This section needs to be updated. Please help update this article to reflect recent events or newly available information.(December 2023)
A vaccine is generally considered effective if the estimate is ≥50% with a >30% lower limit of the 95%
confidence interval.[30]Efficacy is closely related to effectiveness, which is generally expected to slowly decrease over time.[31]
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.[32] Overall efficacy against different
SARS-CoV-2s was 90.4% and efficacy against moderate-to-severe disease was 100%.[33][32]
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.[34]
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).[37]
On 27 January 2023, Australia's Therapeutic Goods Administration indicated it will add
tinnitus to its label.[38]
Handling and administration
The vaccine requires two doses[39] and is stable at 2 to 8 °C (36 to 46 °F) refrigerated temperatures.[40]
The vaccine is produced by creating an engineered
baculovirus containing a gene for a modified
SARS-CoV-2spike protein.[46] 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.[47] The baculovirus is made to infect a
culture of
Sf9moth 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.[41][42][45]
In February 2021, Novavax partnered with
Takeda to manufacture the vaccine in Japan, where its COVID‑19 vaccine candidate is known as TAK-019.[48]
Novavax signed an agreement with
Serum Institute of India for mass scale production for developing and low-income countries.[49] In 2020 it was reported, that the vaccine would be manufactured in Spain[50] and in November 2021 it was reported to be produced in Poland by the Mabion company.[51] As of 2021, antigens were made at Novavax's factory Novavax CZ in the
Czech Republic;[52] 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.[53]
History
In January 2020, Novavax announced development of a vaccine candidate, codenamed NVX-CoV2373, to establish immunity to
SARS-CoV-2.[54] Novavax's work is in competition for vaccine development among dozens of other companies.[55]
In March 2020, Novavax announced a collaboration with
Emergent BioSolutions for
preclinical and early-stage human research on the vaccine candidate.[56] Under the partnership,
Emergent BioSolutions was supposed to manufacture the vaccine at large scale at their
Baltimore facility.[57] 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.[58]
Trials have also taken place in the United Kingdom.[59][60] The first human safety studies of the candidate, codenamed NVX-CoV2373, started in May 2020 in Australia.[61][62]
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.[63][64] 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.[63][64]
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.[65]
Phase III
In September 2020, Novavax started for a phase III trial with 15,000 in the UK.[66][67]
In December 2020 Novavax started the PREVENT-19 (NCT04611802) phase III trial in the US and Mexico, funded by
NIAID and
BARDA.[68][69]
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.[70]
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.[71][40]
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.[35] 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).[35][72]
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%.[39][73]
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.[46][74][75]
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.[76] 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.[77]
Administration
About 216,000 doses of the Novavax COVID-19 vaccine were administered in the EU/EEA from authorization to 26 June 2022.[37]
Legal status
Graphs are unavailable due to technical issues. There is more info on
Phabricator and on
MediaWiki.org.
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.[78] 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.[79][4][80][81]
As of November 2021, it has been authorized for use in Indonesia,[82] the Philippines,[83] as of December in India,[84] as of January 2022 in South Korea,[85][86] Australia,[87][88] as of February 2022 in the United Kingdom,[89] Canada,[90] Taiwan,[91] and Singapore.[92][93] As of December 2021 it was validated by the
World Health Organization.[94]
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.[95][96] In July 2022, the FDA authorized NVX-CoV2373 for
emergency use as a primary immunization (not booster) in adults.[97][24] making it the fourth COVID‑19 vaccine authorized in the US.[34] 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.[98][99] 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.[100]
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).[101][102]
Notes
^
abcd28 September 2020 to January 2021, United Kingdom.[35] According to
Nextstrain, during this period, the Alpha variant completely replaced the previously dominant lineage B.1.282 by the end of October.
^
abcdef"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.
^
ab"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.
^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". The Lancet. 396 (10253): 741–743.
doi:
10.1016/S0140-6736(20)31821-3.
ISSN0140-6736.
PMC7832749.
PMID32861315. 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.
^
ab"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.
^
abWadman 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.
S2CID234058820.
^
abcWadman 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.
S2CID234411557.
^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
^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
^"Nuvaxovid". Union Register of medicinal products. European Commission. 6 July 2022.
Archived from the original on 20 December 2021. Retrieved 23 December 2021.