Novavax Passes First Hurdle for New Zealand Vaccine Rollout

A vial and sryinge are seen in front of a displayed Novavax logo in this illustration taken on Jan. 11, 2021. (Dado Ruvic/Illustration/Reuters)

New Zealand is one step closer to rolling out the Novavax protein-based COVID-19 vaccine called Nuvaxovid, with the country’s medicines regulator, Medsafe, granting provisional approval for the vaccine to be used in adults aged 18 and over.

Announcing the decision on Feb. 4, Chris James, group manager for Medsafe, said the organisation had worked tirelessly to ensure that “COVID-19 vaccine applications are prioritised and urgently reviewed, while still maintaining the same scrutiny that all medicine applications undergo before they can be approved.”

“Medsafe only approves a vaccine or medicine for use in New Zealand once it is satisfied that it has met acceptable standards for quality, safety, and efficacy,” James said in a release.

The provisional approval means the Ardern government must now decide whether or not to approve the use of the Nuvaxovid vaccine in New Zealand. The Ministry of Health has noted that ministers would be seeking guidance on this from the COVID-19 Vaccine Science and Technical Advisory Group.

This brings the total number of vaccines approved by the country’s medicines authority to five and includes Pfizer’s mRNA vaccine, Cominarty, for those aged 12 and over and adults, as well as the vaccines produced by AstraZeneca and Janssen.

At present, Moderna’s Spikevax has not received approval from Medsafe and does not have a purchasing agreement with the Ardern government.

Stuff.co.nz reported that the minister for the COVID-19 response, Chris Hipkins, noted in September 2021 the government was looking to utilise Nuvaxovid as part of the country’s booster program, with the Arden government arranging to purchase around 10 million doses.

“I confirmed to them that we have the ability to source doses of Novavax in the first quarter of next year, should it be required for a booster campaign; and that the preliminary information that we’re getting—and it is just ongoing discussions—from our technical experts is that they think that Novavax is shaping up well as an option for New Zealand,” Hipkins said.

The vaccine comes in a two-dose regime delivered 21 days apart. It is regarded by many as a reliable vaccine due to its use of older technology to produce the inoculation.

According to a Feb. 4 Novavax release, the vaccine is engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease.

The scientists at Novavax then utilised the company’s recombinant nanoparticle technology to generate an antigen derived from the coronavirus spike (S) protein and formulate it with Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralising antibodies.

New Zealand officials are working with Novavax to look at getting delivery of the vaccines in the first quarter of 2022.

Stanley C. Erck, president and chief executive at Novavax, thanked officials at Medsafe for their review of the vaccine, saying it was a thorough assessment.

“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,” Erck said.