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Pfizer and its German partner BioNTech have formally submitted an application to the US Food and Drug Administration to authorize their Covid-19 vaccine for emergency use.
Pfizer CEO Dr. Albert Bourla said it is a critical milestone in his journey to deliver the vaccine to the world.
The companies have also started regulatory filings in the European Union, the United Kingdom, Australia, Canada, and Japan.
The FDA said its vaccine committee would meet Dec. 10 to discuss the emergency use authorization request. If approved, it could be in use by mid-December.
“The FDA recognizes that transparency and dialogue are essential for the public to have confidence in Covid-19 vaccines,” said the organization’s director, Stephen Hahn, in a statement.
“I want to assure the American people that the FDA process and the evaluation of the data for a potential Covid-19 vaccine will be as open and transparent as possible.”
He said he couldn’t predict how long the review would take, but the federal government previously said the final green light would likely come in December.
Dr. Bourla called the presentation “a critical milestone in our journey to deliver a Covid-19 vaccine to the world.”
The BioNTech / Pfizer injection and another being developed by the American firm Moderna have taken the lead in the worldwide search 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 highly complex and controversial question of how to speed up production and distribution means there will be no immediate respite.
And the latest wave of the pandemic is hitting many regions more strongly than the first wave that swept across the world after the virus emerged in the Chinese city of Wuhan late last year.
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Deaths worldwide are approaching 1.4 million and infections are approaching 57 million, although the actual numbers are unknown as countries have different reporting methods and many cases go unrecognized.
India’s infections have surpassed nine million, second only to the United States, and some of its graveyards have run out of space.
And Mexico became the fourth country to see its death toll exceed 100,000.
“We are at a point where we do not see a clear phase of decline,” the former official of the Ministry of Health of Mexico, Malaquias López, told AFP.
In the United States, it was revealed that President Donald Trump’s eldest son, Don Jr, tested positive for the virus earlier this week and was in quarantine “in his cabin” without any symptoms.
Trump Jr. is the latest in a long line of infections related to the White House, including his father. Both Trumps have consistently downplayed the danger of the pandemic even as cases spike across the country.
More than a quarter of a million deaths have been reported in the US since the pandemic began, with 1,800 recorded yesterday.
The current figures have alarmed authorities enough to advise people to stay home during the Thanksgiving holiday next week, when Americans often travel for family celebrations.
Not everyone is happy with the new guidelines and regulations, like the 13,000 petitioners who called New York City’s decision to close schools but leave open bars and gyms “meaningless.”
California will also impose a 10 p.m. to 5 a.m. curfew starting today, a measure that mirrors that imposed by Istanbul for its 15 million residents on weekends starting last night.
Elsewhere, Canada’s largest city Toronto will be placed under a new lockdown starting Monday.
And the latest restrictions in Europe include Northern Ireland’s decision to close bars and shops for two more weeks as Portugal extends the state of emergency until December 8.
But health officials in France said three weeks of restrictions appeared to have helped them overcome the peak of their second wave.
AFP of additional reports
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