POLITICO NIGHTLY: Pfizer’s vaccine breakthrough: What’s next

 

BY LAUREN MORELLO

Presented by The Bouqs Co.

With help from Myah Ward HOW TO TRACK THE VAX — The news today that Pfizer’s coronavirus vaccine is more than 90 percent effective could be the pandemic breakthrough we’ve been waiting for. But the company isn’t quite ready to apply to the FDA for emergency authorization — and even if the vaccine gets the green light, it is expected to be in scarce supply for months. Here’s what to watch for in the coming weeks: — Whether the Pfizer vaccine is safe: The company’s press release summarizing the first data from its 44,000-person Phase III trial left big questions unanswered. There was no data on safety, including the type and severity of any side effects experienced by trial participants. That should become clearer by the time Pfizer files an emergency-authorization application with the FDA, likely later this month. The agency has told vaccine developers they should not apply for emergency authorization until they have two months of post-vaccination safety data on at least half of their trial participants. — Whether it works for everyone: Pfizer’s eventual application to the FDA could reveal whether the vaccine is broadly effective — a crucial question, given that the elderly have weaker immune systems generally, and kids seem to respond to the coronavirus differently than adults do. Pfizer is also testing its vaccine on people with some pre-existing conditions, including HIV and hepatitis C, and has tried to ensure that volunteers come from a wide range of racial and ethnic backgrounds. — How long the immune response lasts: Pfizer determined the vaccine’s effectiveness by comparing how many people in the trial became infected within a week after receiving the second of two doses. The more effective a vaccine, the greater proportion of infections will occur among those who got a placebo, vs. those who got the vaccine. But seven days is a short window — so scientists are eager to see if the vaccine stays effective over a longer period. — What FDA’s outside advisers think: The agency has said it will have its external vaccine advisory committee review all coronavirus shots, and do it publicly. The panel’s members are an important check on the agency’s regulatory staff. If anything in Pfizer’s data is lacking, these are the folks who would pick it apart on a webcast for all to see. The panel will ultimately take an up or down vote on whether each vaccine deserves authorization or approval. The agency doesn’t have to go along with these experts’ advice, but it normally does. — How Pfizer will deal with intense global demand: The company says it can deliver the 100 million doses the U.S. has ordered by March, and produce 1.3 billion doses in 2021. But that’s not enough to meet global demand on a planet with 7.8 billion people. Pfizer would have to figure out how to allocate a limited supply of vaccine to the U.S. — which has an option to buy another 500 million doses — and countries like the U.K., Japan and Canada, which also placed early orders. — Which competitors are hot on Pfizer’s heels: Moderna, AstraZeneca and Johnson & Johnson also have coronavirus vaccines in late-stage U.S. trials. A fourth company, Novavax, plans to start one later this month. Moderna, whose vaccine uses the same mRNA technology as Pfizer’s, is expected to report efficacy data as early as this month. AstraZeneca could follow this month or next, and J&J says it could have proof of efficacy this year as well. Scientists and governments say the best-case scenario would be to have more than one effective vaccine. That would help make more doses available, and increase the likelihood that at least one vaccine works for sub-populations like the elderly, children and pregnant women. Welcome to POLITICO Nightly. Reach out at lmorello@politico.com and rrayasam@politico.com, or on Twitter at @lmorello_dc and @renurayasam.   A message from The Bouqs Co.: The Bouqs Co. has fresh flower bouquets, wreaths, plants, gifts and everything you need for all the coziest fall vibes. The best part: flowers from The Bouqs stay fresher longer because they’re sourced directly from eco-friendly farms. Send smiles no matter the miles, for birthdays, holidays, anniversaries, apologies, or just because you adulted today. Use code POLITICO for 25% off your entire order.   President-elect Joe Biden receives a briefing from the transition Covid-19 advisory board in Wilmington, Del. | Getty Images COVID-2020 LET’S PLAY TWO — Maya King emails the Nightly about the two runoff elections in Georgia on Jan. 5, which will determine which party controls the Senate: Joe Biden racked up 2.4 million votes in Georgia, edging out President Trump by 10,646 votes as of today. Democrats have long maintained that his winning Georgia would bode well for their Senate prospects in the state. But turning his narrow lead into two Senate seats would require the party to replicate nearly a decade of organizing in under 10 weeks. Jon Ossoff and Raphael Warnock, the two Democratic candidates, adopted the Stacey Abrams model of turning out first-time, young and racially diverse voters in waves while holding on to the party base in order to garner enough votes for a runoff. Yet they each did worse than Biden on Election Day: Ossoff won 2.3 million votes statewide and Warnock, who shared the ticket with nearly two dozen other contenders, won 1.6 million. Warnock and Ossoff’s chances of becoming U.S. senators are expected to rest on their ability to turn out these groups again en masse — a heavy lift considering that turnout for runoff elections is usually much lower and more favorable to Republicans. Biden, Ossoff and Warnock all cleaned up in the racially diverse Atlanta suburbs and peppered the state with strong performances in smaller cities like Savannah, Macon and Athens. Still, vote totals show that Biden performed better in these areas than either Senate candidate did. Ossoff trailed the president-elect in the Democratic stronghold of Fulton County, home to Atlanta, by about three percentage points. In the suburban Atlanta counties of Gwinnett and Cobb, Ossoff underperformed Biden by 2.4 points in each. To match Biden’s performance and win statewide, he likely needs to close that gap. Warnock won a plurality of the vote in the same counties as his Democratic counterparts, but by much slimmer margins in a multi-candidate race. In the Atlanta suburbs he trailed Biden and Ossoff by about 20 points on average. But he notched a plurality of the vote in counties neither Biden nor Ossoff won: in Wilkinson, outside of Macon, which Trump won by 12 percentage points, and in rural Baker and Mitchell counties, in the southwest part of the state, which Trump won by 16 and 11 points respectively. These majority-white counties have average populations under 10,000. Warnock has made a point of adding new voters to his coalition by campaigning among the untapped Black communities in these areas, which account for more than 40 percent of their populations. His performances there serve as proof of life for Democrats in rural southern counties, which they have all but conceded to the GOP. To win, Ossoff and Warnock would need to replicate Biden’s coalition in the state, composed largely of Democrats of color along with college-educated white Democrats and Trump defectors. Both would have to do slightly better — a two- to three-point jump for Ossoff and a 15- to 20-point leap for Warnock — in the reliably liberal Atlanta suburbs, home to the Black, Latino and Asian voters who helped put Biden over the top statewide. A crowded ticket gave Warnock the edge in rural Georgia. But besting Kelly Loeffler, who ran on a Trump-adjacent platform, in the same handful of counties and bringing Ossoff along with him, looks like way more of a longshot. Still, it won’t be an easy fight for the GOP, either. Georgia Republicans have often rebuffed the idea of their state as anything but red and chalk up their loss to widespread anti-Trump sentiment rather than changing political dynamics. Loeffler, a wealthy businesswoman, and Sen. David Perdue called for the resignation of the Republican secretary of state, Brad Raffensperger, today. In a joint statement, the two cited “failures” in the election process by Raffensperger, who oversaw both the razor-thin general election and the troubled June primary. They did not provide evidence for their claims. Raffesnperger responded saying his resignation was “not going to happen” and that any illegal voting was unlikely to be significant enough to change the result. To beat Ossoff, Perdue is expected to try to run up the score in rural counties he won by smaller majorities, like Washington in the central part of the state, where he won by less than two percentage points and Baldwin, which he won by half a point. Warnock, who largely eluded Republican criticism in his race, is expected to face negative ads that target his ties to Jeremiah Wright, the former lead pastor of Trinity United Church in Chicago whom Republicans vilified during Barack Obama’s 2008 presidential campaign. SWITCHING SIDES — Seventy percent of Republicans now say they don’t believe the 2020 election was free and fair, according to a new POLITICO/Morning Consult poll. That’s a stark rise from the 35 percent of GOP voters who held similar beliefs before multiple news organizations announced Biden as the election winner on Saturday after four days of counting in several swing states. Meanwhile, trust in the election system grew for Democrats. Ninety percent of Democrats now say the election was free and fair, up from the 52 percent who thought it would be before Nov. 3. TRACK THE TRANSITION, SUBSCRIBE TO TRANSITION PLAYBOOK: The definitive guide to what could be one of the most consequential transfers of power in American history. Our Transition Playbook newsletter—written for political insiders—tracks the appointments, people, and power centers of the new administration. Don't miss out. Subscribe today.     FROM THE HEALTH DESK THE PRESIDENT-ELECT AND THE PANDEMIC — The nation might have been fixated on the election outcome last week, but that didn't put the pandemic on hold. Covid cases are at record-high levels. In the latest POLITICO Dispatch, health care reporter Alice Miranda Ollstein breaks down Biden’s plans for fighting the outbreak — and how another two months of the Trump presidency could complicate things. Listen to the latest POLITICO Dispatch podcast ON THE HILL ‘100 PERCENT WITHIN HIS RIGHTS’ — Senate Majority Leader Mitch McConnell and GOP lawmakers today refused to recognize Joe Biden as the president-elect, defending Trump as he continues to launch unsubstantiated allegations about widespread voter fraud. Speaking at a photo opportunity with the new class of GOP senators elected last week, McConnell did not respond to questions about whether he has seen any evidence of fraud, though on the Senate floor, he said Trump is entitled to challenge the validity of the election results as he sees fit. “Our institutions are actually built for this,” McConnell said. “We have the system in place to consider concerns, and President Trump is 100 percent within his rights to look into allegations of irregularities and weigh his legal options.” Here’s what Republicans have said so far about Trump’s refusal to concede.       FIRST IN NIGHTLY CLIMATE FOR CHANGE — Big Wall Street banks, facing the prospect that Democrats will impose new rules to force lenders to deal with natural disasters and rising sea levels, are positioning themselves as eager allies with a Biden administration in fighting climate change, financial services reporter Zachary Warmbrodt writes. But Biden’s win would expose U.S. banks to intense scrutiny for their role in providing billions of dollars of financing each year to fossil fuel production that contributes to climate change. The fear is that destructive climate events — as well as a costly transition to a lower-carbon economy — will wreak havoc on the banks’ portfolios and destabilize the financial system. How to approach this issue will be one of the new administration’s most consequential decisions affecting both Wall Street and the broader fight to slow man-made climate change. It’s also an area where Biden regulators can force big changes without help from Congress. PALACE INTRIGUE DISTRESSPER — Trump’s abrupt firing of Defense Secretary Mark Esper today is sparking deep concern among Democrats in Congress , who warn that one of the few remaining checks on the commander in chief's national security whims is out of the picture. Trump announced via tweet today that he had “terminated” Mark Esper, ending months of speculation over the Defense secretary’s fate after the two clashed this summer over the proper use of troops in dealing with protests. Within hours of the announcement, a host of congressional Democrats came forward to warn that Esper’s removal could leave the U.S. vulnerable during the presidential transition, erode civilian leadership of the military and put the nation's top officers, led by Joint Chiefs Chairman Gen. Mark Milley, in an untenable position. NIGHTLY NUMBER 17.37 percent The decrease for Zoom in the stock market today. Stay-at-home tech companies suffered on Wall Street after news of the Pfizer vaccine. A woman who normally works in the office of a foundation works at her laptop from home during a four-week semi-lockdown in Berlin. | Getty Images THE GLOBAL FIGHT EUROPE’S ODE TO JOY — Forty-eight hours after Joe Biden emerged as the winner of the U.S. presidential election, Europe was still basking in the afterglow, chief Europe correspondent Matthew Karnitschnig writes. Not even Angela Merkel could resist a victory lap, delivering a live statement on German television to congratulate Biden and Kamala Harris. (Legend has it that Merkel agreed to seek another term as chancellor in 2017 only because of Trump, whose name was conspicuously absent from her remarks today.) For many European leaders, Biden’s win represented more than just the prayed-for end of Donald Trump’s presidency — it was a welcome shot in the arm for Europe’s battered brand of centrist politics as it battles its own populist demons, a glimmer of hope that “the good guys” can win. But the unbridled enthusiasm of the Continent’s dominant political class for Biden reveals another reality as well: Europe’s only friends in Washington these days are Democrats. Since Trump came to power, Europe’s center-left and center-right parties, from Germany to France, Ireland to Finland, have made little secret of their preference for America’s Democrats. As a consequence, the traditional ties between the Republicans and center-right parties like Germany’s Christian Democrats or Ireland’s Fianna Fáil have frayed.   KEEP UP WITH THE GLOBAL HEALTH AGENDA: If nothing else, 2020 revealed how critical it is to keep up with the politics, policy, and people driving global health. How are governments working to improve the health of their citizens? What role are NGOs playing? Who is driving the agenda? Our Global Pulse newsletter connects leaders, policymakers, and advocates to the people, and politics impacting our global health. Join the conversation and subscribe today.     PARTING WORDS QUIT WITHOUT SAVING? From tearing up documents and hiding transcripts of calls with foreign leaders to using encrypted messaging apps and personal email accounts for government business, the Trump White House’s skirting of records preservation rules could limit the incoming Biden administration’s visibility into highly sensitive foreign policy and national security secrets, national security correspondent Natasha Bertrand writes. The Presidential Records Act, which requires a sitting president to preserve and ultimately make public all records relating to the performance of their official duties, was passed 42 years ago in response to President Richard Nixon’s attempts to hide the White House tapes that led to his downfall. But it has no real enforcement mechanism. The National Archives defines presidential records as any documentary materials “created or received” by the president, their immediate staff, or anyone in the Executive Office of the President “whose function is to advise or assist the President” in the course of carrying out official duties. But it is not clear how much has been preserved given Trump’s habit of ripping up documents — the employees once tasked with taping them back together were summarily fired in 2018 — and the White House’s general paranoia about leaks.   A message from The Bouqs Co.: Gatherings are looking a little bit different this holiday season. Luckily, The Bouqs Co. has everything you need to make home feel like somewhere you want to be versus somewhere you have to be. Festive autumn bouquets, wreaths, and plants from The Bouqs stay fresher longer because everything is sourced directly from the farm — even farms from the side of a volcano! Bouqs.com has all the fresh goodness to help spice up your space or brighten someone’s day, and with a thoughtful assortment that has something for everyone, sending smiles no matter the miles has never been easier. Treat yourself or someone else with flower bouquets, plants, wreaths, and gifts from The Bouqs — perfect for birthdays, holidays, anniversaries, apologies, or just because you adulted today! Use code POLITICO for 25% off your order.   Did someone forward this email to you? Sign up here.   Follow us on Twitter Renuka Rayasam @renurayasam Chris Suellentrop @suellentrop Tyler Weyant @tweyant Myah Ward @myahward   FOLLOW US  POLITICO, LLC 1000 Wilson Blvd. Arlington, VA, 22209, USA