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Pfizer/BioNTech seek first vaccine approval in US
WASHINGTON, Nov 21, 2020 (BSS/AFP) – US biotech giant Pfizer and German
partner BioNTech sought approval Friday 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.
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.
Pfizer chief executive Albert Bourla called the filing “a critical
milestone in our journey to deliver a COVID-19 vaccine to the world.”
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 nine 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 –
In the US, President Donald Trump’s eldest son Don Jr was revealed to have
tested positive for the virus earlier this week and was quarantining “at his
cabin” without any symptoms.
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Trump Jr is the latest in a long line of infections linked to the White
House, including his father. Both Trumps have consistently downplayed the
danger of the pandemic even as cases surge around the country.
More than a quarter of a million deaths have been reported in the US since
the pandemic began, with 1,800 registered on Friday.
The current numbers have alarmed authorities enough to advise that people
stay home for next week’s Thanksgiving holiday, when Americans usually travel
for family celebrations.
Not everyone is happy about the new guidelines and regulations — such as
the 13,000 petitioners who called New York City’s decision to close schools
but leave open 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 impose for its 15 million
residents on weekends starting Friday night.
Elsewhere, Canada’s largest city Toronto 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 them past the peak of their second wave.
– ‘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.
Spain is hoping to vaccinate “a very substantial part” of its 47 million
population by mid-2021, while the Netherlands is aiming for 3.5 million in
the first quarter.
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 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 AFP.
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.
But 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.”
BSS/AFP/SSS/0901 hrs