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"I think that changes like this will lead to more unnecessary deaths," said one doctor.
Public health experts on Tuesday warned Tuesday that forthcoming Food and Drug Administration guidance on the Covid-19 vaccine would "cause confusion" and result in fewer people getting inoculated against the virus that killed 350,000 people in the U.S. before the shots became available.
Dr. Vinay Prasad, head of the agency's vaccine division, and Dr. Martin Makary, the FDA commissioner, wrote in the New England Journal of Medicine that the vaccine "booster" doses that have been available for the last several years to anyone aged six months and older carry "uncertain" benefits for much of the population.
The officials said the next round of shots will be available only for adults over 65 and those with certain medical conditions.
They said that before a new round of updated vaccines are made available in the fall, the FDA "anticipates the need" for new clinical trials for many patients under 65. Participants in the trial would be given either the new shots or a placebo and followed by vaccine manufacturers for at least six months to determine if the vaccines continued to provide them with protection from Covid.
Both Prasad and Makary were vocal skeptics of vaccine mandates and other public health measures during the coronavirus pandemic, and Health and Human Services Secretary Robert F. Kennedy, Jr.—who oversees the FDA—has spread baseless misinformation about the Covid shots and other vaccines.
Kennedy said in 2021 that the shots were the "deadliest ever made"; the Centers for Disease Control and Prevention (CDC) has found the vaccines reduce people's risk of developing serious illness, long-term symptoms, and hospitalization.
Dr. Daniel Griffin, a physician in New York, toldThe New York Times that the FDA's plan will ultimately "very slowly [reduce] vaccination in the country."
"I think that changes like this will lead to more unnecessary deaths," said Griffin.
Makary and Prasad made their announcement days before scientific advisers to the FDA are set to decide on the composition of the Covid vaccines that will be offered this fall.
Dr. Lucky Tran, director of science communication and media relations at Columbia University Irving Medical Center, emphasized that many Americans have conditions that raise the risk of severe illness when they get Covid—including asthma, pregnancy, diabetes, obesity, and some mental health conditions.
"However, limiting Covid vaccines to people with specific conditions only causes confusions and decreases uptake," said Tran. "Most are unaware they have a condition that puts them at risk, so many who would want to get vaccinated may not try because they think they don't qualify."
About 74% of people in the U.S. have at least one condition that puts them at higher risk for severe disease, according to the CDC.
For people without medical conditions who are under age 65, it was unclear Wednesday whether they will be able to get vaccinated in the fall—and if shots are available to them, whether insurers will cover the costs.
William Schaffner, an infectious disease physician who is on the CDC's vaccine advisory panel—which recommends who should get FDA-approved vaccines—toldThe Washington Post that the panel could include in this year's recommendations that health people under 65 can still get a shot to protect themselves.
"They could add that line... and it would allow those people very focused on prevention who would like to get the vaccine and have it paid for by their insurance," Schaffner told the Post.
But Prasad said the FDA could still limit access because the agency "can only approve products if it concludes, based on the available scientific evidence, the benefit-to-harm balance is favorable."
Pediatricians expressed concern for children's safety if vaccines become unavailable to them; the CDC reported 150 pediatric deaths from Covid over the 12-month period that ended last August.
"I think there is strong data to suggest Covid should be part of routine childhood vaccinations," Amesh Adalja, an infectious disease physician, toldSTAT News. "We vaccinate kids for things that have less morbidity and mortality than Covid, like chickenpox for example."
Tran denounced the anticipated guidance as "an anti-science move that will kill more Americans."
"The FDA is being led by people who have consistently spread misinformation about Covid and vaccines," said Tran. "Their record indicates that they cannot be trusted to implement evidence-based guidance for vaccines, and their policies will kill people and make them sicker."
"This isn't fiscal responsibility. It's a political decision to let preventable diseases spread—to ignore science, lend legitimacy to anti-vaccine extremism, and dismantle the infrastructure that protects us all."
Public health experts and other critics on Wednesday condemned the Trump administration's decision to cut off funding to the global vaccine alliance Gavi, which the organization estimates could result in the deaths of over 1 million children.
"Abhorrent. Evil. Indefensible," Atlantic staff writer Clint Smith said on social media in response to exclusive reporting from The New York Times, which obtained documents including a 281-page spreadsheet that "the skeletal remains" of the United States Agency for International Development (USAID) sent to Congress on Monday.
The leaked materials detail 898 awards that the Trump administration plans to continue and 5,341 it intends to end. A spokesperson for the U.S. State Department, which runs the gutted USAID, confirmed the list is accurate and said that "each award terminated was reviewed individually for alignment with agency and administration priorities."
The United States contributes 13% of Gavi's budget and the terminated grant was worth $2.6 billion through 2030, according to the Times. Citing the alliance, the newspaper noted that cutting off U.S. funds "may mean 75 million children do not receive routine vaccinations in the next five years, with more than 1.2 million children dying as a result."
"The administration's attempt to unilaterally walk away from its Gavi commitment raises serious legal questions and should be challenged."
Responding to the Trump administration's move in a social media thread on Wednesday, Gavi said that U.S. support for the alliance "is vital" and with it, "we can save over 8 million lives over the next five years and give millions of children a better chance at a healthy, prosperous future."
"But investing in Gavi brings other benefits for our world and the American people. Here's why: By maintaining global stockpiles of vaccines against deadly diseases like Ebola, mpox, and yellow fever, we help keep America safe. These diseases do not respect borders, they can cross continents in hours and cost billions of dollars," Gavi continued.
The alliance explained that "aside from national security, investing in Gavi means smart economics too. Every dollar we invest in lower income countries generates a return of $54. This helps countries develop and communities thrive, taking away pressure to migrate in search of a better life elsewhere."
"The countries Gavi supports, too, see the benefit in our model: Every year they pay more towards the cost of their own immunisation program, bringing forward the day when they transition from our support completely," the group noted. "Our goal is to ultimately put ourselves out of business."
"For 25 years, the USA and Gavi have had the strongest of partnerships," the alliance concluded. "Without its help, we could not have halved child mortality, saved 18 million lives or helped 19 countries transition from our support (some becoming donors themselves). We hope this partnership can continue."
Many other opponents of the decision also weighed in on social media. Eric Reinhart, a political anthropologist, social psychiatrist, and psychoanalytic clinician in the United States, said, "A sick country insists on a sick world."
Dr. Heather Berlin, an American neuroscientist and clinical psychologist, sarcastically said: "Oh yes, this will surely end well. Good thing the U.S. has an invisible shield around it to protect us from 'foreign' diseases."
Some Times readers also praised the reporting. Dr. Jonathan Marro—a pediatric oncologist, bioethicist, health services researcher, and educator in Massachusetts—called the article "excellent but appalling," while Patrick Gaspard, a distinguished senior fellow at the Center for American Progress and its action fund, said that it was "crushing to read this important story."
The newspaper noted that "the memo to Congress presents the plan for foreign assistance as a unilateral decision. However because spending on individual health programs such as HIV or vaccination is congressionally allocated, it is not clear that the administration has legal power to end those programs. This issue is currently being litigated in multiple court challenges."
Liza Barrie, Public Citizen's campaign director for global vaccines access, also highlighted that point in a Wednesday statement. She said that "the Trump administration's decision to end U.S. funding for Gavi will cost more than a million children's lives, make America less secure. It abandons 25 years of bipartisan commitment to global immunization and undermines the very systems that help prevent deadly outbreaks from reaching our own doorsteps."
"Vaccines are the most cost-effective public health tool ever developed," Barrie continued. "This isn't fiscal responsibility. It's a political decision to let preventable diseases spread—to ignore science, lend legitimacy to anti-vaccine extremism, and dismantle the infrastructure that protects us all. In their shocking incompetence, the Trump administration will do it all without saving more than a rounding error in the budget, if that."
"Congress has authority over foreign assistance funding," she stressed. "The administration's attempt to unilaterally walk away from its Gavi commitment raises serious legal questions and should be challenged. Lawmakers must stand up for the rule of law, and for the belief that the value of a child’s life is not determined by geography."
Although the move was "largely symbolic" due to lack of such mandates, one expert still warned it is "legitimization of anti-science and anti-vax noise."
Amid fears of what U.S. President Donald Trump's second term will mean for global health and public education, the Republican on Friday signed an executive order to defund schools that require Covid-19 vaccination for students.
Trump's order bars federal funding "from being used to support or subsidize an educational service agency, state education agency, local education agency, elementary school, secondary school, or institution of higher education that requires students to have received a Covid-19 vaccination to attend in-person education programs," according to a White House fact sheet.
The order, first reported by Breitbart News, also directs the secretaries of education and health and human services (HHS) to develop a plan "to end coercive Covid-19 vaccine mandates, including a report on noncompliant entities and a process for preventing federal funds from supporting educational entities that impose Covid-19 vaccine mandates."
While signing the order in the Oval Office, Trump—who was president during the onset of the pandemic and has received intense criticism for his handling of the public health crisis—said, "OK, that solves that problem."
The White House claimed that "parents are being forced into a difficult position: comply with a controversial mandate or risk their child's educational future." However, according toABC News, Trump's move was actually "largely symbolic" considering that no states currently require K-12 students to have the Covid shots.
The Associated Pressreported that "some colleges started requiring students to be immunized against Covid-19 during the pandemic, but most have dropped the requirements. A few continue to require vaccines at least for students living on campus, including Swarthmore and Oberlin colleges. Most of those colleges allow medical or religious exemptions."
As ABC noted:
One open question is whether the new administration could opt to go beyond Covid vaccines and put pressure on schools to drop requirements for other vaccines.
Currently, all 50 states mandate that students receive certain vaccinations, including to prevent the measles. Many states, however, offer religious exemptions.
"This is anti-vax pandering," Timothy Caulfield, a professor focused on public health and law at Canada's University of Alberta, said of Trump's order. "Still worrisome, however. It is yet more normalization and legitimization of anti-science and anti-vax noise."
The new measure came a day after Senate Republicans voted to confirm vaccine conspiracy theorist Robert F. Kennedy Jr. as HHS secretary and Trump signed another executive order establishing the Make America Healthy Again Commission.
Also on Thursday, the Senate Committee on Health, Education, Labor, and Pensions held a confirmation hearing for Linda McMahon, the billionaire GOP megadonor and former World Wrestling Entertainment CEO nominated to serve as education secretary, even though Trump has signaled that he ultimately intends to fully dismantle the department.