The Novavax Vaccine has been authorized in Great Britain and New Zealand.


Novavax Inc has received authorizations for its COVID-19 vaccine NVX-CoV2373 (brand name Nuvaxovid) in Great Britain and in New Zealand, the company reports.

NVX-CoV2373 is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax’s recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein.

Novavax Vaccine Authorized in Great Britain

The Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional marketing authorization (CMA) for Nuvaxovid for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older in Great Britain.

“We are proud that Nuvaxovid will be the first protein-based vaccine option authorized by MHRA as the United Kingdom tackles this next phase of the pandemic,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “We thank the agency for its thorough review process and are tremendously grateful to the clinical trial participants and trial sites in the U.K., as well as the Vaccines Taskforce, for their ongoing support and vital contributions to this program.”

The MHRA decision was based on the totality of preclinical, clinical, and chemistry, manufacturing and controls (CMC) data reviewed by the agency. This includes two pivotal ongoing Phase 3 clinical trials: PREVENT-19 which enrolled approximately 30,000 participants in the U.S. and Mexico, the results of which were published in the New England Journal of Medicine (NEJM)i; and a trial with almost 15,000 participants in the U.K., the results of which were also published in NEJM. In both trials, the vaccine demonstrated efficacy with a reassuring safety profile. Serious and severe adverse events were low in number and balanced between vaccine and placebo groups. The most common adverse reactions observed during clinical studies (frequency category of very common ≥1/10) were headache, nausea or vomiting, myalgia, arthralgia, injection site tenderness/pain, fatigue, and malaise. Novavax will continue to collect and analyze real-world data, including the monitoring of safety and the evaluation of variants, as the vaccine is distributed. The vaccine is stored at 2° – 8° Celsius and has a current assigned shelf life in Great Britain of 9 months.

Novavax previously announced an agreement with the U.K. Vaccines Taskforce for up to 60 million doses of Novavax’ COVID-19 vaccine.

Novavax Vaccine Authorized in New Zealand

New Zealand’s Medsafe has granted provisional approval of NVX-CoV2373 for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 in individuals 18 years of age and older. The vaccine will be supplied to New Zealand under the brand name Nuvaxovid.

“The provisional approval of Nuvaxovid by Medsafe will enable Novavax to deliver the first protein-based COVID-19 vaccine to New Zealand,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “We thank Medsafe for its thorough review and, as the pandemic continues to evolve, we remain committed to supporting New Zealand and the world in the fight against COVID-19.”

The provisional approval by Medsafe is based on evaluation of the quality, safety, and efficacy data submitted for review. This includes two pivotal Phase 3 clinical trials: PREVENT-19 enrolled approximately 30,000 participants in the U.S. and Mexico, the results of which were published in The New England Journal of Medicine (NEJM); and a trial with almost 15,000 participants in the U.K., the results of which were also published in NEJM. In both trials, NVX-CoV2373 demonstrated efficacy and a reassuring safety and tolerability profile. Serious and severe adverse events were low in number and balanced between vaccine and placebo groups. The most common adverse reactions observed during clinical studies (frequency category of very common ≥1/10) were headache, nausea or vomiting, myalgia, arthralgia, injection site tenderness/pain, fatigue, and malaise. Novavax will continue to collect and analyze real-world data, including the monitoring of safety and the evaluation of variants, as the vaccine is distributed.

Novavax and the New Zealand Government previously announced an advance purchase agreement (APA) for 10.7 million doses of Novavax’ COVID-19 vaccine. This provisional approval leverages Novavax’ manufacturing partnership with Serum Institute of India (SII), the world’s largest vaccine manufacturer by volume, which will supply initial doses to New Zealand. The provisional approval will later be supplemented with data from additional manufacturing sites in Novavax’ global supply chain.

Novavax Vaccine Authorized