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Presented by CVS Health: Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy. | | | | | |  | | By David Lim | Presented by CVS Health | With Lauren Morello and Emily Martin | | | — Biden doubles 100-day vaccination goal. — Pfizer begins studying vaccine in children under 12. — Covid-19 could make developing next year’s flu shot more difficult. It’s Friday, welcome back to Prescription Pulse. Your author is captivated by the ship blocking the Suez Canal along with the rest of the internet. As always, send tips to Sarah Owermohle (sowermohle@politico.com or @owermohle) and David Lim (dlim@politico.com or @davidalim). | | A message from CVS Health: Throughout the COVID-19 pandemic, CVS Health has been there. We’re nearly 300,000 employees ensuring millions of Americans can access health care services. We opened thousands of COVID-19 test sites and administered millions of tests. Now, we’re providing the vaccine in designated states. We’ve been on the frontlines, making health care easier to access and afford. That’s health care, from the heart. Learn more. | | | | | | BIDEN DOUBLES 100-DAY VACCINATION GOAL — President Joe Biden announced at the top of his first press conference his administration now aims to administer 200 million doses of Covid-19 vaccines in its first 100 days, POLITICO’s Dan Goldberg reports. The U.S. is now administering roughly 2.5 million doses per day, with more than 114 million shots given in the two months since Biden's inauguration. Barring any unexpected hiccups in the vaccine rollout, the country is already on pace to hit 200 million vaccinations in roughly five weeks, around Biden's 100th day in office. Republican Whip Steve Scalise (La.) argued President Donald Trump “laid the groundwork for today’s achievement,” and noted he urged Biden to set a 100-day, 200 million shot goal in January. But even as the vaccine campaign ramps up, infection numbers have remained stubbornly high. Several states, including Massachusetts, Michigan and New Jersey, are reporting an increase in cases, and the decline in hospitalizations nationwide has dramatically slowed during the last two weeks. WHAT PANDEMIC? — Despite nearly 400,000 new U.S. Covid-19 cases and 7,114 deaths in the last seven days, no White House reporters asked Biden about the still-raging pandemic at his first press conference. Some Democrats were incensed that Covid never came up, POLITICO’s Anita Kumar reports. But others, including Ron Klain, the White House chief of staff, pushed the notion that the lack of discussion was merely a reflection of Biden’s discipline in handling the pandemic. The president and his team have set low expectations and routinely cleared them, while trying to create a deliberate contrast with Donald Trump’s presidency. PFIZER STUDYING VACCINE IN CHILDREN UNDER 12 — Pfizer is the latest Covid-19 vaccine manufacturer to begin studying its jab in children, according to spokesperson Sharon Castillo. The company is studying three groups of children: those 5 to 11 years, 2 to 5 years, and 6 months to 2 years. Results are expected by the second half of 2021 — If regulators believe the shot is safe and effective Pfizer hopes to begin vaccinating kids by early next year. ASTRAZENECA’S NEW MATH — The British drugmaker on Wednesday updated its estimate of how well its coronavirus vaccine works, two days after federal scientists accused the company of cherrypicking data included in a press release touting the results of the company's Phase III U.S. trial. AstraZeneca now says the vaccine is 76 percent effective against symptomatic Covid-19 infection, slightly lower than the 79 percent it touted Monday. The estimated efficacy in people over 65 rose slightly, from 80 percent to 85 percent. The latest analysis is based on 190 cases of infection among the nearly 33,000 trial participants. AstraZeneca said there are 14 "additional possible or probable" infections among those volunteers that are still being evaluated and could change the overall results slightly. The latest data still place AstraZeneca well above the Food and Drug Administration’s bar for authorizing a coronavirus vaccine — 50 percent efficacy — for both adults overall and the elderly in particular. But the confusion has triggered worries that the public will lose confidence in the shot. The company, which has sold 300 million doses to the U.S., plans to seek emergency authorization from the Food and Drug Administration by mid-April. COVID-19 COULD MAKE NEXT FLU SEASON HARDER — Precautions aimed at tamping down the coronavirus helped nearly eradicate last year’s flu season — but that could backfire by making it harder to develop effective vaccines for next winter’s flu, Jasmine Hilton reports. The hospitalization rate for the 2020-21 flu season was just 0.7 per 100,000 people, the lowest it’s been since the Centers for Disease Control and Prevention began collecting such data in 2005. Measures such as social distancing, wearing masks and staying indoors likely helped hold pediatric flu deaths to just one last flu season, compared to 196 in the 2019-20 season. Public health experts are relieved that the United States avoided a “twindemic” of a strong flu season amid a spiraling Covid-19 outbreak. But the low levels of flu have left a much smaller pool of data to predict which strains will predominate next winter — raising the odds that the 2021-22 vaccine will be less effective than normal. “We may have a combination of low public health measures at the population level with a low effectiveness vaccine. And then so you might have a raging flu season next year,” said Lawrence Gostin, a global health law professor at Georgetown University. | | | FDA HIKES OTC USER FEES — Manufacturers of over-the-counter products subject to user fees will have to pay more than previously expected because HHS decided to exempt some hand sanitizer makers from the fees, FDA announced on Thursday. Over-the-counter monograph drug facilities will be charged $20,322 and contract manufacturing organizations will owe $13,548 for the period between Oct. 1, 2020 and Sept. 30, 2020. | | | |   | | | | | | EU MOVES TO FAST-TRACK VARIANT BOOSTER SHOTS — The European Commission plans to introduce new provisions in EU legislation that would fast-track approval of booster vaccines meant to target new variants, POLITICO EU’s Ashleigh Furlong reports. The Commission’s fast track procedure would allow companies to submit a smaller data set to the European Medicines Agency for booster vaccines. “Faster approval means more vaccines in circulation and more Europeans protected against the virus,” Commission President Ursula von der Leyen said in a statement. U.K., EU VAGUELY PROMISE TO COOPERATE — After days of tension over access to limited vaccine supplies, the U.K. government and the Commission issued a joint statement promising to cooperate but offering no specifics, POLITICO EU’s David Herszenhorn reports. “We are all facing the same pandemic and the third wave makes cooperation between the EU and U.K. even more important," the statement said. "We have been discussing what more we can do to ensure a reciprocally beneficial relationship between the U.K. and EU on COVID-19.” | | | NEWSOM OUTSOURCES VACCINES, RAISES PRIVACY CONCERNS — California’s vaccination rollout was sputtering in the beginning of the year when Gov. Gavin Newsom, who’s facing a recall effort and pressure to get doses out as quickly as possible, inked a deal to outsource distribution, POLITICO Pro’s Victoria Colliver reports. Newsom had tapped Blue Shield of California to create and manage a one-stop shop, called My Turn, with appointment information and dosage data, rather than turning to the state’s underfunded public health departments. However, the rollout still faces challenges with an insufficient vaccine supply, and the deal has raised concerns about data privacy and equity. Plus, the company made sizable contributions to Newsom's reelection, fueling speculation about how money may have influenced the decision. FLORIDA LOWERS VACCINE AGE ELIGIBILITY — Florida Gov. Ron DeSantis announced plans to open Covid-19 vaccine eligibility to people who are at least 18 years old, POLITICO Pro’s Arek Sarkissian reports. DeSantis said there will be enough shots for younger residents since 70 percent of seniors in Florida have been immunized. Beginning March 29, DeSantis will lower the age of vaccine eligibility to 40, and then one week later will drop it to adults 18 and older. The announcement comes a week after DeSantis criticized a Florida Democratic mayor for lowering the age requirement. | | | | SUBSCRIBE TO "THE RECAST" TO JOIN AN IMPORTANT CONVERSATION : Power dynamics are shifting in Washington and across the country, and more people are demanding a seat at the table, insisting that all politics is personal and not all policy is equitable. "The Recast" is a new twice-weekly newsletter that breaks down how race and identity are recasting politics, policy, and power in America. Get fresh insights, scoops, and dispatches on this crucial intersection from across the country, and hear from new voices that challenge business as usual. Don't miss out on this new newsletter, SUBSCRIBE NOW . Thank you to our sponsor, Intel. | | | | | | | | Friday: The HHS Office of Minority Health holds the second meeting of the COVID-19 Health Equity Task Force. | | | Here are some highlights from our colleagues over at AgencyIQ, the regulatory insight platform for FDA. — PDUFA progress: The FDA and industry are tantalizingly close to reaching final, agreed-upon language for several key program areas set to be included in the next iteration of the Prescription Drug User Fee Amendments, according to meeting minutes posted by FDA this week. — What will the FDA do in 2021? POLITICO’s AgencyIQ has developed the first-ever FDA Forecast 2021 – our extensive, in-depth predictions about what the FDA will do in 10 key regulatory areas this year, including Covid-19, cannabis, pharmaceuticals, medical devices, generic drugs, biosimilars, diagnostics, OTC drugs and more. The 93-page report is now free to download in its entirety. | | | | STEP INSIDE THE WEST WING : The Biden administration is more than halfway through its first 100 days and is now facing a growing crisis at the border and escalating violence against Asian Americans, while navigating the pandemic and ongoing economic challenges. Add Transition Playbook to your daily reads to find out what actions are being considered, as well the internal state of play inside the West Wing and across the administration. Track the people, policies, and emerging power centers of the Biden administration. Don't miss out. Subscribe today. | | | | | | | | Longtime Democratic operative Chris Jennings has joined the governance board of the Institute for Clinical and Economic Review, an independent organization that assesses drug values, which worries the drug industry and patient groups, Inside Health Policy reports. Centessa Pharmaceuticals and vaccine developer Vaxcyte are the latest companies to part ways with the Trump administration’s vaccine chief, Moncef Slaoui, after he was fired by Glaxo Smith-Kline following sexual harassment allegations, CNBC News reports. Pfizer started an early-stage U.S. trial of an oral antiviral therapy that could be prescribed to patients at the first sign of infection of Covid-19, Reuters reports. The University of California, San Francisco, and Johns Hopkins University have launched an online archive to store documents from lawsuits claiming drug companies played a role in the opioid epidemic, STAT News reports. Scrutiny by the FDA and its independent advisory boards of AstraZeneca’s vaccine efficacy data is exactly the way pharmaceutical regulation is supposed to work, Quartz reports. | | A message from CVS Health: Throughout the pandemic, in communities across the country, CVS Health has been delivering essential care. Thanks to the efforts of our employees, we opened 4,800 COVID-19 test sites and administered over 15 million tests at our stores and through partners in underserved communities. With millions staying home, we increased access to prescription delivery, virtual visits and mental health services. Now, we’re providing vaccines in designated states. Every day, CVS Health works to bring quality, affordable health care closer to home—so it’s never out of reach for anyone. That’s health care, from the heart. Learn more. | | | | | | The FDA will hold a virtual advisory committee meeting on arthritis regulatory issues on May 6. FDA is requesting nominations for voting members for its Blood Products Advisory Committee. FDA is also asking consumer organizations that want to help select voting and nonvoting consumer representatives for a variety of advisory committees to let the agency know. | | | | Follow us on Twitter | | | | Follow us | | | | |  |
