Two laboratories are in the final stretch for the vaccine 0:59
Editor’s note: David Oshinsky directs the Division of Medical Humanities at New York University Langone Health and is a member of the Vaccine Working Group on Ethics and Policy. His book, “Polio: An American Story,” won the Pulitzer Prize for History in 2006. The opinions expressed in this comment are yours.
. – The headlines about the coronavirus this week are alarming and encouraging. First, the bad news: Hospitalizations in the United States have doubled since Labor Day, surpassing the numbers recorded at any time since the pandemic began. Far from “turning the corner,” the country faces a dangerous winter as temperatures begin to drop and the flu season takes hold.
But there’s good news, too: Two covid-19 vaccine candidates have shown promise, raising hopes that the virus could be contained.
The vaccine developed by pharmaceutical giant Pfizer and its German partner, BioNTech, is said to be 90% effective in phase 3 trials, involving more than 40,000 volunteers. This means that among those who received it there were 90% fewer cases of “symptomatic” Covid-19 than those who received a placebo. A similar vaccine made by the biotech company Moderna showed slightly better efficacy (95%), although the data from both companies is preliminary and it takes longer to show how well they work. Given that a typical flu shot is lucky to be 60% effective, the results are encouraging, to say the least.
Two laboratories are in the final stretch for the vaccine 0:59
What we have to learn from the polio vaccine
The race for a vaccine amid such intense public scrutiny recalls a similar story from the baby boom era, after World War II. The disease at the time was polio, a viral infection that descended like a plague on the nation every summer. The virus primarily attacked children, killing and paralyzing about 50,000 each year. Movie theaters were empty, swimming pools were locked, youth struggled to use crutches and leg braces. Hospital wards were completely filled with iron lungs. It wasn’t long before science triumphed, and Dr. Jonas Salk developed a vaccine that would eventually eliminate the threat of polio in the developed world, and in the process we learned valuable lessons, some quite painful, that we must heed today. while we search for a vaccine to get rid of covid-19.
The 1940s and 1950s predated the key role that the federal government would later play in drug and vaccine testing. The crusade against polio was led by a private charity, the March of Dimes, and the millions of terrified parents it recruited to the cause. Generally, it takes more than a decade to develop a successful vaccine. Under enormous pressure, the March of Dimes released Jonas Salk’s inactivated virus polio vaccine in less than four years.
The 1954 Salk vaccine trials remain the largest public health experiment in American history. More than a million school-age children participated, some receiving three doses of the Salk vaccine, others a similar placebo. It took a full year to analyze the results in the pre-computer era, but the results were surprising. “SALK’S VACCINE WORKS!” headlines proclaimed April 12, 1955. “POLIO WAS D.ATED.”
President Dwight D. Eisenhower invited Salk to the White House, where he praised the young researcher for saving the world’s children. “I have no words to thank you,” said the president, his voice shaking with excitement. “I am very very happy.”
Polio Vaccine Errors
Then disaster struck. Within weeks, the miracle vaccine, designed to end polio, was accused of causing the disease. Reports came in of newly vaccinated children being taken to emergency rooms. It turned out that the astonishing success of Salk’s trials had led the public to demand the immediate launch of the vaccine. And the government had given in quickly, allowing five drug companies to increase production without proper oversight. The worst offender, Cutter Laboratories of Berkley, California, released a vaccine so contaminated with live poliovirus that 164 children were permanently paralyzed and 10 died.
Although almost forgotten today, the Cutter Incident sparked a regulatory revolution in which vaccines are rigorously tested to ensure both efficacy and safety. There has not been a single case of polio caused by the inactivated Salk vaccine since that terrible time in 1955, despite billions of doses administered worldwide.
Vaccines against coronavirus
The dizzying pace at which current covid-19 vaccines are being prepared recalls the history of polio, partly because the term “wrap speed” (name of the operation under which covid-19 vaccines are developed ) is poorly understood. No safety corners found. The data from the phase 3 tests have been thoroughly studied and there have been pauses at the slightest hint of problems. The adverse effects of a vaccine appear overwhelmingly within a small window of time after vaccination, and it has been two months since the volunteers were given the final dose of COVID-19.
The main difference has been the greatly expanded role of the federal government in funding the research, development, and distribution of these vaccines. Rather than eliminating steps, it has allowed them to proceed simultaneously, so that manufacturing can occur while vaccines are being tested. This increases the financial risk to the government, but not the product risk to the public.
Still, many questions remain unanswered. The notable numbers provided by Pfizer and Moderna came in press releases, so far nothing has been peer-reviewed. How long will immunity last? Will it vary between demographics? Do you prevent cases that currently need hospitalization? In the case of Pfizer, can a vaccine that requires storage at minus 70 degrees Celsius appear realistically at your doctor’s office or local pharmacy?
What is still missing from covid-19 vaccines
Pfizer and other manufacturers are expected to apply for an Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA), a lever that was used sparingly. in the past and allowing the FDA to make an unapproved product available in a medical emergency. Some experts, who consider an AUS premature, have suggested less radical measures such as ‘expanded access’, in which patients with life-threatening diseases can access experimental treatments when there are no comparable options.
Unfortunately, as we try to speed up the means to protect those most at risk from covid-19, we also face a downside. Opinion polls show growing skepticism among Americans toward a vaccination process that they fear is moving too fast.
This is no surprise. The polio years proved that laboratory magic was one part of a larger solution. People had to feel confident that scientific standards were being maintained, emergency or not, and scientists had to know that a successful vaccine requires overwhelming public trust.
Polio is a lesson worth remembering.