Novavax COVID-19 vaccine

[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.

[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).

Matrix-M adjuvant is combined with the spike protein from the SARS-CoV-2 antigen to induce immune response in body upon vaccination.

[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.

[56] Novavax signed an agreement with Serum Institute of India for mass scale production for developing and low-income countries.

[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.

[77][78] In December 2020, Novavax started the PREVENT-19 (NCT04611802) phase III trial in the US and Mexico, funded by NIAID and BARDA.

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

[38][85] 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%.

[40] In February 2021, the European Medicines Agency (EMA) started a rolling review of the Novavax COVID-19 vaccine (NVX‑CoV2373).

[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.

[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.

[112][113] In August 2022, the FDA granted Emergency Use Authorization for the Novavax COVID‑19 vaccine in people aged 12–17 years.

[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.