Jack Dorsey and Mark Zuckerberg will face Congress again

A COVID-19 vaccine could come within weeks — at least a limited supply to front-line medical workers. Drug companies Pfizer, Moderna and AstraZeneca have the leading vaccine candidates. Several others remain in development.

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The Food and Drug Administration is responsible for authorizing and approving all vaccines in the USA. Widespread vaccine use once one is given the green light could provide a way to end the coronavirus pandemic. USA TODAY interviewed FDA Commissioner Stephen Hahn about how the approval process works, how quickly it could go, and how the agency will encourage Americans to take the vaccine.

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What is the ACIP? For a COVID-19 vaccine to get cleared by the FDA, these 15 experts will vouch for its safety

How a COVID-19 vaccine will be authorized

Question: How will a COVID-19 vaccine get clearance for use?

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Answer: Companies have the option of applying for either a license (called a Biologics License Application) or an Emergency Use Authorization. It’s their choice.

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Q: What is an Emergency Use Authorization (EUA)?

A: An Emergency Use Authorization is an authority that Congress gave to FDA after the 9/11 terrorist attacks to allow countermeasures, treatments or vaccines to be available earlier than would normally be done under the approval process.

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Q: Has the FDA ever issued an Emergency Use Authorization for a vaccine?

A: Yes, for an anthrax vaccine (in 2005).

Stephen Hahn, commissioner of the Food and Drug Administration, promises transparency in the vaccine approval process.

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How an Emergency Use Authorization differs from FDA approval
Q: What standards must companies meet to get Emergency Use Authorization?

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A: The standard that’s used for an EUA is that it must be effective in the treatment or prevention of COVID-19 and that the risk/benefit ratio is in favor of authorization.

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For vaccines, that’s especially important because unlike treatments, vaccines are given to people who are otherwise healthy. They don’t have COVID-19, so when we look into the risk/benefit ratio … we have to factor that into its safety and effectiveness. We have to be incredibly thoughtful about this.

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How FDA evaluates the safety of a vaccine given emergency authorization

Q: What can you say to reassure people that a vaccine approved under an EUA is just as safe and effective as one approved under a BLA, even though there isn’t as much long-term effectiveness data?

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A: The standards we expect in safety and effectiveness in an EUA are very similar to what we expect in a BLA. Our career scientists have been doing this for years; this is their area of expertise. They will be judging the science and medicine.

US President Donald Trump’s campaign on Sunday (Nov 16) dropped a major part of a lawsuit it brought seeking to halt Pennsylvania from certifying its results in the presidential election, narrowing the case to a small number of ballots.
In an amended complaint filed in federal court, the Trump campaign dropped a claim that election officials unlawfully blocked observers from watching the counting of mail-in ballots in Philadelphia and Pittsburgh.

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The pared-down lawsuit now focuses on a claim that Democratic-leaning counties unlawfully allowed voters to fix errors in their mail-in ballots in violation of state law. Officials have said the dispute affects a small number of ballots in the state, where Democrat Joe Biden is projected to win by more than 60,000 votes.

Pennsylvania officials have asked a judge in toss Trump’s lawsuit, saying the election observers were allowed to assess the processing of mail-in ballots and that all of the state’s counties were permitted to inform residents if their mailed-in ballots were deficient, even if it was not mandatory for them to do so.

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READ: Law firm Porter Wright withdraws from Trump campaign lawsuit in Pennsylvania
In Pennsylvania’s populous Montgomery County, less than 100 voters fixed ballots with technical errors, a county official testified at a court hearing on Nov 4.
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The Trump campaign continues to seek a court order blocking the Pennsylvania secretary of state from ratifying the result.
Biden clinched the election after news media and Edison Research called him as the victor in Pennsylvania, putting him over the 270 electoral votes needed to win. Edison Research said on Friday that Biden had won 306 Electoral College votes to Trump’s 232.

Trump on Sunday briefly appeared to acknowledge that Biden’s victory, but then recanted and claimed he would soon file fresh challenges. His campaign has filed a string of long-shot lawsuits in several battleground states.

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On Twitter on Sunday, Trump said many cases being filed were not from his campaign.
READ: Why Trump’s lawsuits are unlikely to change the outcome of the election
“Our big cases showing the unconstitutionality of the 2020 Election, & the outrage of things that were done to change the outcome, will soon be filed!,” he tweeted.

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Legal experts say the lawsuits have little chance of changing the outcome of the election. A senior Biden legal adviser has dismissed the litigation as “theatrics, not really lawsuits”.

WASHINGTON: President Donald Trump backtracked after appearing on Sunday (Nov 15) to acknowledge for the first time that Joe Biden won the Nov 3 election, saying he conceded “nothing” and repeating his unfounded claims of widespread voting fraud.
Biden defeated Trump by winning a series of battleground states that the Republican incumbent had won in 2016. The Democratic former vice president also won the national popular vote by more than 5.5 million votes, or 3.6 percentage points.

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Trump made his conflicting statements in a series of Twitter posts.
“He won because the Election was Rigged,” Trump wrote on Sunday morning, not referring to Biden by name. “NO VOTE WATCHERS OR OBSERVERS allowed, vote tabulated by a Radical Left privately owned company, Dominion, with a bad reputation & bum equipment that couldn’t even qualify for Texas (which I won by a lot!), the Fake & Silent Media, & more!
About an hour later, Trump wrote, “He only won in the eyes of the FAKE NEWS MEDIA. I concede NOTHING! We have a long way to go. This was a RIGGED ELECTION!”

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Trump had yet to concede the election to Biden who was called the winner on Nov 7 after enough states results came in to hand the former Democratic vice president victory.

Biden has won 306 votes in the state-by-state Electoral College system that determines the presidential winner, according to Edison Research, far more than the 270 needed.
Speaking on the NBC program “Meet the Press,” Biden’s pick for White House chief of staff, Ron Klain, said, “Donald Trump’s Twitter feed doesn’t make Joe Biden president or not president. The American people did that.”
The federal agency in charge of providing those resources, the General Services Administration, has yet to recognise Biden’s victory.

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