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US green lights Pfizer/BioNTech vaccine emergency use order

The US Food and Drug Administration (FDA) on Friday granted an emergency use approval for a Covid-19 vaccine produced by Pfizer and BioNTech, setting the stage for a mass inoculation program in the coming days.

The US Food and Drug Administration (FDA) on Friday granted an emergency use approval for a Covid-19 vaccine produced by Pfizer and BioNTech, setting the stage for a mass inoculation program in the coming days.

With emergency approval for use in people 16 years of age or older, the US government is now expected to start shipping millions of vaccine doses in the coming days. It has already pre-ordered 100 million doses of the vaccine, which is enough to cover 50 million people since it must be administered in two stages.

“The FDA’s authorization for emergency use of the first Covid-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world,” FDA Commissioner Stephen Hahn said in a statement.

First in line to get the shots are health-care workers and nursing home residents. Most people are not expected to get inoculated until spring or summer, health authorities say.

President Donald Trump hailed the news as a “medical miracle” saying that the first doses will be administered in less than 24 hours.

“We have already begun shipping the vaccine to every state and zip code in the country,” Trump said.

The vaccine approval process come as the US daily death toll continues to break records, topping 3,000 people for the first time on Wednesday. The nation is in the midst of a massive surge in cases with dwindling hospital beds across the country, renewed lockdown orders in many states and a total death toll approaching 300,000 Americans – the highest in the world.

The FDA approval was expected after a US government panel comprised of outside experts endorsed the vaccine on Thursday.

The vaccine, developed by US pharma giant Pfizer and its German partner BioNTech and found to be 95-per-cent effective in a late-stage trial, is already approved in countries including Britain and Canada.

Hospitalizations are at record levels, at over 107,000, according to the Covid Tracking Project, pushing health-care systems across the country towards their breaking point.

US states are cracking down with fresh measures to curb the spread of the virus. New York City restaurants must shut down indoor dining again starting next week, Governor Andrew Cuomo said on Friday, citing increased hospitalizations.

The US advisory panel is also set to review a second vaccine, developed by Moderna, next week.

On Friday Moderna said the US government purchased an additional 100 million doses of its Covid-19 vaccine, which has yet which has yet to receive authorization from the FDA.

The US government has now purchased 200 million doses of the Moderna vaccine, which would inoculate 100 million people.

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