Novavax has applied for its Covid-19 vaccine to get provisional approval to be used in New Zealand.
It announced its application was before New Zealand's medical regulatory body Medsafe.
"We remain laser-focused on delivering our vaccine, which is built on a proven, well-understood vaccine platform, and thank the Government of New Zealand for their ongoing partnership and confidence in our Covid-19 vaccine program," Novavax chief executive Stanley Erck said.
In December, the Government announced Novavax was one of two Covid-19 vaccines it had secured at the time. It had agreed to purchase 10.72 million doses, enough for 5.36 million people.
After provisional approval is granted by Medsafe, the vaccine would still need sign off by a group of Government ministers before it can be used in New Zealand.
Novavax's submission also included clinical data from a phase 3 trial of 30,000 participants in the US and Mexico , which demonstrated 100 per cent protection against moderate and severe disease, and 90.4 per cent efficacy overall, Erck said.
Clinical data from a trial of 15,000 participants in the UK had previously been submitted to Medsafe. The vaccine demonstrated efficacy of 96.4 per cent against the original virus strain, 86.3 per cent against the Alpha variant and 89.7 per cent efficacy overall.
Director of Public Health Caroline McElnay was questioned about Novavax on October 14 — and said it wasn't as widely used as the Pfizer vaccine.
"That is not to say anything against Novavax per se — it's just to say that we have Pfizer here in New Zealand. It is widely used, it is safe, and we’re asking all New Zealanders to get on board with it."
Novavax has also applied to use the vaccine in the UK, Australia, Canada and the EU. It expects to submit to the FDA in the US by the end of the year.
The company said its vaccine is packaged as a ready-to-use liquid formulation in a vial containing 10 doses. It calls for two 0.5mL doses, 21 days apart. It is stored at 2-8C, enabling the use of existing vaccine supply and cold chain channels, Novavax said.
According to the Immunisation Advisory Centre, protein vaccines may include fragments extracted from a virus or bacteria. They may also include bacterial sugar/carbohydrate molecules that are joined to proteins. It provides the tetanus, diphtheria, and meningococcal vaccines as examples.
Medsafe has been approached for comment. Its website says Novavax's application has been received.
SHARE ME