In 1955, after a field trial with 1.8 million Americans, the world's first successful polio vaccine was declared "safe, effective, and effective".
It was arguably the most significant biomedical advance of the past century. Despite the polio vaccine's long-term success, manufacturers, government leaders, and nonprofits that funded the vaccine's development made several missteps.
After making a documentary on the field trials of the polio vaccine, we believe the lessons learned in this chapter of the medical history are worth considering as the race to develop COVID-19 vaccines progresses.
Sabin and Salk
There are many competing efforts today to develop a coronavirus vaccine, each employing different methods of generating the production of universally needed antibodies. There were also various approaches to making a polio vaccine in the 1950s.
The prevailing medical orthodoxy under the direction of Dr. Albert Sabin suggested that only a live virus vaccine, which uses a weakened form of the poliovirus to stimulate antibodies, could work. This theory comes from the work of doctor Edward Jenner, who found in the 18th century that milkmaids who were exposed to the cowpox virus-laden pus from cattle infected with cowpox did not catch smallpox. Smallpox was the deadly pandemic of the time, and this discovery led to a vaccine that worked to eradicate the disease.
Jonas Salk, a physician and scientist at the University of Pittsburgh, on the other hand, believed that a killed virus that would lose its infectious properties completely could still induce the body to make protective antibodies against the polio virus.
A nonprofit organization, the National Infantile Paralysis Foundation, funded and directed the search for polio vaccines. The company was founded by Basil O & # 39; Connor, former legal partner of President Franklin D. Roosevelt, and raised funds for polio research and treatment. As part of this fundraising campaign, the Americans were asked to send groschen to the White House in the so-called March of Dimes.
O'Connor played more on Salk than on Sabin.
By 1953, Salk and his team had shown that their experimental vaccine worked – first in monkeys in their lab, then in children who already had polio in the D.T. Watson's home for crippled children, and then with a small group of healthy children in Pittsburgh. One of the largest field trials in medical history soon followed.
It started on April 23, 1954. Around 650,000 children received the Salk polio vaccine or a placebo, and 1.2 million other children received no injection but were monitored as an untreated control group.
Salk's mentor, University of Michigan virologist Thomas Francis, independently monitored the study. After months of careful data analysis, Francis unveiled the results on April 12, 1955 – exactly 10 years after the FDR's death and nearly a year after the trial began.
A manufacturing defect
When asked who owns the patent for his vaccine, Jonas Salk replied that it belongs to the people and that patenting would be like “patenting the sun”.
President Dwight D. Eisenhower expressed his conviction that every child should receive the polio vaccine without saying how it would be done. Eisenhower commissioned the Minister of Health, Education and Social Affairs, Ovetta Culp Hobby, to work out the details in consultation with General Surgeon Leonard Scheele.
The Congress Democrats advocated a plan that would make the polio vaccine free for everyone, rejecting the hobby as a “back door to socialized medicine”.
Hobby also insisted that private companies take care of the manufacture of Salk's vaccine and license six of them for it. However, she admitted that the government lacked a plan to meet the huge vaccination needs.
A black market developed. Hollowing out the price increased the cost of a dose of the vaccine, which was supposed to be $ 2, to $ 20. As a result, the wealthy were given special access to a vaccine funded by the public.
The hands-off approach changed when reports surfaced that children who received Salk's vaccine were in the hospital with symptoms of poliosis. Scheele, the general surgeon, initially reacted with skepticism. He suggested that these children may have been infected before vaccination.
However, as soon as six vaccinated children died, vaccinations were stopped until further information about their safety could be gathered. A total of 10 children who were vaccinated early died after being infected with polio, and about 200 suffered some paralysis.
The government soon found that the cases where children got sick or died could be traced back to one of six companies: Cutter Labs. Salk's detailed protocol for making the vaccine had not been followed because the virus could not be killed. As a result, children were mistakenly injected with the live virus.
Vaccination resumed in mid-June with stricter government controls and a more nervous public. In July Hobby resigned for personal reasons.
Eisenhower then signed the 1955 Polio Vaccination Support Act, which included $ 30 million in payment for vaccines – enough to fund wider public distribution. Within a year, 30 million American children had been vaccinated and the number of polio cases had fallen by almost half.
Notice a lesson learned
By 1962, there were fewer than 1,000 cases of polio in the United States. In 1979 the US was declared polio-free.
Years after developing the vaccine, Jonas Salk said he sometimes met people who didn't even know what polio was – which he found extremely enjoyable. However, the events of last year, with all the ups and downs of coronavirus vaccine research, have shown that the story of polio's defeat should be remembered.
Nine companies who recently developed a coronavirus vaccine have come together on a joint promise that they will not get anything to market until it meets well-defined standards for safety and effectiveness.
However, should a modern cutter incident with a coronavirus vaccine happen again, the already shaky public trust in vaccines could easily collapse further and hamper efforts to quickly immunize as many people as possible against COVID-19.
Ending this pandemic will require more than government approval of one or more working coronavirus vaccines. Coordinating a comprehensive vaccination campaign also requires navigating logistics, business and politics amid an equitable approach to the distribution of these new vaccines and the willingness of the public to be vaccinated.
This final foray also requires the often uncomfortable partnership between government, the private sector, and – as is now the case with massive contributions from the Bill & Melinda Gates Foundation and other nonprofit sources – philanthropy.
Carl Kurlander is a lecturer at the University of Pittsburgh. Randy P. Juhl is a distinguished Emeritus Service Professor of Pharmacy at the University of Pittsburgh.
This article was published with permission from The Conversation.