Pfizer/BioNTech seek first vaccine approval in US

WASHINGTON (AFP) – United States (US) biotech giant Pfizer and German partner BioNTech sought approval on 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 (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.

European Union (EU) Commission President Ursula von der Leyen said the European bloc could also approve both before the end of the year.


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 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.

Developing countries will face deeper challenges. The World Health Organization (WHO) called on G20 nations to help plug a USD4.5 billion funding gap for a programme to distribute vaccines globally, according to a letter seen by AFP.

And the unprecedented speed at which the vaccines are being developed raised some alarm. China’s Sinopharm revealed on Friday that it has already given its experimental vaccine to nearly a million people.

But top US infectious disease official Anthony Fauci 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 scientific advances in these types of vaccines”.