US FDA says it is working to authorise Pfizer COVID-19 vaccine fast

WASHINGTON: The United States Food and Drug Administration said on Friday (Dec 11) it was working rapidly to finalise and issue an emergency use authorisation for Pfizer's COVID-19 vaccine.

Approval of the experimental COVID-19 vaccine should come within days, with the first Americans getting immunised as early as Dec 14 or Dec 15, US Health and Human Services Secretary Alex Azar also said on Friday.

Azar, speaking on ABC News' Good Morning America programme, added that the FDA had informed the drugmaker it planned to move forward towards authorisation.

The federal government would also work with the company to get the vaccine shipped out, he added.

A panel of outside advisers to the FDA on Thursday voted overwhelmingly to endorse emergency use of the vaccine, paving the way for the agency to authorise the shot for a country that has lost more than 285,000 lives to COVID-19.

READ: Any COVID-19 vaccine adverse effects up to national agencies to review: WHO

Pfizer has asked that the two-dose vaccine, developed with German partner BioNTech, be approved for use in people aged 16 to 85.

The companies last month said that a two-dose regimen of the vaccine was 95 per cent effective in preventing illness from COVID-19, and detailed data released in the FDA's documents showed the vaccine began showing some protection even before volunteers received a second dose.

The vaccine is already approved in Britain, and people there began receiving the shots on Tuesday. Bahrain and Canada have also authorised the vaccine, and Canada expects to start inoculations next week.

READ: British grandmother is first in the world to get Pfizer-BioNTech COVID-19 vaccine outside trial

The FDA has notified the US Centers for Disease Control and Prevention and Operation Warp Speed so that they can execute their plans for timely vaccine distribution, it said in a statement.

Healthcare workers, first responders and nursing home residents are expected to receive the first doses, but a wider roll-out faces significant logistical challenges.

Another 2,902 US deaths were reported on Thursday, a day after a record 3,253 people died, a pace projected to continue for the next two to three months until the vaccine can be widely distributed.

For months, US President Donald Trump had pressured the FDA in tweets and press conferences to move more quickly, accusing staff and Pfizer of dragging their feet.

Shortly after the FDA's statement, the outgoing president criticised the agency for what he said was its slow handling of the vaccines and criticised FDA Commissioner Steven Hahn.

Trump said his "pushing" the agency had sped up new vaccine approval, but that the FDA was "still a big, old, slow turtle. Get the dam vaccines out NOW, Dr. Hahn @SteveFDA. Stop playing games and start saving lives!!!"

Pfizer shares rose 1 per cent before the opening bell, while BioNTech US shares were flat.

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