Pfizer/BioNTech seek first vaccine approval in US

WASHINGTON: US biotech giant Pfizer and German partner BioNTech sought approval to roll out their coronavirus vaccine early, a first step towards relief as surging infections prompt a return to shutdowns that traumatised 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 authorisation.

“The FDA recognises that transparency and dialogue are critical for the public to have confidence in COVID-19 vaccines,” the organisation’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.
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.