Kennedy, who was tapped last week by Trump to lead the Department of Health and Human Services, called fluoride an “industrial waste” and linked it to cancer and other diseases and disorders while campaigning for Trump.

“On January 20, the Trump White House will advise all U.S. water systems to remove fluoride from public water. Fluoride is an industrial waste associated with arthritis, bone fractures, bone cancer, IQ loss, neurodevelopmental disorders, and thyroid disease,” Kennedy Kennedy linked to a video from an attorney who recently the Environmental Protection Agency to take additional measures to regulate fluoride in drinking water.

Kennedy, who ending water fluoridation, following Trump’s election win. When asked before the election whether his administration would remove fluoride from drinking water, , “Well, I haven’t talked to him about it yet, but it sounds OK to me. You know it’s possible.”

Kennedy is an influential vaccine skeptic whose campaign of conspiracy theories earned PolitiFact’s 2023 “.”

Longtime research has found that adding fluoride to U.S. drinking water is a safe way to boost children’s oral health. Since 2015, the recommended level in the U.S. has been 0.7 milligrams per liter. Public health organizations, including the, the , and the , support the practice.

Recent studies, however, have shown possible links between fluoride and bone problems and children’s IQs, particularly when fluoride is above the U.S. recommended levels.

“There is evidence that fluoride exposure has been associated with the diseases [and] disorders that RFK listed, but with caveats,” said Ashley Malin, who is an assistant professor in the University of Florida’s Epidemiology Department and has studied fluoride’s effects in pregnant women.

Malin referred to studies showing that higher fluoride exposure, particularly during pregnancy, is associated with reduced child IQ, and that prenatal exposure also is linked to decreased intellectual functioning and executive function. For high exposure in pregnancy, the studies showed symptoms associated with other neurobehavioral issues, such as attention-deficit/hyperactivity disorder.

However, many of these studies took place in countries other than the U.S. and looked at fluoride in drinking water at sometimes twice the United States’ recommended level. Also, some of the other ailments that Kennedy listed, such as an association with bone cancer, have less robust evidence and need more study.

“Aside from fluoride’s impacts on neurodevelopment, I think that there is more that we don’t know about health effects of low-level fluoride exposure than what we do know, particularly for adult health outcomes,” Malin said.

David Bellinger, a Harvard Medical School neurology professor and professor in Harvard School of Public Health’s Environmental Health Department, said the risk-benefit calculation of added fluoride differs depending on whether typical fluoride exposure levels cause health problems, or if problems occur only when recommended levels are exceeded.

“In toxicology, ‘the dose makes the poison’ is a long-standing principle,” he said. “So a general statement that fluoride is associated with diseases X, Y, and Z is not very helpful unless the dose that might be responsible is specified.”

PolitiFact contacted Kennedy through his Children’s Health Defense organization but received no reply. The organization sued PolitiFact and Meta related to a 2020 fact check. That lawsuit was . The dismissal was upheld on appeal, and the case is pending a possible appeal to the U.S. Supreme Court.

What Is Fluoride and What Are Its Benefits?

naturally occurring in soil, water, and some foods that helps prevent tooth decay and cavities. It strengthens tooth enamel that acid from bacteria, plaque, and sugar can wear away.

Water fluoridation has been happening in the U.S. since 1945.

The federal Public Health Service first recommended fluoridation of tap water in 1962, but the decision still lies with states and municipalities. Around 72% of the U.S. population, , had access to fluoridated water in 2022, the CDC reported. Fluoride also has been added to oral care products such as toothpaste and mouth rinse.

In 2015, U.S. health officials of fluoride in drinking water to 0.7 milligrams per liter, saying a higher level was less necessary given other sources of fluoride, and that the lowered amount would still help protect teeth without .

Pediatric that applying fluoride with toothpaste and rinses is beneficial, but small amounts circulating in the body via water consumption helps younger children who still have their baby teeth, because it can benefit the developing permanent teeth.

The says studies have shown that fluoride in community water systems prevents at least 25% of tooth decay in children and adults and that “for more than 75 years, the best scientific evidence has consistently shown that fluoridation is safe and effective.”

The association says : “It’s similar to fortifying other foods and beverages — for example, fortifying salt with iodine, milk with vitamin D, orange juice with calcium, and bread with folic acid.”

, health experts and scientists from the U.S. and other countries have so far “not found convincing scientific evidence linking community water fluoridation with any potential adverse health effect or systemic disorder such as an increased risk for cancer, Down syndrome, heart disease, osteoporosis and bone fracture, immune disorders, low intelligence, renal disorders, Alzheimer’s disease, or allergic reactions.”

The agency says risks of water fluoridation are limited to , which can alter dental enamel and cause white flecks, spots, lines, or brown stains on the teeth when too much fluoride is consumed.

Do Studies Show Fluoride Posing Any Other Risks?

Some studies have said that excess fluoride exposure, often at higher levels than the recommended U.S. limit, can harm infants’ and young children’s developing brains and that during pregnancy were associated with declines in children’s IQs.

A that Malin led with University of Southern California and Indiana University researchers suggested that fluoride exposure during pregnancy was linked to an increased risk of childhood neurobehavioral problems and were “urgently needed to understand and mitigate the impacts in the entire U.S. population.”

Experts noted prenatal fluoride exposure is most strongly linked to children’s IQ loss, and said timing of fluoride consumption might need to be considered when making recommendations.

A of dozens of studies published in August by the Department of Health and Human Services’ National Toxicology Program concluded that higher levels of fluoride exposure were linked to lower IQs in children. But the report was based primarily on studies in countries such as Canada, China, India, Iran, Mexico, and Pakistan and involved fluoride levels at or above 1.5 milligrams per liter, twice the recommended U.S. limit. The authors said more research is needed to understand whether lower exposure has any adverse effects.

In the report, researchers said they found no evidence that fluoride exposure adversely affected adult cognition.

Bellinger, of Harvard, pointed to the review as an example of how the amount of fluoride matters. He noted how researchers concluded that a very small percentage of people in the U.S. are exposed to levels that correlate with IQ loss.

“Second, the fact that there are now multiple pathways of exposure to fluoride besides fluoridated water (toothpaste and other dental products, etc.) makes it really difficult to attribute a particular adverse effect to the fluoride added to the water,” he wrote via email. “It is the cumulative exposure from all sources that contribute to any adverse health effects.”

In September, a federal judge ordered the Environmental Protection Agency to further regulate fluoride in drinking water because of the potential risk that higher levels could affect children’s intellectual development.

U.S. District Judge Edward Chen wrote that the court’s finding didn’t “conclude with certainty that fluoridated water is injurious to public health,” saying it’s unclear whether the amount of fluoride typically added to water is causing children’s IQs to drop. But he wrote that there was enough risk to warrant investigation and that the EPA must act to further regulate it. The ruling did not specify what actions the agency should take, and the EPA is reviewing the decision.

After the ruling, the American Association of Pediatrics that fluoride in drinking water is safe for children and said the policy is based on a robust foundation of evidence.

Besides dental fluorosis, experts say that fluoride exposure over many years above the U.S. recommended amount can cause , a rare condition that causes weaker bones, stiffness, and joint pain. Although the Public Health Service recommends a fluoride concentration of 0.7 milligrams per liter for community water systems, the EPA, under the Safe Drinking Water Act, sets enforceable standards for drinking-water quality. Currently, to prevent skeletal fluorosis, the EPA requires that water systems not exceed 4 milligrams of fluoride per liter of water.

Malin said she and her research team are investigating a potential link between fluoride and bone fractures. She said that although several studies have found high fluoride exposure associated with increased risk of bone fractures, and some have linked fluoride with thyroid disease, rigorous, U.S.-based studies haven’t been done.

The that recent research found no link between cancer risk and high levels of fluoride in drinking water.

The American Cancer Society between water fluoridation and cancer risk. An organization spokesperson pointed PolitiFact to its review and said it has no data showing a definitive answer.

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President Joe Biden, in a March 22 speech

The cost of insulin in the United States has risen considerably in recent years, with some estimates finding that Americans have paid around as much for the drug as people in other developed countries.

But recent changes by the federal government and drug manufacturers have started to drive insulin prices down, something President Joe Biden often mentions at campaign events.

Biden told the crowd at a in Reno, Nevada, that he’s fought for years to allow Medicare to negotiate with drug companies.

“How many of you know someone who needs insulin?” Biden asked. “OK, well, guess what? It was costing 400 bucks a month on average. It now costs $35 a month.”

We’ve heard Biden make this point several times on the campaign trail — in , he has said beneficiaries were paying “as much as” $400 a month — so we wanted to look into it.

The Inflation Reduction Act, which Biden signed in 2022, caps out-of-pocket insulin costs at $35 a month for Medicare enrollees. The cap took effect in 2023. In response, three drug manufacturers said to reduce the price of insulin to $35 through price caps or savings programs.

The legislation also helped patients by clarifying how much they would have to pay for insulin and other drugs.

But Biden overstated the average monthly cost that Medicare beneficiaries were paying before the law.

One government estimate for out-of-pocket insulin costs found that people with diabetes enrolled in Medicare or private insurance paid an average of $452 a year — not a month, as Biden said. That’s according to a by the Department of Health and Human Services using 2019 data. Uninsured users, however, paid more than twice as much on average for the drug, or about $996 annually.

About Half of US Insulin Users Are on Medicare

More than 37 million Americans have diabetes, and more than 7 million of them need insulin to control their blood sugar levels and prevent dangerous complications. Of the Americans who take the drug, about .

It’s unlikely that many Medicare enrollees were paying the $400 out-of-pocket monthly average Biden referred to, though it could be on target for some people, especially if they’re uninsured, drug pricing experts told us.

“It would be more accurate to say that it could cost people on Medicare over $400 for a month of insulin, but the average cost would have been quite a bit lower than $400 on Medicare,” said Stacie Dusetzina, a health policy professor at Vanderbilt University School of Medicine.

, also called the Medicare prescription drug benefit, helps beneficiaries pay for self-administered prescriptions. The benefit has several phases, including a deductible, an initial coverage phase, a coverage gap phase, and catastrophic coverage. What Medicare beneficiaries pay for their prescriptions often depends on which phase they’re in.

“It is confusing, because the amount that a person was supposed to pay jumps around a lot in the Part D benefit,” Dusetzina said. For example, she said, Medicare beneficiaries would be more likely to pay $400 a month for insulin during months when they hadn’t yet met their deductible.

Mariana Socal, an associate scientist at Johns Hopkins Bloomberg School of Public Health, said it’s also difficult to estimate insulin’s precise cost under Medicare because individual prices hinge on other factors, such as how many other prescription medications patients take.

“Because the Medicare program has multiple instances where the patient is required to pay a coinsurance (percentage of the drug’s cost) to get their drug, it is very likely that patients were paying much more than $35 per month, on average, before the cap established by the Inflation Reduction Act went into effect,” Socal wrote in an email.

There are different ways to , including through a pump, inhaler, or pen injector filled with the medicine.

, HHS researchers estimated that about 37% of insulin fills for Medicare enrollees cost patients more than $35, and 24% of fills exceeded $70. Nationally, the average out-of-pocket cost for insulin was $58 per fill, typically for a 30-day supply, the report found. Patients with private insurance or Medicare paid about $63 per fill, on average.

For people with employer-sponsored insurance, the average monthly out-of-pocket spending on insulin in 2019 was $82, according to a by the Health Care Cost Institute, a nonprofit that studies health care prices. The study found that the majority of patients were spending an average of $35 a month, or lower, on the drug. But among the “8.7% of individuals in the highest spending category,” the median monthly out-of-pocket spending on insulin was about $315, the study said.

Our Ruling

Biden said Medicare beneficiaries used to pay an average of $400 per month for insulin and are now paying $35 per month.

The Inflation Reduction Act capped the monthly price of insulin at $35 for Medicare enrollees, starting in 2023. The change built in price predictability and helped insulin users save hundreds of dollars a year.

However, most Medicare enrollees were not paying a monthly average of $400 before these changes, according to experts and government data. Costs vary, so it is possible some people paid that much in a given month, depending on their coverage phase and dosage.

Research has shown that patients with private insurance or Medicare often paid more than $35 a month for their insulin, sometimes much more, but not as high as the $400 average Biden cited.

We rate Biden’s statement Half True.

PolitiFact copy chief Matthew Crowley contributed to this report.

our sources

WhiteHouse.gov, “,” , March 19, 2024

U.S. Department of Health and Human Services, “,” Jan. 24, 2023

U.S. Department of Health and Human Services, “,” revised Oct. 26, 2023

Bloomberg Law, “,” Oct. 26, 2023

The American Diabetes Association, “,” accessed March 28, 2024

NPR, “,” March 1, 2023

WhiteHouse.gov, “,” March 2, 2023

Health Care Cost Institute, “,” Oct. 15, 2021

Centers for Disease Control and Prevention, “,” updated November 2023

Â鶹ŮÓÅ, “,” July 28, 2022

Â鶹ŮÓÅ Health News, “America Worries About Health Costs — And Voters Want to Hear From Biden and Republicans,” March 8, 2024

USA Facts, “,” April 15, 2023

The Associated Press, “” Aug. 5, 2018

USA Today, “,” Jan. 3, 2024

Email interview with Mariana Socal, associate scientist at Johns Hopkins Bloomberg School of Public Health, March 28, 2024

Email interview with Stacie Dusetzina, professor of health policy at Vanderbilt University, March 29, 2024

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Joe Biden on Feb. 22, 2024, at a campaign reception

It’s well documented that Americans pay high prices for health care. But do they pay double or more for prescriptions compared with the rest of the world? President Joe Biden said they did.

“If I put you on Air Force One with me, and you have a prescription — no matter what it’s for, minor or major — and I flew you to Toronto or flew to London or flew you to Brazil or flew you anywhere in the world, I can get you that prescription filled for somewhere between 40 to 60% less than it costs here,” Biden  at a campaign reception in California.

He followed up by touting provisions in the 2022 Inflation Reduction Act to lower drug prices, including capping insulin at  for Medicare enrollees and limiting older Americans’ out-of-pocket prescription spending to $2,000 a year starting in 2025. The law also authorized Medicare to negotiate prices directly with drug companies for 10 prescription drugs, a list that will expand over time.

Research has consistently found that, overall, U.S. prescription drug prices are significantly higher, sometimes two to four times as high, compared with prices in other high-income industrialized countries. Unbranded generic drugs are an exception and are typically cheaper in the U.S. compared with other countries. (Branded generics,Ìý, are close to breaking even with other countries.)

However, such factors as country-specific pricing, confidential rebates, and other discounts can obscure actual prices, making comparisons harder.

“The available evidence suggests that the U.S., on average, has higher prices for prescription drugs, and that’s particularly true for brand-name drugs,” said Cynthia Cox, director of the , which tracks trends and issues affecting U.S. health care system performance. “Americans also have relatively high out-of-pocket spending on prescription drugs, compared to people in similarly large and wealthy nations.”

Andrew Mulcahy, a senior health economist at Rand Corp., a nonpartisan research organization, agreed that Biden’s overall sentiment is on target but ignores some complexities.

He said price comparisons his team has conducted reflect the amounts wholesalers pay manufacturers for their drugs, which can differ sharply from prices consumers and their drug plans  pay.Ìý

“In many of those other countries, [patients] pay nothing,” Mulcahy said. “So I think that’s part of the complication here when we talk about prices; there are so many different drugs, prices, and systems at work.”

What International Drug Pricing Comparisons Show

´¡Ìý that Mulcahy led found that, across all drugs, U.S. prices were 2.78 times as high as prices in 33 other countries, based on 2022 data. The report evaluated  in the Organization for Economic Co-operation and Development, or OECD, a group of 38 advanced, industrialized nations.

The gap was largest for brand-name drugs, the study found, with U.S. prices averaging 4.22 times as high as those in the studied nations. After adjusting for manufacturer-funded rebates, U.S. prices for brand-name drugs remained more than triple those in other countries.

The U.S. pays less for one prescription category: unbranded, generic drugs, which are about 33% less than in other studied countries. These types of drugs account for about 90% of filled prescriptions in the U.S., yet make up only one-fifth of overall prescription spending.

“The analysis used manufacturer gross prices for drugs because net prices — the amounts ultimately retained by manufacturers after negotiated rebates and other discounts are applied — are not systematically available,” a  about the report said.Ìý

People with health insurance pay prices that include both markups and discounts negotiated with insurers. Uninsured people may pay a pharmacy’s “usual and customary” price — which tends to be higher than net prices paid by others — or a lower amount using a manufacturer discount program. But many of these adjustments are confidential, making it hard to quantify how they affect net prices.In 2021, the Government Accountability Office released  of 20 brand-name drugs in the U.S., Canada, Australia, and France. The study found that retail prices were more than two to four times as high as in the U.S.Like Rand, the agency adjusted for rebates and other price concessions for its U.S. estimate, but the other countries’ estimates reflected gross prices without potential discounts.Ìý

“As a result, the actual differences between U.S. prices and those of the other countries were likely larger than GAO estimates,” the report said.

 by the Peterson-Â鶹ŮÓÅ Health System Tracker that Cox co-authored compared the prices of seven brand-name drugs in the U.S., Germany, the Netherlands, and the United Kingdom, and found that some U.S. prices were two to four times as high. For unbranded, generic drugs, the price gaps were smaller.

“Despite the fact that the U.S. pays less for generic drugs and Americans appear to use more generic drugs than people in other countries, this did not offset the higher prices paid for brand-name drugs,” Cox said.

The Peterson-Â鶹ŮÓÅ report, using 2019 OECD data, found that the U.S. spent about $1,126 per person on prescription medicines, higher than any peer nation, with comparable countries spending $552. This includes spending by insurers and out-of-pocket consumer costs.

“Private and public insurance programs cover a similar share of prescription medicine spending in the U.S. compared to peer nations,” the report noted. “However, the steep costs in the U.S. still contribute to high U.S. health care spending and are passed on to Americans in the form of higher premiums and taxpayer-funded public programs.”

Why Is the US Such an Outlier on Drug Pricing?

The U.S. has much more limited price negotiation with drug manufacturers;  often rely on a single regulatory body to determine whether prices are acceptable and negotiate accordingly. Many nations conduct public cost-benefit analyses on new drugs, comparing them with others on the market. If those studies find the cost is too high, or the health benefit too low, they’ll reject the drug application. Some countries also set 

In the U.S., negotiations involve smaller government programs and thousands of separate private health plans, lowering the bargaining power.

“It’s complicated. Everything in health care costs more here, not just [prescriptions],” said Joseph Antos, a senior fellow at the American Enterprise Institute, a conservative-leaning think tank, in an email interview. Although the government’s new Medicare drug negotiation is the United States’ first attempt to set drug prices, Antos noted that U.S. drug price negotiation still doesn’t operate as price-setting for prescriptions in Europe does because it’s limited to a few drugs and doesn’t apply to Medicaid or private insurance.Drug patents and exclusivity is another factor keeping U.S. drug prices higher, experts said, as U.S. pharmaceutical companies have amassed patents to prevent generic competitors from bringing cheaper versions to market.Drug companies have also argued that high prices reflect research and development costs. Without higher consumer prices to offset research costs, the companies say, new medicines wouldn’t be discovered or brought to market. But recent studies haven’t supported that.Ìý 

 found that from 1999 to 2018, the world’s largest 15 biopharmaceutical companies spent more on selling and general and administrative activities, which include marketing, than on research and development. The study also said most new medicines developed during this period offered little to no clinical benefit over existing treatments.

Our Ruling

Biden said, if you went “anywhere in the world,” you could get a prescription filled for 40% to 60% less than it costs in the U.S.

He exaggerated by saying “anywhere in the world,” but for comparable high-income, industrialized countries, he’s mostly on target.Research has consistently shown that Americans pay significantly higher prices overall for prescription medication, averaging between two times to four times as high, depending on the study. The U.S. pays less for unbranded, generic drugs, but those lower prices don’t offset the higher prices paid for brand-name drugs, researchers said.

Factors including country-specific pricing, confidential rebates. and other discounts also obscure true consumer prices, making comparisons difficult.

Biden’s statement is accurate but needs clarification and additional information. We rate it Mostly True.

PolitiFact copy chief Matthew Crowley contributed to this report.

Our sources:

°Â³ó¾±³Ù±ð±á´Ç³Ü²õ±ð.²µ´Ç±¹,Ìý, Feb. 22, 2024

±Ê´Ç±ô¾±³Ù¾±¹ó²¹³¦³Ù,Ìý“,” May 18, 2023

Rand Corp.,Ìý“” Feb. 1, 2024

Rand Corp.,Ìý“,” Feb. 1, 2024 

Peterson-Â鶹ŮÓÅ Health System Tracker,Ìý“”

Peter G. Peterson Foundation,Ìý“” Nov. 7, 2022

Government Accountability Office,Ìý“” March 29, 2021

Commonwealth Fund,Ìý“” Jan. 4, 2024

°ä-³§±Ê´¡±·,Ìý“,” Feb. 8, 2024 

Center for American Progress,Ìý“,” Oct. 12, 2023

Congressional Budget Office,Ìý“,” January 2022

The New York Times,Ìý“,” Jan. 17, 2024 

The Commonwealth Fund,Ìý“” Oct. 5, 2017

¹ó´Ç°ù²ú±ð²õ,Ìý“” July 22, 2022

The BMJ,Ìý“,” February 2023 

°Â¾±°ù±ð»å,Ìý“,” Oct. 13, 2022

Email interview, Kelly Scully, spokesperson for the White House, Feb. 26-27, 2024

Phone interview, Andrew Mulcahy, senior health economist at Rand Corp., Feb. 27, 2024

Email interview, Michelle Mello, law and health policy professor at Stanford University, Feb. 27, 2024

Email interview, Joseph Antos, senior fellow at the American Enterprise Institute, Feb. 26, 2024

Email interview, Cynthia Cox, director of the Peterson-Â鶹ŮÓÅ Health System Tracker at Â鶹ŮÓÅ, Feb. 27, 2024

READ ABOUT OUR PROCESS:

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“I know a lady in Florida named Penny,” . “She survived multiple abortion attempts. She was left discarded in a pan. Fortunately, her grandmother saved her and brought her to a different hospital.”

Some accused the governor of fabricating the story.

“Let me see if I understand this correctly. Doctors tried to abort ‘Penny’ multiple times and discarded her in a pan, and then her grandmother took her to another hospital? DeSantis lies like a toddler,” one person , formerly known as Twitter.

Our research found that a woman named Penny, who tells an unusual birth story about an attempted abortion, does exist.

We asked DeSantis’ campaign for evidence or more information. The campaign replied via email, sending to a Daily Signal article that identified “Penny” by her full name and recounted her story.

The woman DeSantis referred to is Miriam “Penny” Hopper, an anti-abortion activist who said she survived an abortion attempt in Florida in 1955. Her claim, which is uncorroborated, has been featured online by Protect Life Michigan, an anti-abortion advocacy group.

In and in interviews, Hopper said she had been delivered around 23 weeks gestation after her mother went to a hospital in Wauchula, Florida, while experiencing bleeding. In , Hopper said she believes an abortion had been attempted at home before her parents went to the hospital, which also could be why DeSantis referenced “multiple” abortion attempts.

Hopper said the doctor at the hospital induced labor, and she was born at 1 pound, 11 ounces, and was left in a bedpan. She told WFSU her grandmother later found her alive and was enraged about her being abandoned. Then a nurse volunteered to transport Hopper to what was then in Lakeland, Florida, now the site of Lakeland Regional Health Medical Center. That’s about 40 miles north of the hospital where Hopper said she was born.

Her story has been used to support “born alive” bills in state legislatures, which aim to protect infants that survive an abortion, even though there are federal laws for that purpose.

We were unable to gauge the accuracy of Hopper’s account. We couldn’t find records, such as news reports, dating to the 1950s, and people who could corroborate the story, such as her grandmother, are no longer living. Hopper did not respond to requests for comment.

Medically speaking, the scenario is dubious.

From the 1950s through 1980, “newborn death was virtually ensured” for infants born at or before 24 weeks of gestation, the American College of Obstetrics and Gynecology says on .

Recent studies have shown wide variation in modern-day survival rates for infants born around 23 weeks, partly because of improved hospital practices for resuscitation and active treatment.

A published in 2022 found that between 2013 and 2018 babies born at 23 weeks — who were “actively treated” at academic medical centers in the National Institutes of Health-funded Neonatal Research Network — had nearly a 56% chance of survival.

This is considerably higher than the 23-week survival rate at many other institutions, as well as a previous study conducted from 2008 to 2012 in the same network, which put the rate at 32%. (Lifesaving care for babies born at 22 and 23 weeks varies by hospital policy and physician opinion, according to a .)

, most babies born before 28 weeks’ gestation died because they lacked the ability to breathe on their own for more than a short time, and reliable mechanical ventilators for these infants did not yet exist. That also makes it improbable that Hopper could have survived for long without medical intervention when born at 23 weeks in the 1950s.

PolitiFact researcher Caryn Baird contributed to this report.

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— Feb. 3 in a Facebook post

Vaccine makers Pfizer and Moderna earned praise for creating highly effective covid-19 vaccines in record time. But are they inadvertently hurting the public by not sharing their technology with other pharmaceutical companies to help speed up vaccine manufacturing and distribution?

That’s what  circulating on social media claims.

“The vaccine shortage doesn’t need to exist,” reads an image of a  shared thousands of times on Facebook. “Pfizer and Moderna could share their design with dozens of other pharma companies who stand ready to produce their vaccines and end the pandemic.”

In short, the situation is not that simple. The post was flagged as part of Facebook’s efforts to combat false news and misinformation on its News Feed. (Read more about PolitiFact’s .)

The tweet doesn’t mention that the two drugmakers are already partnering with other companies to produce the vaccine. It also makes it appear as if dozens of companies are regulated to make vaccines and have a ready supply of the raw materials, equipment and storage needed to efficiently and effectively produce them. Experts say that’s not the case.

When PolitiFact reached out to the tweet’s author, Dr. James Hamblin, a public health policy lecturer at Yale University and writer at The Atlantic, he acknowledged that using the words “stand ready” in the tweet inaccurately implied the process could begin immediately.

“It takes time and investment to begin making mRNA vaccines,” Hamblin told PolitiFact. “The companies would need the assurance that they not lose money by getting into that space, possibly in some way similar to the assurances given during the research phase of [Operation] Warp Speed.” 

Vaccine Technology Narrows the Field

Both Pfizer and Moderna’s vaccines rely on newer messenger RNA technology. (It has been studied for some time but hasn’t been used in a vaccine until now.) The mRNA is fragile and needs to be handled carefully, with specific temperatures and humidity levels to keep it from breaking down.Ìý

It’s highly unlikely, experts say, that “dozens” of manufacturing plants have the capability to get this type of production off the ground immediately. Even if Pfizer-BioNTech and Moderna made their vaccine designs open source today, pharmaceutical researchers estimate, it would still take several months for other companies to produce the shots, and by then mass distribution and inoculation will be well underway.Ìý

PolitiFact reached out to both companies for comment but did not hear back.

Dr. Rajeev Venkayya, president of the Global Vaccine Business Unit at Takeda Pharmaceuticals and former director of vaccine delivery at the Bill & Melinda Gates Foundation’s Global Health Program,Ìý addressing the complexity and risk of vaccine manufacturing.

Among many other issues, Venyakka said, vaccines are complex biologics and it’s hard to predict whether changes to the manufacturing process will affect the vaccines’ effectiveness or safety.

“Many vaccines are made by growing viruses in cells, and when that doesn’t happen as expected, it can lead to losses in production and delayed timelines. This is an area where cell- and virus-free mRNA vaccine production has a major advantage,” .Ìý

“For these reasons, every aspect of vaccine manufacturing is tightly controlled: raw materials, equipment, production processes, training, operating procedures etc. All of it happens under GMP [good manufacturing practice] regulations, and facilities are regularly inspected.” 

According to the Food and Drug Administration, manufacturers may share any information or data about their products they choose, as they are the owners of the information. But the company is responsible for ensuring that any contract manufacturer is in compliance with the FDA’s Ìý°ù±ð²µ³Ü±ô²¹³Ù¾±´Ç²Ô²õ.

These rules establish minimum requirements for the methods, facilities and controls used in making and packing pharmaceuticals. They aim to ensure that a product is safe for use and that it has the ingredients and strength it claims to have.

Existing Partnerships Are Already Speeding Production

John Grabenstein, associate director for scientific communications at the , a vaccine information organization that works in partnership with the Centers for Disease Control and Prevention, told PolitiFact the tweet wrongly presumes that the companies aren’t already outsourcing production. Grabenstein tracks partnerships between pharmaceutical companies and contract manufacturers.Ìý

He said Pfizer-BioNTech is working with biopharmaceutical companies Ìý²¹²Ô»åÌý, while Moderna has partnered with ,ÌýÌý²¹²Ô»åÌý Some of the companies are located exclusively overseas, while others have plants in the U.S.Ìý

Typically, the contractors are doing one of the major portions of production, Grabenstein said, such as manufacturing the bulk product, formulation of the bulk into the final preparation, filling the drug product into vials, or finishing the final packaging, which could include labeling vials, inserting them and paperwork into boxes, and assembling boxes for a carton.

For example, Rovi, one of the companies working with Moderna,Ìý in July to start filling and packaging 100 million doses of the vaccine in early 2021.

In fewer cases, a full-fledged manufacturer is commissioned to make a mirror image of the original product, from start to finish.Ìý

One example of this is the Serum Institute of India — the world’s  — which is already producing a parallel version of the  that the institute will market with the trade name CoviShield. The institute launched the construction of new facilities in June to make that happen. The organization recently announced a similar partnership with .Ìý

“This is incredibly intricate and the number of facilities and trained personnel is really, really small,” Grabenstein said. “It’s not like you’re just giving a recipe to another restaurant. That ‘recipe’ is thousands and thousands of pages long, and then you have to validate and show that you meet all the really tight performance specifications and prove consistency of process before any of the regulators will let you distribute any of the vaccine.”

Hamblin, the author of the Twitter post, said it’s unlikely the companies would share their vaccine designs, given the current system of intellectual property and funding, though he noted exceptions, like Sanofi.

Sanofi, a French multinational pharmaceutical company,Ìý that it had entered into a partnership with BioNTech, the company that co-developed the vaccine with Pfizer. Sanofi said it will provide the company access to its “established infrastructure and expertise to produce over 125 million doses of COVID-19 vaccine in Europe.” Initial supplies will originate from Sanofi’s production facilities in Frankfurt, Germany, this summer.

Hamblin noted that if vaccine makers open the intellectual property in a permanent, unconditional way — rather than on a small scale for a finite period — it could help get more companies and governments into the production “in a more permanent, cost-effective way.” 

“If we have to manufacture boosters in specific areas for new strains, for example, or for the next coronavirus, we could be on it right away,” Hamblin said. “Again, speaking hypothetically about that — not implying it will happen or would be quick or easy or anything else.”

Defense Production Act Allows Greater Collaboration But Takes Time

With President Joe Biden , couldn’t that serve to help speed things up? Yes, but the law is not as sweeping as some think.Ìý

 gives presidential authority to promote national defense by expediting and expanding the supply of materials and services from the U.S. industrial base.

Dr. George Siber, a vaccine expert on the advisory board of CureVac, a German mRNA vaccine company,Ìýtold KHN that invoking the act would allow the government to commandeer an appropriate plant to expand production, but that it would still take about a year to get going.

Companies would first have to undertake a thorough cleaning of their equipment and facilities to prevent cross-contamination and would need to set up, calibrate and test equipment, and train scientists and engineers to run it,ÌýSiber told KHN.

“Do you want glass? Aluminum? Filter resins? What is the thing that you need?” Grabenstein said. “For example, vaccine manufacturers say, ‘If only I had more glass vials, I could increase my weekly production.’ OK, the government gets you more glass vials. Then it reveals the next bottleneck.”

He added: “Is there production that could be stopped or delayed, and let those machines be used for this goal? Sure, but you still have to clean it, and quality-control that it’s really clean, and then the transfer and validation of process. It’s months or years of commitment. This is not turn-on-a-dime kind of stuff.” 

According to the CDC, nearly  of the Moderna and Pfizer-BioNTech vaccines had been distributed and roughly 45 million administered by the second week in February.

The U.S. has vaccinated about 10% of the population, putting it about sixth in the world,.Ìý

Our Ruling

A post claims the covid-19 vaccine shortage doesn’t need to exist because Pfizer and Moderna can share their vaccine designs with “dozens” of other pharmaceutical companies that are ready to produce the vaccines and end the pandemic.

This premise oversimplifies the vaccine manufacturing process.

First, the post doesn’t mention that Pfizer-BioNTech and Moderna already have partnerships with various contract manufacturers to help speed up vaccine production. Second, industry experts say it’s highly unlikely “dozens” of pharmaceutical companies that aren’t already producing the vaccines stand ready to do so. Supplies, personnel training and facility compliance are just a few aspects that make the process complex and lengthy.

So, while such partnerships are clearly an asset to rapid vaccine production, they are not entirely practical in the grand sense that this tweet implies.

The statement contains an element of truth but ignores critical facts that would give a different impression. We rate it Mostly False.

Source List:

¹ó²¹³¦±ð²ú´Ç´Ç°ìÌý Feb. 3, 2021

Science Magazine,Ìý“,” Feb. 2, 2021

KHN,Ìý“Why Even Presidential Pressure Might Not Get More Vaccine to Market Faster,” Jan. 26, 2021

Twitter,ÌýDr. , Feb. 1, 2021 

Centers for Disease Control and Prevention,Ìý“,” accessed Feb. 8, 2021

The New York Times,Ìý“,” accessed Feb. 8, 2021

±Ê´Ç±ô¾±³Ù¾±¹ó²¹³¦³Ù,Ìý“, Feb. 4, 2021 

Modernatx.com,Ìý“,” July 9, 2020

Food and Drug Administration,Ìý“,” updated Sept. 21, 2020 

Message from Dr. James Hamblin, Feb. 8, 2021

Phone interview, John Grabenstein, associate director for scientific communications for the Immunization Action Coalition, Feb. 5, 2021

Email interview, Alison Hunt, spokesperson for the Food and Drug Administration, Feb 5. 2021

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