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coronavirus
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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Scientists to G7 Leaders: Prepare for Next Pandemic by Combating Big Pharma Greed
"The pharmaceutical industry will always lobby to maximize their own profits, regardless of the impact on public health, but G7 leaders must resist."
May 18, 2023
A group of scientists warned the leaders of rich countries on Thursday that the world is badly unprepared for the next pandemic and must urgently lay the groundwork for a swift, equitable global response that puts lives over pharmaceutical industry profits.
In a letter to the heads of G7 nations as they gathered in Hiroshima for their annual summit, 16 scientists from South Africa, Brazil, the U.S., the United Kingdom, Japan, Indonesia, and other nations wrote that "it is critical that in the next health crisis the world rapidly deploys medical countermeasures in every country, regardless of their ability to pay," invoking the deadly failure to ensure sufficient access to Covid-19 vaccines in poor nations.
A just response, the scientists wrote, "requires removing every barrier to the development and production of medicines and vaccines—an area where the world failed during the Covid-19 and AIDS pandemics."
"Upholding strict intellectual property rules secured monopolies for pharmaceutical companies and prevented the widespread production of affordable generic vaccines and medicines in developing countries," they continued. "We write to you to emphasize and ask that you center the protection of human rights, such as the right to health and the right to benefit from scientific progress, over windfall profits."
The scientists' letter comes weeks after two dozen pharmaceutical company CEOs—including Eli Lilly chief David Ricks—met with Japanese Prime Minister Fumio Kishida to discuss ways to "strengthen the power of science and an innovation ecosystem built on the protection of intellectual property rights and free access to pathogens."
That was how the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)—a powerful industry trade group whose membership list includes Pfizer, Moderna, and Merck—described the meeting with Kishida, which took place less than a month after the World Health Organization (WHO) formally declared the coronavirus pandemic over as a global health emergency.
The death toll from the pandemic is believed to be in the tens of millions, and research has shown that many deaths could have been averted with more equal vaccine access worldwide.
But efforts to remove barriers that hindered vaccine production and distribution—including patent laws—were blocked by rich countries at the behest of the pharmaceutical industry, which furiously opposed any changes that threatened their monopoly control over the lifesaving shots.
IFPMA was at the center of those aggressive lobbying efforts.
"We cannot double-down on implementation of intellectual property rules that make pandemics longer, costlier, and deadlier."
In their letter to G7 leaders—a group that includes Kishida, U.S. President Joe Biden, and Canadian Prime Minister Justin Trudeau—the scientists expressed dismay that the pharmaceutical industry is still "advocating a maximalist approach to intellectual property, disregarding the impact on public health."
"This is an extreme view that flies in the fact of mainstream scientific opinion," they wrote. "This position endangers the kind of scientific collaboration that is essential to properly prevent, prepare for, and respond to health crises, especially infectious diseases. It condemns most people who live in low and middle-income countries to remain at the back of the line in any future pandemic and exposes them inequitably to death and devastation for longer than people in high-income countries."
Dr. Craig Spencer, associate professor of the practice at Brown University School of Public Health and one of the new letter's signatories, said in a statement Thursday that "we believe that the right to health is more important than windfall profits, particularly in a health crisis."
"The pharmaceutical industry will always lobby to maximize their own profits, regardless of the impact on public health, but G7 leaders must resist," said Spencer. "We cannot double-down on implementation of intellectual property rules that make pandemics longer, costlier, and deadlier."
Another letter signatory, Dr. Quarraisha Abdool Karim of the Center for the AIDS Program of Research in South Africa (CAPRISA), added that "G7 Health Ministers have discussed preparing for the next pandemic but have not considered important lessons from Covid-19."
The letter cited one model that put the possibility of another pandemic as deadly as Covid-19 within the next 10 years at 27.5%. It also points to a study published in Proceedings of the National Academy of Sciences suggesting that "the annual probability of extreme epidemics occurring could increase threefold in the coming decades."
While the scientists said they were encouraged by elements of the WHO's draft pandemic treaty, noting that it includes "provisions to increase the transfer of medical technology to developing countries and to support the suspension of intellectual property rules," they expressed concern that those proposals could suffer the same fate as earlier efforts to waive patent rules.
"We are not asking you to force or demand that institutions are uncompensated for their work, but we urge you make sure compensation is fair and just, and to resist the lobbying of institutions that have prioritized profits over people and public health needs," the scientists wrote. "There is no time to waste."
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'The Sheer Greed Is Obscene': Moderna Plans 4,000% Markup for Covid Vaccine
"This vaccine isn't just Moderna's, it was developed in collaboration with a government agency," said one campaigner. "It should be available and affordable for everyone, everywhere."
Jan 10, 2023
The Massachusetts-based pharmaceutical giant Moderna faced angry backlash on Tuesday following the CEO's announcement that the firm is considering pricing its Covid-19 vaccine somewhere between $100 and $130 per dose in the United States.
The upper end of that range, according to the People's Vaccine Alliance (PVA), would represent a 4,000% markup above the cost of manufacturing the shot, which experts have pegged at roughly $2.85 per dose.
"The sheer greed is obscene," said PVA policy co-lead Julia Kosgei, who stressed that "billions of taxpayer dollars went into the development of mRNA vaccines."
"This vaccine isn't just Moderna's, it was developed in collaboration with a government agency based on decades of publicly-funded research," Kosgei said. "It is the people's vaccine—and it should be available and affordable for everyone, everywhere."
Stephane Bancel, Moderna's billionaire CEO, defended the proposed price range in an interview on the sidelines of the J.P. Morgan Healthcare Conference in San Francisco, tellingThe Wall Street Journal that he believes "this type of pricing is consistent with the value" of the vaccine, which was developed with the crucial help of government scientists.
In 2020, Moderna admitted that 100% of the funding for its vaccine development program came from the federal government—which, despite its leverage, has refused to force the company to share its vaccine recipe with the world.
"We need to learn from this pandemic and break big pharma's monopolies."
Moderna's pricing plans come as the Biden administration is transitioning away from its free coronavirus vaccine program, shifting costs onto insurers and patients—and leaving the uninsured and underinsured with potentially significant bills.
In August, the Health and Human Services Department announced that "as early as January 2023, the administration anticipates no longer having federal funds to purchase or distribute vaccines and will need to transition these activities to the commercial market, similar to seasonal flu or other commercially available vaccines."
The Washington Post's Rachel Roubein noted Tuesday that "the federal government has paid far less for the company's vaccine than the potential price for commercial insurers. Moderna's updated booster shot cost the Biden administration about $26 per dose last summer, according to federal supply contracts."
The Kaiser Family Foundation (KFF) warned in a recent policy brief that the commercial price of coronavirus shots "could discourage vaccination."
"The suggested average price for Covid-19 vaccines after commercialization ($96 to $115 per dose) is significantly higher than the commercial price for the annual flu vaccine ($18 to 28 per dose), and could be a cost barrier for the uninsured and underinsured, who have no guaranteed mechanism for receiving COVID-19 (or any) vaccines once federal supplies are depleted," KFF observed. "While most consumers with public and private insurance will be protected from having to pay directly for vaccine costs, those who are uninsured and underinsured may face cost barriers when the federally-purchased vaccine doses are depleted. In addition, as private payers take on more of the cost of vaccinations and boosters, this could have a small upward effect on health insurance premiums."
In a statement, Kosgei argued that "it doesn't have to be like this."
"The World Health Organization is supporting a program to share mRNA vaccine technology with producers in low and middle-income countries," said Kosgei. "In a future pandemic, this could rapidly supply doses for the entire world, but Moderna's patents are standing in the way. We need to learn from this pandemic and break big pharma's monopolies."
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