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FDA announces emergency authorization of plasma treatment for COVID-19

The FDA announced Sunday it will grant an emergency authorization (EUA) of convalescent plasma as a treatment for the coronavirus, one day after President Trump accused the agency of slow-walking the development of vaccines and therapeutics to hurt him politically.

The state of play: The authorization for plasma, which is safe but not yet proven to work on COVID-19, had been on hold after federal health officials intervened with the FDA last week and argued that the current data on the effectiveness of the treatment was too weak, The New York Times reported.


  • Former FDA commissioner Scott Gottlieb said on Sunday that plasma is "probably weakly beneficial," but that health officials "wanted to see more rigorous data to ground this decision."
  • It's unlikely to be the major "breakthrough" that White House press secretary Kayleigh McEnany touted in a tweet previewing the announcement on Saturday, according to Gottlieb and other health experts.

What they're saying:

"We’re encouraged by the early promising data that we’ve seen about convalescent plasma. The data from studies conducted this year shows that plasma from patients who’ve recovered from COVID-19 has the potential to help treat those who are suffering from the effects of getting this terrible virus. At the same time, we will continue to work with researchers to continue randomized clinical trials to study the safety and effectiveness of convalescent plasma in treating patients infected with the novel coronavirus.”
FDA commissioner Stephen Hahn

How it works: The therapeutic, which has been undergoing testing in clinical trials, involves infusions of antibody-rich plasma from people who have recovered from the virus.

  • The idea is to kick-start an infected patient's immune system so that they can fight off COVID-19 until they're able to generate their own antibodies, according to Stat News.
  • A study of 35,000 people who received plasma treatment through the Mayo Clinic found that the therapeutic has had some impact on reducing mortality among hospitalized coronavirus patients.
  • However, the study was not peer-reviewed and did not include a control group, making the data difficult to interpret.

The big picture: White House chief of staff Mark Meadows defended Trump's attacks on the FDA on Sunday, claiming on Fox News that "deep state" bureaucrats don't understand the "urgency" of the moment.

  • "We are facing unprecedented times, which require unprecedented action," Meadows said. "This president is right to call it out, and I can tell you that the announcement that's coming today should have been made several weeks ago."

Between the lines: Trump administration officials told Axios' Alayna Treene in July that the president was planning to change his messaging to heavily promote vaccines and therapeutics, including by personally announcing developments at press briefings.

  • Officials believe that's the fastest way to restore confidence in Trump and avoid having the election be a referendum on his handling of the pandemic.
  • Trump's plasma announcement comes one day before the start of the Republican National Convention.

The bottom line: The EUA — which is not the same as a full FDA approval — will make the treatment easier to obtain in some settings, but won't help advance the type of randomized trial needed to fully determine its effectiveness.

Iran's nuclear dilemma: Ramp up now or wait for Biden

The world is waiting to see whether Iran will strike back at Israel or the U.S. over the assassination of Mohsen Fakhrizadeh, the architect of Iran's military nuclear program.

Why it matters: Senior Iranian officials have stressed that Iran will take revenge against the perpetrators, but also respond by continuing Fakhrizadeh’s legacy — the nuclear program. The key question is whether Iran will accelerate that work now, or wait to see what President-elect Biden puts on the table.

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U.K. clears Pfizer-BioNTech coronavirus vaccine for mass rollout

The United Kingdom became on Wednesday the first Western country in the world to license the Pfizer/BioNTech COVID-19 vaccine for widespread use.

What they're saying: "Today’s emergency use authorisation in the UK marks a historic moment in the fight against COVID-19," said Albert Bourla, the chairman and chief executive officer of Pfizer, per the Guardian.

  • "This authorisation is a goal we have been working toward since we first declared that science will win, and we applaud the MHRA for their ability to conduct a careful assessment and take timely action to help protect the people of the UK."

Editor's note: This a breaking news story. Please check back for updates.

Biden tells NYT he won't immediately remove U.S. tariffs on China

President Trump's 25% tariffs imposed on China under the phase one trade deal will remain in place at the start of the new administration, President-elect Biden said in an interview with the New York Times published early Wednesday.

Details: "I'm not going to make any immediate moves, and the same applies to the tariffs," Biden said. He plans to conduct a full review of the current U.S. policy on China and speak with key allies in Asia and Europe to "develop a coherent strategy," he said.

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Trump threatens to veto Defense spending bill over social media shield

President Trump tweeted Tuesday a threat to veto a must-pass end-of-year $740 billion bill defense-spending authorization bill unless Conress repeals a federal law that protects social media sites from legal liability.

Why it matters: Trump's attempt to get Congress to end the tech industry protections under Section 230 of the Communications Decency Act is the latest escalation in his war on tech giants over what he and some other Republicans perceive as bias against conservatives.

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The walls close in on Trump

With Bill Barr's "Et tu, Brute!" interview with AP, President Trump is watching the walls close in on his claims of fraud, hoaxes and conspiracies.

Why it matters: Trump and his legal team continue to claim election fraud. But the Republican governors of Arizona and Georgia have certified their elections, a loyalist like Barr has weighed in, and lower-ranking officials have taken potshots.

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Congress plots COVID pandemic-era office upgrades

The House plans to renovate members' suites even though staff are worried about an influx of contractors and D.C. is tightening restrictions on large gatherings, some staffers told Axios.

Why it matters: The Capitol has been closed to public tours since March. Work over the holiday season comes as U.S. coronavirus cases spike, Americans beg for more pandemic assistance and food lines grow.

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Trump applies extreme pressure on Bill Barr to release so-called Durham Report

President Trump and his allies are piling extreme pressure on Attorney General Bill Barr to release a report that Trump believes could hurt perceived Obama-era enemies — and view Barr's designation of John Durham as special counsel as a stall tactic, sources familiar with the conversations tell Axios.

Why it matters: Speculation over Barr's fate grew on Tuesday, with just 49 days remaining in Trump's presidency, after Barr gave an interview to the Associated Press in which he said the Justice Department has not uncovered evidence of widespread fraud that could change the election's outcome.

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CDC to cut guidance on quarantine period for coronavirus exposure

The CDC will soon shorten its guidance for quarantine periods following exposure to COVID-19, AP reported Tuesday and Axios can confirm.

Why it matters: Quarantine helps prevent the spread of the coronavirus, which can occur before a person knows they're sick or if they're infected without feeling any symptoms. The current recommended period to stay home if exposed to the virus is 14 days. The CDC plans to amend this to 10 days or seven with a negative test, an official told Axios.

  • The CDC did not immediately respond to a request for comment.

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