^ a b c d 28 September 2020 to January 2021, United Kingdom.[38] According to Nextstrain, during this period, the Alpha variant completely replaced the previously dominant lineage B.1.282 by the end of October.
  2. ^ a b No cases detected.

References

[edit]
  1. ^ a b "WHO issues emergency use listing to Novavax-Serum Institute's COVID-19 vaccine". Reuters. 17 December 2021. Archived from the original on 17 December 2021. Retrieved 17 December 2021.
  2. ^ a b c "Nuvaxovid APMDS". Therapeutic Goods Administration (TGA). 20 January 2022. Archived from the original on 5 February 2022. Retrieved 5 February 2022.
  3. ^ a b "Regulatory approval of COVID-19 vaccine Nuvaxovid". Medicines and Healthcare products Regulatory Agency (MHRA). 3 February 2022. Archived from the original on 3 February 2022. Retrieved 3 February 2022.
  4. ^ a b c d e f g h "Nuvaxovid EPAR". European Medicines Agency (EMA). 17 December 2021. Archived from the original on 23 December 2021. Retrieved 23 December 2021. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  5. ^ a b "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. Archived from the original on 21 June 2021. Retrieved 29 June 2021.
  8. ^ "SARS-CoV-2 rS (NVX-CoV-2373) vaccine for prevention of COVID-19". secondary. Aust Prescr. 45 (2): 62. April 2022. doi:10.18773/austprescr.2022.012. PMC 9081941. PMID 35592366. Archived from the original on 26 March 2022. Retrieved 14 May 2022.
  9. ^ "Updates to the Prescribing Medicines in Pregnancy database". Therapeutic Goods Administration (TGA). 21 December 2022. Archived from the original on 3 April 2022. Retrieved 2 January 2023.
  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. ^ a b "TGA eBS - Product and Consumer Medicine Information Licence". Archived from the original on 5 February 2022. Retrieved 5 February 2022.
  12. ^ a b "AusPAR: SARS-CoV-2 rS with Matrix-M adjuvant". Therapeutic Goods Administration (TGA). 21 January 2022. Archived from the original on 24 March 2022. Retrieved 23 March 2022.
  13. ^ "Updates to the Prescribing Medicines in Pregnancy database". Therapeutic Goods Administration (TGA). 12 May 2022. Archived from the original on 3 April 2022. Retrieved 13 May 2022.
  14. ^ "AusPAR: SARS-CoV-2 rS vaccine with Matrix-M1 adjuvant". Therapeutic Goods Administration (TGA). 27 June 2022. Archived from the original on 16 July 2022. Retrieved 17 July 2022.
  15. ^ "AusPAR: SARS-CoV-2 rS vaccine with Matrix-M1 adjuvant". Therapeutic Goods Administration (TGA). 24 June 2022. Archived from the original on 16 July 2022. Retrieved 17 July 2022.
  16. ^ "Novavax) (Biocelect Pty Ltd) Labelling Exemption 2022". Therapeutic Goods Administration (TGA). 21 June 2022. Archived from the original on 19 March 2023. Retrieved 9 April 2023.
  17. ^ "Nuvaxovid". Australian Public Assessment Report (AusPAR). The Department of Health and Aged Care, Australian Government.
  18. ^ Novavax, Inc. (24 March 2022). "Product Monograph, NUVAXOVID ™, COVID-19 Vaccine (Recombinant protein, Adjuvanted)" (PDF). Archived (PDF) from the original on 29 May 2022. Retrieved 14 July 2022.
  19. ^ "Novavax Nuvaxovid COVID-19 vaccine". Health Canada. 17 February 2022. Archived from the original on 29 May 2022. Retrieved 29 May 2022.
  20. ^ "Summary Basis of Decision (SBD) for Nuvaxovid". Health Canada. 23 October 2014. Archived from the original on 29 May 2022. Retrieved 29 May 2022.
  21. ^ "Nuvaxovid". Health Canada. 17 February 2022. Archived from the original on 1 June 2022. Retrieved 31 May 2022.
  22. ^ "Summary Basis of Decision (SBD) for Nuvaxovid XBB.1.5". Health Canada. 9 February 2024. Retrieved 24 February 2024.
  23. ^ "Novavax COVID-19 Vaccine: Standing Orders for Administering Vaccine to Persons 12 Years of Age and Older" (PDF). Centers for Disease Control and Prevention. 22 August 2022. Archived (PDF) from the original on 3 August 2022. Retrieved 3 September 2022.
  24. ^ a b "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.
  25. ^ "Novavax COVID-19 Vaccine". U.S. Food and Drug Administration. 13 July 2022. Archived from the original on 14 July 2022. Retrieved 15 July 2022.
  26. ^ Novavax, Inc. (13 July 2022). "Novavax HCP Fact Sheet 07132022". Food and Drug Administration. Archived from the original on 14 July 2022. Retrieved 15 July 2022.
  27. ^ a b "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.
  28. ^ "Novavax COVID-19 Vaccine, Adjuvanted- nvx-cov2373 injection, suspension". DailyMed. 11 October 2023. Retrieved 18 December 2023.
  29. ^ a b "Novavax COVID-19 Vaccine, Adjuvanted". U.S. Food and Drug Administration (FDA). 3 October 2023. Archived from the original on 4 October 2023. Retrieved 4 October 2023.
  30. ^ a b "Novavax COVID-19 Vaccine, Adjuvanted- nvx-cov2705 injection, suspension". DailyMed. 3 September 2024. Retrieved 16 September 2024.
  31. ^ "COVID-19 medicines". European Medicines Agency (EMA). 14 October 2024. Retrieved 14 October 2024.
  32. ^ Leo L (27 March 2021). "Hope to launch Covovax by September, says Serum Institute CEO". mint. Archived from the original on 13 May 2021. Retrieved 28 March 2021.
  33. ^ a b "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. Public Domain This article incorporates text from this source, which is in the public domain.
  34. ^ Krause P, Fleming TR, Longini I, Henao-Restrepo AM, Peto R, Dean NE, et al. (12 September 2020). "COVID-19 vaccine trials should seek worthwhile efficacy". secondary. The Lancet. 396 (10253): 741–743. doi:10.1016/S0140-6736(20)31821-3. ISSN 0140-6736. PMC 7832749. 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.
  35. ^ Khoury DS, Cromer D, Reynaldi A, Schlub TE, Wheatley AK, Juno JA, et al. (May 2021). "Neutralizing antibody levels are highly predictive of immune protection from symptomatic SARS-CoV-2 infection". primary. Nature Medicine. 27 (7): 1205–1211. doi:10.1038/s41591-021-01377-8. ISSN 1546-170X. PMID 34002089. S2CID 234769053.
  36. ^ a b Dunkle LM, Kotloff KL, Gay CL, Áñez G, Adelglass JM, Barrat Hernández AQ, et al. (December 2021). "Efficacy and Safety of NVX-CoV2373 in Adults in the United States and Mexico". primary. New England Journal of Medicine. 386 (6): 531–543. doi:10.1056/NEJMoa2116185. PMC 8693692. PMID 34910859.
  37. ^ Henderson J (1 January 2022). "What Happened to the Novavax Vaccine?". MedPage Today. Archived from the original on 7 February 2022. Retrieved 5 February 2022.
  38. ^ a b c d e Heath PT, Galiza EP, Baxter DN, Boffito M, Browne D, Burns F, et al. (June 2021). "Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine". primary. The New England Journal of Medicine. 385 (13): 1172–1183. doi:10.1056/NEJMoa2107659. PMC 8262625. PMID 34192426. S2CID 235697707.
  39. ^ Shinde V, Bhikha S, Hoosain Z, Archary M, Bhorat Q, Fairlie L, et al. (May 2021). "Efficacy of NVX-CoV2373 Covid-19 Vaccine against the B.1.351 Variant". primary. The New England Journal of Medicine. 384 (20): 1899–1909. doi:10.1056/NEJMoa2103055. PMC 8091623. PMID 33951374.
  40. ^ a b "COVID-19 vaccines safety update" (PDF). European Medicines Agency. 3 August 2022. Archived (PDF) from the original on 3 August 2022. Retrieved 3 August 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  41. ^ a b c Stertman L, Palm AE, Zarnegar B, Carow B, Lunderius Andersson C, Magnusson SE, et al. (December 2023). "The Matrix-M™ adjuvant: A critical component of vaccines for the 21st century". primary. Human Vaccines & Immunotherapeutics. 19 (1): 2189885. doi:10.1080/21645515.2023.2189885. PMC 10158541. PMID 37113023.
  42. ^ Heath PT, Galiza EP, Baxter DN, Boffito M, Browne D, Burns F, et al. (30 June 2021). "Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine". login.uml.idm.oclc.org. Retrieved 21 April 2024.
  43. ^ "COVID-19 vaccine safety report - 27-01-2023". Therapeutic Goods Administration (TGA). 27 January 2023. Archived from the original on 31 January 2023. Retrieved 31 January 2023.
  44. ^ a b 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. S2CID 234058820.
  45. ^ a b "New Covid vaccine shows 89% efficacy in UK trials". BBC News. 28 January 2021. Archived from the original on 30 January 2021. Retrieved 28 January 2021.
  46. ^ a b Crawley A, LeBras M, Regier L (February 2024). "COVID-19 PREVENTION" (PDF). Rxfiles. Retrieved 19 April 2024.
  47. ^ a b "COVID-19 Protein Subunit Vaccine (Novavax)". Mother To Baby Fact Sheets [Internet]. Brentwood (TN): Organization of Teratology Information Specialists (OTIS). May 2023.
  48. ^ a b c Wadman M (November 2020). "The long shot". comment. Science. 370 (6517): 649–653. Bibcode:2020Sci...370..649W. doi:10.1126/science.370.6517.649. PMID 33154120. S2CID 226270339.
  49. ^ a b c 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. S2CID 234411557.
  50. ^ Chung YH, Beiss V, Fiering SN, Steinmetz NF (October 2020). "COVID-19 Vaccine Frontrunners and Their Nanotechnology Design". secondary. ACS Nano. 14 (10): 12522–12537. doi:10.1021/acsnano.0c07197. PMC 7553041. PMID 33034449.
  51. ^ Moitra P, Alafeef M, Dighe K, Frieman MB, Pan D (June 2020). "Selective Naked-Eye Detection of SARS-CoV-2 Mediated by N Gene Targeted Antisense Oligonucleotide Capped Plasmonic Nanoparticles". primary. ACS Nano. 14 (6): 7617–7627. doi:10.1021/acsanm.0c01978. PMC 7482545. PMID 32437124.
  52. ^ a b c "Urgent global health needs addressed by Novavax". Novavax. Archived from the original on 12 May 2021. Retrieved 30 January 2021.
  53. ^ a b Hotez PJ, Bottazzi ME (January 2022). "Whole Inactivated Virus and Protein-Based COVID-19 Vaccines". secondary. Annual Review of Medicine. 73 (1): 55–64. doi:10.1146/annurev-med-042420-113212. PMID 34637324. S2CID 238747462.
  54. ^ Zimmer C (5 April 2021). "Researchers Are Hatching a Low-Cost Coronavirus Vaccine". The New York Times. ISSN 0362-4331. Archived from the original on 28 April 2021. Retrieved 23 April 2021.
  55. ^ a b Majumder J, Minko T (January 2021). "Recent Developments on Therapeutic and Diagnostic Approaches for COVID-19". secondary. The AAPS Journal. 23 (1): 14. doi:10.1208/s12248-020-00532-2. PMC 7784226. PMID 33400058.
  56. ^ "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.
  57. ^ "Novavax signs COVID-19 vaccine supply deal with India's Serum Institute". Reuters. 5 August 2020. Archived from the original on 19 March 2021. Retrieved 21 February 2021.
  58. ^ "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. Archived from the original on 19 March 2021. Retrieved 29 January 2021.
  59. ^ Bujnicki P, Krasuski K (25 March 2021). "Novavax Deal With Mabion Boosts Poland's Nascent Biotech Scene". Bloomberg. Archived from the original on 9 March 2021. Retrieved 24 March 2021.
  60. ^ "EU approves Novavax shot as fifth COVID vaccine". Al Jazeera English. Archived from the original on 21 December 2021. Retrieved 21 December 2021.
  61. ^ Chandna H (26 May 2021). "SII begins manufacturing, stockpiling 2nd Covid vaccine Covovax after Modi govt nod". ThePrint. Archived from the original on 29 May 2021. Retrieved 29 May 2021.
  62. ^ 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.
  63. ^ "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.
  64. ^ 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.
  65. ^ McCartney R (4 May 2020). "Maryland plays an outsized role in worldwide hunt for a coronavirus vaccine". The Washington Post. Archived from the original on 7 May 2020. Retrieved 8 May 2020.
  66. ^ Stolberg SG, LaFraniere S, Hamby C (7 April 2021). "Top Official Warned That Covid Vaccine Plant Had to Be 'Monitored Closely'". The New York Times. Archived from the original on 6 May 2021. Retrieved 6 May 2021.
  67. ^ Boseley S, Davis N (28 January 2021). "Novavax Covid vaccine shown to be nearly 90% effective in UK trial". The Guardian. Archived from the original on 12 April 2021. Retrieved 29 January 2021.
  68. ^ Brown M (14 August 2020). "60m doses of new covid-19 vaccine could be made in Billingham – and be ready for mid-2021". Teesside News. Archived from the original on 7 February 2021. Retrieved 29 January 2021.
  69. ^ 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.
  70. ^ "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.
  71. ^ a b 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.
  72. ^ a b 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.
  73. ^ Dunleavy K (10 May 2024). "Sanofi keeps Novavax afloat with $1.2B bet on its vaccine platform". Fierce Pharma. Retrieved 6 August 2024.
  74. ^ Joseph A (10 May 2024). "Sanofi enters vaccine licensing deal with Novavax, giving beleaguered biotech a lifeline". STAT. Retrieved 6 August 2024.
  75. ^ a b "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 October 2024". European Medicines Agency (EMA). 18 October 2024. Retrieved 21 October 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  76. ^ "Human trials of potential coronavirus vaccine begin in Melbourne". Australian Broadcasting Corporation. 25 May 2020. Archived from the original on 2 June 2021. Retrieved 27 July 2021.
  77. ^ "Novavax Initiates Phase 3 Efficacy Trial of COVID-19 Vaccine in the United Kingdom". Novavax. 24 September 2020. Archived from the original on 14 August 2021. Retrieved 14 August 2021.
  78. ^ "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. Archived from the original on 25 May 2021. Retrieved 13 August 2020.
  79. ^ 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
  80. ^ "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.
  81. ^ "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.
  82. ^ "2022.0001 | Collections Online". collections.thackraymuseum.co.uk. Retrieved 21 May 2024.
  83. ^ Lovelace B (28 January 2020). "Novavax says Covid vaccine is more than 89% effective". CNBC. Archived from the original on 30 January 2021. Retrieved 28 January 2021.
  84. ^ "Novavax COVID vaccine has been approved! - Thackray Museum of Medicine". thackraymuseum.co.uk. Retrieved 21 May 2024.
  85. ^ "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.
  86. ^ Facher L, Joseph A (28 January 2021). "Novavax says its Covid-19 vaccine is 90% effective in late-stage trial". Stat. Archived from the original on 29 January 2021. Retrieved 29 January 2021.
  87. ^ Shinde V, Bhikha S, Hoosain Z, Archary M, Bhorat Q, Fairlie L, et al. (May 2021). "Efficacy of NVX-CoV2373 Covid-19 Vaccine against the B.1.351 Variant". primary. The New England Journal of Medicine. 384 (20): 1899–1909. doi:10.1056/NEJMoa2103055. PMC 8091623. PMID 33951374.
  88. ^ 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
  89. ^ Johnson L (14 June 2021). "Large study finds that vaccine maker Novavax's shot is about 90% effective". Los Angeles Times. Archived from the original on 18 June 2021. Retrieved 15 June 2021.
  90. ^ Howard J (14 June 2021). "Novavax says Covid-19 vaccine shows 90.4% overall efficacy in US/Mexico Phase 3 trial". CNN. Archived from the original on 14 June 2021. Retrieved 14 June 2021.
  91. ^ "EMA receives application for conditional marketing authorisation of Novavax's COVID-19 vaccine, Nuvaxovid". European Medicines Agency (EMA). 17 November 2021. Archived from the original on 1 December 2021. Retrieved 5 December 2021.
  92. ^ "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.
  93. ^ "Nuvaxovid". Union Register of medicinal products. European Commission. 6 July 2022. Archived from the original on 20 December 2021. Retrieved 23 December 2021.
  94. ^ "Nuvaxovid : EPAR - Product information" (PDF). European Medicines Agency. 5 July 2022. Archived (PDF) from the original on 17 August 2022. Retrieved 11 August 2022.
  95. ^ O'Donnell C, Nadeem D (1 November 2021). "Novavax COVID-19 vaccine receives first emergency use authorization". Reuters. Archived from the original on 24 December 2021. Retrieved 1 November 2021.
  96. ^ "Philippines approves emergency use of Novavax's COVID-19 vaccine". Reuters. 17 November 2021. Archived from the original on 23 December 2021. Retrieved 17 November 2021.
  97. ^ Achom D (28 December 2021). "India Clears 2 New Vaccines And Merck's Covid Pill". NDTV.com. Archived from the original on 28 December 2021. Retrieved 28 December 2021.
  98. ^ Jeong A (12 January 2022). "South Korea approves Novavax coronavirus vaccine". The Washington Post. Archived from the original on 12 January 2022. Retrieved 15 January 2022.
  99. ^ "S.Korea authorises Novavax COVID-19 vaccine, imports Pfizer pills". Reuters. 12 January 2022. Archived from the original on 15 January 2022. Retrieved 16 January 2022.
  100. ^ "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.
  101. ^ "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.
  102. ^ Reed J (3 February 2022). "Novavax Covid jab approved by UK drugs regulator". BBC News. Archived from the original on 3 February 2022. Retrieved 3 February 2022.
  103. ^ "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.
  104. ^ "Novavax's COVID-19 shot authorized in Taiwan for adults". Reuters. 23 June 2022. Archived from the original on 2 July 2022. Retrieved 23 June 2022.
  105. ^ Chong C (14 February 2022). "Novavax Covid-19 vaccine approved for those aged 18 and above in Singapore". The Straits Times. Archived from the original on 9 March 2022. Retrieved 6 March 2022.
  106. ^ Andres G (14 February 2022). "Novavax's Nuvaxovid COVID-19 vaccine granted interim authorisation in Singapore". CNA. Archived from the original on 11 March 2022. Retrieved 6 March 2022.
  107. ^ "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.
  108. ^ Kimball S (9 June 2022). "FDA decision on Novavax's Covid shots could be delayed to review changes in manufacturing". CNBC. Archived from the original on 9 June 2022. Retrieved 9 June 2022.
  109. ^ Khemlani A (7 June 2022). "FDA advisory committee recommends Novavax vaccine for use in adults". Yahoo! Finance. Archived from the original on 9 June 2022. Retrieved 9 June 2022.
  110. ^ Christensen J, Goodman B (13 July 2022). "FDA gives emergency use authorization to Novavax's Covid-19 vaccine". CNN. Archived from the original on 14 July 2022. Retrieved 14 July 2022.
  111. ^ Robbins R, Zimmer C (19 July 2022). "A fourth Covid vaccine is cleared for use in the United States". The New York Times. ISSN 0362-4331. Archived from the original on 21 July 2022. Retrieved 21 July 2022.
  112. ^ "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.
  113. ^ Neergaard L (19 July 2022). "CDC endorses more traditional Novavax COVID shot for adults". Associated Press. Archived from the original on 22 July 2022. Retrieved 21 July 2022.
  114. ^ "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.
  115. ^ "Ministério da Saúde anuncia como será a vacinação contra Covid em 2025" [Ministry of Health announces how Covid vaccination will be carried out in 2025]. G1 (in Portuguese). 12 December 2024. Retrieved 13 December 2024.
  116. ^ "COVID-19 vaccine Zalika is registered in Brazil". Agência Brasil. 9 January 2024. Retrieved 13 December 2024.
  117. ^ a b c "FDA Authorizes Updated Novavax COVID-19 Vaccine to Better Protect Against Currently Circulating Variants". U.S. Food and Drug Administration (FDA) (Press release). 30 August 2024. Retrieved 31 August 2024.

Further reading

[edit]
[edit]
Scholia has a profile for NVX-CoV2373 (Q97154235).
Retrieved from "https://wiki.riteme.site/w/index.php?title=Novavax_COVID-19_vaccine&oldid=1262997453"