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Lohmann: Friends for life and vaccine 'pioneers,' from polio to COVID

Lohmann: Friends for life and vaccine 'pioneers,' from polio to COVID

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They were in second grade in 1954 at St. Catherine’s School when their class was marched across Grove Avenue to Saint Bridget Catholic School. They remember that much.

They also remember the somewhat startling sight of nuns in their habits, which made a lasting impression on a pair of little Episcopalian girls. The injections, on the other hand, they really don’t remember much at all.

Ashby Roberts and Caroline “Cacky” Winfree were “polio pioneers” — that was on the buttons and certificates they were given. They were part of a nationwide vaccine trial for the polio vaccine developed by Dr. Jonas Salk that involved 1.8 million children, according to the March of Dimes, then known as the National Foundation for Infantile Paralysis, which helped organize the trial.

Roberts, Winfree and other participants received a series of three inoculations over a period of weeks, all at Saint Bridget School where the shots were being administered.

The following year, the Salk vaccine was declared safe and effective, and polio was on its way to being eradicated from North America.

Roberts and Winfree, best of friends then and now, are vaccine pioneers once again.

They are currently volunteers in a global, late-stage trial for a potential COVID-19 vaccine. Neither Roberts and Winfree, each of whom is 74, had any worries about signing up.

“We never hesitated,” Winfree said. “People said, ‘You’re crazy to do that.’ But why not?

They are part of the Phase 3 trial of a vaccine from British drugmaker AstraZeneca. They originally tried to sign up for a trial of the Pfizer vaccine, but the local trial group was full and they would have had to travel to Baltimore for the injections and follow-up visits. When they learned of the AstraZeneca trial being conducted locally by Clinical Research Partners, they were all in.

They had their first shots in November and then booster shots last week. Neither experienced any side effects, and both are feeling fine. They don’t know yet if they received the actual vaccine or a saline placebo. Two of every three participants receive the vaccine in the “double-blind” study. (Neither the volunteers nor the firm administering the shots knows who gets which.)

It appears volunteers will learn if they received the vaccine or the placebo when they become eligible for a federally approved vaccine from any manufacturer, though exactly how that process will play out is “evolving,” said Dr. Robert S. Call, president and medical director of Clinical Research Partners, which is conducting the AstraZeneca trial in the Richmond area at its office just off Forest Avenue in Henrico County.

There is some thought among health experts that volunteers who received a placebo should be notified as soon as a mass vaccine is available so they may move to the front of the line to receive a vaccine; others believe “unblinding” too soon would jeopardize the study, making it impossible to compare the long-term health of those who received the vaccine and those who did not.

“It’s an ongoing dialogue at AstraZeneca,” Call said. “The thing about it is in a clinical trial, the directive is do no harm first. Keeping people safe is the most important thing.

Roberts and Winfree had volunteered in September, but their involvement was delayed as AstraZeneca’s trial of AZD1222 was put on hold for more than a month after neurological side effects were reported in two volunteers in a United Kingdom trial. In October, the Wall Street Journal reported federal health regulators allowed AstraZeneca to resume after concluding there was no evidence the vaccine was responsible for the two cases, though the agency couldn’t rule out a link.

The potential AstraZeneca vaccine takes an approach that’s different from the Pfizer and Moderna vaccines — the Pfizer vaccine received emergency authorization from the FDA on Friday — in that it uses a weakened version of the common cold virus to deliver a genetic material that triggers an immune response to fight COVID-19. The AstraZeneca vaccine also reportedly can be stored in regular refrigerators and will be available at a price, $3 to $4 per shot, much lower than the projected prices of Pfizer’s and Moderna’s, according to The New York Times.

An early analysis of trial results found AstraZeneca’s vaccine was either 62% or 90% effective, depending on the manner in which the doses were given, compared to Pfizer and Moderna, which both reported greater than 90% effectiveness.

“The chance to get the vaccine was big, but also the fact we had done it before,” Roberts said of their earlier polio adventure. “We were totally sure … they wouldn’t give it to us if it wasn’t OK.”

***

From the beginning, Roberts and Winfree seemed destined to be friends.

Their grandmothers were classmates and friends at St. Catherine’s, graduating in the Class of 1905. Their mothers also attended the school, though were in different grades. In more recent years, Roberts and Winfree and their husbands have become traveling companions on cruises. Every year, they cook and host adventurous birthday dinners for each other.

“We have to do recipes we’ve never tried before,” Winfree said.

As children, they had their pictures in the newspaper, along with their mothers and grandmothers, representing three generations of St. Catherine’s students on the occasion of their grandmothers’ 50th class reunion. That would have been 1955 — the year after their participation in the polio vaccine trial.

In the 1940s and 1950s, polio was one of the most feared diseases in the United States. The highly contagious viral disease paralyzed and killed young people and left parents too afraid to let their children go outside, particularly in the summer when outbreaks seemed to occur most often.

“I wasn’t allowed to go to the circus,” Roberts recalled.

“Or the pool,” Winfree said, “because you might get polio.”

Roberts in particular recalls her mother being “a little frantic” about polio and talking about it “quite a bit.”

The idea of so many parents nationwide volunteering to have their children serve as guinea pigs in a bold public health experiment might seem remarkable in our current social climate, but such was the desperation of the times. Perhaps, too, they were operating with a notion of pulling together for the public good.

So, the year they turned 8, Roberts and Winfree bravely lined up with the rest of their second-grade class at St. Catherine’s — they recall only one classmate not receiving parental permission to participate — and headed over to Saint Bridget School for their shots.

(The polio vaccine rollout in 1955 was tarnished when some batches of the vaccine were found to contain live polio virus, leaving 200 children with varying degrees of paralysis and killing 10. The nationwide mass vaccination program was temporarily halted until investigators determined the problem vaccine had originated in the manufacturing process at one of several vaccine producers. The Centers for Disease Control cites the so-called Cutter Incident as a turning point that led to a better system regulating vaccines.)

In time, polio was largely eradicated, and life returned to normal. Roberts and Winfree hope the vaccines now in development will do the same for our current predicament.

“We want to go back to traveling, go out and have fun and have lunch and all those things we miss so much,” said Roberts, who has largely self-quarantined since March to avoid contracting the disease. Winfree is about the only person she’s spent any time with outside of her home. “The vaccine is what’s going to do it.”

“We want this vaccine to get out there so we can get over this thing,” said Winfree, who has been out and about more than Roberts over recent months. She is happy to “do the least little part.”

The day before I talked with Call of Clinical Research Partners, he had been reading reports of the rollout of Pfizer’s vaccine in the United Kingdom, which included praise for those willing to get the shot on the first day. He thought such commendation was slightly misdirected.

“The true heroes are the people who stepped up for the local trials,” Call said. “They are so upbeat and willing to ... basically save the world. That’s the kind of feeling we’ve gotten while doing this trial.”

The Richmond trial just passed the 1,000 mark in volunteers, and more are sought, particularly those at high risk of exposure to the virus. Besides the two injections, participants will have follow-up calls and visits, including several blood draws over two years to determine the immune system’s response. Participants will be paid for being part of the study: $100 per visit, up to $1,000.

What Roberts and Winfree really want is to be able to return to life as they knew it. They also wouldn’t mind having their “Polio Pioneers” button, which they haven’t seen in many years.

“Long gone,” Winfree said.

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