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Presented by PhRMA: Delivered daily by 10 a.m., Pulse examines the latest news in health care politics and policy. | | | | | |  | | By Sarah Owermohle | Presented by |  | | | Editor’s Note: POLITICO Pulse is a free version of POLITICO Pro Health Care's morning newsletter, which is delivered to our s each morning at 6 a.m. The POLITICO Pro platform combines the news you need with tools you can use to take action on the day’s biggest stories. Act on the news with POLITICO Pro. | | | — As public health officials race to inoculate hard-to-reach populations, ensuring equity remains a top priority. — President Joe Biden is pressing the Senate to move the next Covid relief package after the House passed it on Saturday. — The CDC’s vaccine advisory panel meets today, fresh off its vote to recommend a third Covid vaccine. WELCOME TO MONDAY PULSE — where your host would actually watch this show. Send TV and/or vaccine eligibility recommendations to me at sowermohle@politico.com and tips for Tuesday Pulse to Adam Cancryn at acancryn@politico.com. | | | | A message from PhRMA: As we usher in a new administration and Congress, there are many things on which we can all agree, like ending the pandemic. America’s biopharmaceutical companies will continue to develop treatments and vaccines to combat COVID-19, and we are working closely with governments, insurers and others to make sure vaccines and treatments are accessible and affordable. | | | | | | J&J SHOTS SHIP — The Food and Drug Administration issued an emergency authorization for Johnson & Johnson’s one-dose, easy-to-store coronavirus shot on Saturday, the third Covid vaccine to receive authorization in the U.S. Key points: The J&J vaccine is 66 percent effective against coronavirus infection broadly but shows higher efficacy at preventing hospitalization and death. It also can be shipped and stored in regular refrigerators instead of ultra-cold freezers. And while Pfizer and Moderna are already funneling millions of shots into U.S. reserves, the J&J vaccine could be a critical alternative for vaccinating hard-to-reach or skeptical Americans. The 100 million shots J&J promises to provide by June would also bump U.S. supply past what would be needed to hit Biden’s goal of offering every American a shot by this summer. Four million J&J doses are ready to ship starting today, with half going to state health officials and the others heading to pharmacies and community health centers. J&J has said it will provide 20 million shots by the end of this month — hot on the heels of Pfizer and Moderna’s offers of another influx of supply in the coming weeks. What’s next: The new vaccine was authorized just one week after the U.S. passed half a million deaths from the virus. And federal and state health officials say the country has reached a critical juncture in the fight to vaccinate millions of Americans, while novel Covid variants loom, and that the J&J shot will be critical to vaccinating underserved populations, like minorities and lower-income people. Because the vaccine is “easy to transport and store,” it “allows for expanded availability in most community settings and mobile sites, as supply scales up,” CDC Director Rochelle Walensky said in a statement Sunday. BIDEN: WE NEED THE RELIEF PACKAGE FAST — Biden was quick Saturday to call on the Senate to swiftly pass what his administration has dubbed the American Rescue Plan to meet some of these vaccine distribution and equity challenges. “If we act now, decisively, quickly and boldly, we can finally get ahead of this virus, we can finally get our economy moving again and the people of this country have suffered far too much for too long. We need to relieve that suffering,” he said, hours after the House passed the massive bill. Besides $1,400 stimulus checks, unemployment relief and child tax credits for many Americans, the package includes millions for state and local governments to expand their vaccination efforts. J&J’s shot opens new opportunities for vaccinating millions, said Barbara Alexander, President, Infectious Diseases Society of America. “We ask Congress to swiftly pass the COVID-19 rescue bill with the funding that is urgently needed to support accelerated and equitable vaccine access and to ensure we are able to capitalize on the opportunity before us.” CDC PANEL TALKS VARIANTS AND VACCINES — The Advisory Committee on Immunization Practices, responsible for recommending Covid vaccines, will meet today to discuss clinical considerations and potential safety updates for existing Covid-19 vaccines. The members will also discuss the threat of emerging variants that have been identified in more than 40 states, our Brianna Ehley reports. | | | | DON'T MISS "THE RECAST": Power dynamics are changing. "Influence" is changing. More people are demanding a seat at the table, insisting that all politics is personal and not all policy is equitable. "The Recast" is our new, twice-weekly newsletter that breaks down how race and identity are recasting politics, policy, and power in America. And POLITICO is recasting how we report on this crucial intersection, bringing you fresh insights, scoops and dispatches from across the country, and new voices that challenge "business as usual." Don't miss out on this important new newsletter, SUBSCRIBE NOW. Thank you to our sponsor, Intel. | | | | | | | | ZIENTS BLAMES TRUMP LEGACY FOR SLUGGISH ROLLOUT — The Biden administration has been working to get coronavirus vaccines distributed “as fast … and as equitably as possible,” but “there was no comprehensive plan or strategy when we came into office,” White House Covid-19 coordinator Jeff Zients told CBS 60 Minutes’ Bill Whitaker on Sunday. The Biden administration has since bought enough shots to vaccinate 300 million Americans by the end of July and has boosted vaccination rates for seniors, Zients said. Math check: The Trump administration’s Operation Warp Speed struck deals with at least five manufacturers to secure an initial cache of 700 million shots, with the option of buying hundreds of millions more. Warp Speed announced late last year that they would double their Pfizer and Moderna orders, to 200 million each, which the Biden administration bumped to 300 million apiece. At the time Warp Speed inked its agreements, it was not clear which vaccine candidates would eventually be submitted to the FDA; AstraZeneca, for instance, promised the U.S. 300 million doses of its vaccine but has not yet filed for authorization in the United States. But the frontrunners were also plagued with manufacturing challenges in early weeks, leading to fewer-than-expected doses in December and January. Zients also pointed to logistical snags, such as difficulties staffing up sites to administer vaccines, as an early drag on mass vaccination. “I understand the frustration,” he told Whitaker about Americans’ rush to receive shots and return to normality. “We’re doing all we can to move as fast as we can.” FAUCI RESPONDS TO CPAC CRITICISM — Chief medical adviser Anthony Fauci on Sunday said South Dakota Gov. Kristi Noem’s criticism of him at the Conservative Political Action Conference was “not really helpful” to the nation’s recovery from the coronavirus pandemic, Quint Forgey reports. “Sometimes you think things are going well, and just take a look at the numbers. They don't lie,” he said on CBS’ “Face the Nation.” South Dakota’s numbers are grim: The state ranks eighth for Covid-19 deaths nationwide. Noem, who said the longtime director of the National Institute of Allergy and Infectious Diseases was “mostly wrong,” to loud applause at CPAC, followed Fauci’s appearance on the show and defended her state’s record. The Trump ally told CBS’ Margaret Brennan that the trend is because “our state peaked earlier … than New York, than California,” referring to two of the first states to report coronavirus cases, hospitalizations and deaths and to implement broad lockdowns. | | | |   | | | | | | ANALYSIS: MEDICARE RATE LIMITS WOULD SLASH INSURANCE SPENDING — Insurers and employers would pay $352 billion less in 2021 if private insurers were limited to reimbursing providers at Medicare rates, according to a Kaiser Family Foundation analysis. That would represent a 41 percent drop from the projected $859 billion in private insurance spending this year, mostly driven by outpatient spending (where the gap between private insurance and Medicare payments is relatively large.) Still, it’s highly unlikely that private insurance will be tied to Medicare rates anytime soon. Policies championed by progressives but questioned by moderate Democrats, such as a single-payer “Medicare for All” system, would come the closest to such a change. Relatively smaller (but still significant) changes, such as lowering the Medicare eligibility age, could also feed into savings: KFF found that one-third of reduced spending would be in the 55 to 64 age group. | | | | For regulatory affairs professionals: AgencyIQ FDA Forecast 2021. In its inaugural year, AgencyIQ’s FDA Forecast predicts the FDA regulatory changes coming in 2021 and how they will impact the life sciences industry. Follow this link to learn more and download the summary. | | | | | | | | ANGER MOUNTS OVER FDA FAILURE TO REGULATE METAL IN FOOD — A congressional report out this month found that popular baby foods contain concerning levels of toxic heavy metals has ignited swift blowback against the manufacturers. But the underlying issue is bigger, POLITICO’s Helena Bottemiller Evich writes. “This is not a baby food problem. This is a food problem,” said Tom Neltner, chemicals policy director at the Environmental Defense Fund, which has lobbied for more regulation of heavy metals. Some of the companies investigated knew their ingredients contained elevated levels of heavy metals. But the baby food makers implicated by the report — Beech-Nut, Gerber, Earth’s Best Organic and HappyBABY — weren’t violating any rules, because the FDA has not set standards for most heavy metals in baby food.
| | | | A message from PhRMA: Despite our divisions, there are many things on which Americans agree. The biopharmaceutical industry is committed to working with Congress and the new administration to:
• End the pandemic. The industry remains committed to getting COVID-19 treatments and vaccines to patients, and we are working closely with governments, insurers and others to make sure they are accessible and affordable.
• Make health care better and more affordable. People want quality, affordable health coverage that works when they need it. We support solutions that will help patients better afford their medicines and protect access to innovation today and in the future.
• Build a more just, equitable society. We must address systemic racism, as has been made clear by the murders of George Floyd, Breonna Taylor, and many others and the outsized impact of the pandemic on Black and Brown communities. We remain committed to this important issue on behalf of our communities, the patients we serve and our employees. | | | | | | Why is it so hard to build a permanent artificial heart? The New Yorker’s Joshua Rothman sketches out years of medical challenges and mysteries around the vital organ. Intelligence agencies have a role to play in spotting the next pandemic and working with public health officials to mitigate those threats, writes former FDA Commissioner Scott Gottlieb in the Wall Street Journal. Anti-vaccination sentiments and conspiracy theories that persuade people not to get the coronavirus vaccine should be likened to domestic terrorism, argues California state senator and pediatrician Richard Pan in a Washington Post op-ed. | | | | Follow us on Twitter | | | | Follow us | | | | |  |
