Officials sound the alarm on vaccine supply

Presented by The American Beverage Association: Delivered daily by 10 a.m., Pulse examines the latest news in health care politics and policy.

Mar 30, 2022 View in browser   By Sarah Owermohle and Krista Mahr Presented by Editor's Note: POLITICO Pulse is a free version of POLITICO Pro Health Care's morning newsletter, which is delivered to our subscribers 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. QUICK FIX — Fourth Covid shots are here for many but could be difficult to supply to the broader population. — Moderna thinks it has the data for young kids' vaccines, but their studies have split health researchers on what's enough. — BA.2's moment has arrived as the highly transmissible strain becomes dominant in the U.S. WELCOME TO WEDNESDAY PULSE — The perfect gown accessory is a public health graph. Send your favorite Oscar looks (or graphs), news and tips to sowermohle@politico.com and kmahr@politico.com. POLITICO will host its inaugural health care summit on Thursday, March 31, as the U.S. enters its third year of the Covid-19 pandemic. Through a series of interviews and panel discussions, summit participants — including providers, policymakers, regulators and patient representatives — will discuss the policies, political dynamics and tech trends shaping the sector. For details, or to attend in person or watch online, click here.   A message from The American Beverage Association: America's leading beverage companies – The Coca-Cola Company, Keurig Dr Pepper and PepsiCo – are bringing consumers more choices with less sugar. From sparkling, flavored and bottled waters to zero sugar sodas, sports drinks, juices and teas, consumers have more options than ever before. In fact, nearly 60% of beverages sold contain zero sugar. Americans are looking for more choices to support them in their efforts to find balance, and America's beverage companies are delivering. BalanceUS.org   Driving The Day BROADER BOOSTING TURNS UP SUPPLY PRESSURES — The Centers for Disease Control and Prevention's Tuesday recommendation that people over 50 get another booster dose was expected. But what occurs next — like the possibility of another Covid-19 vaccine for all adults — could get dicey. What happened: The CDC said people over 50 and immunocompromised adults should get an additional dose of Moderna's or Pfizer and BioNTech's vaccine. Immunocompromised teens can also get another Pfizer booster. It's "especially important" for people over 65 and people with underlying conditions, Director Rochelle Walensky said. The agency also recommended that people who received the Johnson & Johnson vaccine and booster get an mRNA shot. Where it gets tricky: Biden officials say they have enough mRNA vaccines on hand for this wave of booster dosing, but they don't have the funds for more supply. "What worries us is … if a different variant comes up and we need a variant-specific boost in a few months," Dawn O'Connell, the Department of Health and Human Services' assistant secretary for preparedness and response, said during a press conference on Monday. "That would be quite a bit more expensive, and we don't have those doses on hand nor do we currently have the funding to cover those doses." White House spokesperson Kate Bedingfield reiterated the point Tuesday, telling reporters that if "the full population requires a fourth shot, we're going to need additional funding." Biden officials are publicly turning up the pressure on Congress, which dropped new Covid-19 funding from the omnibus package and hasn't come up with a vehicle for new spending (as Republicans demand accounts of how earlier funds were spent). "When it comes to funding, timing matters," Surgeon General Vivek Murthy and Covid-19 Chief Science Officer David Kessler wrote in a New York Times op-ed Tuesday. "Manufacturers cannot turn the production of vaccines, treatments and tests on and off like a switch. Purchases have to be made months in advance if we want supplies to be available when we need them." WHAT'S THE KID VACCINE DELAY? Moderna says it has gathered sufficient data to support its Covid-19 vaccine for use in the youngest children. But it may not be enough for regulators to green-light the shot for kids. Public health officials, pediatricians and infectious disease experts are split over whether the company's trial results are sufficient for the Food and Drug Administration and its independent advisers or whether they'll want to see data on a third dose as they did with Pfizer and BioNTech's vaccine for children under 5, POLITICO's Katherine Ellen Foley writes. The backdrop: Children under 5 make up about 3 percent of U.S. Covid cases and 0.1 percent of deaths, according to CDC data, but during Omicron, this age group was more likely to be hospitalized than older kids. Moderna said last week that two shots reduced symptomatic cases by 43.7 percent among children 6 months to 2 years old and by 35.7 percent in children 2 to 6. That's below the 50 percent threshold the FDA set for adults, but Moderna officials said the regimen met a metric called immunobridging, meaning the pediatric doses produced the same immune response that's been seen in young adults. Not everyone agrees. Immunogenicity alone might not be enough because it doesn't guarantee better protection. The FDA might need to demand a higher standard, Peter Hotez, a professor of pediatrics and molecular virology & microbiology at the Baylor College of Medicine, told POLITICO. "Given the other data that surrounds it, I don't know that it's a slam dunk that the FDA will move forward in terms of releasing it for emergency use." And the stakes are high. An FDA authorization that doesn't show clear and strong benefits, especially for the youngest kids, could do more harm than good to vaccine confidence. "We have to do our job extremely well to make sure that we ensure that there is a very good evaluation of the safety and effectiveness so that when we make our recommendation, people will trust that recommendation," Peter Marks, the head of the FDA's Center for Biologics Evaluation and Research, told reporters Tuesday. BA.2 TAKEOVER — New CDC data released on Tuesday indicates that the BA.2 Omicron subvariant is now the dominant Covid-19 strain in the U.S., Krista reports . The subvariant accounted for more than 54 percent of new cases in the U.S. as of last week, an increase from 39 percent the week before. Why it matters: The BA.2 strain is more transmissible than Omicron, though nothing indicates it's any more severe. It's been driving the surge of cases in Europe, and though cases in the U.S. are still falling, along with deaths and hospitalizations rates, White House officials and public health experts agree that the government needs to be prepared if cases here reverse course. What's next: Those new numbers won't be lost on administration officials who have been pushing Congress to get behind their $22.5 billion request for more Covid-19 aid to shore up vaccine, treatment and testing supplies should another wave wash ashore.   SUBSCRIBE TO NATIONAL SECURITY DAILY : Keep up with the latest critical developments from Ukraine and across Europe in our daily newsletter, National Security Daily. The Russian invasion of Ukraine could disrupt the established world order and result in a refugee crisis, increased cyberattacks, rising energy costs and additional disruption to global supply chains. Go inside the top national security and foreign-policymaking shops for insight on the global threats faced by the U.S. and its allies and what actions world leaders are taking to address them. Subscribe today.     Coronavirus RACIAL DISPARITIES IN COVID-19 AMONG PATIENTS WITH CANCER — A new study published in JAMA Network Open found that Black patients with cancer who are infected with Covid-19 had worse outcomes with the disease than white patients with cancer. "Higher rates of hospitalization, intensive care unit admission, and mechanical ventilation were observed among Black patients compared with White patients," the researchers wrote. All-cause mortality rates were also higher among Black patients, at 19 percent versus 17 percent in white patients. Black patients also experienced an increased prevalence of lung and heart and vascular complications and acute kidney injuries. They were less likely to be treated with remdesivir than white patients and more likely to be treated with hydroxychloroquine. Separately, disparities in both Covid-19 and cancer outcomes in racial and ethnic minority groups are well documented. "These findings suggest that, within the framework of structural racism in the US, having cancer and COVID-19 is associated with worse outcomes among Black patients compared with White patients," the researchers wrote.   A message from The American Beverage Association:   In Congress BIPARTISAN RESOLUTION HIGHLIGHTS ENDOMETRIOSIS — Sen. Tammy Duckworth (D-Ill.) and Sen. Shelley Moore Capito (R-W.Va.) introduced a resolution Tuesday to draw attention to the underrecognized but common chronic disease of endometriosis. Endometriosis is an often painful gynecological condition that can lead to infertility and affects 6.5 million American women, who often are not diagnosed for years. The resolution would mark March 2022 as National Endometriosis month and calls on the Secretaries of Health and Human Services, Defense and Veterans Affairs "to provide information on the disease to women, patients and providers and to improve screening tools and treatment options." Around the Nation FLORIDA SUES BIDEN OVER MASK MANDATE — Florida and 20 other states are suing the Biden administration over its decision to keep a mask mandate in place for travel until April 18, POLITICO's Arek Sarkissian writes. Gov. Rick DeSantis, who has made his disapproval of masking well known, announced the lawsuit at a press conference Tuesday. State attorney general Ashley Moody, who joined DeSantis for the announcement, said the TSA order, which was extended earlier this month, is illegal. The Florida governor said it wasn't grounded in science. "If you have somebody sitting in a window seat, and they're nibbling on peanuts for two and a half hours, they can have their masks down," DeSantis told reporters. "Then you have the person in the middle seat, that is not eating, they just wanted to read a magazine without the mask, that somehow that would be a big problem."   DON'T MISS POLITICO'S INAUGURAL HEALTH CARE SUMMIT ON 3/31: Join POLITICO for a discussion with health care providers, policymakers, federal regulators, patient representatives, and industry leaders to better understand the latest policy and industry solutions in place as we enter year three of the pandemic. Panelists will discuss the latest proposals to overcome long-standing health care challenges in the U.S., such as expanding access to care, affordability, and prescription drug prices. REGISTER HERE.     What We're Reading Kaiser Health News tells the story of a Tennessee pharmacy that courted opioid buyers by filling dodgy prescriptions. There's a monkey involved. The National Institutes of Health made its first foray into studying long Covid, and it's not going well, reports STAT News. While lead poisoning has plummeted since the 1970s, roughly 500,000 children under 6 still have risky levels, and it's increasingly difficult to find legal recourse for health care costs, Ellen Gabler writes in The New York Times.   A message from The American Beverage Association: Families are looking for more choices to support their efforts to find balance. That's why America's beverage companies are offering more choices with less sugar. It's all part of our commitment to reduce beverage calories consumed per person nationally by 20% by 2025. And it's working. Today, nearly 60% of beverages sold contain zero sugar. Our commitment to helping our consumers find balance also includes: · Putting clear calorie labels on every bottle, can and pack. · Reminding consumers to think about balance with signs on coolers and displays in store. · Working with local organizations across the country to build awareness of the many choices available – and increase the access to zero sugar beverages in communities where it's needed most. Learn more at BalanceUS.org     Follow us on Twitter Tucker Doherty @tucker_doherty Dan Goldberg @dancgoldberg Erin Banco @ErinBanco Katherine Ellen Foley @katherineefoley Lauren Gardner @Gardner_LM Ben Leonard @_BenLeonard_ Rachael Levy @rachael_levy David Lim @davidalim Megan Messerly @meganmesserly Alice Miranda Ollstein @aliceollstein Sarah Owermohle @owermohle Carmen Paun @carmenpaun Darius Tahir @dariustahir Megan R. Wilson @misswilson   Follow us

To change your alert settings, please log in at https://www.politico.com/_login?base=https%3A%2F%2Fwww.politico.com/settings This email was sent to rouf@idiot.cloudns.cc by: POLITICO, LLC 1000 Wilson Blvd. Arlington, VA, 22209, USA Please click here and follow the steps to unsubscribe.