Pfizer/BioNTech seek early vaccine approval as second virus wave hits hard

Washington (AFP) – US giant Pfizer and its German partner BioNTech confirmed they would seek approval on Friday to roll out their coronavirus vaccine early as surging infections forced New York to shut schools and California braced for nighttime curfews.

The world is looking to scientists for salvation from the global pandemic but a second wave of infections is prompting a return to the shutdowns and closures that traumatised nations and upturned the global economy at the start of the year.

The first tangible signs of relief could come Friday when Pfizer and BioNTech file an emergency use authorisation request with the US Food and Drug Administration.

“Our work to deliver a safe and effective vaccine has never been more urgent,” Pfizer chief executive Albert Bourla said. “Filing in the US represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world.”

The scientific head of the US operation to develop a vaccine said the final green light would probably come in December.

– No quick fix –

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.

Spanish Prime Minister Pedro Sanchez said Friday he hoped to get “a very substantial part” of the nation of 47 million people vaccinated by mid-2021.

But no immediate reprieve is coming and the new wave of the pandemic is hitting many regions harder than the first since the virus emerged in the Chinese city of Wuhan late last year.

Worldwide deaths are approaching 1.4 million and total 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 since it lifted restrictions to save the economy after the loss of millions of jobs.

“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. “We don’t know where it’s going.”

– 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 request 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 rules.

More than 13,000 people have signed an online “Keep NYC Schools Open” petition after the city closed schools for its 1.1 million students but left open its bars and gyms.

“Indoor dining remains open. Gyms remain open. Nail salons and barbershops remain open. Only schools are threatened with closure. This is nonsensical,” the petition says.

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

The latest restrictions in Europe include decision by Northern Ireland to shut its pubs and shops for an extra two weeks.

But health officials in France said three weeks of curfews and shutdowns appear to have helped the country pass the worst of its latest wave.

“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 closures and the stay-at-home orders that put people’s mental health under severe strain.

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.

The UK government hopes its production can be ramped up quickly if it passes its final hurdle in a phase 3 trial and is approved.

But 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 sought to dispel concerns about the candidates from Pfizer and Moderna.

“The process of the speed did not compromise at all safety nor did it compromise scientific integrity,” he said. “It was a reflection of the extraordinary scientific advances in these types of vaccines.”