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food and drug administration
In 'Anti-Science Move,' FDA Expected to Broadly Restrict Access to Covid Vaccines
"I think that changes like this will lead to more unnecessary deaths," said one doctor.
May 21, 2025
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."
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Republicans Are Trying, But They Can’t Stop Abortion Pills
Despite RFK Jr.’s review of mifepristone, two things will remain true: Abortions pills will still be extremely safe, and abortion pills will still be available—everywhere.
May 20, 2025
In a disturbing advancement of the Project 2025 playbook for eradicating abortion, Health and Human Services Secretary Robert F. Kennedy Jr. is using the release of a new pseudo-study as a pretense for the Food and Drug Administration to review mifepristone’s safety and efficacy. The use of this widely discredited self-published report is a clear political maneuver by the Trump administration and anti-abortion extremists to curb access to telehealth abortion and end access to mifepristone more widely, against the scientific evidence and the will of the American public.
I am a public health researcher and abortion access advocate and have been tracking access to the abortion pill since it was first approved in France in 1988. I feel confident that, regardless of the outcome of this illegitimate review, two things will remain true: Abortions pills will still be extremely safe, and abortion pills will still be available—everywhere.
Abortion pills are safe. Period. The fact that Secretary Kennedy has asked the FDA to reevaluate the medications based on a single, unpublished junk science report is absurd. We have mountains of data and decades of clinical experience documenting their safety, whether provided through an in-person visit at a clinic or, since 2020, via telehealth. The World Health Organization has also said that abortion pills are safe even when taken without medical supervision, also known as self-managed abortion. Data support the safety of all of these forms of access.
As activists and clinicians expand these new routes of access to abortion pills, we are providing an immediate, practical solution for people who need abortion access, and thereby reducing the harm that abortion bans create.
Abortion pills are everywhere. As courts and legislatures have been systematically blocking access to abortion across the country, clinicians and activists—myself included—have been setting up and illuminating innovative routes of access that reach people where they are with safe abortion access, including in states with restrictions. As a result of our collective efforts, abortion pills are now readily available by mail for $150 or less—and free for those who can’t afford any amount—in all 50 states, even states with bans. Access routes currently include telehealth from U.S. providers operating from states with laws that shield them from prosecution, international telehealth services that mail pills to the U.S., community networks that send pills by mail for free, and e-commerce vendors that mail pills to all states.
An organization I co-founded, Plan C, tracks these different services to learn about their offerings, including whether they do a medical screening, what type of pills they offer, and how much they cost. Our ongoing investigations—which include mystery shopping and laboratory testing to verify that the pills are real—document a rich ecosystem of abortion pill access. These are real services providing practical, affordable, medically-safe abortion access, even in states with bans. They are all discoverable online. We index and share this information through our Guide to Pills so that people can learn about this ecosystem, and those who are seeking abortions know that they still have options.
These routes of access, combined with the clinic-based care options that exist in states that still allow it, have been so successful in reaching people that there are now even more abortions occurring in the United States than prior to the Supreme Court decision that overturned Roe v. Wade. Guttmacher, a leading abortion research organization, reports that clinician-provided abortions in the United States rose by more than 100,000 between 2020 and 2024, and that figure does not even include self-managed abortions or abortions facilitated by telehealth shield providers prescribing across state lines into states with bans. The Society of Family Planning also has been documenting abortion post-Roe and reports that these shield providers are serving approximately 10,000 people per month in states that totally or partially ban access to care.
As activists and clinicians expand these new routes of access to abortion pills, we are providing an immediate, practical solution for people who need abortion access, and thereby reducing the harm that abortion bans create, particularly for populations underserved by healthcare systems. We are also showing a new way forward for modern abortion access and laying the groundwork for eventual policy change (which will likely only be possible after our U.S. democracy is restored).
This scenario has already played out in other countries, with resulting improvements in abortion access. For instance, it was largely based on the experiences of patients in Ireland who received abortion pills by mail from Women on Web to safely terminate their pregnancies that parliament liberalized abortion access. In Mexico, the widespread grassroots sharing of information about how to use misoprostol—a widely available ulcer medication—for abortion, ultimately paved the way to policy reform, with abortion pills now officially registered in the country.
For decades, abortion pills have been so severely restricted by politics and overregulation that envisioning a radically different future in which the pills are universally available by mail—or even over the counter—is difficult for most. But this future is coming. Many would say it is largely already here. And, what is particularly notable, given the current FDA safety review based on fabricated claims about the “dangers” of abortion pills, is that these new, modern routes of access are possible precisely because abortion pills are so safe. They are safer than Tylenol, safer than Viagra, and research has demonstrated time and again that they are absolutely safe enough to put directly in the hands of the person who needs them.
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Abortion Rights Defenders 'Sound the Alarms' Over RFK Jr. Attack on Mifepristone
"Hawley is pointing to new junk science to motivate RFK Jr. and FDA to review the science on mifepristone," said one public health scientist. "The science is clear: Mifepristone is safe."
May 15, 2025
Abortion rights defenders and scientists expressed deep concern after U.S. Health and Human Services Secretary Robert F. Kennedy Jr.'s remarks about mifepristone, a key medication used to end pregnancies, at a Wednesday congressional hearing.
During the Senate Health, Education, Labor and Pensions Committee hearing, Sen. Josh Hawley (R-Mo.) inquired about the secretary's previous pledge to conduct "top-to-bottom review" of mifepristone, asking, "Do you continue to stand by that and don't you think that this new data shows that the need to do a review is, in fact, very pressing?"
Kennedy, one of President Donald Trump's most controversial Cabinet picks, responded by describing the data cited by Hawley as "alarming," suggesting that "the label should be changed," and confirming that he has asked Marty Makary, commissioner of the Food and Drug Administration (FDA), "to do a complete review and to report back."
Ushma Upadhyay, a public health scientist and professor at the University of California, San Francisco, posted the exchange on social media. She said that "Hawley is pointing to new junk science," and research has made clear "mifepristone is safe."
Hawley is pointing to new junk science to motivate RFK Jr. and FDA to review the science on mifepristone. I've been studying #abortion safety for a decade. The science is clear: mifepristone is safe. Let me tell you about a couple of **peer-reviewed and published** studies I've done... 🧪
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— Ushma Upadhyay, PhD, MPH ( @ushma.bsky.social) May 14, 2025 at 9:20 PM
In one study of Upadhyay's studies, "among 11,000 medication abortions, less than a third of one percent (0.3%) had a serious adverse event," the expert noted. In another from last year, she continued, "we found that telehealth abortion was just as safe and effective as published estimates of in-person care. Serious adverse events were 0.25%."
However, anti-abortion groups have seized on the paper cited by Hawley—published in April by the think tank Ethics & Public Policy Center—to pressure the Trump administration to restrict mifepristone further, or even remove it from the market.
The April paper conflicts with a mountain of research. A 2023 New York Timesreview found that "more than 100 scientific studies, spanning continents and decades, have examined the effectiveness and safety of mifepristone and misoprostol, the abortion pills that are commonly used in the United States. All conclude that the pills are a safe method for terminating a pregnancy."
Upadhyay said Wednesday that "one crappy report cannot silence decades of peer-reviewed high-quaility published research."
Other critics of RFK Jr.'s comments similarly stressed medical conclusions about mifepristone's safety.
"Mifepristone has a 25-year record of safety and efficacy under the FDA's watch, but now anti-abortion extremists are peddling junk science in an effort to deny people access to it," the group Power to Decide said on social media Thursday. "The reality is that medication abortion is safe, widely used basic healthcare."
The Center for Reproductive Rights also responded on social media, declaring, "SOUND THE ALARMS!"
"Let us be clear: President Trump, who once suggested injecting bleach, should not be making decisions about our healthcare, and RFK Jr. should not be interfering with our ability to access medication that's been PROVEN SAFE AND EFFECTIVE," the center said. "In putting this target on mifepristone—and therefore on abortion access at large—Trump's administration is making it clear that they do not care about science, or our health and safety. They only care about taking away our rights. But we refuse to let that happen."
"We'll be in court on Monday, fighting to protect mifepristone and make sure this VITAL, LIFESAVING medication is accessible and available to anyone who needs it," the center added, referring to oral arguments for Whole Woman's Health Alliance v. FDA, a case aimed at eliminating restrictions that impede access to mifepristone.
The ACLU pointed out in a Wednesday statement that the "pseudo-science paper" at the center of Hawley and Kennedy's exchange echoes calls made in Project 2025—a Heritage Foundation-led guide for a far-right overhaul of the federal goverment, from which Trump unsuccessfully tried to distance himself on the campaign trail—to severely restrict access to medication abortion.
"Secretary Kennedy just revealed that he has ordered the FDA to consider making it harder for people to get medication abortions based on propaganda pushed out by a Project 2025 sponsor," said Julia Kaye, senior staff attorney for the ACLU's Reproductive Freedom Project. "Even leading anti-abortion advocates admit this junk science is 'not a study in the traditional sense,' and is 'not conclusive proof of anything,' but that clearly won't stop extremist politicians from waving it around as a basis to restrict abortion."
"We should all be scared if our access to safe, FDA-approved medications turns on President Trump's gut instinct rather than credible scientific evidence," she warned. "This new FDA review has nothing to do with science and everything to do with teeing up nationwide restrictions on abortion."
Kaye added that "if the FDA moves forward with this politically motivated review, that is a dangerous sign that the president is going back on his promises to voters not to restrict abortion access even further."
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