Johnson & Johnson Inc (NYSE:JNJ) said last night it has filed for emergency use authorisation of its one-dose Coronavirus (COVID-19) vaccine with US regulator, the Food & Drug Administration (FDA).
The application follows the publication of trial data last month that showed the drug was 66% effective in preventing infections, though the figure was higher at 72% among US participants.
J&J said the treatment was also almost 100% effective in preventing deaths and hospitalisations among those who caught the virus.
The US company added that it is aiming to start a roll-out of the vaccine in March in what would be a huge boost to jab programmes in the US and European Union.
New US President Joe Biden has promised that 150mln vaccination shots will be administered within the first 100 days of his term in office and the fact that the J&J vaccine is only one dose and can be stored in a fridge is expected to give the prospect of achieving the target a significant lift.
The US has ordered 100mln doses of the vaccine at a cost of US$1bn with an option for further 200mln shots, while the European Union has placed an order for 200mln with an option over 200mln.
J&J said it will apply for approval in Europe in the coming weeks.
Once approved, the Johnson & Johnson vaccine will be the third allowed for use in the US after Pfizer/BioNTech and Moderna's alternatives.
“Today’s submission for Emergency Use Authorization of our investigational single-shot COVID-19 vaccine is a pivotal step toward reducing the burden of disease for people globally and putting an end to the pandemic,” said Paul Stoffel, J&J’s chief scientific officer in a statement.
"Upon authorization of our investigational COVID-19 vaccine for emergency use, we are ready to begin shipping,” he added.
Johnson & Johnson’s target is to administer one billion doses of the vaccine worldwide in 2021.
COVID-19 has infected over 26mln Americans and killed more than 455,000 since the pandemic began according to John Hopkins University.