FDA ‘very close’ to granting emergency authorisation of Pfizer vaccine

The Food and Drug Administration is "very close" to granting emergency use authorisation for a coronavirus vaccine developed by Pfizer in partnership with the German firm BioNTech, said Alex Azar on Friday.

The vaccination of the first Americans outside clinical trials could begin on Monday, the health secretary said.

“I’ve got some good news for you here,” Mr Azar told ABC’s Good Morning America on Friday. “Just a little bit ago the FDA informed Pfizer that they do intend to proceed towards an authorization for their vaccine.

“We will work with Pfizer and get that shipped out so we could be seeing people getting vaccinated Monday, Tuesday of next week.”

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The step followed a vote on Thursday by an outside panel of experts convened by the FDA to recommend authorisation of the vaccine. The recommendation signaled that the first approval of a Covid-19 vaccine for use in the US was imminent.

That would mark a major milestone in a pandemic that has killed more than 285,000 Americans and 1.5 million people globally. The US would become the third country in the world to have authorised the use of the Pfizer/BioNTech vaccine in the broader public behind the UK and Canada, and it will be the most populous country to do so.

A similar advisory panel will review a second vaccine, developed by Moderna with the National Institute of Allergy and Infectious Diseases, on December 17th.

The United States recorded more than 224,000 confirmed cases on Thursday and 2,768 deaths, slightly down from a record high 3,124 deaths a day earlier, according to the coronavirus resource center at Johns Hopkins University.

"If we have a smooth vaccination programme where everybody steps to the plate quickly, we could get back to some form of normality, reasonably quickly," Dr Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told CNN. "Into the summer, and certainly into the fall."

But that was a distant promise for many communities with overtaxed healthcare systems struggling to handle the surge of patients. At least 200 US hospitals were at full capacity last week and in one-third of all hospitals, more than 90 per cent of all ICU beds were occupied, according to a CNN review of weekly data released by the health department.

A top coronavirus adviser to president-elect Joe Biden warned that Americans should plan "no Christmas parties", with weeks of continued pressure on healthcare systems anticipated ahead.

"The next three to six weeks at minimum are our Covid weeks," Dr Michael Osterholm, the director of the center for infectious disease research and policy in Minnesota and a member of Biden's coronavirus advisory board, told CNN. "It won't end after that, but that is the period right now where we could have a surge upon a surge upon a surge."

The US Congress failed again on Thursday to strike a deal on a new package for coronavirus relief, after the Senate majority leader, Mitch McConnell, torpedoed $160 billion in state and local funds from what had been an emerging $900 billion deal.

The Senate adjourned until next week when legislators were expected to resume their efforts.

The United Kingdom began administering the Pfizer/BioNTech vaccine earlier this week. Mr Azar said that the FDA had reviewed a recommendation by UK health officials that people with a medical history of serious allergic reactions should avoid the vaccine, after two healthcare workers who suffer from severe allergies and carry epipens had allergic reactions to the vaccine, and had to be treated. They have since recovered.

“There was really good discussion at the advisory committee yesterday, especially around these issues of the allergic reactions that we saw in the United Kingdom,” Mr Azar said.

As a last step before issuing the authorisation, the regulator needs to finalise guidance for doctors about prescribing the vaccine and advising patients.

“It’s very close, it’s really just the last dotting of Is and crossing of Ts,” Mr Azar said.

Mr Azar said earlier this week that he had been in contact with members of the Joe Biden transition team to ensure a smooth rollout of the vaccines. Both the Pfizer and Moderna vaccines require two does for maximum efficacy. Hundreds of millions of Americans could be vaccinated over the next year. - Guardian