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Pfizer/BioNTech seek first vaccine approval in US

AFP
US biotech giant Pfizer and German partner BioNTech sought approval on Friday to roll out their coronavirus vaccine early.
AFP
Pfizer/BioNTech seek first vaccine approval in US
AFP

US biotech giant Pfizer and German partner BioNTech sought approval on Friday to roll out their coronavirus vaccine early, a first step toward relief as surging infections prompt a return to shutdowns that traumatized nations and the global economy earlier this year.

The world is looking to scientists for salvation from the global pandemic, as a new wave of infections forces New York to shut schools and California to implement night time curfews.

The US Food and Drug Administration said its vaccines committee would meet on December 10 to discuss the request for emergency use authorization.

"The FDA recognizes that transparency and dialogue are critical for the public to have confidence in COVID-19 vaccines," the organization'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.

"Filing in the US represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world," Pfizer Chief Executive Albert Bourla said.

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.

No quick fix

But the vexed and enormously complex question of how to expedite production and distribution means there will be no immediate reprieve.

And the latest wave of the pandemic is hitting many regions harder than the first that swept the globe.

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.

And 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.

Schools out in NYC

Current US numbers — more than quarter of a million deaths have been reported with 2,200 registered just on Thursday — have alarmed authorities enough to advise that people stay at home for next week's Thanksgiving holiday, when Americans usually travel from coast to coast to be with their families.

Not everyone is happy about the new guidelines and regulations.

More than 13,000 people have signed an online "Keep NYC Schools Open" petition which calls the city's decision to close schools for its 1.1 million students but leave open its bars and gyms "nonsensical."

California will also impose a 10pm to 5am curfew from Saturday — a measure that mirrors one that Istanbul will start imposing for its 15 million residents on weekends starting Friday night.

Canada's largest city Toronto and much of its suburbs 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 December 8.

But health officials in France said three weeks of restrictions appeared to have helped.

"Although indicators are still at high levels, they suggest that the peak of the second wave is behind us," the country's health agency said.

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