Pfizer and its German partner BioNTech have formally submitted an application to the US Food and Drug Administration to authorise their Covid-19 vaccine for emergency use.
Pfizer's Chief executive Dr Albert Bourla said it is a critical milestone in its journey to deliver the vaccine to the world.
The companies have also begun regulatory submissions in the European Union, the UK, Australia, Canada and Japan.
The FDA said its vaccines committee would meet on 10 December to discuss the request for emergency use authorisation. If approved it could be in use by mid-December.
"The FDA recognises that transparency and dialogue are critical for the public to have confidence in Covid-19 vaccines," the organisation's head Stephen Hahn said in a statement.
"I want to assure the American people that the FDA's process and evaluation of the data for a potential Covid-19 vaccine will be as open and transparent as possible."
He said he could not predict how long the review would take, but the federal government said earlier the final green light would probably come in December.
Dr Bourla called the filing "a critical milestone in our journey to deliver a Covid-19 vaccine to the world".
The BioNTech/Pfizer shot and another one being developed by the US firm Moderna have taken the lead in the global chase for a vaccine.
EU Commission President Ursula von der Leyen said the European bloc could also approve both before the end of the year.
But the vexed and enormously complex question of how to expedite production and distribution means there will be no immediate reprieve.
The latest wave of the pandemic is hitting many regions harder than the first that swept the globe after the virus emerged in the Chinese city of Wuhan late last year.
Worldwide deaths are approaching 1.4 million and infections nearing 57 million, although the true numbers are unknown since countries have different reporting methods and many cases go undetected.
India's infections have surpassed nine million, second only to the United States, and some of its graveyards have been running out of room.
Mexico became the fourth country to see its death toll breach 100,000.
"We're at a point where we don't see a clear phase of descent," former Mexican health ministry official Malaquias Lopez told AFP.
In the US, President Donald Trump's eldest son Don Jr was revealed to have tested positive for the virus earlier this week and was quarantining "at his cabin" without any symptoms.
Mr Trump Jr is the latest in a long line of infections linked to the White House, including his father. Both Trumps have consistently downplayed the danger of the pandemic even as cases surge around the country.
More than a quarter of a million deaths have been reported in the US since the pandemic began, with 1,800 registered yesterday.
The current numbers have alarmed authorities enough to advise that people stay home for next week's Thanksgiving holiday, when Americans usually travel for family celebrations.
Not everyone is happy about the new guidelines and regulations, such as the 13,000 petitioners who called New York City's decision to close schools but leave open bars and gyms "nonsensical".
California will also impose a 10pm to 5am curfew from today, a measure that mirrors one that Istanbul will impose for its 15 million residents on weekends starting last night.
Elsewhere, Canada's largest city Toronto will be placed under a new lockdown beginning Monday.
And the latest restrictions in Europe include Northern Ireland's decision to shut pubs and shops for an extra two weeks, as Portugal extends a state of emergency until 8 December.
But health officials in France said three weeks of restrictions appeared to have helped them past the peak of their second wave.
Additional reporting AFP