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Moderna's medical officer on how it felt to learn vaccine is 94.5% effective
02:58 - Source: CNN

Editor’s Note: David Oshinsky directs the Division of Medical Humanities at NYU 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 commentary are his own. View more opinion on CNN.

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The headlines about the novel coronavirus this week are both alarming and encouraging. First, the bad news: Hospitalizations in the United States have doubled since Labor Day, exceeding the numbers recorded at any time since the pandemic began. Far from “rounding the corner,” the nation faces a perilous winter as temperatures start to plunge and flu season takes hold.

But there’s also good news: Two Covid-19 vaccine candidates have shown promise, boosting hopes that the virus can 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 – meaning that those injected with the actual vaccine had 90% fewer cases of “symptomatic” Covid-19 than those injected with a placebo. A similar vaccine made by biotech company Moderna showed slightly better efficacy – 95% – although the data from both companies are preliminary and more time is needed to show how well they work. Given that a typical flu vaccine is fortunate to reach 60% effectiveness, the results are encouraging, to say the least.

David Oshinsky

The race for a vaccine in the midst of such intense public scrutiny brings to mind a similar storyline from the baby boom era following World War II. The disease at that time was polio, a viral infection that descended upon the nation each summer like the plague. The virus mainly struck children, killing and paralyzing close to 50,000 each year. Movie theaters sat empty, swimming pools were padlocked, youngsters struggled to use crutches and leg braces, hospital wards were lined wall-to-wall with iron lungs. It wasn’t long before science proved triumphant, 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 should heed today as we search for a vaccine to rid us of Covid-19.

The 1940s and ’50s predated the key role that the federal government would later play in the testing of drugs and vaccines. 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. It usually takes more than a decade to develop a successful vaccine. Under enormous pressure, the March of Dimes rolled out Jonas Salk’s killed-virus polio vaccine in less than four years.

The Salk trials of 1954 remain the largest public health experiment in American history. More than a million school children participated – some given three doses of the Salk vaccine, others a look-alike placebo. It took a full year to analyze the results in the age before computers, but the results were stunning. “SALK’S VACCINE WORKS” screamed the headlines on April 12, 1955. “POLIO IS CONQUERED.”

President Dwight D. Eisenhower invited Salk to the White House, where he lauded the young researcher for saving the world’s children. “I have no words to thank you,” the president said, his voice trembling with emotion. “I am very, very happy.”

Then disaster struck. Within weeks, the miracle vaccine designed to wipe out polio stood accused of causing it. Reports flooded in of newly vaccinated children being rushed to emergency rooms. It turned out that the amazing success of the Salk trials had led the public to demand an immediate release of the vaccine. And the government had quickly relented, allowing five drug companies to ramp up 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.

Though nearly forgotten today, the Cutter Incident triggered a regulatory revolution in which vaccines undergo rigorous testing to ensure both their efficacy and their safety. There has not been a single case of polio caused by the killed-virus Salk vaccine since that awful moment in 1955, despite the billions of doses administered worldwide.

The lightning pace at which the current Covid-19 vaccines are being readied is reminiscent of the polio story – in part because the term “warp speed” is so poorly understood. No safety corners have been cut. Data from the Phase 3 trials have been meticulously studied, and pauses have occurred at the slightest hint of trouble. Adverse effects from a vaccine overwhelmingly appear within a small time window following vaccination, and two months have now passed since volunteers were administered the final Covid-19 dose.

The main difference has been the vastly expanded role of the federal government in underwriting 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 the 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 remarkable numbers provided by Pfizer and Moderna both came in news releases nothing thus far has been peer reviewed. How long will the immunity last? Will it vary among demographics? Will it prevent the cases that currently need hospitalization? In Pfizer’s case, can a vaccine that requires storage at temperatures of minus 70 degrees Celsius realistically appear at your doctor’s office or the local pharmacy?

Pfizer and other manufacturers are expected to request emergency use authorization from the US Food and Drug Administration, a lever employed sparingly in the past that allows the FDA to make an unapproved product available in a medical emergency. Some experts, seeing an EUA as premature, have suggested less sweeping measures such as “expanded access,” where patients with life-threatening conditions can gain access to experimental treatments when no comparable options exist.

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    Unfortunately, as we attempt to speed up the means to protect those most at risk from Covid-19, we face a downside as well. Recent opinion polls show a growing skepticism among Americans toward a vaccine process that they fear is moving much too quickly.

    This is hardly surprising. The polio years demonstrated that laboratory magic was one part of a larger solution. People needed to feel confident that scientific standards were being upheld, emergency or not, and scientists needed to learn that a successful vaccine requires overwhelming public trust.

    It’s a lesson well worth remembering.