POLITICO NIGHTLY: When will you get a vaccine?

By Renuka Rayasam Presented by A SHOT IN THE ARM — President Donald Trump says he’s taking hydroxychloroquine, but that may not have been today’s most important news in Covid-19 pharmacology. Moderna, a Massachusetts biotech company, said it had made progress in its first round of human trials for a Covid vaccine. Eight people in the trial developed antibodies against Covid, a sign that a vaccine might arrive with record-breaking speed. But Moderna still has months, if not longer, to go before it can declare victory. It might not get there at all. Health care reporter Sarah Owermohle and your host chatted over Slack this afternoon about what the news actually means, how Covid changed the drug development process and plans to scale up vaccine manufacturing. This interview has been edited. Is the Moderna news a big deal? So, there were actually 45 people who were dosed but eight whose results were ready. Moderna, in a sign of the times and the urgency everyone is feeling, wanted to share that right away. They also found out that low doses of their potential vaccine work as well as high doses, which might seem small but means that a little could go a long way. It is going to be extremely important when billions of people want it. The next two phases will be bigger and longer. Those stages are key to understanding how safe and effective the vaccine is, whether it is more effective for certain people rather than others, and how strong the immune response is. Still, we are going to need more than one vaccine to quell this. No one manufacturer can meet worldwide demand in a reasonable time, but also we could find out down the line that one vaccine is better suited for one population (like kids, or the elderly) while another is important for other groups (like, say, pregnant women). Those are hypotheticals but that is how it works sometimes — for instance with flu vaccines, sometimes there is an inhalable that works better than an injectable for young and healthy people. How has vaccine development changed with Covid? The U.S. government alone has put almost a billion dollars toward the Moderna candidates and another from Johnson & Johnson. Regulators are loosening requirements that can slow the process, like the need for extensive animal studies before human trials — stuff that FDA's vaccine chief Peter Marks has called “dead space” in the development process. Those animal trials are still happening, but in tandem with human trials — so information is flowing fast. It will be interesting to see if this changes the vaccine development process for good, even after Covid-19. Are there risks to rushing a vaccine? FDA has said it will cut no corner on safety and effectiveness, but it can be hard to recognize signs when we are moving this fast. Phase III trials are going to be key in recognizing any side effects or unintended consequences. Are there plans in place to scale up vaccine manufacturing? Something interesting I learned along the way with reporting this — anti-vaccine sentiment has changed the way many of them get produced. Anti-vaxxers believe that the preservatives used in multi-dose vials — so that several people can get a dose from one vial — are what cause harm. Manufacturers have shifted away from multi-dose vials. But that will likely need to change with eventual coronavirus vaccines because there is already concern about a glass shortage — imagine making billions and billions of doses, each requiring its own vial. I never thought I would learn this much about glass, or stoppers. Apparently there is already a potential glass shortage because it is hard to secure the angular sand needed to make medical glass, which is not your average jar or something. Stoppers are also vital because certain vaccines need certain types for sensitive chemicals. And it's not exactly a huge market. The U.S. government funding is supposed to help the manufacturers to start massively scaling up now, before it’s clear their vaccines will even be used. Manufacturers don't ever do that — it would be a huge cost without a sure end game. Does this mean we can get the vaccine earlier, by the end of the year, as Trump noted the other day? It is possible that there is a known vaccine by the end of the year, but that does not mean people will get it. When Trump says, "There will be a vaccine by the end of the year," the average person hears, "I will get a vaccine by the end of the year" — and that is far from the case. Welcome to POLITICO Nightly: Coronavirus Special Edition. Kudos for creativity to this Ocean City, Md., restaurant that’s come up with its own way to ensure social distancing. (h/t our wonderful Nightly producer and proud Marylander, Tyler Weyant.) Reach out with tips: rrayasam@politico.com or on Twitter at @renurayasam.   A message from PhRMA: While America’s biopharmaceutical companies are working around the clock to develop a treatment for COVID-19, companies are also expanding efforts to help patients access other medicines they need. PhRMA’s Medicine Assistance Tool was built to connect patients with resources that may help lower out-of-pocket costs.   First In Nightly THE VACCINE RACE’S FIRST WINNERS — The promise of a coronavirus vaccine by the end of the year creates a difficult political and public health question: Who gets the vaccine first? Sarah reports that the question is fraught with ethical dilemmas and ripe for political power plays. The politics of vaccine distribution could get ugly fast if there aren’t clear rules. “It absolutely should not be the White House who decides,” said Nicole Lurie, who led the Department of Health and Human Services' emergency preparedness efforts during the Obama presidency. “Operation Warp Speed” is gearing up for massive manufacturing — all in the U.S. — that will save “years” in production, Trump said Friday as he introduced the administration’s new vaccine czar, Moncef Slaoui. “When a vaccine is ready, the U.S. government will deploy every plane, truck, and soldier required to help distribute it to the American people as quickly as possible,” Trump said.   JOIN TOMORROW – HOW DO WE STRATEGICALLY REOPEN THE ECONOMY? Join chief economic correspondent Ben White tomorrow at 9 a.m. EDT for a virtual conversation with Rep. Andy Kim (D-N.J.), to discuss his work on the newly launched House Select Committee on the Coronavirus Crisis and whether he believes that the fiscal response so far has been enough. Should there be more transparency on how stimulus dollars are being spent? What more does Congress need to do to keep the economy afloat? Have questions? Submit yours by tweeting it to @POLITICOLive using #AskPOLITICO. REGISTER HERE.     Around the Nation GOING THE DISTANCE — As states around the country begin to reopen, new data shows that social distancing measures had a strong effect on the number of cases confirmed in the U.S. CALIFORNIA DREAMIN’ — In the coming weeks and months, should improving trend lines hold, California residents may be able to return to church services and get their hair trimmed , and the vast majority of counties will be able to resume restaurant dining, Democratic Gov. Gavin Newsom signaled today. He cited declining hospitalization and intensive care unit rates as indicators that California can move deeper into its nascent economic reopening, Jeremy White writes. Newsom also said California could allow pro sporting events to resume by June , although games would be without spectators and with “very prescriptive conditions.” In the preceding months, Newsom has been wary of major sporting events functioning as hubs for transmission. The governor did caution that areas with more dire outbreaks like Los Angeles and the Bay Area can impose tougher controls. DIVIDED CITY — People living in the poorest New York City neighborhoods are dying from coronavirus at more than double the rate of more affluent neighborhoods, according to new data released by the city's health department, reports Erin Durkin , co-author of New York Playbook. The data suggests that residents of poor neighborhoods are both more likely to contract the virus, and more likely to die if they get it. The Corona neighborhood in Queens leads the city in number of cases, followed by Fordham in the Bronx, Elmhurst in Queens and Borough Park in Brooklyn. Only two zip codes in the city, both in lower Manhattan’s financial district, had no deaths from Covid-19. Nightly Number 20 percent The percentage of people in Switzerland who would refuse a coronavirus vaccine, according to preliminary results of a survey being run by the Vaccine Confidence Project — which monitors public trust in vaccination programs worldwide. The same survey showed 9 percent of German respondents would refuse a coronavirus vaccine. Among Austrians, that rose to 16 percent, and 18 percent in France — all figures that point to Europe’s status as the most anti-vaccine region in the world. On The Hill BIG SHOT — With the House’s new $3 trillion relief package almost certainly going nowhere in the Senate, California Rep. Jackie Speier explains, in the latest edition of POLITICO Dispatch , why Dems passed it anyway: “We are putting forth our marker, these are the things we value. … Now the Senate can develop its measure or amend ours, in a manner that reflects their interests, and then there’s a compromise that is agreed to.” Listen to the latest POLITICO Dispatch podcast     Palace Intrigue FORMER VS. CURRENT — ICYMI this weekend , former President Barack Obama, while not naming the current White House resident, took some lightly veiled shots at Trump, saying, “This pandemic has fully, finally torn back the curtain on the idea that so many of the folks in charge know what they’re doing. A lot of them aren’t even pretending to be in charge.” Trump’s response, when asked about Obama’s comments? “Look, he was an incompetent president. That’s all I can say. Grossly incompetent.” Ask The Audience Our question for our readers this week: Memorial Day weekend is almost here. How has the pandemic changed your plans for the summer? Use the form to send us your responses, and we plan to feature several later this week.   YOUR TIME IS PRECIOUS: This global crisis has countries across the world and states across the country trying to balance public health with economic survival. POLITICO Dispatch is a short, daily podcast featuring experts from across our newsroom who provide the critical news and context you need in 15 minutes or less. Cut through the noise, subscribe and start listening today.     The Global Fight EUROPE ON THE MOVE — Apple Maps data shows that some European countries have returned to their pre-Covid levels of walking activity. Calling the shots — The real takeaway from today’s World Health Assembly (the oversight convention of the World Health Organization) is that China is no longer subtle or strategic about its global rise, tossing out trade threats and policy bribes on a daily basis. Today’s example was a $2 billion Chinese donation to the global Covid-19 response — two weeks after China withheld donating at a global conference — which conveniently distracted attention from news that 116 of the WHO’s 194 members want an independent inquiry into how the pandemic became a pandemic. The U.S. supported the inquiry, but it happened in spite of the Trump administration, not because of it. The U.S. has annoyed allies by shopping flimsy and inaccurate coronavirus intelligence to them, and by undercutting global coordination at forums including the WHO, the U.N. Security Council and the G-7. Instead of preparing a serious alternative to the Chinese donation, the U.S. was busy arguing against a coronavirus vaccine being declared a “global public good.” Doing good would not have been hard for the U.S.: Tiny Norway donated half as much as China. The World Food Programme is looking for less than $1 billion to feed 30 million people for the rest of the year. Yet governments globally are spending $1,000 on domestic stimulus for every $1 they are spending on global pandemic coordination. Parting Words Matt Wuerker TWILIGHT OF THE MALLRATS — Your host has a confession to make: I love malls. My first job was at the now-defunct men’s clothing store Structure in suburban Atlanta’s Southlake Mall. When I first moved to Austin from New York 16 years ago and didn’t know anyone, I quietly avoided trendier hangouts on lonely weekends to window shop and try on makeup at the Nordstrom at Barton Creek Mall. Today JCPenney became the latest mall anchor tenant to file for bankruptcy. Nordstrom has announced it is closing 16 stores around the country. The pandemic may kill the mall, but it also merely hastened its demise. The mall’s death was coming, sooner or later. For many it might even be a welcome end. Younger people tend to see malls as a wasteland of generic, soulless commercialism. But growing up in Jonesboro, Ga., in the 1980s and 1990s, we didn’t have independent bookstores or boutiques or online shopping. I had to go to Waldenbooks in the mall to get the latest “Baby-Sitters Club” book. I still remember the torture of trying to pick out just one pencil or mini notebook at the Hello Kitty store. Last year, I took my two babies back to Southlake Mall, during a visit to my parents, to get their picture taken with Santa. My mom still walks there regularly with a friend. It was sad to see the boarded-up stores (and shocking to see a Things Remembered store). Online shopping is not just easier now — with the pandemic, it’s a necessity. Someday, when we are allowed to more safely venture out to the Foot Locker or Sunglass Hut, many people won’t even notice that the mall is gone. They never went there in the first place. There are fancier places to get a kid’s picture with Santa and cooler places to buy books. But the people who don’t live near those types of stores, who live in towns not likely to see a renewal anytime soon, the people like my mom and my dad — well, where will they go?   A message from PhRMA: In the midst of coronavirus, PhRMA members are expanding efforts to help millions of Americans dealing with other diseases that need to be treated and may be struggling to afford their medicines. Our Medicine Assistance Tool was built to connect patients with resources that may help lower out-of-pocket costs.   Did someone forward this email to you? Sign up here.   Follow us on Twitter Renuka Rayasam @renurayasam

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