From The Washington Post

What You Need to Know About the Moderna and Pfizer Coronavirus Vaccines

November 18, 2020

The vaccines are made by different companies: One is being developed by pharmaceutical giant Pfizer and its German partner, BioNTech, and the other by biotechnology firm Moderna, in partnership with the National Institute of Allergy and Infectious Diseases. Both drugmakers have moved at record speed and will seek regulatory clearance for their vaccines in the coming weeks.

Why is the FDA using emergency powers to approve a vaccine?

The vaccines are made by different companies: One is being developed by pharmaceutical giant Pfizer and its German partner, BioNTech, and the other by biotechnology firm Moderna, in partnership with the National Institute of Allergy and Infectious Diseases. Both drugmakers have moved at record speed and will seek regulatory clearance for their vaccines in the coming weeks.

Why is the FDA using emergency powers to approve a vaccine?

The FDA has emergency authority to issue temporary approvals of medical products to get them to the public more quickly during public health emergencies. Such authorizations require less data and can be done more rapidly than full approvals. Since February, the FDA has used this power to authorize hundreds of coronavirus tests and a few treatments. But it has authorized a vaccine that way only once in its history — in 2005, against anthrax — and that was under sharply different circumstances….

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Biden Presses to Expand Health Insurance on Uncertain Congressional Terrain

November 11, 2020

President-elect Joe Biden intends to make the case that the coronavirus pandemic and the Affordable Care Act’s uncertain future drive home the importance of helping more Americans gain health insurance and the care they need.

The likelihood that the incoming president can persuade Congress to build upon the ACA — a core pledge during his campaign — depends in large part on whether Republicans or Democrats end up controlling a narrowly divided Senate.

President-elect Joe Biden intends to make the case that the coronavirus pandemic and the Affordable Care Act’s uncertain future drive home the importance of helping more Americans gain health insurance and the care they need.

The likelihood that the incoming president can persuade Congress to build upon the ACA — a core pledge during his campaign — depends in large part on whether Republicans or Democrats end up controlling a narrowly divided Senate.

Biden spoke Tuesday afternoon about his aspirations to “work quickly with the Congress to dramatically ramp up health care protections, get Americans universal coverage, lower health care costs as soon as humanly possible….”

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Controversial Alzheimer’s Drug Gets Boost From FDA Staff

November 5, 2020

A drug that would be the first new treatment for Alzheimer’s disease in nearly two decades received a vote of confidence Wednesday from Food and Drug Administration clinical reviewers, who said “exceptionally persuasive” data showed the drug slowed cognitive decline caused by the devastating ailment.

The FDA assessment also concluded the drug, called aducanumab, was safe. The document was released before an advisory committee meeting Friday during which outside experts will decide whether to recommend the agency approve the drug.

A drug that would be the first new treatment for Alzheimer’s disease in nearly two decades received a vote of confidence Wednesday from Food and Drug Administration clinical reviewers, who said “exceptionally persuasive” data showed the drug slowed cognitive decline caused by the devastating ailment.

The FDA assessment also concluded the drug, called aducanumab, was safe. The document was released before an advisory committee meeting Friday during which outside experts will decide whether to recommend the agency approve the drug.

But in a sign of the controversy that has shadowed the drug, an FDA statistical review, contained in the same document, concluded there was conflicting evidence on the drug’s effectiveness because one major study indicated it was effective, while another showed scant benefit. The statistician said a third study should be conducted to clear the matter up….

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Trump Acknowledges He Intentionally Downplayed Deadly Coronavirus, Says Effort Was to Reduce Panic

September 10, 2020

President Trump acknowledged Wednesday that he intentionally played down the deadly nature of the rapidly spreading coronavirus last winter as an attempt to avoid a “frenzy,” part of an escalating damage-control effort by his top advisers to contain the fallout from a forthcoming book by The Washington Post’s Bob Woodward.

Trump’s comments came hours after excerpts from the book and audio of some of the 18 separate interviews he conducted with the author were released, fueling a sense of outrage over the president’s blunt description of knowing that he was not telling the truth about a virus that has killed nearly 190,000 Americans.

President Trump acknowledged Wednesday that he intentionally played down the deadly nature of the rapidly spreading coronavirus last winter as an attempt to avoid a “frenzy,” part of an escalating damage-control effort by his top advisers to contain the fallout from a forthcoming book by The Washington Post’s Bob Woodward.

Trump’s comments came hours after excerpts from the book and audio of some of the 18 separate interviews he conducted with the author were released, fueling a sense of outrage over the president’s blunt description of knowing that he was not telling the truth about a virus that has killed nearly 190,000 Americans.

Democrats, led by presidential nominee Joe Biden, denounced Trump’s actions as part of a deliberate effort to lie to the public for his own political purposes when other world leaders took decisive action to warn their people and set those nations on a better path to handling the pandemic….

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Trump Pushing Officials to Speed Up Already-Ambitious Coronavirus Vaccine Timeline

June 17, 2020

President Trump, faced with multiple crises and falling poll numbers less than five months before the presidential election, is prodding top health officials to move faster on a historically ambitious timeline to approve a coronavirus vaccine by year’s end.

The goal is to instill confidence among voters that the virus can be tamed and the economy fully reopened under Trump’s stewardship.

President Trump, faced with multiple crises and falling poll numbers less than five months before the presidential election, is prodding top health officials to move faster on a historically ambitious timeline to approve a coronavirus vaccine by year’s end.

The goal is to instill confidence among voters that the virus can be tamed and the economy fully reopened under Trump’s stewardship.

In a meeting last month with Health and Human Services Secretary Alex Azar — who is overseeing the effort called Operation Warp Speed, along with Defense Secretary Mark T. Esper — Trump pushed Azar repeatedly to speed up the already unprecedented timeline, according to two senior White House officials familiar with the meeting who spoke on the condition of anonymity to discuss private conversations. Trump wants some people to be able to get the vaccine sooner than the end of the year to demonstrate an end to the pandemic is within reach, according to those officials and two others….

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