The jab was analysed on 29,960 participants across 119 sites in the US and Mexico, showing 100% protection against moderate and severe disease and 90% efficacy overall.
The company will file for approval in the third quarter although it was initially aiming for the spring months, but experienced delays in putting together all the data.
It said on Tuesday it is on track to reach a production of 150mln doses per month by the end of 2021.
GSK will provide ‘fill and finish’ manufacturing capacity at its Barnard Castle facility in the North East of England.
In a separate announcement, Novavax unveiled data from a study combining its COVID-19 shot with Seqirus, an approved influenza vaccine.
The analysis took a cohort of 431 volunteers in the UK as part of the wider phase III trial for the shot, led by researchers at St George’s, University of London and St George’s Hospital, London.
All received an approved seasonal influenza vaccine with half the participants co-vaccinated with NVX-CoV2373 while the remainder received placebo.
The vaccine efficacy seen in the trials with the COVID-19 jab alone was preserved, while participants also gained protection against influenza.
“As the next influenza season approaches and people still need a primary COVID-19 vaccine series or a booster, separate healthcare visits to cover both COVID-19 and influenza vaccinations will be burdensome,” said Gregory M. Glenn, President of Research and Development, Novavax.
“As the first clinical study to evaluate safety, immunogenicity, and efficacy of a COVID-19 vaccine when co-administered with a seasonal influenza vaccine, these results demonstrate the promising opportunity for concomitant vaccination, which may improve the uptake of both vaccines.”
Shares rose 1% to US$209.43 in premarket trading.