Lessons from how the polio vaccine went from the lab to the public that Americans can learn from today - PhillyVoice.com

Posted: 17 Sep 2020 07:44 PM PDT

In 1955, after a field trial involving 1.8 million Americans, the world's first successful polio vaccine was declared "safe, effective, and potent."

It was arguably the most significant biomedical advance of the past century. Despite the polio vaccine's long-term success, manufacturers, government leaders and the nonprofit that funded the vaccine's development made several missteps.

Having produced a documentary about the polio vaccine's field trials, we believe the lessons learned during that chapter in medical history are worth considering as the race to develop COVID-19 vaccines proceeds.

Sabin and Salk

Today, many competing efforts are underway to create a coronavirus vaccine, each employing different methods to generate the production of universally needed antibodies. Likewise, in the 1950s there were different approaches to making a polio vaccine.

The prevailing medical orthodoxy, led by Dr. Albert Sabin, held that only a live-virus vaccine, which involved using a weakened form of the polio virus to stimulate antibodies, could work. That theory stemmed from work by the physician Edward Jenner, who in the 1700s determined that milkmaids exposed to the cowpox virus-laden pus of cowpox-infected cattle did not catch smallpox. Smallpox was the deadly pandemic of the era, and this discovery led to a vaccine that brought about the disease's eradication.

Jonas Salk, a doctor and scientist based at the University of Pittsburgh, on the other hand, believed a killed virus, which would completely lose its infectious qualities, could still trick the body into creating protective antibodies against the polio virus.

A nonprofit organization, the National Infantile Paralysis Foundation, funded and thus directed the polio vaccine quest. Established by President Franklin D. Roosevelt's former law partner, Basil O' Connor, it raised money for polio research and treatment. As part of this fundraising effort, Americans were called upon to send dimes to the White House in what became known as the March of Dimes.

O'Connor gambled on Salk rather than Sabin.

Clinical trials

By 1953, Salk and his team had shown their experimental vaccine worked – first on monkeys in their lab, then on children who already had polio at the D.T. Watson Home for Crippled Children, and then on a small group of healthy children in Pittsburgh. One of the largest field trials in medical history soon followed.

It began on April 23, 1954. Some 650,000 children got the Salk polio vaccine or a placebo, and 1.2 million other kids 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 meticulously analyzing data, Francis revealed the results on April 12, 1955 – exactly 10 years after FDR's death and nearly a year after the trial began.

A manufacturing error

When asked who owned the patent to his vaccine, Jonas Salk famously replied that it belonged to the people and that patenting it would be like "patenting the sun."

President Dwight D. Eisenhower expressed his belief that every child should receive the polio vaccine, without indicating how that would happen. Eisenhower charged Health, Education and Welfare Secretary Ovetta Culp Hobby to work out the details in coordination with Surgeon General Leonard Scheele.

Congressional Democrats advocated for a plan that would make the polio vaccine free to everyone, which Hobby rejected as a "back door to socialized medicine."

Hobby also insisted that private companies should take care of producing Salk's vaccine, licensing six of them to do so. However, she acknowledged that the government lacked a plan to meet the vast vaccination demand.

A black market arose. Price gouging jacked up the cost of a dose of the vaccine, which was supposed to be US$2, to $20. As a result, the well-to-do got special access to a vaccine the public had funded.

The hands-off approach changed once reports surfaced that children who had received Salk's vaccine were in the hospital, with polio symptoms. At first, Scheele, the surgeon general, reacted with skepticism. He suggested that those kids might have been infected before vaccination.

But once six vaccinated children died, inoculations halted until more information about their safety could be gathered. In all, 10 kids who were vaccinated early on died after becoming infected with polio, and some 200 experienced some degree of paralysis.

The government soon determined that the cases in which children became sick or died could be traced back to one of the six companies: Cutter Labs. It had not followed Salk's detailed protocol to manufacture the vaccine, failing to kill the virus. As a result, children were incorrectly injected with the live virus.

Inoculation resumed in mid-June with tighter government controls and a more nervous public. In July, Hobby stepped down, citing personal reasons.

Eisenhower then signed the Polio Vaccination Assistance Act of 1955, which slated $30 million to pay for vaccines – enough to fund wider public distribution. Within a year, 30 million American kids had been inoculated, and the number of polio cases had fallen almost by half.

Heeding a lesson learned

By 1962, there were fewer than 1,000 cases of polio in the U.S. And by 1979, the U.S. was declared polio-free.

Years after the vaccine's development, Jonas Salk would recount that sometimes he would meet people who would not even know what polio was – which he found tremendously gratifying. But the events of this past year, with all the ups and downs of coronavirus vaccine research, have proved that the history of polio's defeat is worth remembering.

Nine companies developing a coronavirus vaccine recently joined forces to jointly promise that they would not rush anything to market until and unless the clearly delineated standards for safety and efficacy are met.

But should a modern-day Cutter incident happen again with a coronavirus vaccine, the public's already shaky faith in vaccines could easily crumble further, impeding the effort to get as many people quickly immunized against COVID-19 as possible.

Bringing this pandemic to an end will require more than the government's approval of one or more coronavirus vaccines that work. Coordinating a widespread vaccination campaign will also demand the navigation of logistics, economics and politics amid an equitable approach to the distribution of these new vaccines and the public's willingness to be inoculated.

This final push will, in addition, require the often uneasy partnership among the government, the private sector and – as is true today with massive contributions from the Bill & Melinda Gates Foundation and other charitable sources – philanthropy.

Carl Kurlander, Senior Lecturer, University of Pittsburgh and Randy P. Juhl, Distinguished Service Professor Emeritus of Pharmacy, University of Pittsburgh

This article is republished from The Conversation under a Creative Commons license. Read the original article.

Somali parents face dilemma over COVID-19 amid polio vaccination - Anadolu Agency

Posted: 23 Sep 2020 12:57 AM PDT

MOGADISHU, Somalia

Sagal Faduma, a mother of three including five-month-old Maryan, is seated on a mat outside her house, a tree that lies next to the house in Xirkadheere, Banaadir region of Somalia providing a shade for the mother and daughter.

Maryan has a crestfallen look on her face indicating that despite being hungry she does not want any of the porridge that her mother is trying to feed her, her eyes are wide with a partially opened mouth. Sometimes she can be seen eating the porridge but mostly rejects it.

Sagal gives up on feeding her and Maryan screams with delight, her face gleaming with joy as she bounced up and down on her mother's lap.

Somalia is among high-risk Polio outbreak countries due to its fragile and vulnerable population that mostly includes nomads, displaced people and people living in rural and slum areas.

In recent years Somalia has witnessed two polio outbreaks in 2013-2014 and 2017-2018, outbreaks which mostly affect children who are not vaccinated against the disease-causing virus, like baby Maryan.

Currently, there is a polio outbreak in southern and central parts of Somalia.

UN agencies in Somalia have rolled out a program to immunize children against polio but parents such as Sagal are scared about the spread of the coronavirus.

"I follow news about the coronavirus on radio," Faduma said.

"It affects children and old people. My father is close to his 80s and I am afraid that the people going around might infect my child or my father with the virus. I am not sure whether I want my child to be vaccinated, other mothers have said they will not."

44-year-old Thabit Liban who is also a father to a new-born baby boy said: "People are afraid of the coronavirus disease, there is no trust among parents, if they ask me to bring my child somewhere I will go but I will not put the lives of my friends and family at risk, also I am supposed to travel to the Galguduud district today, so as I move there I doubt my child will be vaccinated because we will be on the road".

Somalia is currently conducting a polio immunization campaign targeting over 1.65 million children. Polio vaccinators can be seen going from door to door with megaphones calling on families with children under the age of five to come and be vaccinated.

The World Health Organization (WHO) and UNICEF, which have launched the vaccination drive, have assured the masses that all precautionary measures have been taken to ensure that the exercise is safe.

The UN agencies say that their health workers are observing all COVID-19 health and safety measures as they conduct the immunization drive.

"Carefully selected health workers were given protective face masks and gloves and were trained rigorously to ensure they kept themselves and their families safe from COVID-19," the WHO said in a statement.

Precautionary measures taken during the workday include washing hands regularly, wearing face masks and ensuring physical distancing.

The WHO says that its teams are spread across all regions with the main aim being to reach as many children as possible: those living in urban and rural locations, with nomadic lifestyles, as well as those living in camps for internally displaced people.

Mamunur Rahman Malik, the WHO representative for Somalia, said in a statement that "the only way to stop such outbreaks from vaccine-preventable diseases, including polio, is to vaccinate every child every time immunization services are offered, either through routine programmes or through such mass campaigns.

"We all have a moral responsibility to reach and boost the immunity of every last child in Somalia. Owing to access, security and health-seeking behaviour, we are missing a large number of children every year, who are not receiving these life-saving vaccines."

For his part, Werner Schultink, UNICEF representative for Somalia, stated: "It is critical that all routine immunizations continue, especially during the COVID-19 pandemic, These vaccination drives will help prevent further outbreaks and will protect children from deadly diseases so they can survive and thrive."

According to the UN, 6,266 vaccinators in urban areas and 2,685 vaccinators in rural areas will be going from door to door to vaccinate 1.65 million children aged under five with oral polio vaccine during the ongoing campaign. In efforts to reach every child possible, an additional 1,125 team supervisors will be visiting households in targeted areas. As many as 3,390 community mobilizers, sensitizing target communities, will play a key role in helping families to understand, trust and accept vaccines.

The four-day vaccination campaign will end on Sept. 23.

Anadolu Agency website contains only a portion of the news stories offered to subscribers in the AA News Broadcasting System (HAS), and in summarized form. Please contact us for subscription options.

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