'Light at the end of the tunnel' as US readies Covid-19 vaccine distribution

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Pfizer Inc cleared the next hurdle in the race to get its Covid-19 vaccine approved for emergency use on Tuesday after the US Food and Drug Administration (FDA) released documents that did not raise any new issues about its safety or efficacy.

WASHINGTON - The rollout of the Covid-19 vaccine in the United States has started to take shape, with the army and logistics giants primed to distribute the Pfizer-BioNTech and Moderna vaccines as soon as federal regulators give the green light.

Both vaccines are on the verge of regulatory approval, which could be granted as early as this week. An independent advisory panel convened by the Food and Drug Administration (FDA) advisory committee will meet to evaluate the Pfizer vaccine on Thursday (Dec 10) and the Moderna vaccine next Thursday.

The FDA will then decide whether to authorise the vaccines for emergency use, which could take a few days to a few weeks after the meeting.

Americans with priority, like healthcare workers and vulnerable seniors, could start receiving shots within days of that authorisation.

The Pfizer vaccine moved a step closer to approval on Tuesday, as FDA scientists concluded in an analysis of clinical data that it "met the prescribed success criteria".

The herculean task of vaccine distribution, which will take place over months on a rolling basis as more doses become available, will be one of the hardest and most costly operational challenges in the history of America, said President-elect Joe Biden on Tuesday.

Speaking at an event in which he unveiled more of his Cabinet picks, Mr Biden promised "at least 100 million Covid-19 vaccine shots into the arms of Americans in 100 days".

Both Pfizer and Moderna vaccines involve two doses three to four weeks apart, meaning that 100 million shots would cover 50 million people fully.

The rollout represents light at the end of the tunnel for a country where 284,000 people have died of the coronavirus. Tens of thousands more are likely to perish in coming months before the vaccine becomes widely available, as America faces a surge in case numbers and hospitalisations.

"If authorised, tens of millions of vaccine doses will be available this month...and hundreds of millions more will quickly follow," President Donald Trump said at a summit on Operation Warp Speed, his administration's partnership with private companies to develop and distribute Covid-19 vaccines.

At the summit, Mr Trump signed an executive order to ensure that Americans have priority access to Covid-19 vaccines developed in the US, although the order did not appear to have any enforcement action.

He also said he would invoke the Defence Production Act, which would require companies to prioritise vaccine doses for Americans, if needed, but added that he did not think it would be.

His comments come amid news reports that the White House passed on a chance to secure millions of additional doses of the Pfizer vaccine, which would likely have since been snapped up by other countries. A government spokesman said that it had five other vaccine candidates, including 100 million doses from Moderna.

Vaccine doses will be allocated to states, and governors will decide how to prioritise the vaccines for their state.

The army will coordinate between states and delivery companies FedEx and UPS, and America's largest drug distributor McKesson. These companies will transport the vaccine doses across the country to the hospitals, clinics, pharmacies, long-term care facilities and other sites where they will be administered.

"Our goal is upon EUA, emergency use authorisation, we will start moving vaccines within 24 hours," said General Gustave Perna, the chief operating officer of Operation Warp Speed, at the summit.

"Every day, every week the vaccine becomes available, allocations will be provided to the states, and we will start and we will execute a consistent cadence of vaccine delivery."

He added: "We will start to have shots in arms within 96 hours of EUA."

FedEx and UPS executives promised they had enough air cargo capacity and ultra-low temperature storage facilities to handle Covid-19 vaccine deliveries.

The CVS Health and Walgreens pharmacy chains will play major roles in administering the vaccine to Americans in their on-site clinics, nursing homes, and elsewhere.

Customers at CVS, for instance, will be able to make an appointment online and come in at their scheduled time for their vaccination, receiving reminders and records by text and email.

"There's no cost to the consumer. Everyone who wants a vaccine should be able to get it," said CVS Health executive vice-president Jonathan Roberts, adding that CVS will be able to administer 25 million Covid-19 vaccines each month.

But renewed vigilance is required as cases rise across America, Vice-President Mike Pence said at the summit.

"We can see the light at the end of the tunnel. But to reach the end of the tunnel and to save American lives, we just need to redouble our efforts. We have a ways to go, America," he said.

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