Pfizer, BioNTech seek first vaccine approval in US

US biotech giant Pfizer and German partner BioNTech sought approval on Friday, November 20, to roll out their coronavirus vaccine early, a first step towards 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 (FDA) 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 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 9 million – second only to the United States – and some of its graveyards have been running out of room.

“Initially when the virus broke (out), I thought I’ll bury 100-200 people and it’ll 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 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 10:00 pm to 5:00 am 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 3 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.

‘Extraordinary advances’

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

Spanish Prime Minister Pedro Sanchez said he hoped to get “a very substantial part” of the nation of 47 million people vaccinated by mid-2021, while the Netherlands said they were ready to roll vaccines out to some 3.5 million people in the first quarter of the year.

The British government said it had asked its independent medicines regulator to study Pfizer/BioNTech’s coronavirus vaccine with a view to an imminent rollout.

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 called on G20 nations to help plug a $4.5 billion funding gap for a program to distribute vaccines globally, according to a letter seen by the Agence France-Presse.

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

China’s Sinopharm revealed Friday that it has already given its experimental vaccine to nearly a million people — including state employees and students heading to study abroad.

Top US infectious disease official Anthony Fauci has sought to dispel concerns about the candidates from Pfizer and Moderna, saying the speed at which they were developed “did not compromise safety” but was a “reflection of the extraordinary scientific advances in these types of vaccines.” – Rappler.com