Pfizer / BioNTech seek first approval of a vaccine in the US.

WASHINGTON (AP) – US biotech giant Pfizer and its German partner BioNTech on Friday sought approval to launch its coronavirus vaccine early, a first step toward relief as rising infections prompts a return to shutdowns that they traumatized nations and the world economy earlier this year.

The world hopes that scientists will be saved from the global pandemic, as a new wave of infections forces New York to close schools and California to implement night curfews.

The US Food and Drug Administration (FDA) said its vaccine committee would meet on December 10 to discuss the application for emergency use authorization.

“The FDA recognizes that transparency and dialogue are essential for the public to have confidence in COVID-19 vaccines,” FDA Director Stephen Hahn said 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 said the final green light would likely come in December first.

“Applying in the US represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world,” said Pfizer CEO Albert Bourla.

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.

No quick fix

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.

Deaths worldwide are close to 1.4 million and infections to 57 million, although the actual figures 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.

“Initially, when the virus broke out, I thought it would bury 100 to 200 people and it would be done. But the current situation is beyond my wildest thoughts, ”New Delhi gravedigger Mohammed Shamim told AFP.

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.

Schools in New York

Current US figures, more than a quarter of a million deaths reported with 2,200 recorded on Thursday alone, have alarmed authorities enough to advise people to stay home during the Thanksgiving holiday. Thank you for next week, when Americans generally travel from coast to coast to be with their families. families.

Not everyone is happy with the new guidelines and regulations.

More than 13,000 people have signed an online petition “Keep New York City Schools Open” calling the city’s decision to close schools for its 1.1 million students but leave its bars and gyms open as “absurd. ”.

California will also impose a 10:00 pm to 5:00 am curfew beginning Saturday, a move that mirrors one that Istanbul will begin to impose for its 15 million residents on weekends beginning Friday night.

Toronto, the largest city in Canada, and much of its suburbs will be subject to 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.

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

‘Extraordinary advances’

Governments are now pinning their hopes on a vaccine that can save them from business and school closings and stay-at-home orders that put people’s mental health under severe strain.

Spanish Prime Minister Pedro Sánchez said he expected “a very substantial part” of the nation of 47 million people to be vaccinated by mid-2021, while the Netherlands said they were ready to distribute the vaccines to about 3, 5 million people in the first quarter of the year.

The British government said it had asked its independent drug regulator to study the Pfizer / BioNTech coronavirus vaccine with a view to an imminent launch.

A separate candidate vaccine being developed by the University of Oxford and AstraZeneca has been shown to be safe and effective in a smaller study of older adults, and is now in a phase 3 trial.

But developing countries will face deeper challenges. The World Health Organization has asked G20 nations to help fill a funding gap of $ 4.5 billion for a program to distribute vaccines globally, according to a letter seen by AFP.

And the unprecedented speed at which vaccines are being developed has raised some alarm.

China’s Sinopharm revealed on Friday that it has already administered its experimental vaccine to nearly one million people, including state employees and students heading to study abroad.

Anthony Fauci, America’s top infectious diseases official, has tried to allay concerns about the Pfizer and Moderna candidates, saying the speed at which they were developed “did not compromise safety” but was a “reflex. of the extraordinary scientific advances in this type of vaccines “. “

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