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FDA review of Pfizer vaccine clears way for emergency authorization

The FDA's vaccine advisory committee released a detailed analysis on Tuesday finding that Pfizer's coronavirus vaccine appears to meet the safety and efficacy requirements necessary for an emergency use authorization (EUA).

Why it matters: The FDA's initial review suggests that the agency will issue an EUA after its advisory committee meets on Thursday. The publication of the analysis comes the same day that the U.K. began administering its first doses of the Pfizer vaccine, which regulators cleared for emergency use last week.


Details: The FDA found that there are no specific safety concerns from Pfizer's vaccine by race, age, ethnicity, medical co-morbidities, or a prior COVID infection.

  • The most common negative side effects of vaccination were fatigue, headache, muscle pain, chills, joint pain, and fever.
  • Severe adverse reactions only occurred in 0.0% to 4.6% of Pfizer's study participants, and were more frequent after the second dose than the first dose. Adults under 55 experienced less serious side effects.
  • Pfizer's data suggests that the vaccine could help prevent COVID infections following the first dose, but available data did not allow for a firm conclusion, the FDA said.

Of note: Two people in the vaccine group died over the course of the study — one participant with pre-existing atherosclerosis and another participant that went through cardiac arrest after the second dose and died three days later.

The bottom line: The FDA writes that although Pfizer's data shows the vaccine is highly effective against symptomatic COVID-19 patients, data from more people is needed to determine how effective the vaccine is at saving lives.

  • It is also possible that the vaccine's efficacy against asymptomatic infection is lower than its efficacy against against symptomatic infection, per the FDA.
  • Additional testing is needed to see how effective the vaccine is in preventing the transmission of the virus.

What's next: The FDA's advisory committee will meet on Dec. 10 to discuss Pfizer's request for an emergency use authorization and whether further study on the vaccine is needed.

Report: U.S. urges UN-led Afghan peace talks and warns of Taliban "territorial gain" threat

Secretary of State Antony Blinken proposed in a letter to President Ashraf Ghani steps including a UN-facilitated summit to revive stalled peace talks between the Afghan government and the Taliban, Afghanistan's TOLOnews first reported Sunday.

Why it matters: Blinken expresses concern in the letter, also obtained by Western news outlets, of a potential "spring offensive by the Taliban" and that the "security situation will worsen and the Taliban could make rapid territorial gain" after an American military withdrawal, even with the continuation of U.S. financial aid.

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Harry and Meghan accuse British royal family of racism

Prince Harry and Meghan Markle delivered a devastating indictment of the U.K. royal family in their conservation with Oprah Winfey: Both said unnamed relatives had expressed concern about what the skin tone of their baby would be. And they accused "the firm" of character assassination and "perpetuating falsehoods."

Why it matters: An institution that thrives on myth now faces harsh reality. The explosive two-hour interview gave an unprecedented, unsparing window into the monarchy: Harry said his father and brother "are trapped," and Markle revealed that the the misery of being a working royal drove her to thoughts of suicide.

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Pfizer CEO Albert Bourla has taken the coronavirus vaccine

Pfizer CEO Albert Bourla tells "Axios on HBO" that he recently received his first of two doses of the company's coronavirus vaccine.

Why it matters: Bourla told CNBC in December that company polling found that one of the most effective ways to increase confidence in the vaccine was to have the CEO take it.

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Ripple CEO Brad Garlinghouse: SEC lawsuit is "bad for crypto" in the U.S.

Ripple CEO Brad Garlinghouse tells "Axios on HBO" that if his company loses a lawsuit brought by U.S. regulators, it would put the country at a competitive disadvantage when it comes to cryptocurrencies.

Between the lines: The SEC in December sued Ripple, and Garlinghouse personally, for allegedly selling over $1.3 billion in unregistered securities. Ripple's response is that its cryptocurrency, called XRP, didn't require registration because it's an asset rather than a security.

Pfizer CEO: "It will be terrible" if COVID vaccine prices limit access

Pfizer CEO Albert Bourla told "Axios on HBO" that it "will be terrible for society" if the price of coronavirus vaccines ever prohibits some people from taking them.

Why it matters: Widespread uptake of the vaccine — which might require annual booster shots — will reduce the risk of the virus continuing to spread and mutate, but it's unclear who will pay for future shots or how much they'll cost.

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Lindsey Graham intends to "lean into" climate change during Biden era

Sen. Lindsey Graham (R-S.C.) told "Axios on HBO" he intends to "lean into" climate change and that he has already discussed potential common ground with President Biden's special climate envoy John Kerry.

Behind the scenes: In a follow-up interview with Axios, Graham said Kerry called him in November, around the time Kerry's new position was announced, to see if there were openings to work together.

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Lindsey Graham: Trump could make the GOP "stronger" or "destroy" it

Sen. Lindsey Graham told "Axios on HBO" that Donald Trump has a "dark side" but he tries to "harness the magic" because he succeeded where Republican candidates like John McCain and Mitt Romney failed.

Why it matters: The South Carolina Republican gyrates between support and criticism of the former president, even after Trump harshly criticized McCain — Graham's longtime friend — and helped spark the Capitol insurrection.

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Senate plots its own earmark comeback

With the Senate done battling over President Biden's coronavirus rescue package, it's preparing to tackle another priority: earmarks.

Driving the news: Sens. Patrick Leahy (D-Vt.) and Richard Shelby (R-Ala.), the top members on the Senate Appropriations Committee, are expected to work out a deal restoring the congressional spending tool in the coming weeks, committee aides tell Axios.

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