| | | | |  | | By Katherine Ellen Foley and Daniel Payne | | | With Carmen Paun
| | |  Covid vaccine manufacturers are waiting to learn what the predominant strain of the virus will likely be so they can begin developing boosters. | Emily Elconin/Getty Images | AT SUMMER’S KICKOFF, PREPARING FOR FALL — The FDA’s independent advisers will discuss and recommend this week which strain of SARS-CoV-2 should be included in the newest Covid booster to be rolled out ahead of fall and winter. The FDA doesn’t have to follow its advisers’ recommendations, but it often does. Since the beginning of the year, the regulatory agency has made it clear that it will shift gears to prepare for annual Covid-19 shots as the virus becomes endemic. Now that we’re four months out from the intended rollout, the FDA must select a strain that will most likely be prevalent so manufacturers can start developing vaccines. Novavax, Pfizer-BioNTech and Moderna, the companies that manufacture the three vaccines available in the U.S., need the FDA’s recommendations to begin tweaking their existing platforms. They must also conduct clinical trials to show that the updated formulas generate a similar immune response to their existing products. Regulators and industry are in a balancing act: They must wait as long as possible to have the most recent data on commonly circulating virus strains, but they can’t wait too long to decide because manufacturers need time to bolster production. “There’s certainly public health interest in waiting as long as possible to provide the strain while balancing manufacturers’ ability to deliver,” Silvia Taylor, executive vice president and chief corporate affairs and advocacy officer at Novavax, told Katherine at the BIO International Convention last week. Manufacturers are already developing new shots. Pfizer-BioNTech and Moderna have said they’re working on updated mRNA-based boosters that protect against the latest strains, as well as combination shots with other seasonal respiratory viruses and those that offer more durable protection. Novavax, which has a protein-based Covid-19 vaccine, is working to develop four potential updated vaccines based on different strains. Global experts are eying XBB.1.5, a sublineage of the Omicron variant, as the potential target strain. Last week, the European Medicines Agency and the European Center for Disease Prevention and Control named XBB.1.5 as the strain it would like to see vaccines protect against in the fall, as leaders from other international regulatory groups and the World Health Organization did previously. XBB1.5, which makes up about 40 percent of the Covid cases in the U.S., is one of the strains Novavax has been developing a candidate against. “I feel really good that we’re in the right Zip code,” said Taylor. WELCOME TO MONDAY PULSE. Greetings from your friendly neighborhood FDA reporter, Katherine Ellen Foley. I’ll be your host for the next few days. Send your news, tips and pictures of neighborhood wildlife to kfoley@politico.com and to your regular Pulse author Daniel Payne at dpayne@politico.com. TODAY ON OUR PULSE CHECK PODCAST, host Kelly Hooper talks with Robert King about his reporting on the Biden administration’s announcement that the makers of 43 drugs will have to pay rebates to Medicare because they raised prices faster than inflation — and how it will affect Medicare participants.
| | | | A message from PhRMA: Pharmacy benefit managers (PBMs) decide if medicines get covered and what you pay, regardless of what your doctor prescribes. They say they want lower prices, yet they often deny or limit coverage of lower-cost generics and biosimilars, instead covering medicines with higher prices so they make more money. What else are they hiding? | | | | | | | | | | 
A panel of independent experts recommend that the FDA grant traditional approval to the Alzheimer's drug, Leqembi. | Sebastien Bozon/AFP via Getty Images | ALZHEIMER’S DRUG MOVES CLOSER TO APPROVAL — The FDA is considering granting traditional approval to Leqembi, an Alzheimer’s therapy from Eisai and Biogen that received accelerated approval in January, Katherine reports. Late last week, the agency’s independent advisers unanimously recommended that the agency fully approve the drug. Traditional approval would broaden coverage for the drug, which costs $26,500 annually out of pocket. The Centers for Medicare and Medicaid Services covers the drug for only beneficiaries enrolled in a randomized, NIH-approved clinical trial — of which there have been none enrolling since the drug hit the market — even as the Department of Veterans Affairs covers the drug. Under traditional approval, CMS would cover the drug for beneficiaries enrolled in a national patient registry to track their outcomes, which it said would be “easy to use” for providers. Alzheimer’s patient advocates applauded the committee’s recommendation, which is nonbinding. “It is time for CMS to step up and provide Medicare access on the day of an FDA traditional approval,” Joanne Pike, president and CEO of the Alzheimer’s Association, said in a statement. The association had formally asked CMS to broaden its coverage of the drug late last year, and the agency denied the request. What’s next: The FDA will decide on Leqembi’s approval by July 6.
| | | | GET READY FOR GLOBAL TECH DAY: Join POLITICO Live as we launch our first Global Tech Day alongside London Tech Week on Thursday, June 15. Register now for continuing updates and to be a part of this momentous and program-packed day! From the blockchain, to AI, and autonomous vehicles, technology is changing how power is exercised around the world, so who will write the rules? REGISTER HERE. | | | | | | | | TAKING ANOTHER SWING AT OPIOIDS — Republicans and Democrats have launched an effort to reauthorize a five-year-old law that marked a bipartisan commitment to combat the opioid addiction crisis, Carmen reports. At the time, it was seen as a potential turning point in the fight to quell it. Despite the law, the crisis has continued to spiral, with the overdose death count from synthetic opioids growing from 31,000 at the time of the law’s enactment to more than 70,000 at the end of 2021, according to the CDC. Still, representatives at a House Energy and Commerce Health Subcommittee hearing on Friday agreed that the law’s reauthorization could serve as a vehicle for enhancing support for people with opioid use disorder and reducing stigma around the disease. Accounting for $21 billion in spending, the SUPPORT Act has funded opioid use disorder treatment, prevention, recovery and enforcement. It also helped states use Medicaid to better serve people in need of treatment. But many of its provisions are set to expire in September. What’s next? Lawmakers and witnesses discussed how to improve the SUPPORT Act could be improved, such as by: — Relaxing rules that restrict Medicaid funding to cover addiction treatment in mental health institutions — Expanding telehealth access — Improving addiction treatment for incarcerated people “There are legitimate medical, physiological changes in people who become addicted, and that we have to recognize and that we have to find medical ways to get them out of it,” said Rep. Larry Bucshon (R-Ind.), the panel’s vice chair. “Addressing the disease of addiction must include a compassionate response bolstered by the pillars of prevention, of treatment and of recovery,” said Rep. Paul Tonko (D-N.Y.).
| | | | A message from PhRMA:   | | | | | FDA TO EXAMINE SYNTHETIC COOLANTS — The FDA said Friday it seeks to work with an external company in providing additional evidence on the potential toxicity of synthetic chemicals used to replace menthol flavoring in e-cigarettes. The chemicals, WS-3 and WS-23, provide cooling effects to smokers. POLITICO previously reported that WS-3 is in cigarettes in California, which banned most menthol tobacco products late last year. The coolants are also popular in e-cigarettes. The agency said that as it prepares to ban menthol cigarettes and flavored cigars at a federal level, it anticipates that “the tobacco industry may use synthetic coolants … as replacements” and that even though the chemicals are generally regarded as safe outside of tobacco products, “there is insufficient information to determine the potential toxicity of inhaling aerosolized synthetic coolants.”
| | | | LISTEN TO POLITICO'S ENERGY PODCAST: Check out our daily five-minute brief on the latest energy and environmental politics and policy news. Don't miss out on the must-know stories, candid insights, and analysis from POLITICO's energy team. Listen today. | | | | | | | | | The world’s most prolific researcher publishes a new scientific paper every other day, highlighting the dark world of academia’s pressure to publish, Manuel Ansede writes for El País. Covid-19’s jump to at least 32 animal species worldwide means there’s virtually no chance the world will ever be rid of the virus, Melissa Healy writes for the Los Angeles Times. It’s time to give up on the idea that we need 10,000 steps a day, Gretchen Reynolds writes for The Washington Post.
| | | | A message from PhRMA: Middlemen say they want lower prices, yet they often deny or limit coverage of lower-cost generics and biosimilars while giving preferential coverage to medicines with higher prices. This might be good for PBM’s bottom line, but it can lead to higher costs for patients. What else are they hiding? | | | | | | | Follow us on Twitter | | | | Follow us | | | | |
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