Pfizer seeks first vaccine approval in US

Agence France-Presse . Washington | Published: 00:40, Nov 22,2020

 
 

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 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 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.

The British government on Friday said it has asked its independent medicines regulator to study Pfizer/BioNTech’s coronavirus vaccine with a view to an imminent roll-out.

The announcement came after the pharma giant and its German partner said they will ask US regulators for emergency use authorisation for the vaccine in what would be a major step towards fighting back against the global pandemic.

In another potential boost, a UK study indicated individuals infected with coronavirus are unlikely to catch the illness again for at least six months.

Health secretary Matt Hancock said the government had formally asked the Medicines and Healthcare products Regulatory Agency to assess the Pfizer/BioNTech vaccine for its suitability.

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 said.

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 said.

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