IDT offers rival bid to make 100 millions MRNA vaccines, page-201

Phase 3 clinical trial results today confirm it will likely be a very important part of Australia’s vaccination program.

New data suggests Novavax’s COVID vaccine is well tolerated, with tenderness around the injection site the most common symptom.

The results of Novavax’s phase 3 ‘PREVENT-19’ trial of the NVX-CoV2373 vaccine suggest it is 90.4 % effective, and also protective against many of the new COVID variants of concern that have emerged since the pandemic began.
 
The trial, which involved 29,960 participants spread across 119 sites in the US and Mexico, also indicates that the vaccine offers 100% protection against moderate and severe disease, shoring up interim findings announced in January.
 
The results suggest the vaccine could be rolled out in Australia by the start of next year, according to infectious diseases physician and microbiologist, Associate Professor Paul Griffin, who was a Principal Investigator for Novavax’s phase 1/2 study in Australia.

While the earlier phase 1/2 trial showed very promising antibody responses, the phase 3 trial was set up to establish how effective the vaccine is, as well as its safety and immunogenicity, in communities Novavax said had been the most affected by the disease.
 
Data suggests the vaccine candidate is ‘well tolerated’, with adverse events ‘low in number and balanced between vaccine and placebo groups’, Novavax reported in its announcement.
 
Tenderness in the area of the injection, described as generally mild-to-moderate, was cited as the most common symptom, lasting less than three days. Fatigue, headache and muscle pain featured as the common systemic symptoms, reported as lasting less than two days.
 
Once wide-scale manufacturing begins, the vaccine is expected to come in a ready-to-use liquid format in 10-dose vials.
 
As of yet, there is no deal in place to manufacture the vaccine on Australian soil, but Associate Professor Griffin said he is still hopeful that one might eventuate.
 
IDT and NOVAVAX partnership will be announced in less than 8 weeks.