Plus: Moderna advances bird flu vaccine |
In this week’s edition of InnovationRx, we look at health policies from the new Administration, Moderna’s anti-pandemic fight, Obamacare’s recordbreaking numbers and more. (Did someone forward this email to you? You can sign up for InnovationRx here.)
On the first day of his Presidency, Donald Trump announced that he would withdraw the United States from the World Health Organization, a move that drew significant criticism from public health experts.The move was one of a flurry of executive orders, many of which could have significant impacts on healthcare–presuming they survive nearly inevitable legal challenges in the courts. The United States provides a significant amount of funding for WHO, which is tasked with coordinating the international response to health emergencies. In a statement, WHO said that it “regrets the announcement” of the United States’ intended withdrawal and hopes that “the United States will reconsider,” further commenting: “For over seven decades, WHO and the USA have saved countless lives and protected Americans and all people from health threats. Together, we ended smallpox, and together we have brought polio to the brink of eradication.” Lawrence Gostin, a public health policy professor at Georgetown University, called the decision “cataclysmic” in a post on X (formerly Twitter). “Withdrawal is a grievous wound to world health, but a still deeper wound to the U.S.,” he wrote. Whether the President has the authority to unilaterally withdraw the United States from the organization is not clear. It’s a member by treaty, which makes it the law of the land according to the Constitution. A paper authored by several legal policy experts in 2020, when the first Trump Administration tried to withdraw from the agency, argued that the President lacks this legal authority to withdraw from WHO without the express approval of Congress. Other Trump executive orders included repealing a 2022 Biden executive order to test Medicaid models to lower the price of drugs and orders related to access to Covid-19 vaccines and treatments. Additionally, on Tuesday, The Washington Post reported that all communications from the Department of Health and Human Services are to be indefinitely “paused.” The pause includes scientific reports, known as the Morbidity and Mortality Weekly Report about public health incidents, data updates to the CDC website, and public health data releases from the National Center for Health Statistics. It is not clear yet if this also extends to announcements such as drug approvals or recalls. |
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| | | Moderna Gets $590 Million To Develop Vaccines For Pandemic-Potential Viruses |
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| Last Friday, the Department of Health and Human Services awarded a $590 million grant to Moderna to develop mRNA-based vaccines against viruses that have pandemic potential. One of those vaccines is against avian flu strain H5N1, which is currently circulating in wild birds and dairy farms. The new grant will also support clinical studies for five other pandemic flu strains. The grant, made during the final days of the Biden Administration, is a continuation of work that the federal government has been doing with the company to combat pandemics. Moderna developed its Covid-19 vaccine with the help of the first Trump Administration’s “Operation Warp Speed” and last June received a $176 million grant for its H5N1 vaccine. Moderna’s vaccine has already undergone a phase 1/2 study in adults, which included testing of vaccines against H5N1 as well as H7 strains, another set of avian flus currently circulating among birds around the world. The company said it’s now planning to move into phase 3 trials. The federal government is working with several other companies on pandemic flu preparations in addition to Moderna. In May, CSL Sequiris received a contract to manufacture 4.8 million doses of H5N1 vaccines, and in October the Biden Administration awarded $72 million to CSL Sequiris, Sanofi and GSK to fill and finish their vaccines into ready-to-use vials and syringes in case immediate distribution is required. It’s an open question the extent to which these programs will continue under the second Trump Administration. On the one hand, Trump has consistently touted his first Administration’s Covid vaccine programs, particularly Operation Warp Speed. On the other, his pick to run the Health and Human Services Department, Robert F. Kennedy, Jr., is opposed to many vaccines, and, according to the New York Times, he petitioned the FDA to revoke Covid-19 vaccine authorizations during the pandemic. |
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| The FDA has approved Datroway, a new treatment for certain advanced breast cancers from pharmaceutical companies AstraZeneca and Daiichi Sankyo. Datroway is an antibody drug conjugate, which directly targets tumor cells and delivers chemo to them, which helps mitigate side effects. A clinical trial found that the drug significantly increased the time between treatment and the cancer’s progression compared to standard chemotherapy with fewer side effects, though overall survival rate did not improve. The companies are now studying the drug use against other breast cancers and lung cancer. |
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| PUBLIC HEALTH AND HOSPITALS |
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| Last Friday, the outgoing Biden Administration announced that 24.2 million Americans had enrolled in health insurance coverage under the Affordable Care Act for 2025, surpassing last year’s previous record of 21.3 million. Much of the enrollment growth was in Republican states, including Florida, Texas and Georgia. Whether future years will continue to be recordsetting is an open question as President Trump is widely expected to try to chip away at the ACA. During his first term, he and Congress unsuccessfully tried to repeal the ACA on several occasions. During the Biden Administration, Congress passed enhanced financial assistance for those seeking coverage, which outgoing CMS Administrator Chiquita Brooks-Lasure credited for the record enrollment. |
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| Umoja Biopharma became the latest clinical stage biotech startup to raise a megaround. The Seattle-based company announced that it had raised $100 million, led by Double Point Ventures and DCVC Bio, to support its work in oncology and autoimmune disease. The company’s technology aims to induce the body to create its own CAR-T cells to target solid tumors, as opposed to conventional CAR-T therapies where the cells are manufactured outside the body and administered to patients. Dr. Andrew Scharenberg, who had previously co-directed the program in cell and gene therapy at Seattle Children’s Research Institute, launched Umoja in 2020 with $53 million in funding. |
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