Pfizer and its partner BioNTech were filing for emergency authorisation in the US of their Covid-19 vaccine, BBC reported.
It will be the job of the US Food and Drug Administration (FDA) to decide if the vaccine is safe to roll out.
It is not clear how long the FDA will take to study the data. However, the US government expects to approve the vaccine in the first half of December.
Data from an advanced trial showed the vaccine protects 94% of adults over 65.
The trial involved 41,000 people worldwide. Half were given the vaccine, and half a placebo.
The UK has pre-ordered 40 million doses and should get 10 million by the end of the year.
So when could we expect vaccinations?
If FDA authorisation does come in the first half of next month, Pfizer and BioNTech will “be ready to distribute the vaccine candidate within hours,” the two companies said.
This would be remarkably quick for vaccine development – within 10 months of detailing the genetic code. The average wait for approval in the US is nearer eight years.
Pfizer CEO Albert Bourla said on Thursday that the filing for emergency use was a “milestone in our journey to deliver a Covid-19 vaccine to the world”.
Initial doses would be scarce, though, and the Centers for Disease Control and Prevention (CDCP) will decide who is first in line.
European Commission president Ursula von der Leyen said the EU could move quickly too – by the end of the year.
But there are caveats. Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine, said both the FDA and the European Medicines Agency (EMA) would “conduct a very careful evaluation”.
And BBC health correspondent Naomi Grimley says this vaccine is still a long way off widespread use, not least because it adopts an experimental technology that has never been approved before.
How effective is it?
Data released this week suggested the Pfizer and BioNTech vaccine had 95% effectiveness.
This effectiveness was also consistent across age groups – essential given the vulnerability of the elderly – as well as ethnicities and gender.
The vaccine also had only mild-to-moderate and short-lived side-effects.