Covid-19 Phase 3 Testing To Begin Today

Ken AshfordEbola/Zika/COVID-19 VirusesLeave a Comment

Phase 3 of an experimental COVID-19 vaccine begins today in the U.S. According to Dr. Stephen Hoge, president of Massachusetts-based Moderna, they are “optimistic, cautiously optimistic” that the vaccine will work and that the data will eventually prove it:

The biggest test yet of an experimental COVID-19 vaccine got underway Monday with the first of some 30,000 Americans rolling up their sleeves to receive shots created by the U.S. government as part of the all-out global race to stop the outbreak.

Final-stage testing of the vaccine, developed by the National Institutes of Health and Moderna Inc., began with volunteers at various U.S. sites given either a real shot or a dummy without being told which.

It will be months before results trickle in, and there is no guarantee the vaccine will ultimately work against the scourge that has killed about 650,000 people around the world, including almost 150,000 in the U.S.

After two doses, scientists will closely track which participants — those getting real shots, or a dummy — experience more infections as they go about their daily routines, especially in hard-hit areas where the virus still is spreading. Testing is planned at close to 90 sites, officials said.

From a test volunteer’s perspective:

In Binghamton, New York, nurse Melissa Harting received one of the first injections of the Moderna vaccine candidate. saying she was volunteering “to do my part to help out.”

“I’m excited,” Harting said. Especially with family members in front-line jobs that could expose them to the virus, she said, “doing our part to eradicate it is very important to me.”

But because a Covid-19 vaccine may go online in a comparatively short period of time (compared to the standard amount of time), there are reasons to be concerned:

The end of this global pandemic almost certainly rests with a vaccine. Experts caution, however, that it’s important to have realistic expectations about how much the first vaccines across the finish line will — and won’t — be able to accomplish.

First-generation vaccines often aren’t the ones that stop a new virus in its tracks, and experts’ hopes for an initial coronavirus vaccine are much more modest.

“Right now, we just need something that’s going to mitigate the damage this virus causes,” said Amesh Adalja, an infectious-diseases expert at Johns Hopkins University. “Maybe it doesn’t prevent you from getting infected, but it prevents you from getting hospitalized, or prevents you from dying … that would be huge.”

Questions remain about just how a Covid vaccine might work:

Some vaccines, like the one for measles, mumps and rubella, produce near-complete and long-lasting immunity. Others, like the annual flu shot, are important tools to help contain a virus but don’t achieve “sterilizing immunity.”

It’s not yet known how much protection any of the potential coronavirus vaccines might provide, or how long it would last.

“It’s hard to make vaccines against coronaviruses,” said Mark Poznansky, an infectious-disease specialist at Massachusetts General Hospital. “It doesn’t mean its not possible but it is a challenge, especially with COVID-19, where we don’t yet understand the inflammatory response to the virus and what part of the immune response is critical to prevent infection.”

While the initial evidence for COVID-19 vaccines seems promising, second- and even third-generation products will likely target more of the virus and, hopefully, generate stronger and longer-lasting immunity than the first few vaccines will offer, Poznansky said.

And of course, there are a number of questions that will be factored in when deciding who will receive a Covid-19 vaccine first, says Paul Kelleher, a professor of bioethics and philosophy at UW-Madison:

A pretty standard principle when it comes to healthcare resources is the goal of saving as many lives as possible, Kelleher says — or, when we’re thinking about a preemptive vaccine, really preventing as many deaths as possible. This utilitarian perspective aims to create the greatest benefit for the greatest number of people.

Even though this principle is a commonly used one in a public health crisis, “it’s somewhat foreign or unfamiliar for many healthcare professionals, whose main goal on a day-to-day basis in normal times is to do the best for the patient that’s in front of them,” Kelleher says. Sometimes tied to this is the concept that we should preserve those who are most essential to keeping society — and especially health infrastructure — running, because that will in turn keep more people safe.

Another idea in bioethics is the “life cycle” or “fair innings” principle, which argues that everyone should have an equal chance to live through life’s various stages, Kelleher adds. In the case of a pandemic, this would mean we should prioritize protecting young people over elderly people who have already had the chance to move through these stages.

Complicating questions abound: Should we focus on the people who are more likely to recover — like doctors in Italy, who were told to help those with the “greatest life expectancy” as hospitals were overrun and resources spread thin? Or is it our moral responsibility to protect the most vulnerable, following the principle of beneficence and the need to do good for others?

There’s also the argument of seeking out justice by prioritizing resources for those who have been treated unfairly in the past. Kelleher points out that throughout history, society has pushed some people into “social and environmental conditions that are hazardous to health,” making them more vulnerable in a health crisis like this one.