cloudy.png
Wednesday November 25th, 2020 8:38AM

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

By The Associated Press

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.

___

The AP is answering your questions about the coronavirus in this series. Submit them at: FactCheck@AP.org.

Who will be the first to get COVID-19 vaccines?

What does COVID-19 vaccine effectiveness mean?

How can I volunteer for a COVID-19 vaccine study?

  • Associated Categories: U.S. News, Associated Press (AP), AP National News, AP Online National News, Top U.S. News short headlines, Top General short headlines, AP Health, AP Business, AP Business - Corporate News, AP Business - Industries, AP Business - Health Care
© Copyright 2020 AccessWDUN.com
All rights reserved. This material may not be published, broadcast, rewritten, or redistributed without permission.
Advocates want light show moved from former mental facility
A battle is underway in a Boston suburb over whether it is appropriate to hold a joyous holiday celebration at the site of a now-closed institution where developmentally disabled children were once abused
2:32PM ( 4 minutes ago )
What does emergency use of a COVID-19 vaccine mean?
The first COVID-19 vaccines to be given in the U.S. are expected to get a green light from regulators under a process known as emergency use authorization
2:25PM ( 11 minutes ago )
Daily COVID-19 deaths in US reach highest level since May
The coronavirus surge is taking an increasingly dire toll across the U.S. just as a vaccine appears close at hand
2:06PM ( 30 minutes ago )
U.S. News
Europe, US 'climate guardian' satellite to monitor oceans
A satellite developed by Europe and the United States set for launching this weekend will greatly help scientists keep track of global sea level rise, one of the most daunting effects of climate change
2:09PM ( 27 minutes ago )
Trump to meet Michigan leaders in bid to subvert election
Michigan state legislators are headed to the White House as President Donald Trump makes an extraordinary and sure-to-be futile attempt to block Joe Biden’s victory in the battleground state and subvert the results of the 2020 presidential election
2:07PM ( 29 minutes ago )
VP Mike Pence campaigns in Georgia ahead of Senate runoffs
Vice President Mike Pence is campaigning Friday in Georgia in support of the state’s two Republican senators
2:07PM ( 29 minutes ago )
Associated Press (AP)
German-speaking Italian province conducts mass rapid test
Citizens in Italy’s small Germany-speaking province of South Tyrol have lined up at schools, gymnasiums and pharmacies for rapid coronavirus tests, the largest testing initiative in the country to date
12:44PM ( 1 hour ago )
The Latest: Biden task force member wants coronavirus detail
Dr. Atul Gawande, a member of President-Elect Joe Biden’s coronavirus task force, says Biden’s team needs to know the status of national personal protective equipment and plans for vaccine distribution
12:35PM ( 2 hours ago )
Mexico tops 100,000 COVID-19 deaths, 4th country to do so
Mexico has passed the 100,000 mark in confirmed COVID-19 deaths, becoming only the fourth country to do so amid concerns about the lingering physical and psychological scars on survivors and those close to them
11:11AM ( 3 hours ago )
AP Health
France postpones 'Black Friday' to help locked-down shops
France's government has gotten e-commerce businesses like Amazon and supermarket chains to delay the “Black Friday” discount shopping promotion by a week to Dec. 4
11:45AM ( 2 hours ago )
APEC leaders, including Trump, agree on free trade
Leaders from the Asia-Pacific Economic Cooperation forum, including U.S. President Donald Trump, have pledged to work toward free, open and non-discriminatory trade and investment to revive their coronavirus-battered economies
11:39AM ( 2 hours ago )
Mnuchin denies trying to hinder incoming administration
Treasury Secretary Steven Mnuchin is denying that he is trying to limit the choices President-elect Joe Biden will have to promote an economic recovery by ending several emergency loan programs being run by the Federal Reserve
11:32AM ( 3 hours ago )
AP Business
Criminal probe, legal fights await Trump after White House
President Donald Trump’s legal entanglements are likely to intensify when he leaves the White House and loses immunity from prosecution
1:01AM ( 13 hours ago )
NY probes Trump consulting payments that reduced his taxes
New York’s attorney general has sent a subpoena to the Trump Organization for records related to consulting fees paid to Ivanka Trump as part of an investigation into the president’s business dealings
12:45AM ( 13 hours ago )
The Latest: Hawaii imposes new COVID-19 travel restrictions
Gov. David Ige says anyone flying to Hawaii will be required to have a negative COVID-19 test result prior to their departure for the state, with the new rule going into effect two days before Thanksgiving
11:17PM ( 15 hours ago )
AP Business - Corporate News
Markets subdued as vaccine hopes offset outbreak concerns
Global shares are mixed in muted trading amid a continuing conflict between worries about the worsening pandemic and optimism that vaccines will help the economy next year
7:32AM ( 7 hours ago )
Global shares mixed amid tug of war between hope, fear
Global shares are mixed in muted trading amid a continuing conflict between current worries about the worsening pandemic and optimism that vaccines will rescue the economy in the future
3:47AM ( 10 hours ago )
US government executes man convicted of killing Texas teen
The U.S. government has executed a man who kidnapped and raped a 16-year-old Texas girl before dousing her with gasoline and burying her alive
1:25AM ( 13 hours ago )
AP Business - Industries
The Latest: Pence offers positive COVID-19 assessment in US
Vice President Mike Pence is offering an upbeat assessment of the status of the coronavirus in the U.S., despite a surge in cases, hospitalizations and more than a quarter of a million deaths
5:04PM ( 21 hours ago )
Stocks rise amid investors’ tug of war between hope, fear
Stocks ended higher, shaking off a weak start and nearly erasing the S&P 500's losses for the week
4:51PM ( 21 hours ago )
Biden tells governors he'll help states overcome coronavirus
In a virtual meeting with governors, Joe Biden has expressed concern that President Donald Trump’s unprecedented attempt to block the peaceful transition of power at the White House has hindered the flow of information about programs to fast-track a coronavirus vaccine
4:29PM ( 22 hours ago )
AP Business - Health Care
Advocates want light show moved from former mental facility
A battle is underway in a Boston suburb over whether it is appropriate to hold a joyous holiday celebration at the site of a now-closed institution where developmentally disabled children were once abused
2:32PM ( 4 minutes ago )
Daily COVID-19 deaths in US reach highest level since May
The coronavirus surge is taking an increasingly dire toll across the U.S. just as a vaccine appears close at hand
2:06PM ( 31 minutes ago )
Study: Motorcycle rally sparked COVID-19 cases in next state
This summer’s huge motorcycle rally in South Dakota led to dozens of coronavirus cases in neighboring Minnesota
1:58PM ( 38 minutes ago )
Midwest health system CEO says he had virus, won't wear mask
The head of one of the largest health systems in the Midwest has told his employees he's recovered from COVID-19 and is back in the office — without a mask
1:41PM ( 55 minutes ago )
Trump objects to counting thousands of Wisconsin ballots
The recount of the presidential election in Wisconsin’s two most heavily Democratic counties has begun with President Donald Trump’s campaign seeking to discard tens of thousands of absentee ballots
1:27PM ( 1 hour ago )