Dr. Jonas Salk announces polio vaccine

Dr. Jonas Salk announces polio vaccine


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On March 26, 1953, American medical researcher Dr. Jonas Salk announces on a national radio show that he has successfully tested a vaccine against poliomyelitis, the virus that causes the crippling disease of polio. In 1952—an epidemic year for polio—there were 58,000 new cases reported in the United States, and more than 3,000 died from the disease. For promising eventually to eradicate the disease, which is known as “infant paralysis” because it mainly affects children, Dr. Salk was celebrated as the great doctor-benefactor of his time.

READ MORE: 8 Things You May Not Know About Jonas Salk and the Polio Vaccine

Polio, a disease that has affected humanity throughout recorded history, attacks the nervous system and can cause varying degrees of paralysis. Since the virus is easily transmitted, epidemics were commonplace in the first decades of the 20th century. The first major polio epidemic in the United States occurred in Vermont in the summer of 1894, and by the 20th century thousands were affected every year. In the first decades of the 20th century, treatments were limited to quarantines and the infamous “iron lung,” a metal coffin-like contraption that aided respiration. Although children, and especially infants, were among the worst affected, adults were also often afflicted, including future president Franklin D. Roosevelt, who in 1921 was stricken with polio at the age of 39 and was left partially paralyzed. Roosevelt later transformed his estate in Warm Springs, Georgia, into a recovery retreat for polio victims and was instrumental in raising funds for polio-related research and the treatment of polio patients.

READ MORE: Why FDR Decided to Run for a Fourth Term Despite Ill Health

Salk, born in New York City in 1914, first conducted research on viruses in the 1930s when he was a medical student at New York University, and during World War II helped develop flu vaccines. In 1947, he became head of a research laboratory at the University of Pittsburgh and in 1948 was awarded a grant to study the polio virus and develop a possible vaccine. By 1950, he had an early version of his polio vaccine.

Salk’s procedure, first attempted unsuccessfully by American Maurice Brodie in the 1930s, was to kill several strains of the virus and then inject the benign viruses into a healthy person’s bloodstream. The person’s immune system would then create antibodies designed to resist future exposure to poliomyelitis. Salk conducted the first human trials on former polio patients and on himself and his family, and by 1953 was ready to announce his findings. This occurred on the CBS national radio network on the evening of March 25 and two days later in an article published in the Journal of the American Medical Association. Dr. Salk became an immediate celebrity.

In 1954, clinical trials using the Salk vaccine and a placebo began on nearly two million American schoolchildren. In April 1955, it was announced that the vaccine was effective and safe, and a nationwide inoculation campaign began. Shortly thereafter, tragedy struck in the Western and mid-Western United States, when more than 200,000 people were injected with a defective vaccine manufactured at Cutter Laboratories of Berkeley, California. Thousands of polio cases were reported, 200 children were left paralyzed and 10 died.

READ MORE: How a New Polio Vaccine Faced Shortages and Setbacks

The incident delayed production of the vaccine, but new polio cases dropped to under 6,000 in 1957, the first year after the vaccine was widely available. In 1962, an oral vaccine developed by Polish-American researcher Albert Sabin became available, greatly facilitating distribution of the polio vaccine. Today, there are just a handful of polio cases in the United States every year. Among other honors, Jonas Salk was awarded the Presidential Medal of Freedom in 1977. He died in La Jolla, California, in 1995.

READ MORE: How 5 of History's Worst Pandemics Finally Ended


Jonas Salk and Albert Bruce Sabin

In the 1950s Salk and Sabin developed separate vaccines—one from killed virus and the other from live virus—to combat the dreaded disease polio.

Jonas Salk became a national hero when he allayed the fear of polio with his vaccine, approved in 1955. Although it was the first polio vaccine, it was not to be the last Albert Sabin introduced an oral vaccine in the 1960s that replaced Salk’s.


​The Salk polio vaccine: "Greatest public health experiment in history"

A nationwide trial of an experimental vaccine using school children as virtual guinea pigs would be unthinkable in the United States today.

But that's exactly what happened in 1954 when frantic American parents -- looking for anything that could beat back the horror of polio -- offered up more than 1.8 million children to serve as test subjects. They included 600,000 kids who would be injected with either a new polio vaccine or a placebo.

Equally remarkable, the Salk polio vaccine trial stands as the largest peacetime mobilization of volunteers in American history, requiring the efforts of 325,000 doctors, nurses, educators and private citizens -- with no money from federal grants or pharmaceutical companies. The results were tracked by volunteers using pencils and paper.

And it lasted just one year, with officials hopeful at the outset that they would be able to begin giving the vaccine to children within weeks of the final results.

"I can't imagine what the disease would be today that could get that many parents to sign up their children for an experimental vaccine trial," said Daniel Wilson, a history professor at Muhlenberg College in Allentown, Pa., who has written three books on the history of polio in the United States and is himself a polio survivor. "I think it's a measure of how much people feared polio that mothers and fathers were willing to accept the word of researchers that the vaccine was safe."

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Financing for the trial came from donations made to the National Foundation for Infantile Paralysis -- the forerunner of the March of Dimes. The foundation was created in 1938 by President Franklin D. Roosevelt and his law partner, Basil O'Connor.

Roosevelt had a profoundly personal interest in defeating polio -- the disease left him crippled in 1921 at age 39, and he spent his entire presidency in leg braces, confined to a wheelchair, unable to even get up by himself.

The National Foundation spent $7.5 million in donations -- $66.3 million in today's dollars -- to initiate, organize and run the vaccine trial, with little participation from the federal government.

"That's what makes it the greatest public health experiment in history," said David Oshinsky, who wrote the Pulitzer Prize-winning book "Polio: An American Story." "It's not just the success of the trials. It's the incredible organization involved, with tens of thousands of mothers and families coming together to save their children. And it was all done privately. That's what makes this so incredible."

There was enormous pressure to get the field trial under way in advance of the 1954 polio season. Polio epidemics took place during the summer, with the number of cases rising through June and July and peaking in August.

"We realized we wanted to get it accomplished in 1954, early enough that it could possibly have an impact on that year's polio season," said David Rose, archivist for the March of Dimes.

A grass-roots movement without precedent

The National Foundation for Infantile Paralysis already had a nationwide network of health officials, medical professionals, elementary educators and volunteers in place to help respond to polio outbreaks. These were the same people who would form the workforce needed for the clinical trial. In addition, the foundation's annual "Mother's March" raised millions in dimes and dollars each year, which was used for polio research and aid to communities enduring polio epidemics.

Some of that money had funded Dr. Jonas Salk's creation in 1952 of an experimental "killed-virus" polio vaccine, and his subsequent experiments that proved the vaccine's safety in humans.

Basil O'Connor and the National Foundation's scientific advisors had taken a keen interest in Salk's vaccine, especially when his early experiments suggested that it increased the level of polio antibodies in a person's blood without any ill effects. So plans were made for the national trial.

O'Connor announced in November 1953 that the field trial would begin the following spring, and would be based on an "observed-control" design. That meant one group of children would receive the vaccine, and another group of kids in the same age range would be observed but not injected with either the vaccine or a placebo.

There were, of course, major concerns. Some questioned whether the National Foundation could perform an impartial evaluation of a vaccine that it had had a hand in creating. They also expressed doubts about the "observed control" design of the trial.

The problem with the "observed-control" approach was that middle- and upper-class neighborhoods were more likely to suffer a polio outbreak than poorer areas. The reason: better sanitation, which meant less exposure to germs and resulting immunity, said Dr. Peter Salk, Jonas Salk's son and president of the Jonas Salk Legacy Foundation.

"The concern was that the children who would end up receiving the real vaccine would be from a different social cut from those who would serve as observed controls," Salk said. "It was the wealthier neighborhoods that had more polio. If you took kids from the wealthier areas, they would have a higher risk of polio, and those kids would be expected to have a higher incidence than controls."

To counter potential charges of scientific bias, the National Foundation turned the polio vaccine field trial over to Jonas Salk's mentor, Dr. Thomas Francis, Jr., a virologist at the University of Michigan who had worked with Salk years before on an influenza vaccine.

Francis established the Poliomyelitis Vaccine Evaluation Center at the University of Michigan, which would guide the trial and independently analyze the results.

Soon after taking charge, Francis announced that the trial would be conducted using two separate "arms." One arm would follow the "observed-control" design originally proposed by the National Foundation. The second arm would utilize a "placebo-control" design, with half the children getting the vaccine and the other half a placebo.

Salk himself, who had only a supporting role in the massive undertaking, initially resisted the idea of a "placebo-control" trial, arguing that doctors shouldn't be giving kids something that deliberately would not protect them against polio, his son recalled.

"Very fortunately, my father ended up yielding to the forces at work, which was that the only way it would be possible to convince anyone and to understand the effectiveness of the vaccine would be to use a placebo-controlled design," said Peter Salk.

Legions of proud "Polio Pioneers"

Between April 26 and July 10, 1954, volunteers distributed Salk's series of three polio shots. In all, more than 443,000 children received at least one polio inoculation, while more than 210,000 received a placebo, according to the March of Dimes.

"There were three shots and it was a double-blind study," Oshinsky said. "Neither the child nor the caregiver knew who was receiving the vaccine or a placebo, so the paperwork was enormous."

All the kids in the trials became known as the "Polio Pioneers," and each received what would become a much-treasured Polio Pioneer metal pin and certificate of membership signed by O'Connor himself.

The vaccine was tested in massive field trials, beginning in 1954, that involved 1.8 million schoolchildren known as "polio pioneers," (seen here) according to the March of Dimes. March of Dimes

Bonnie Yarry of Maitland, Fla., still had her Polio Pioneer pin and certificate in 2005 when she wrote a personal remembrance for the non-profit group Post-Polio Health International.

Calling herself a "tiny peg in Dr. Salk's success story," Yarry recalled how her New York City second grade class at monthly intervals "traipsed down to P.S. 148's makeshift infirmary, a kindergarten classroom filled with New York Health Department doctors and nurses prepared to inoculate us."

"With butterflies in my stomach, I stuck out my arm, never looked at the needle, waited for the prick and then the pain," Yarry wrote. "I heard others cry, but I didn't."

The Salk vaccine trial also served as one of the earliest and largest examples of informed consent, the process by which researchers get permission to experiment on human subjects, Oshinsky said.

"Parents actually signed a piece of paper saying, 'I give my consent to have my child participate in this experiment,' " he said.

Researchers spent the rest of 1954 following the health of all the children, and taking blood samples from 40,000 kids in the study to examine their antibody response.

Through three months of winter and the early spring of 1955, the researchers analyzed and evaluated the data gathered on inoculation, blood samples, and resulting cases of polio. Much of the work was done by hand, although some computations were performed using punch cards that were fed into a primitive computer the size of a room, Oshinsky said.

People were on pins and needles waiting for the results of the trial. Even Salk himself knew nothing about how the analysis was proceeding, his son said.

"An instant hero"

Then, just one year after the trial started, the National Foundation announced the results: The Salk vaccine proved 80 to 90 percent effective in preventing polio.

"The vaccine works. It is safe, effective and potent," stated the press release issued by the National Foundation on Tuesday, April 12, 1955. It concluded, "There can be no doubt now that children can be inoculated successfully against polio."

The New York Times blared the news with a banner headline: "SALK POLIO VACCINE PROVES SUCCESS MILLIONS WILL BE IMMUNIZED SOON CITY SCHOOLS BEGIN SHOTS APRIL 25."

"Salk became sort of an instant hero," said Muhlenberg College's Wilson. "He appeared on the cover of Time magazine. He really was celebrated. [President Dwight] Eisenhower entertained him at the White House."

For some children, however, the vaccine came too late. Wilson contracted polio at age 5 in September 1955, months after the vaccine's success had been announced.

"The vaccine was out and available in the fall of 1955, but it was in short supply at that time in rural Wisconsin," said Wilson, who lived in Wausau back then. "I was a year short of going to school, and so I didn't get the vaccine." Now 64, he has had lifelong health problems due to his childhood polio.

Once Salk's vaccine became widely available, Oshinsky said, it saved the lives of tens of thousands of children in the United States and Canada.

And by 1961, the rate of polio had dropped by 96 percent in the United States, thanks to the Salk vaccine, according to the March of Dimes.

Salk's legacy, however, extends far beyond his vaccine. Oshinsky contends that Salk's true contribution to science was his demonstration that a killed virus vaccine could be as effective as using a live virus. The flu shot people receive every year is a killed virus vaccine, as are modern vaccines that protect against typhoid, cholera and whooping cough, he said.

"Jonas Salk showed that a killed virus vaccine would work and would be damned effective in fighting disease," Oshinsky said. "This was something that virologists of the day pooh-poohed. And Salk proved them wrong."

But Salk's vaccine, still available and the primary polio vaccine for the United States, isn't as widely used across the globe today as the live virus polio vaccine developed by his rival, Dr. Albert Sabin.

Sabin, a Polish medical researcher who become a naturalized U.S. citizen in 1930, tested the effectiveness of his oral vaccine on at least 100 million people in the USSR and other countries between 1955 and 1961.

His vaccine proved even better at preventing polio, and much easier to deliver.

"You can give it in drops, you can put the drops on sugar cubes," Wilson said. "You don't need to have an expert doctor or nurse to give the vaccine. Sabin's vaccine was the vaccine to bring polio to the edge of eradication."

However, Sabin's vaccine doesn't completely eradicate polio, because a minute number of children given the live virus vaccine will actually contract polio, Oshinsky said.

"When you get the numbers way, way down, you have to come in with the Salk vaccine to finish it off," Oshinsky noted.

He added, "I don't think the irony would be lost on Sabin or Salk, two scientific rivals who truly did not like each other. We need both their vaccines to end polio forever. We can't do it with just one of them."

First published on December 2, 2014 / 10:32 AM

© 2014 HealthDay. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.


Salk Polio Vaccine Conquered Terrifying Disease

A physical therapist works with two polio-stricken children in the 1950s. In the early '50s, the U.S. had some 20,000 polio cases a year. Following the introduction of the vaccine in 1955, that figure dropped, falling to about 3,000 per year by 1960. Charles Farmer/CDC hide caption

Dr. Albert Sabin developed the oral polio vaccine in 1961. Above, an infant receives the oral vaccine in Georgia in the 1970s. Meridith Hickson/CDC hide caption

Global eradication efforts continue. Above, an Ethiopian child receives the oral polio vaccine. Global Polio Eradication Initiative hide caption

Dr. Jonas Salk, left, and Dr. Julius Youngner shown working in a research lab during the development of the first polio vaccine, which was injectable.

Now 84 and a professor emeritus at the University of Pittsburgh, Youngner says Salk offended some of his colleagues by refusing to credit their contributions to the development of the polio vaccine.

Hear Youngner Discuss Salk's Legacy as a Scientist

Fifty years ago, on April 12, 1955, the world heard one of the most eagerly anticipated announcements in medical history: Dr. Jonas Salk's polio vaccine worked. The vaccine turned a disease that once horrified America into a memory.

NPR's Joe Palca looks back at the science that created a successful vaccine -- and the people behind the medical milestone.

Timeline: The Fight Against Polio

Maxine Fisher, left, and Beatrice Sharp Slutsky were both stricken with polio as children. At age 13, Slutsky received Salk's polio vaccine in the first pilot trials of the vaccine, held in the Pittsburgh area Fisher declined to participate. Joe Palca, NPR hide caption

Hear Maxine Fisher's Story

Hear Beatrice Sharp Slutsky's Story

1800s Paralytic poliomyelitis (polio) takes its toll worldwide, affecting mostly children. The disease is known as infantile paralysis.

1894 The first known polio epidemic in the United States occurs in Vermont.

1908 Dr. Karl Landsteiner discovers that a virus causes polio.

1916 The first major polio epidemic strikes in the United States 27,000 people suffer paralysis and 6,000 die. Increasing numbers of outbreaks occur each year.

1921 Franklin D. Roosevelt is diagnosed with polio.

1928 Iron lungs are introduced to help patients with acute polio breathe.

1932 Franklin D. Roosevelt is elected President of the United States.

1938 President Roosevelt founds the National Foundation for Infantile Paralysis (NFIP, known today as the March of Dimes).

-- At the New York University School of Medicine, Dr. Jonas Salk begins working with virologist and epidemiologist Dr. Thomas Francis Jr. on an influenza vaccine later used by the U.S. military during World War II.

1947 The University of Pittsburgh recruits Dr. Jonas Salk to develop a virus research program. Techniques Salk picked up while working with influenza are later used to develop the polio vaccine.

1948-49 Scientists confirm the existence of three strains of poliovirus.

1949 Dr. John Enders, Dr. Frederick Robbins and Dr. Thomas Weller develop a way to grow poliovirus in tissue culture, a breakthrough that aided in the creation of the polio vaccine. Their work earned the three scientists the Nobel Prize in physiology or medicine in 1954.

1952 The United States reports 57,628 polio cases -- the worst U.S. epidemic on record.

-- Dr. Salk and his colleagues develop a potentially safe, injectable vaccine against polio. Nearly 15,000 Pittsburgh-area subjects, mostly children, receive the vaccine in pilot trials.

-- Salk's former mentor, Dr. Thomas Francis, designs, directs and evaluates field trials of the polio vaccine. Unprecedented in their scope and size, the trials involve around 1.8 million children from the United States, Canada and Finland. They are among the first to use the double-blind process that has since become standard.

1955 On April 12, Francis announces the results of the field trials, declaring that Salk's vaccine is "safe, effective and potent."

1955-57 Once the vaccine becomes available, U.S. polio cases drop by 85-90 percent.

1961 Dr. Albert Sabin develops an oral polio vaccine.

1963 Congress creates the Immunization Grant Program. Reported U.S. polio cases plummet to just 396.

1979 The last U.S. case of polio caused by wild poliovirus is reported.

1985 Rotary International establishes its PolioPlus program. Rotary has contributed more than $500 million to fight polio worldwide.

1988 Worldwide, polio continues to affect some 350,000 people in 125 countries. In response, the World Health Organization, UNICEF, Rotary International and the U.S. Centers for Disease Control and Prevention launch the Global Polio Eradication Initiative.

1994 The Americas are certified polio-free.

1999 The U.S. Public Health Service recommends that the oral vaccine be discontinued in the United States, and a modified injectable vaccine becomes the preferred vaccine. The oral vaccine -- which is cheaper and easier to administer -- remains the vaccine of choice for eradication efforts elsewhere around the globe.

2000 The Western Pacific region is certified polio-free.

2002 Europe is certified polio-free.

2005 April 12, 2005, marks the 50th anniversary of the Salk vaccine. Global eradication efforts have helped lower worldwide polio cases to just 1,263 reported cases in 2004.


Salk worked on developing an AIDS vaccine used 'killed' cells of the virus

In the 1980s, AIDS was a little-known, much-feared, and widely stigmatized disease, which had affected 100,000 Americans by the end of the decade, according to Avert. It also had no cure, but Dr. Salk believed that an AIDS vaccine was possible, saying, "the principles of immunology do apply, even to this agent," per The New York Times.

Dr. Salk and his team set to work attempting to make AIDS, like polio, a thing of the past, using his effective polio vaccine as a model. As with his polio vaccine, he focused on using "killed" cells, which were taken after stripping the AIDS virus's outer coat and then killing the cells with chemicals, irradiation, and mineral oil, per The New York Times. This differed from previous attempts to develop an AIDS vaccine, which were made using the AIDS virus's outer coat and focused on preventing people from ever contracting the disease. Instead, Dr. Salk's team believed that their killed vaccine could help defeat the virus, not by preventing infection, but by enabling the immune system to destroy the AIDS virus cells already inside the body.


Dr. Jonas Salk announces polio vaccine - HISTORY

Editor’s Note:
Despite the progress in polio and other diseases made possible by vaccines, today we are witnessing a resurgence of vaccine-preventable illnesses as nervous parents skip their children’s shots. Watch the PBS documentary Vaccines—Calling the Shots to find learn more.

BIO is also a leading voice on the patent-ability of biotech inventions and other IP matters. To get the most recent updates on IP in the biotech world, please sign up for BIO’s free bi-monthly IP Newsletter.

A guest writer in a recent article in the Wall Street Journal repeated the oft quoted Jonas Salk statement about his Polio vaccine: “There is no patent. Could you patent the sun?” Many use this statement as the moral impetus for refusing patents on medically important innovations (see Michael Moore’s Capitalism: A Love Story). Unfortunately, Jonas Salk created a myth that day by leaving out several crucial details.

As pointed out by Robert Cook-Deegan at Duke University, “When Jonas Salk asked rhetorically “Would you patent the sun?” during his famous television interview with Edward R. Murrow, he did not mention that the lawyers from the National Foundation for Infantile Paralysis had looked into patenting the Salk Vaccine and concluded that it could not be patented because of prior art – that it would not be considered a patentable invention by standards of the day. Salk implied that the decision was a moral one, but Jane Smith, in her history of the Salk Vaccine, Patenting the Sun, notes that whether or not Salk himself believed what he said to Murrow, the idea of patenting the vaccine had been directly analyzed and the decision was made not to apply for a patent mainly because it would not result in one. We will never know whether the National Foundation on Infantile Paralysis or the University of Pittsburgh would have patented the vaccine if they could, but the simple moral interpretation often applied to this case is simply wrong.”

While the debate on whether patents are the best way to incentivize medical innovation and commercialization continues, that debate should proceed without reliance on this myth regarding the history of the Polio vaccine.


Jonas Salk: Good at Virology, Bad at Economics

Photo courtesy FDA/University of Pittsburgh

Also in Slate: Jonas Salk didn’t patent the polio vaccine, but Google Doodles—like today’s on Salk—are patented.

On April 12, 1955, Edward R. Murrow asked Jonas Salk who owned the patent to the polio vaccine. “Well, the people, I would say,” Salk responded. “There is no patent. Could you patent the sun?”

By the time of his chat with Murrow, which aired on the day the polio vaccine was announced as safe and 90 percent effective, Salk was already more messiah than virologist to the average American. Polio paralyzed between 13,000 and 20,000 children annually in the last pre-vaccine years, and Salk was the face of the inoculation initiative. Appearing on television to present the vaccine as a gift to the American people was a public relations masterstroke.

Over the last half-century, Salk’s rhetorical question to Murrow has become a rallying cry for those who campaign against pharmaceutical company profiteering. To many, it represents a generous view of scientific discovery distilled down to a beautiful simplicity. One critic of the big pharma called Salk “the foster parent of children around the world with no thought of the money he could make by withholding the vaccine from the children of the poor.”

In fact, Salk’s three-sentence response to Murrow is a dangerous intuition pump—a misdirection from complex questions. It represents an easy but wrongheaded way to avoid the messy work of constructing a system to incentivize medical breakthroughs and make them widely available in the context of 21 st -century economic realities. That’s not to say Salk was a propagandist or a panderer—he probably meant every word he said. But his thoughts on the polio vaccine applied to a specific situation at a specific time in our history.

It helps to break Salk’s famous quote into two distinct claims: First, he argued that the polio vaccine belonged to the people. Second, he posed the rhetorical question comparing a vaccine to the sun.

The first claim is nearly indisputable as it applies to the polio vaccine itself, because the public voluntarily funded the vaccine’s incredibly expensive research and field testing.

“People worked on the polio vaccine like it was the Normandy invasion,” says Jane Smith, author of the book Patenting the Sun: Polio and the Salk Vaccine. More than 650,000 children were vaccinated. Their doctors had to submit forms, and public health officials tracked the information. Then it all had to happen again for placebo and control groups.

In the single year that the polio vaccine was unveiled, 80 million people donated money to the National Foundation for Infantile Paralysis, which spearheaded the vaccine effort. Many donors could only afford a few cents, but gave anyway (hence the foundation’s modern name, the March of Dimes). Schools, communities, and companies joined in a remarkable display of unity against the disease. Even Walt Disney’s cartoon characters contributed their talents, appearing in a film that adapted the Snow White and the Seven Dwarfs’ song “Heigh Ho” to an anti-polio ditty. In the 13 years leading up to the vaccine’s roll out, the budget of the National Foundation for Infantile Paralysis swelled from $3 million to $50 million. An entire generation of microbiologists received money from the foundation, which even played a role in Watson and Crick’s description of DNA.

There was near unanimity within the organization that the public had already paid for the polio vaccine through their donations, and patenting it for profit would have represented double charging. That’s what Jonas Salk should have said to Murrow—not that all vaccines belong to the people, but rather that this vaccine belonged to the people.

There is an important footnote regarding Salk’s statement that “there is no patent.” Prior to Murrow’s interview with Salk, lawyers for the National Foundation for Infantile Paralysis did look into the possibility of patenting the vaccine, according to documents that Jane Smith uncovered during her dive into the organization’s archives. The attorneys concluded that the vaccine didn’t meet the novelty requirements for a patent, and the application would fail. This legal analysis is sometimes used to suggest that Salk was being somewhat dishonest—there was no patent only because he and the foundation couldn’t get one. That’s unfair. Before deciding to forgo a patent application, the organization had already committed to give the formulation and production processes for the vaccine to several pharmaceutical companies for free. No one knows why the lawyers considered a patent application, but it seems likely that they would only have used it to prevent companies from making unlicensed, low-quality versions of the vaccine. There is no indication that the foundation intended to profit from a patent on the polio vaccine.

The decision not to patent the vaccine made perfect economic sense under the circumstances. “The National Foundation for Infantile Paralysis was a nonprofit, centralized research and development operation,” says Robert Cook-Deegan, who studies intellectual property and genomics at Duke University. “They didn’t need an incentive structure.”

That brings us to Salk’s grand question: Can you patent the sun? When you unpack this query, which is really a policy argument, you find two assumptions. Most obviously, Salk assumed that a vaccine is a naturally occurring phenomenon rather than a human invention. In addition, and perhaps more importantly, he implies that this distinction should be central in patent law. Both of these points are debatable.

Whether a vaccine should be viewed as a naturally occurring substance, rather than a product of human engineering, may depend on the details of the individual inoculation. In 1796, Edward Jenner immunized an 8-year-old boy against smallpox by injecting him with pus from a milk maid who had been exposed to cowpox, a related disease. (The word vaccine comes from vaccinia, the Latin name for cowpox.) While ingenious, moving pus from one person to another would not entitle Jenner to a patent in modern America. Few modern vaccines are that simple, though. Some still contain live or dead cells from the pathogen itself, but others contain genetically modified versions of the virus or bacteria. Some rely on one or more proteins from the pathogen, or a part of a protein that’s sufficient to trigger an immune response. The flu vaccine, which has to be made anew every year, involves months of work by highly trained scientists working in state-of-the-art laboratories. It’s a stretch to describe modern vaccines as naturally occurring, even if parts of them are.

Although the U.S. government has issued thousands of patents related to vaccines, American jurisprudence is still in a state of confusion on this issue. The Patent Act of 1952, which established the current structure of patent law, did not recognize a difference between inventions and discoveries. When that distinction came from the Supreme Court in 1980, the court made clear that “products of nature”—like the sun, as Salk might say—are not patentable. Isolating and purifying a product, however, may render it patentable under the right conditions.

Should the Supreme Court ever get around to clarifying the patentability of vaccines, it may consider revisiting the distinction between discovery and invention, because it misses the point of intellectual property law: to incentivize research that will benefit humanity. Even if a vaccine is a product of nature, discovering that product and making it useful is absolutely nothing like discovering the sun and putting it to work. (Most living creatures have managed that trick on a daily basis for billions of years.) Since Jenner, few microbiologists have stumbled upon effective vaccines. Without the promise of exclusive marketing rights for some period, no profit-minded private entity would undertake the necessary research.

The landscape has shifted since Salk’s heyday. The U.S. government is now the primary applicant for vaccine-related patents, followed by GlaxoSmithKline and a number of other corporations. Private groups, like the Pasteur Institute, are also active. Responsibility for vaccine development is more evenly distributed now than in the 1950s, and that’s a good thing.

“There is no one solution,” says Cook-Deegan. “There will be a complicated set of solutions, including government, nonprofits, and private sector incentives. That’s the structure of innovation.”

At the end of his life, Salk helped found a corporation to develop an HIV vaccine. Although the vaccine eventually failed, Salk’s company moved to patent it in its early days of promise. The man who asked rhetorically when you could patent the sun eventually saw the light of financial incentives. There’s nothing wrong with that.


Darrell Salk relates a tale of two viruses

Polio and COVID-19 both fanned fear and uncertainty, but generated different public sentiment on control efforts.

When pediatric geneticist Dr. Darrell Salk arrived for his COVID-19 vaccine at UW Medical Center-Montlake, the setting reminded him of similar immunization lines from childhood.

He recalled scenes of grade-school students in the early 1950s ready for their first polio shot. 1952 had witnessed one of the worse outbreaks of polio in the nation’s history.

A candidate vaccine had just been developed by his father, Dr. Jonas Salk, and was entering clinical testing. A major national field trial was organized to evaluate its safety and efficacy.

Parents bravely consented to enroll their children in a double-blind trial, with no certainty of any benefit. Families longed for a way to save their children from paralysis, iron lungs, metal leg braces, or weakened limbs as a result of polio.

More than 1.8 million first- and second-graders took part in the vaccine trial. Earlier, Darrell Salk had received one of the first vaccine doses at home at the kitchen table. His father had been studying different polioviruses since 1948, and was determined to put a stop to infantile paralysis.


As a young boy, Darrell Salk received a polio vaccination from his father, Jonas Salk. Salk Family photo

After Jonas Salk reached a point in his research where he believed the vaccine he had developed could safely prevent infection, he vaccinated himself and his laboratory colleagues, who heroically had accepted the risks of working with the virus. His family was next. Darrell Salk, age 6 at the time, said his mother went first. Seeing that she was fine with it made it seem OK to him.

In adulthood, Darrell Salk, like many of his relatives, chose a career in medicine. He did his residency training at the UW School of Medicine in the mid-1970s. He is now retired from the UW medical school’s pediatrics faculty.

He has written on the history of polio and its prevention. Paralysis, he explained, was rare before modern sanitation was developed. Babies were exposed to the virus while still protected by maternal antibodies. Improvements in sanitation meant that babies did not come in contact with the virus until older, when not protected against paralysis.

When summer outbreaks started surfacing, public health departments tried to keep children safe by closing swimming pools, movie theaters and beaches. Playing with the neighborhood kids was also discouraged.

The America public, Salk said, rallied to end the threat of polio. Families pressed coins into “Join the March of Dimes” collection cards. Mothers canvassed door-to-door to raise donations.

By 1955, the killed-virus vaccine was announced as a success.

Salk said, “Church bells rang, parades were held, and people danced in the streets. People welcomed the vaccine with relief. It was rapidly accepted. Of course, there were doubters, but many of them changed their minds. ”

It’s hard not to draw comparisons between how the country reacted to polio epidemics of the past century and the present coronavirus pandemic.

“The public response was unified against polio,” Salk said. “Almost everyone wanted to participate in the effort.” While some other countries have created a uniform approach to the coronavirus, the United States response has varied, he said.

There also was a difference in Presidential leadership style.

“Pres. Franklin D. Roosevelt understood polio first hand,” Salk noted. “He had suffered, and did not minimize what was happening. He took action. In addition to leading government efforts, he converted his own personal property [Warm Springs] into a place where patients could have rehabilitation.”

In contrast, the early months of the coronavirus pandemic were met with the White House “ignoring, blaming, and hoping it would go away,” Salk said.


In the 1950's, a colleague vaccinates Dr. Jonas Salk with the Salk polio vaccine. Salk family photo

Speaking to the concern that warning the public early on how dangerous and easily spread this coronavirus was would have caused widespread panic, Salk said, “There is no panic if officials are open and honest. People would respond appropriately.”

When the polio vaccine became available, the National Foundation for Infantile Paralysis distributed it through a coordinated, centralized national

system that attempted to be fair. But, as is the case today with coronavirus vaccines, Salk said, back then, inner city Black populations were also less well vaccinated.

Coronavirus vaccine inequities are made worse by a disjointed manufacturing and distribution system. Each state is approaching getting the vaccine to people differently, Salk said, States are competing with each other to obtain supplies.

Lessons from polio epidemics are still used today. Polio surveillance was the start of Centers for Disease Control and Prevention programs. Vaccine testing and approval was the model for Food and Drug Administration practices. Research and manufacturing methods used now were created during the polio vaccine development.

Non-infectious killed-virus vaccines were then thought to be ineffective. Since killed polio vaccine was proven successful, we take killed virus vaccines, which cannot cause disease, for granted, Salk said.

Dr. Darrell Salk had preferred never to become a public figure. When he realized that a portion of the public was hesitant to have a coronavirus vaccine, he came forward.

“Getting vaccinated against coronavirus is the right thing to do. Get it for your own sake, to protect your loved ones, and to contribute to ending the pandemic.

“If you have concerns about quality control of the vaccines because they were created so quickly that scientists must have skipped steps and cut corners, that’s not true. They were developed fast because of the amount of resources applied and the large numbers of scientists working on different aspects all at once. The time between steps was reduced and the review of data was done immediately.


A poster from the 1950's pomotiing public support of efforts against polio. National Library of Medicine.

“If you are worried about a severe or unknown possible reaction, have your vaccine in a medical setting, where an allergic response can be readily treated. After a vaccine, people are asked to wait for at least 15 minutes before leaving. If an allergic reaction is going to occur, it usually happens in that time frame.

“Most people have a minimal reaction to the vaccine. Typically it is a sore arm or a minor fever. That means the vaccine is working as it should to activate your immune system. The biggest risk of a COVID-19 infection is death. Compare that outcome with the outcome of a treatable allergic reaction to the vaccine.”

Salk believes it is unwise to play the odds with the pandemic coronavirus: “I wouldn’t bet my life or the life of someone I love by not getting vaccinated. That’s not a good bet.”


The tainted polio vaccine that sickened and fatally paralyzed children in 1955

On Aug. 30, 1954, Bernice E. Eddy, a veteran scientist at the National Institutes of Health in Bethesda, Md., was checking a batch of a new polio vaccine for safety.

Created by Jonas Salk, the vaccine was hailed as the miracle drug that would conquer the dreaded illness that killed and paralyzed children. Eddy’s job was to examine samples submitted by the companies planning to make it.

As she checked a sample from Cutter Laboratories in Berkeley, Calif., she noticed that the vaccine designed to protect against the disease had instead given polio to a test monkey. Rather than containing killed virus to create immunity, the sample from Cutter contained live, infectious virus.

Something was wrong. “There’s going to be a disaster,” she told a friend.

As scientists and politicians desperately search for medicines to slow the deadly coronavirus, and as President Trump touts a malaria drug as a remedy, a look back to the 1955 polio vaccine tragedy shows how hazardous such a search can be, especially under intense public pressure.

Despite Eddy’s warnings, an estimated 120,000 children that year were injected with the Cutter vaccine, according to Paul A. Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia.

Roughly 40,000 got “abortive” polio, with fever, sore throat, headache, vomiting and muscle pain. Fifty-one were paralyzed, and five died, Offit wrote in his 2005 book, “The Cutter Incident: How America’s First Polio Vaccine Led to the Growing Vaccine Crisis.”

It was “one of the worst biological disasters in American history: a man-made polio epidemic,” Offit wrote.

In those days, polio, or infantile paralysis, was a terror.

“A national poll … found that polio was second only to the atomic bomb as the thing that Americans feared most,” Offit wrote.

“People weren’t sure how you got it,” he said in an interview last week. “Therefore, they were scared of everything. They didn’t want to buy a piece of fruit at the grocery store. It’s the same now. … Everybody’s walking around with gloves on, with masks on, scared to shake anybody’s hand.”

“I remember my mother … wouldn’t let us go to a public swimming pool,” said Offit, 69. We “all had to go into one of those little plastic pools in the back so that we wouldn’t be in a public place.”

The worst polio outbreak in U.S. history struck in 1952, the year after Offit was born. It infected 57,000 people, paralyzed 21,000 and killed 3,145. The next year there were 35,000 infections, and 38,000 the year after that.

Many survivors had to wear painful metal braces on their paralyzed legs or had to be placed in so-called iron lungs, which helped them breathe. There was no vaccine and few treatments. (One bogus approach was to spray acid into the noses of children to block the virus. All it did was ruin the sense of smell.)

Often polio victims were children, but the most famous affected American was President Franklin D. Roosevelt, who got polio and was paralyzed from the waist down in 1921 when he was 39.

In 1951, Jonas Salk of the University of Pittsburgh’s medical school received a grant from the National Foundation for Infantile Paralysis to find a vaccine. During intense months of research, he took live polio virus and killed it with formaldehyde until it was not infectious but still provided virus-fighting antibodies.

When tests showed that the vaccine was safe, Salk told his wife, “I’ve got it,” Offit wrote.

Word of his success soon leaked out. Public pressure grew for the vaccine and for a large-scale trial.

In 1953, Salk tested it on himself, his wife and three children.

On April 26, 1954, Randy Kerr, a 6-year-old second-grader from Falls Church, Va., stood in the cafeteria of the Franklin Sherman Elementary School in McLean and became the first to be vaccinated in a massive field study.

Salk’s vaccine was given to 420,000 children. A placebo was given to 200,000. And 1.2 million were given nothing.

The study found that children who did not get the vaccine were three times more likely to be paralyzed with polio than those who received the vaccine.

A year later, on April 12, 1955, when officials announced the results at a news conference at the University of Michigan, there was jubilation. Reporters hollered: “It works! It works!” Offit wrote.

The news made front-page headlines across the country. “People wept,” Offit said. “There were parades in Jonas Salk’s honor. … That’s what contributed to the tragedy of Cutter more than anything else … the irony.”

That same day, licenses were hurriedly granted to several drug companies, including Cutter Laboratories, to make the vaccine.

But the officials granting the licenses were never told of Eddy’s findings, Offit wrote.

The year before, Eddy’s scrutiny of the Cutter vaccine had continued through the summer and fall.

It must have been a difficult time. She was 52. Her husband, Jerald Guy Wooley, 64, a fellow National Institutes of Health scientist, had died suddenly the previous April, leaving her with three daughters, two of them still at home in Bethesda, according to his obituary. Her mother moved in to help out.


The University of Michigan Information and News Service
3564 Administration Building, Normandy 3-1511, ext. 2623
April 12, 1955

POLIO VACCINE EVALUATION RESULTS -- FOR RELEASE AT 10:20 E.S.T.

ANN ARBOR: The vaccine works. It is safe, effective, and potent.

Dr. Thomas Francis, Jr., UM Director of the Poliomyelitis Vaccine Evaluation Center, told an anxious world of parents that the Salk vaccine has been proved to be up to 80-90 percent effective in preventing paralytic polio.

At a meeting of over 500 scientists and physicians and before the penetrating eyes of cameras and powerful spotlights, Dr. Francis spoke on the effectiveness of the Salk vaccine. The meeting was held at the Rackham Auditorium in Ann Arbor under the joint sponsorship of the National Foundation for Infantile Paralysis and the University of Michigan.

Dr. Francis declared the vaccine had produced "an extremely successful effect" among bulbar-patients in the areas where vaccine and an inert substance had been tried interchangeably.

Financed by nearly one million dollars worth of dimes which have been donated to the National Foundation, the Francis Report may slow down what has become a double-time march of disease to a snail's pace.

In strong statistical language the historic trial of a vaccine and its subsequent analysis was revealed. Over 113 pages in length, the Report at long last called a halt to speculations and finally re-enforced laboratory findings with concrete field evidence. There can be no doubt now that children can be inoculated successfully against polio.

There can be no doubt that humanity can pull itself up from its own bootstraps and protect its children from the insidious invasion of ultramicroscopic disease.

For one thing what was feared turned out to be unfounded -- the vaccine proved incredibly safe. Reactions were nearly negligible. Only 0.4 percent of the vaccinated children suffered minor reactions. An even smaller percent (0.004-0.006) suffered so-called "major reactions."

And the persistence of protection appears reasonably good. When good antibody responses were obtained from vaccination, the report said "the effect was maintained with but moderate decline after five months."

Distribution of antibody levels among vaccinated persons was much higher than that in the control population from the same areas.

Out of a total population of 1,829,916 children a total of 1013 cases of polio developed during the study period and were reported to the Center.

In placebo control areas, where vaccine was interchanged with an inert substance, 428 out of 749,236 children contracted the disease.

In the observed control areas where only second graders were inoculated, 585 cases out of 1,080,680 children developed.

Percentages in the placebo areas were: 67.5 paralytic, 17.6 non-paralytic, 7.2 doubtful, and 7.6 not polio. Specifically, 33 inoculated children receaving the complete vaccination series became paralyzed in the placebo areas. This is opposed to 115 uninoculated children. Similarly, in the observed areas there were 38 such children who became paralyzed, as opposed to 330 uninoculated children.

There were four deaths among children who received placebo none among the vaccinated. In observed areas there were 11 fatalities none among children receiving the vaccine.

Only one child who had been inoculated with the vaccine died of polio, and this death followed a tonsillectomy two days after the second injection of the vaccine in an area where polio was already prevalent.

The Report also stated that in no area did Type II virus prevail. There was, however, prevalence in certain areas of Types I and III.

Marked sociological differences were noted by the U-M's Survey Research Center among the participating and non-participating children in the study. For example, there was a higher proportion of children participating who had been vaccinated against small-pox, diphtheria, and whooping cough than among the non-participants. Significant auxiliary findings were:

  1. The vaccine's effectiveness was more clearly seen when measured against the more severe cases of the disease
  2. Although data were limited, findings in Canada and Finland support the Report in showing a significant effect of the vaccine among cases from whom virus was isolated
  3. Vaccination protected against family exposure. Only 1 out of 233 inoculated children developed the disease, while 8 out of 244 children receiving placebo contracted the disease from family contact.
  4. In picking the field trial areas, the National Foundation scored a major victory. Although in placebo areas cases were 27 per cent under the 1949-53 average, and 12 per cent less in the observed control areas, it was found that there had been a 26 per cent increase per 100,000 in trial areas as a non-trial areas. This meant that trial areas were appropriately selected for the best testing conditions for the vaccine.

The field trials and the evaluation were made possible by grants totalling $7,500,000 in March of Dimes Funds from the National Foundation for Infantile Paralysis.


Watch the video: JONAS SALK DISCOVERS POLIO VACCINE - 1955


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