Pfizer and its partner BioNTech announced on Friday that they are filing for emergency authorisation in the United States for their COVID-19 vaccine.
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.
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 Chief Executive Officer, 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.
Last week, Pfizer and BioNTech published preliminary data suggesting the vaccine offered 90% protection against COVID-19 and said there were no safety concerns.
Subsequent data released on Wednesday suggested 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.
It uses an experimental approach, called mRNA, which involves injecting part of the virus’s genetic code into the body to train the immune system.
Antibodies and T-cells are then made by the body to fight the coronavirus.