As the United States struggles to distribute and administer COVID-19 vaccines, we’re looking back at the history of vaccine rollouts in our country, including the logistical roadblocks to shots and communicating with a fearful public. The COVID vaccines have been widely shown to be safe and effective, unlike some historical examples that had significant associated risks. But what can stories of failures from the past teach us about how to fairly administer them?
On Tuesday, Feb. 16, at 1 p.m. Eastern, join Future Tense for a conversation with Atul Gawande and Helene Gayle, co-chair of the National Academies framework for vaccine distribution, about the COVID-19 vaccine rollout.
Baby boomers remember both the fear of poliomyelitis—the viral infection that attacks the nervous system, leaving some who contract it paralyzed, or dead—and the relief that they felt when the rollout of Jonas Salk’s vaccine put an end to repeated midcentury summer outbreaks of the disease. In 1954, the summer before this rollout, 1.8 million kids participated in a widely publicized trial of the new vaccine. From the vantage point of 2020, when vaccine skepticism floats right below the surface of public debate, the widespread embrace of the new vaccine feels surprising. Was the March of Dimes–financed rollout of Salk’s miracle jab, conducted in a hurry as polio threatened to strike again in the summer of 1955, really as smooth as history makes it seem?
I sent Charlotte DeCroes Jacobs, a historian and medical doctor whose books include the biography Jonas Salk: A Life, some questions about the surprising level of public acceptance of the new vaccine, which persisted even after a series of children were paralyzed by a “bad batch” the summer of the rollout. Jacobs—also a “Polio Pioneer” who participated, as a child, in the huge 1954 trial—replied over email. Our conversation has been edited and condensed for clarity.
Rebecca Onion: Before Salk’s vaccine, there had been failed attempts to vaccinate for polio, including in the 1930s. Can you tell us about them? How did they affect public perception of Salk’s vaccine in 1954–55, if at all?
Charlotte DeCroes Jacobs: In 1934, a polio outbreak had just devastated Los Angeles; the public was becoming frantic. The press announced that two scientists were on the verge of preventing polio. Maurice Brodie of New York University prepared a polio vaccine using inactivated virus from the spinal cord of infected monkeys. After inoculating himself and a handful of children, he reported the vaccine to be safe. At the same time, Philadelphia researcher John Kolmer made a vaccine using a live virus weakened by chemicals. Having inoculated 42 monkeys, his two children, and himself, he publicized his success two days after Brodie’s announcement. In a race to see whose vaccine would be first to rid the world of polio, they vaccinated around 10,000 children each, in two different trials. When a number of children became paralyzed, Brodie and Kolmer were chastised by the scientific community for rushing into human experimentation without proper animal work and safety tests. Brodie’s career plummeted; a few years later, he died suddenly from a suspected suicide.
At the time many questions remained about the poliovirus: How was it transmitted? How many strains existed? Following the 1934 tragedy, investigators became leery, constraining further vaccine work. Years passed with almost no progress. The public had long forgotten about Brodie and Kolmer. Near panic erupted year after year when the “summer plague” afflicted children. And then polio dealt a blow to its most famed victim, Franklin D. Roosevelt.
Basil O’Connor, Roosevelt’s law partner, helped found the National Foundation for Infantile Paralysis, a voluntary health organization devoted to fighting polio. O’Connor organized the March of Dimes, collecting millions of dollars from the public to help defray polio victims’ medical costs and to initiate a research program, under the direction of Harry Weaver [a neuroscientist who was director of research at the foundation]. Weaver recruited elite scientists, including esteemed virologist Albert Sabin, to solve the polio problem. They advanced slowly until an eager, young physician-scientist named Jonas Salk joined them.
How much did the public know, or understand, about the science of Salk’s vaccine, before the large-scale trial in 1954? There were heated debates between scientists over the idea of using a “killed” virus, as Salk’s did, versus a “live” one—and, then, whether it would be safe to use the virulent strain named “Mahoney” in the vaccine, as Salk’s did. Were those debates public knowledge—or were these behind-the-scenes conversations?
When Salk joined the group of senior scientists supported by the March of Dimes, he had a major point of divergence. They believed that only a vaccine containing live, weakened virus could impart effective lifelong immunity by inducing a low-grade infection, as was the case with smallpox and yellow fever. Salk believed he could make a vaccine with an inactivated or killed virus which could impart immunity while being completely safe. Most researchers, led by Sabin, maintained that protection from a killed virus vaccine would last only a few months.
Salk didn’t want to stand in line behind this cadre of senior scientists, waiting to help make a live-virus vaccine on their timeline. He and his relatively small Pittsburgh laboratory group—not some large pharmaceutical company—made a killed poliovirus vaccine in just over three months, in 1952. Later that year, he conducted trials at the Watson Home for Crippled Children, giving every shot himself. The parents and staff were sworn to secrecy as he knew the press would hover, and senior scientists would try to block him. After he measured anti-polio antibodies in the first vaccinated child, he knew he could prevent poliomyelitis.
When Salk disclosed his work to the scientific advisory group for the March of Dimes, they took sides: those in favor of an immediate nationwide trial and those who were adamantly opposed, waiting for a live virus vaccine. The former prevailed. Such a trial would constitute one of the largest clinical trials ever conducted, and it would involve experimentation with children.
A Pittsburgh Press reporter leaked the story. The public didn’t know about the scientific arguments over live versus killed virus vaccine, or whether the one of the strains used in the vaccine may be too virulent. They were anxiously anticipating a vaccine, and Jonas Salk rapidly became a hero in waiting. Starting in the spring, hundreds of thousands of children would be getting shots—half with a polio vaccine, half with salt solution.
Although most objections stayed within the scientific community, they occasionally made headlines: “Polio vaccine researchers got into a hassle last week,” Time reported. “Several States Balk at Tests of Polio Vaccine,” read a headline in the Chicago Daily News. The World Health Organization issued a statement that read, “Mass immunization should not be generally adopted until such times as scientific data are available on the innocuity and efficacy of the vaccine.”
At the same time, Salk began to receive disturbing mail. Among the most vitriolic came from D.H. Miller, self-proclaimed president of Polio Prevention Inc., who circulated anti–polio vaccine articles nationwide. One, titled “Little White Coffins,” began, “Only God above will know how many thousands of little white coffins will be used to bury the victims of Salk’s heinous, fraudulent vaccine.”
But most of the public believed in Jonas Salk. He had come to personify the fight against polio. Pictures of this humble physician with an engaging smile appeared on the front pages of newspapers, on the cover of magazines. Few scientists had reached out to the public as did Salk. He answered their questions, calmed their concerns.
In April 1954, Walter Winchell, radio commentator and gossip columnist, broadcast a report on ABC raising alarm over Salk’s vaccine. What happened?
Before the clinical trial, all vaccine had been made in Salk’s laboratory. Once production left his hands [since there was no way his lab could make enough doses for the trial], there was always the possibility for error. He found vaccine made by one pharmaceutical company tainted with live virus. Someone leaked the story, and three weeks before the trial was to begin, Winchell shocked the public when he announced: “In a few moments I will report on a new polio vaccine. It may be a killer!” The public reaction ranged from fear to outrage. “The public is entitled to accuracy in journalistic reporting,” a Pittsburgh judge wrote to ABC, “not statements made in reckless disregard of their accuracy.” Even Albert Sabin [usually a Salk opponent] called Winchell’s broadcast “irresponsible.” Still the harm had been done: Frightened parents withdrew an estimated 150,000 children from the trial, and the state of Minnesota declined to participate.
Nevertheless, at 9:35 a.m. on April 26, 1954, the biggest clinical trial in the history of American medicine commenced when 6-year-old Randy Kerr of McLean, Virginia, was vaccinated against poliomyelitis.
What do you recall about being part of the “Polio Pioneers” trials? How did your parents talk to you about it, before it happened? Do you remember your parents being at all worried about it?
When I was a child, the carefree atmosphere of summer was dampened by the threat of polio. I cringed at the newsreel at the local movie house showing clips of children struggling with crutches and rooms full of iron lungs. When the ushers passed around the March of Dimes collection boxes, I dropped in my dime. Then in 1954, my hometown of Kingsport, Tennessee, was selected as a test site for the trial of Salk’s polio vaccine. I was sent home from school with a note to my parents from [the March of Dimes], which read, “This is one of the most important projects in medical history. Its success depends on the cooperation of parents. We feel sure you will want your child to take part.” My parents had no qualms. They trusted the government, and they trusted Jonas Salk.
On April 28, 1954, Miss Thompson, my second grade teacher, told us how lucky we were: We were Polio Pioneers. We had been chosen to get the first polio shots. Then she lined us up and marched us into the gymnasium at Andrew Johnson Elementary School. I could smell the alcohol the minute I entered the gym. Since my last name began with D, I was near the front of the line. I knew I had to be brave, even though I wasn’t, because if I started to cry, I would scare everyone behind me. So I rolled up my sleeve and gritted my teeth as the nurse stuck a needle in my arm. As compensation I received a Polio Pioneer button, a red lollipop, and the hope that I would be spared.
What a historic trial that was—monumental in size, conducted solely in children, financed and conducted by volunteers through the March of Dimes. In selected elementary schools across the country, over a million first, second, and third graders were assigned by random draw to receive vaccine or placebo. The March of Dimes carried out the trial not with some professional research organization but with an army of volunteers: 20,000 physicians and public health officials, 40,000 nurses, 14,000 school principals, 50,000 teachers, and 220,000 housewives.
On April 12, 1955, the results of the trial were announced. The vaccine had been 80 to 90 percent effective against paralytic polio and harmed not one child. Jonas Salk became an international hero overnight.
After the vaccine was licensed in the spring of 1955, what was the government’s approach to prioritizing who would get the shots, and when? And what major logistical issues did companies face in producing the vaccine?
Within hours after the announcement, the director of the Laboratory of Biologics Control said the vaccine warranted careful consideration for licensure under the Biologics Control Act. That same afternoon Secretary of Health, Education, and Welfare Oveta Culp Hobby announced amid great fanfare that the vaccine had been licensed.
The March of Dimes was ready. Six months before he knew the trial’s outcome, O’Connor had ordered 27 million doses of vaccine from Parke, Davis, and Eli Lilly, which had supplied vaccine for the trial, and four other firms. All agreed to follow Salk’s detailed manufacturing guidelines. Vaccine would first be offered free to the 1.4 million children who had participated in the study but not received vaccine, followed by 4.8 million children who would enter the first grade (the most susceptible group) and pregnant women.
Thousands of pounds of polio vaccine were rushed across the country within hours of its being licensed. The nationwide vaccination plans did not proceed smoothly, however. The U.S. government had relied on the March of Dimes to perform the vaccine trial, after which O’Connor passed oversight of production and distribution to the Department of Health, Education, and Welfare. The government faltered in that transition.
With an overwhelming demand for vaccine, the American system of free enterprise gave rise to chaos. Before children to whom vaccine had been allocated were given a shot, half a million doses were shipped to private physicians. Employees in some pharmaceutical firms were vaccinated. Price gouging became rampant so that families with means received shots first. The six manufacturers could not produce vaccine fast enough for the waiting public, creating mass exasperation. The polio season had just started, heightening the distress. President Eisenhower took charge and ordered that an equitable distribution plan be created.
What about what’s been called the “Cutter incident”—the paralysis of children injected with vaccine from Cutter Laboratories? What is your best explanation of why these events unfolded? And what effects did the Cutter incident have on the production process for Salk’s vaccine, going forward?
Two weeks into the national immunization program, the surgeon general received reports that seven children had become paralyzed following inoculation, most with vaccine from Cutter Laboratories in Berkeley, California. He suspended all vaccinations. Although government regulators reported no problems with Cutter’s production, Salk did his own investigation and found Cutter had deviated from his procedures, which left behind live virus in some lots of vaccine.
In the March of Dimes trial, no one had contracted polio from the vaccine. But commercial vaccine production differed from that used in the field trial in several major ways. [In the trial], triple-testing for live virus was performed by the company, the Biologics Control Laboratory, and Jonas Salk’s laboratory. [In commercial vaccine production, that] had been reduced to one test, done by the company itself. The government laboratory had neither the funds nor staff to test all manufactured vaccine before its release. Secondly, the six pharmaceutical companies varied somewhat in their interpretation of the manufacturing requirements. And thirdly, the Public Health Service rules had been relaxed such that the companies did not have to divulge how many batches they had thrown away because of live virus contamination.
Two hundred sixty people contracted polio directly or indirectly from Cutter’s vaccine; 11 died. Salk felt devastated. Then came the finger-pointing: The government, the companies, the March of Dimes, and Salk himself were among those blamed for the tragedy. Stricter manufacturing guidelines were imposed, and the vaccination program resumed.
Parents obviously continued to vaccinate their children with Salk’s vaccine, so in some way, the government, scientists, and pharmaceutical companies must have regained their trust. How?
By the fall of 1955, six states reported a 75 percent reduction in incidence of polio in those inoculated. Not a single case of paralytic polio occurred in New York among vaccinated children. Denmark reported inoculation of 430,000 children; none developed polio. Nine hundred thousand Canadian children got vaccinations [leading to] a dramatic reduction in polio cases. On Aug. 12, 1955, the Polio Vaccination Assistance Act allotted grants to states to buy vaccine for the needy. By 1961, the total number of polio cases nationwide had declined by 97 percent below the pre-vaccine years. Six years following the introduction of the Salk vaccine, polio was almost eradicated as a major public health problem in the United States.
Even so, most senior virologists still maintained that only a live-virus vaccine could provide lifelong immunity. Albert Sabin prepared such a vaccine that could be delivered in a sugar cube, and tested it in Russia, demonstrating efficacy and safety. In 1961, the U.S. Public Health Service replaced Salk’s vaccine with Sabin’s oral vaccine, citing cost and convenience. Salk warned that live virus, although weakened, could revert to a virulent form and cause polio. In his efforts to have Sabin’s vaccine delicensed, he was overruled by the major medical decision-makers, and by 1968, U.S. pharmaceutical companies had stopped manufacturing the Salk vaccine.
Although with time most cases of paralyzing polio in the U.S. could be traced to Sabin’s vaccine, the numbers were few, and Sabin denied the charge. Salk tried desperately to reverse what he called a risky, politically driven decision. He petitioned the major medical associations, testified before two congressional committees, appealed to presidents. In 1999, the U.S. government recalled the Sabin vaccine, replacing it with a newer version of Salk’s vaccine. By then Jonas Salk was dead.
In a sense both vaccines played a role in eradicating polio. The United States has been polio-free since 1979. Salk’s inactivated poliovirus vaccine is the only vaccine available in the U.S. today and is used in most developed countries. Due to cost and ease of administration, live virus vaccines are still used in some developing countries.