| | | | |  | | By David Lim , Lauren Gardner and Katherine Ellen Foley | | | | — Questions abound after the FDA announced its decision to stretch monkeypox vaccine doses through alternative administration. — The FDA is reminding the public to repeat rapid Covid-19 tests over two to three days to boost accuracy. — The House is set to vote on Democrat's sweeping reconciliation package that would allow Medicare to negotiate some drug prices for the first time. It's Friday. Welcome to Prescription Pulse, where we've always been bigger fans of Baked and Wired anyway . Send tips and feedback to David Lim ( dlim@politico.com or @davidalim ), Lauren Gardner ( lgardner@politico.com or @Gardner_LM ) or Katherine Ellen Foley ( kfoley@politico.com or @katherineefoley ).
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HHS will employ a dose-sharing strategy for the monkeypox vaccine. | Mario Tama/Getty Images | HHS TO SHARE VACCINE DOSES, BUT CONCERNS, EVEN FROM THE MAKER, ABOUND — When HHS officials on Tuesday announced they had a plan to stretch the doses of Jynneos, the only FDA-cleared monkeypox vaccine, it was met with mixed reactions. On the one hand, doses have been in short supply while cases are rising at an alarming rate. As of Wednesday, 10,392 cases were confirmed in 49 states, up from 8,934 the day before. Under the new authorization, health care providers would administer one-fifth of the usual vaccine dose in between layers of the skin — a technique called intradermal administration — instead of beneath it. The 441,000 doses of Jynneos vaccine in the Strategic National Stockpile would be stretched to 2.2 million doses. But on the other hand, health experts and advocates immediately expressed concerns over the limited data backing the strategy, as did executives at Bavarian Nordic, the Danish company that manufactures Jynneos. In an Aug. 9 letter to HHS officials first obtained by The Washington Post , the company's president and CEO Paul Chaplin wrote that "we do have some reservations … due to the very limited safety data available." Chaplin also noted that his company has received a high volume of calls from U.S. health care providers about administration. The CDC issued guidance for intradermal administration of the vaccine to providers Thursday. The FDA said it is basing its strategy on a 2015 study that found that intradermal administration of a smaller dose led to a comparable immune response to the traditional dose under the skin. The study did not look at the shot's overall efficacy, and it's still unclear how much protection the vaccine offers under either mode of administration. Experts stressed that the strategy could work but fear that potential recipients may not trust the strategy. "My primary worry — even if this turns out to be equally equivalent, which I think odds are it will — will people trust it enough to get the vaccine?" James Krellenstein, managing director of the advocacy group PrEP4All, told POLITICO. Requesting information: Chaplin's letter echoed a similar sentiment to what other public health experts have stressed: There needs to be ongoing data collection about the vaccine's efficacy, particularly with an alternative delivery method, as the rollout continues. "We need answers to [these questions] to provide to people who are getting vaccinated so we give them full information on what this vaccine can and can't do," said Michael Osterholm, the director of the Center for Infectious Disease Research and Policy at the University of Minnesota. Rollout roadblocks: There's also the practical question about vaccine distribution. Intradermal administration is more common among health care providers who regularly test for tuberculosis, Osterholm said. It's "often considered more art than science," he added. Meanwhile, vaccination supply could be limited: Although the Biden administration is working with multiple companies to put more doses of Jynneos into vials before they are shipped, it could take three to six months to get them ready , POLITICO's Erin Banco and Adam Cancryn scoop.
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The FDA has updated its guidance about Covid-19 at-home tests to include repeat testing. | Mario Tama/Getty Images | FDA: TEST AT LEAST TWICE AT HOME, EVEN IF ASYMPTOMATIC — People using at-home Covid-19 tests should conduct repeat testing following a negative result within two or three days to cut down on the risk of unknowingly spreading the virus to others, the FDA said in a new safety communication issued Thursday . For those with a known exposure to Covid-19, the agency recommends testing at least three times. "If you do not have Covid-19 symptoms and believe you have been exposed to Covid-19, test again 48 hours after the first negative test, then 48 hours after the second negative test, for a total of at least three tests," the FDA said. The recommendation is consistent with new CDC guidelines that aim to loosen quarantine recommendations and overhaul how schools approach mitigation when students return, POLITICO's Krista Mahr reports . The agency dropped its guidance that unvaccinated people or those not up to date on their vaccines quarantine after exposure and said that schools should take the same approach for students. The CDC also lifted previous recommendations that students quarantine if exposed to someone positive for the virus and that schools limit students' contacts by cohorting them in groups during the day. The agency now says schools no longer need to conduct Covid-19 routine testing for asymptomatic or unexposed students, suggesting schools consider doing that only in response to an outbreak, a high community risk or a high-risk event at the school, like a prom or a large sports event. GSK, VIR SHELVE PLANS FOR MONOCLONAL ANTIBODY LICENSE — GlaxoSmithKline and Vir Biotechnology no longer plan to file for FDA approval of sotrovimab, their Covid-19 monoclonal antibody, because of pandemic shifts and talks with the agency, Vir announced Tuesday. The FDA halted use of the biologic in April once the BA.2 Omicron subvariant, against which sotrovimab wasn't effective, became dominant in the U.S. The companies also don't intend to pursue a U.S.-based trial of sotrovimab as a Covid prophylaxis. "Discussions with the FDA remain ongoing regarding the appropriate path forward for sotrovimab in the US," Vir said in a statement announcing its second-quarter financial results.
| | | | DON'T MISS DIGITAL FUTURE DAILY - OUR TECHNOLOGY NEWSLETTER, RE-IMAGINED: Technology is always evolving, and our new tech-obsessed newsletter is too! Digital Future Daily unlocks the most important stories determining the future of technology, from Washington to Silicon Valley and innovation power centers around the world. Readers get an in-depth look at how the next wave of tech will reshape civic and political life, including activism, fundraising, lobbying and legislating. Go inside the minds of the biggest tech players, policymakers and regulators to learn how their decisions affect our lives. Don't miss out, subscribe today . | | | | | | | | HOUSE POISED TO PASS RECONCILIATION MEASURE — The House is expected to vote today on a budget reconciliation deal that includes long-fought provisions allowing Medicare to negotiate some drug prices, capping off an 18-month slog just in time for midterm campaign season. But the bill's anticipated passage is still bittersweet for Democrats as they take stock of what had to fall out of the legislation to get it over the finish line — and how long it may take for the party to get another crack at overhauling the U.S. health care system, POLITICO's Alice Miranda Ollstein writes . Dems are expected to lose control of one or both legislative chambers in November. Democratic lawmakers are expected to campaign on their health wins, but nearly every policy change voters would have immediately felt was stripped from the measure — Medicare drug price negotiations, for example, won't begin until 2026. "There's a lot of heartache in legislation," said Rep. Peter Welch (D-Vt.), one of the bill's lead House negotiators who's running for Senate.
| | | BAYER TO LOBBY ON CONTRACEPTION ACCESS — Pharmaceutical giant Bayer will use outside lobbyists to advocate for access to contraceptives for the first time. Former congresswoman and former acting U.S. Consumer Product Safety Commission Chair Ann Marie Buerkle, Susan Hirschmann, Laura Simmons, Cheryl Jaeger, Nicole Bertsch, Matthew Hoekstra and Karina Lynch will lobby on the account for Williams and Jensen. The company, which makes the birth control pill Yaz and intrauterine device Mirena vowed last year to invest more than €400 million, or nearly $413 million at the current conversion rate, in an initiative to provide 100 million women and girls across the globe — focusing on low- and middle-income countries — with access to "modern contraception" in the next decade. New disclosures show Bayer hired the lobbying firm in early July. Williams and Jensen will also lobby on drug pricing issues, Medicare coverage policies and the 340B drug discount program.
| | | EXCLUSIVE: SENATORS URGE FDA TO CONDUCT FURTHER PULSE OXIMETER STUDIES — Today, five Democratic Senators sent a letter to FDA Commissioner Robert Califf, asking the agency to provide further information on its process for clearing pulse oximeters, which have been found to sometimes inaccurately read oxygen saturation levels in people with darker skin. In the letter, Sens. Elizabeth Warren (D-Mass.), Cory Booker (D-N.J.), Tammy Duckworth (D-Ill.), Ron Wyden (D-Ore.) and Ed Markey (D-Mass.) also urged the agency to conduct a postmarketing study to assess what updates need to be made for devices to be effective for all skin tones.
| | | Johnson & Johnson's executive vice president for pharmaceutical R&D, Mathai Mammen, has decided to leave the company, J&J announced. William Hait will serve as interim head of that group. Monica Bertagnolli will be the next director of the National Cancer Institute, President Joe Biden announced Wednesday. She currently is a Harvard Medical School professor in surgical oncology, a surgeon at Brigham and Women's Hospital and a member of the Gastrointestinal Cancer and Sarcoma Disease Centers at Dana-Farber Cancer Institute. Anali Alegria has been promoted to communications director for Senate HELP Committee Democrats. The Alliance for Regenerative Medicine, which represents the cell and gene therapy sector, announced Timothy Hunt has been appointed its next CEO. Trentqual Rhone is now the press and staff assistant for Rep. Suzan DelBene (D-Wash.). He was previously a press assistant at the advocacy group Protect Our Care.
| | | | INTRODUCING POWER SWITCH: The energy landscape is profoundly transforming. Power Switch is a daily newsletter that unlocks the most important stories driving the energy sector and the political forces shaping critical decisions about your energy future, from production to storage, distribution to consumption. Don't miss out on Power Switch, your guide to the politics of energy transformation in America and around the world. SUBSCRIBE TODAY . | | | | | | | | Inflation in the health care sector has not been as rapid as in the broader economy, but rising prices may be on the horizon, POLITICO's Tucker Doherty reports .
| | | On Thursday, Sen. Ron Wyden (D-Ore.) sent a letter to Amgen , asking for more information about the company's tax practices. | | | | Follow us on Twitter | | | | Follow us | | | | |
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