What does emergency use of a Covid-19 vaccine mean?

It's when regulators allow shots to be given to certain people while studies of safety and effectiveness are ongoing.

Before any vaccine is permitted in the U.S., it must be reviewed by the Food and Drug Administration, which requires study in thousands of people. Normally, the process to approve a new vaccine can take about a decade. But the federal government is using various methods to dramatically speed up the process for Covid-19 vaccines.

During a health crisis, the FDA can loosen its normal scientific standards to allow emergency use of experimental drugs, devices, vaccines and other medical products. The first vaccines to get the provisional green light in the U.S. are almost certain to be made available under this process, known as emergency use authorization.

Instead of the usual requirement of “substantial evidence” of safety and effectiveness for approval, the FDA can allow products onto the market as long as their benefits are likely to outweigh their risks. It has already used its emergency powers to authorize hundreds of coronavirus tests and a handful of treatments during the pandemic.

But the agency has almost no experience granting emergency use for vaccines and has laid out extra standards it will use to make decisions on upcoming Covid-19 shots.

In October, FDA officials told vaccine makers they should have two months of safety follow-up from half of the people enrolled in their studies before requesting emergency authorization. That data is expected to be enough for FDA to allow vaccinations of certain high-risk groups, such as front-line health workers and nursing home residents.

Full approval of a vaccine will likely require six months of safety follow-up as well as extensive inspections of company manufacturing sites. The leading vaccine makers are not expected to complete that process until next spring or summer. Only then is the FDA expected to grant full approval, which would allow vaccinations of the general population.

BEIJING/DUBAI, Nov 21 — Leaders of the 20 biggest economies are debating this weekend how to distribute Covid-19 vaccines, drugs and tests around the world so that poorer countries are not left out as nations look for ways to manage a post-coronavirus recovery.

The leaders are holding a two-day virtual meeting via video-conference due to the pandemic, under the chairmanship of Saudi Arabia, which holds the rotating presidency of the G20 until the end of November.

The Covid-19 pandemic, which will throw the global economy into a deep recession this year before an economic rebound expected in 2021, is at the top of the agenda.

"We must work to create the conditions for affordable and equitable access to these tools for all peoples," Saudi Arabia's King Salman bin Abdulaziz said in his opening remarks.

G20 leaders are concerned that the pandemic might further deepen global divisions between the rich and the poor.

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The United States topped 12 million cases of Covid-19 on Saturday, as the third wave's uncontrolled spread prompted the Centers for Disease Control and Prevention to urge Americans not to travel for Thanksgiving.

The country recorded more than 200,000 coronavirus cases over the last 24 hours, bringing the total to 12,002,863, according to NBC News' tally. The total number of deaths is 255,567.

More than 40 states plus Washington D.C., Puerto Rico, the U.S. Virgin Islands, and Guam are experiencing a percentage increase in cases from over the past 14 days. Of those, a dozen states are seeing a spike in new cases.

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BEIJING — President Xi Jinping said on Saturday that China is ready to step up global Covid-19 vaccine cooperation, and called for better international coordination on policies to facilitate movement of people.

Pharmaceutical companies and research centers around the world are working on potential Covid-19 vaccines, with large global trials of several of the candidates involving tens of thousands of participants underway. China has five home-grown candidates undergoing Phase III trials.

"China is willing to strengthen cooperation with other countries in the research and development, production, and distribution of vaccines," Xi told the G20 Riyadh Summit via video link.

"We will fulfill our commitments, offer help and support to other developing countries, and work hard to make vaccines a public good that citizens of all countries can use and can afford," he said.

He also called for stronger international policy coordination to establish travel "fast tracks" that would facilitate orderly global movement.

With that in mind, Xi said China would propose the creation of a mechanism by which travelers' coronavirus test results were recognized internationally through digital health codes.

As the coronavirus surges and new case records are broken daily, President Donald Trump is at his golf course for the third straight weekend at his Trump National Golf Club in Sterling, Virginia.

Trump, who has visited his club each weekend since the election, has not answered reporter's questions about the virus in weeks and he has not attended a White House coronavirus task force meeting since April or May and has no plans to attend any in the coming weeks, according to an administration official. 

Online orders have surged for confectioner Laszlo Rimoczi's chocolate Santas wearing marzipan masks, made in his small workshop in rural Hungary.

Rimoczi said he intended the sweet treats as a light-hearted joke to raise people's spirits, amid a worsening coronavirus pandemic. Now, he can hardly keep pace with demand.

He has had to simplify the design, to keep up with orders, and now produces about 100 Santas a day, using gluten-free Italian chocolate. He paints the hat red, and makes the masks from tiny white marzipan strips, adding the ribbons with icing.

Russia's President Vladimir Putin told G20 leaders on Saturday that Russia was ready to provide its Sputnik V coronavirus vaccine to other countries who need it.

Russia is also preparing its second and third vaccine, Putin said, adding that creation of vaccine portfolio was "our common goal."

Donald Trump Jr. gave a casual assessment of his condition on social media Friday night in first comments since his Covid-19 diagnosis was reported. 

"Apparently I got the ‘Rona," he said in a video posted on Instagram, adding that he feels no symptoms, "so it's a little bit odd. Maybe it's a false positive, maybe not."

"But you know, I'll follow the protocols take a little bit more time, maybe get another couple tests. And hopefully I can test a couple times in a row negative before the holidays, just again, out of an abundance of precaution," he said.

Trump Jr., 42, was among the more than a hundred people who attended an election night party at the White House, where many were seen not wearing masks. He has also been traveling around the country as a campaign surrogate to defend his father's election loss in various states.

President Donald Trump tweeted Saturday morning, "My son Donald is doing very well. Thank you."

A record 196,100 in the United States were reported to have Covid-19 Friday, another record was set in a month marked by new records.

There were 1,904 reported dead due to the coronavirus, according to NBC News' count of state and county health department figures.

An average 1,419 have been reported dead per day this week, up from an average 801 deaths per day four weeks ago, an increase of 77 percent.

Ten states counted new single-day records Friday:

• Delaware with a record 663 cases
• Idaho with 1,786 cases
• 53 reported deaths in Iowa
• 84 dead in Kansas
• 3,816 new cases in Kentucky
• 4,743 in Louisiana
• 43 dead in Nebraska
• Ohio had 8,808 new cases
• Utah reported 17 dead
• Vermont tied its previous record high set the day before with 149 cases

Track all state-level Covid-19 surges.

Iran on Saturday shuttered businesses and curtailed travel between its major cities including the capital, Tehran, as it grapples with the worst outbreak of the coronavirus in the Middle East.

Top Iranian officials initially downplayed the risks posed by the virus, before recently urging the public to wear masks and avoid unessential travel.

The country has recorded daily death tolls of above 430 over the past five days and the Iranian Health Ministry said on Saturday that the total number of confirmed cases has risen to above 840,000.

The new lockdown measures, which include shuttering most businesses, shops, malls, and restaurants, include Iran's largest cities of Mashhad, Isfahan, and Shiraz.