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On March 20, members of the World Health Organization adopted the worlds first pandemic agreement, following three years of intensive negotiations launched by governments in response to the devastating impacts of the COVID-19 pandemic. The U.S., however, did not participate, in part because of its intention to withdraw from the WHO. Global health experts are hailing the agreement as a historic moment. What does the agreement mean for the world, and how can it make everyone safer and more prepared for the next pandemic? The Conversation asked Nicole Hassoun, a professor at Binghamton University and executive director of Global Health Impact, to explain the pandemic accord, its prospects for advancing global health, and the significance of the U.S.s absence from it. What will the pandemic agreement do? The accord will bolster pandemic preparation within individual countries and around the world. Countries signing onto the agreement are committing to improve their disease surveillance, grow their healthcare workforces, strengthen their regulatory systems, and invest in research and development. It encourages countries to strengthen their health regulations and infrastructure, improve communication with the public about pandemics, and increase funding for preparation and response efforts. It also includes new mechanisms for producing and distributing vaccines and other essential countermeasures. Finally, it encourages countries to coordinate their responses and share information about infectious diseases and intellectual property so that vaccines and other essential countermeasures can be made available more quickly. The agreement will take effect once enough countries ratify it, which may take several years. Why isnt the U.S. involved? The Biden administration was broadly supportive of a pandemic agreement and was an active participant in negotiations. Prior to Donald Trumps reelection, however, Republican governors had signed a letter opposing the treaty, echoing a conservative think tanks concerns about U.S. sovereignty. The U.S. withdrew from negotiations when President Trump signed an executive order to withdraw from the WHO on the day he was inaugurated for his second term. Why could the lack of U.S. involvement be beneficial for the world? The lack of U.S. involvement likely resulted in a much more equitable treaty, and it is not clear that countries could have reached an agreement had the U.S. continued to object to key provisions. It was only once the U.S. withdrew from the negotiations that an agreement was reached. The U.S. and several other wealthy countries were concerned with protecting their pharmaceutical industries’ profits and resisted efforts aimed at convincing pharmaceutical companies to share the knowledge, data, and intellectual property needed for producing new vaccines and other essential countermeasures. Other negotiators sought greater access to vaccines and other treatments during a pandemic for poorer countries, which often rely on patented technologies from global pharmaceutical companies. While most people in wealthy countries had access to COVID-19 vaccines as early as 2021, many people in developing countries had to wait years for vaccines. How could the agreement broaden access for treatments? One of the contentious issues in the pandemic agreement has to do with how many vaccines manufacturers in each country must share in exchange for access to genetic sequences to emerging infectious diseases. Countries are still negotiating a system for sharing the genetic information on pathogens in return for access to vaccines themselves. It is important that researchers can get these sequences to make vaccines. And, of course, people need access to the vaccines once they are developed. Still, there are many more promising aspects of the agreement for which no further negotiations are necessary. For instance, the agreement will increase global vaccine supply by increasing manufacturing around the world. The agreement also specifies that countries and the WHO should work together to create a mechanism for fairly sharing the intellectual property, data, and knowledge needed to produce vaccines and other essential health products. If financing for new innovation requires equitable access to the new technologies that are developed, many people in poor countries may get access to vaccines much more quickly in the next pandemic. The agreement also encourages individual countries to offer sufficient incentives for pharmaceutical companies to extend access to developing countries. If countries implement these changes, that will benefit people in rich countries as well as poor ones. A more equitable distribution of vaccines can contain the spread of disease, saving millions of lives. What more should be done, and does the U.S. have a role to play? In my view, the best way to protect public health moving forward is for countries to sign on to the agreement and devote more resources to global health initiatives. This is particularly important, given declining investment and participation in the WHO and the contraction of other international health initiatives, such as USAID. Without international coordination, it will become harder to catch and address problems eary enough to prevent epidemics from becoming pandemics. It will also be imperative for member countries to provide funding to support the agreements goals and secure the innovation and access to new technologies. This requires building the basic health infrastructure to ensure shots can get into peoples arms. Nicole Hassoun is a professor of philosophy at Binghamton University, State University of New York. This article is republished from The Conversation under a Creative Commons license. Read the original article.
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On May 20, 2025, the Food and Drug Administration announced a new stance on who should receive the COVID-19 vaccine. The agency said it would approve new versions of the vaccine only for adults 65 years of age and older as well as for people with one or more risk factors for severe COVID-19 outcomes. These risk factors include medical conditions such as asthma, cancer, chronic kidney disease, heart disease and diabetes. However, healthy younger adults and children who fall outside of these groups may not be eligible to receive the COVID-19 shot this fall. Vaccine manufacturers will have to conduct clinical trials to demonstrate that the vaccine benefits low-risk groups. FDA Commissioner Martin Makary and the agencys head of vaccines, Vinay Prasad, described the new framework in an article published in the New England Journal of Medicine and in a public webcast. The Conversation U.S. asked Libby Richards, a nursing professor involved in public health promotion, to explain why the changes were made and what they mean for the general public. Why did the FDA diverge from past practice? Until the May 20 announcement, getting a yearly COVID-19 vaccine was recommended for everyone ages 6 months and older, regardless of their health risk. According to Makary and Prasad, the Food and Drug Administration is moving away from these universal recommendations and instead taking a risk-based approach based on its interpretation of public health trends specifically, the declining COVID-19 booster uptake, a lack of strong evidence that repeated boosters improve health outcomes for healthy people and the fact that natural immunity from past COVID-19 infections is widespread. The FDA states it wants to ensure the vaccine is backed by solid clinical trial data, especially for low-risk groups. Was this a controversial decision or a clear consensus? The FDAs decision to adopt a risk-based framework for the COVID-19 vaccine aligns with the expected recommendations from the Advisory Committee on Immunization Practices, an advisory group of vaccine experts offering expert guidance to the Centers for Disease Control and Prevention on vaccine policy, which is scheduled to meet in June 2025. But while this advisory committee was also expected to recommend allowing low-risk people to get annual COVID-19 vaccines if they want to, the FDAs policy will likely make that difficult. Although the FDA states that its new policy aims to promote greater transparency and evidenced-based decision-making, the change is controversial in part because it circumvents the usual process for evaluating vaccine recommendations. The FDA is enacting this policy change by limiting its approval of the vaccine to high-risk groups, and it is doing so without any new data supporting its decision. Usually, however, the FDA broadly approves a vaccine based on whether it is safe and effective, and decisions on who should be eligible to receive it are left to the CDC, which receives research-based guidance from the Advisory Committee on Immunization Practices. Additionally, FDA officials point to Canada, Australia and some European countries that limit vaccine recommendations to older adults and other high-risk people as a model for its revised framework. But vaccine strategies vary widely, and this more conservative approach has not necessarily proven superior. Also, those countries have universal health care systems and have a track record of more equitable access to COVID-19 care and better COVID-19 outcomes. Another question is how health officials positions on COVID-19 vaccines affect public perception. Makary and Prasad noted that COVID-19 vaccination campaigns may have actually eroded public trust in vaccination. But some vaccine experts have expressed concerns that limiting COVID-19 vaccine access might further fuel vaccine hesitancy because any barrier to vaccine access can reduce uptake and hinder efforts to achieve widespread immunity. What conditions count as risk factors? The New England Journal of Medicine article includes a lengthy list of conditions that increase the risk of severe COVID-19 and notes that about 100 million to 200 million people will fall into this category and will thus be eligible to get the vaccine. Pregnancy is included. Some items on the list, however, are unclear. For example, the list includes asthma, but the data that asthma is a risk factor for severe COVID-19 is scant. Also on the list is physical inactivity, which likely applies to a vast swath of Americans and is difficult to define. Studies have found links between regular physical activity and reduced risk of severe COVID-19 infection, but its unclear how health care providers will define and measure physical inactivity when assessing a patients eligibility for COVID-19 vaccines. Most importantly, the list leaves out an important group caregivers and household members of people at high risk of severe illness from COVID-19 infection. This omission leaves high-risk people more vulnerable to exposure to COVID-19 from healthy people they regularly interact with. Multiple countries the new framework refers to do include this group. Why is the FDA requiring new clinical trials? According to the FDA, the benefits of multiple doses of COVID-19 vaccines for healthy adults are currently unproven. Its true that studies beyond the fourth vaccine ose are scarce. However, multiple studies have demonstrated that the vaccine is effective at preventing the risk of severe COVID-19 infection, hospitalization and death in low-risk adults and children. Receiving multiple doses of COVID-19 vaccines has also been shown to reduce the risk of long COVID. The FDA is requiring vaccine manufactures to conduct additional large randomized clinical trials to further evaluate the safety and effectiveness of COVID-19 boosters for healthy adults and children. These trials will primarily test whether the vaccines prevent symptomatic infections, and secondarily whether they prevent hospitalization and death. Such trials are more complex, costly and time-consuming than the more common approach of testing for immunological response. This requirement will likely delay both the timeliness and the availability of COVID-19 vaccine boosters and slow public health decision-making. Will low-risk people be able to get a COVID-19 shot? Not automatically. Under the new FDA framework, healthy adults who wish to receive the fall COVID-19 vaccine will face obstacles. Health care providers can administer vaccines off-label, but insurance coverage is widely based on FDA recommendations. The new, narrower FDA approval will likely reduce both access to COVID-19 vaccines for the general public and insurance coverage for COVID-19 vaccines. The FDAs focus on individual risks and benefits may overlook broader public health benefits. Communities with higher vaccination rates have fewer opportunities to spread the virus. What about vaccines for children? High-risk children age 6 months and older who have conditions that increase the risk of severe COVID-19 are still eligible for the vaccine under the new framework. As of now, healthy children age 6 months and older without underlying medical conditions will not have routine access to COVID-19 vaccines until further clinical trial data is available. Existing vaccines already on the market will remain available, but it is unclear how long they will stay authorized and how the change will affect childhood vaccination overall. Libby Richards is a professor of nursing at Purdue University. This article is republished from The Conversation under a Creative Commons license. Read the original article.
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Early this morning, the House voted 215214 to pass a sweeping budget reconciliation bill with provisions that include a cancellation or phaseout for just about everything that was in the Inflation Reduction Act. The measure, which now heads to the Senate, is being described by clean energy and environmental groups as a monumental betrayal of the country that will cost jobs and increase electricity bills. But during the floor debate overnight, the energy parts of the bill were an afterthought to higher priority issues for members of both parties, such as tax cuts, revisions to Medicaid, and a desire to support or oppose the agenda of President Donald Trump. Two months ago, 21 House Republicans sent a letter to the chair of the House Ways & Means Committee about the need to preserve the IRA tax credits, warning against premature credit phase outs or additional restrictive mechanisms. House leadership was able to assuage some of those concerns when the draft of the bill showed that tax credits for biofuels would be preserved, among other changes. But some House Republicans still objected. Last week, 14 of the signers of the previous letter issued a joint statement affirming their support for the credits. This was a smaller number than the March letter, but it was more than enough to sink the bill if even a few of them held firm. So how many of them ended up voting against the bill? Zero. Rep. Andrew Garbarino (R-N.Y.) missed the vote, but had intended to vote for the bill. The other 13 people who issued the statement last week all voted yes. Before the vote, I spoke with David Spence, a professor at the University of Texas at Austin, to try to get a sense of the factors that were most likely to influence each member. Theyre feeling pressure to go along with whatever Trump wants and whatever the leadership wants, he said. Whats putting counterpressure on them is that for some of them that means giving up a lot of jobs and money that came from the IRA. And for others, its about how far they can be pushed away from their principles. The counterpressure turned out to be weak. Spence is the author of Climate of Contempt: How to Rescue the U.S. Energy Transition from Voter Partisanship, a 2024 book that I wrote about last summer. He wrote a blog post this month describing the factors influencing how Congress may vote on IRA-related measures. He was paying close attention to a debate within the debate between 38 Republicans who had signed a letter this month attesting to the urgent need to fully repeal the Inflation Reduction Act, and also the 21later 14who said they wanted at least some parts of the law to be preserved. A brief aside about the merits of the bill: Energy researchers are describing it as an economic and environmental disaster. The think tank Energy Innovation said this week that the bill would lead to the loss of 830,000 jobs by 2030 and increase consumer energy costs by $16 billion in 2030. Any discussion of who voted for it in the House and who might in the Senate may sound like a parlor game, but the stakes are incredibly high when it comes to shaping the world of future generations. Spence made a chart showing each of the members who signed the two letters, along with factors that may shape their views, such as the partisan lean of their districts and the extent of IRA projects there. Of the 38 people calling for a full repeal, 28 represent districts with a Republican lean of at least 10 points, which means their district favored the GOP by at least 10 percentage points more than the country as a whole did in the 2024 general election, according to Cook Political Report. These members have a much higher risk of losing in a primary challenge from another Republican than of losing in a general election. Among the 38 are some of the Houses most outspoken budget hawks, who are so committed to their ideology that they have been willing to go against the House leadership and the Trump administration on issues related to spending. Examples include Reps. Josh Brecheen of Oklahoma, Andrew Clyde of Georgia, and Ralph Norman of South Carolina. Only 10 of the 38 have IRA-funded projects in their districts, based on data from E2, a clean energy business group. Among them is Norman, whose district has six such projects that have led to commitments for 1,933 jobs. One of those projects, a solar panel plant planned by Silfab Solar of Canada, has been controversial. Some residents have said they are alarmed about chemicals that would be used to make solar equipment. Norman said on Wednesday that his main concern is that he doesnt like subsidies. Embracing an all-of-the-above energy strategy is crucial, and solar plays a role in that mix, Norman said in a statement. But let me be clearthat does not mean we support endless subsidies. The real value of energy production lies in strengthening our infrastructure, streamlining permitting, and reducing our dependence on foreign suppliers. We need to rely on what works where it works, without burdening taxpayers to prop up any one industry. Based on the outcome, the House members who really hate the IRA were able to win the internal debate over those who wanted to preserve some parts of the lawand it wasnt even close. The final negotiations were more about making the bill palatable to budget hardliners, which involved making the IRA provisions even more onerous for energy companies and implementing faster phaseouts. Among the potential holdouts that voted for the bill was Rep. Don Bacon (R-Neb.), who was re-elected despite his district favoring Democrats by a narrow margin in the presidential election. He was part of both the letter and the joint statement calling for tax credits to be maintained. Others who said they supported tax credits come from heavily Republican districts that have major projects funded in part by the IRA. This includes Rep. Buddy Carter of Georgia, who has seven projects and 4,462 jobs in his district related to the law, and still voted for the bill. This is a once-in-a-generation bill that will unlock President Trumps full domestic agenda, which Georgians voted for overwhelmingly back in November, Carter said in a statement after the vote. With the One, Big, Beautiful Bill Act we are unleashing our nations energy dominance, securing the border, putting more money back into hardworking Americans wallets, kicking illegal immigrans off Medicaid so that it is available for those who need it, and ending the waste, fraud, and abuse that risks sending our country into economic ruin. The larger lesson was that the power of partisanship overwhelmed just about everything else. This gives credence to a view I hear a lot from grassroots environmental advocates: The only way to pass and maintain strong climate and energy policies is to elect Democrats because even the Republicans who care about those topics will be marginalized and ultimately run over by their leadership. But this isnt over yet. Four Senate Republicans have raised concerns about the phaseout of energy tax credits. If the Senate makes any changes, the House will need to vote again. In the meantime, entire industriesincluding solar, wind, batteries, EVs, and energy efficiencymay need to throw out their business plans, scrap investments, and prepare for a challenging near future. This article originally appeared on Inside Climate News. It is republished with permission. Sign up for their newsletter here.
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