Checking in on avian flu vaccines

Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy.

Sep 13, 2024 View in browser   By David Lim and Lauren Gardner With Connor O’Brien Driving The Day The government is working to have a vaccine for the current form of bird flu that's circulating in cows ready to deploy. | Angela Weiss/AFP via Getty Images BIRD FLU VAX PREP INCHES FORWARD — Federal health officials maintain the risk of avian flu to the public remains low despite the CDC’s unsuccessful sequencing efforts from a recent infection in Missouri in a hospitalized patient with no known animal contacts. But the government says efforts to position vaccines that target the flu circulating in dairy cows are nearly complete. The federal government has prefilled syringes of vaccine candidates and is finalizing bulk fill of multidose vials, but the FDA has not yet greenlighted them, David Boucher, director of infectious disease preparedness and response in the HHS Administration for Strategic Preparedness and Response, told reporters on Thursday. FDA advisory committee? Dr. Paul Offit, a Children’s Hospital of Philadelphia vaccine expert who sits on the FDA’s vaccine advisory committee, wants the panel to review data before the agency authorizes or approves the candidate vaccines. “We did this for Covid when thousands of people were dying a day, and we still went through that committee process,” Offit said. “This is not the same virus, this does not even spread easily person to person, there’s plenty of time to do that and I think we owe it to the American population to have an independent advisory board look at those data.” Dr. Georges Benjamin, executive director of the American Public Health Association, said he would prefer that the government be ready to deploy avian flu vaccines in short order if needed. “[The FDA] probably should do their advisory committee as soon as they have what they need to do that,” Benjamin said. Boosting surveillance? Some public health experts are concerned the flu surveillance system is not sensitive enough to detect other avian flu cases. “Given the denominator, you would need to see a big uptick to pick up a signal,” Dr. Celine Gounder, editor-at-large for public health at KFF Health News said. “We may well be caught flat-footed again because Congress isn’t investing enough in public health surveillance.” Rick Bright, who led the Biomedical Advanced Research and Development Authority and raised the alarm about the Trump administration’s early response to the Covid-19 pandemic, described the surveillance system as “random, reactive and very slow.” “We need to tighten up our surveillance capabilities and speed turnaround times for outbreak investigation or we will easily miss the emergence and spread of pandemic viruses, until it’s too late,” Bright said. “There are many unanswered questions about the case in Missouri. Some that might’ve been answered if samples were collected sooner.” IT’S FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. Your author finds himself reacquainted with Covid-19. Reach out with tips to David Lim (dlim@politico.com or @davidalim) and Lauren Gardner (lgardner@politico.com or @Gardner_LM). LIVE EVENT ON WEDNESDAY: THE FUTURE OF PATIENT CARE AND ACCESS Join us on Wednesday, Sept. 18, starting at 8:30 a.m. ET, as we dive into how health care delivery innovations fueled by AI and tech are empowering providers to focus more time and resources on patients. Watch our keynote conversation with HHS’ Micky Tripathi, assistant secretary for technology policy and acting chief artificial intelligence officer. Stick around for a panel conversation with Nancy Howell Agee, CEO of Carilion Clinic; Andrea Downing, president and co-founder of The Light Collective; Kolaleh Eskandanian, VP and CIO of Children’s National Hospital; and Hafeezah Muhammad, founder and CEO of Backpack Healthcare. RSVP to attend and watch here. In Congress Sen. Gary Peters is the lead sponsor of the BIOSECURE Act. | Anna Rose Layden/Getty Images BIOSECURE IN THE SENATE — The Senate’s lead sponsor of legislation to curb Chinese biotechs’ access to the U.S. market told Lauren this week he’s “looking at avenues to get it passed.” The House passed a companion bill Monday night in a 306-81 vote. “It’s something I strongly support, and we’re working to get it passed,” Sen. Gary Peters (D-Mich.) said when asked whether he’s targeting the annual defense policy bill to move it. Industry analysts predict the legislation, known as the BIOSECURE Act, will pass this year as part of a larger legislative vehicle, likely the fiscal 2025 defense authorization measure. Next steps: The Senate won't debate and vote on its own defense bill, a Senate aide familiar with the process said, but the chamber could advance a revised version of the bill with a package of bipartisan amendments as early as next week. It’s unclear whether the BIOSECURE Act would be included in that package. Kentucky Sen. Rand Paul, the ranking Republican on the Homeland Security Committee, was the only panel member to oppose the measure at markup. His office didn’t respond to a request for comment on whether he’d oppose other legislation like the defense bill if the BIOSECURE Act were added to it. Peters said he hasn’t spoken to Paul about the legislation since the panel approved it in March. AROUND THE AGENCIES ASPR API AWARD — HHS’ Administration for Strategic Preparedness and Response awarded $14 million Thursday to a nonprofit coalition focused on manufacturing active pharmaceutical ingredients domestically. The funding is the first award under a Defense Production Act program geared toward creating, maintaining or expanding manufacturing of critical base materials needed to respond to public health emergencies. The funding will go to the API Innovation Center, a nonprofit coalition in St. Louis, Missouri, to build continuous flow manufacturing and other advanced operations across the group’s network — practices HHS says are ideal for rapidly responding to emergencies and shortages. The investments aim to create complete supply chains for three essential drugs. The API Innovation Center said those APIs are used in drugs to treat asthma, anxiety disorders and diabetes. MEDICAL DEVICES AN APPLE A DAY — The FDA said Thursday it has cleared novel hearing aid software for certain Apple AirPods, bringing a ubiquitous consumer brand into the burgeoning over-the-counter market for hearing aids. The authorization gives Apple the opportunity to reach a widespread customer base with mild to moderate forms of hearing loss for which people might not seek prescription hearing aids. The agency finalized rules in August 2022 establishing an over-the-counter category for hearing aids and outlining performance and design specifications. Eye on the FDA WARNING LETTERS — The FDA is reviewing data from two Chinese labs used in premarket medical device applications after issuing warning letters over oversight failures and animal care issues that the agency says raises concerns about the “quality and integrity of data generated by the labs.” The FDA said it won’t authorize submissions in which the data is needed for the agency to decide on device applications. The two firms that received warning letters are Mid-Link Testing Company Ltd. and Sanitation & Environmental Technology Institute of Soochow University Ltd. “The agency is evaluating any impact these findings have had on past submissions and will take action to address any public health risks as necessary,” the FDA said in a press release. Pharma Moves Biogen appointed two new directors to its board: Stanford University School of Medicine dean Lloyd Minor and Menelas Pangalos, who recently was an executive vice president of biopharmaceutical research and development at AstraZeneca. Minor will join Oct. 1, and Pangalos will join Jan. 1, 2025. Document Drawer The FDA issued guidance Thursday on its enforcement policy for mandatory health warnings for cigarette packages and advertisements. The FDA issued a drug safety communication Thursday warning that Veozah, used to treat hot flashes during menopause, can cause rare but serious liver injury. A National Academies of Sciences, Engineering, and Medicine report released Thursday called on the FDA to improve engagement with rare disease patients, their caregivers and European regulators to expedite and increase the number of drugs developed and approved for those conditions. WHAT WE'RE READING FDA Commissioner Robert Califf dismissed criticism this week of the agency’s approval of a controversial Duchenne muscular dystrophy therapy, arguing trial results for rare disease drugs should be interpreted with more nuance, STAT’s Brittany Trang reports. Moderna plans to slash its research and development spending by $1.1 billion by 2027, Endpoints News’ Andrew Dunn reports.   Follow us on Twitter David Lim @davidalim Lauren Gardner @Gardner_LM   Follow us

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