By Helena Oliviero – The Atlanta Journal-Constitution
Eric Stirgus – The Atlanta Journal-Constitution
The director of the Centers for Disease Control and Prevention has told governors that, by Election Day, they need to have plans in place for distributing a COVID-19 vaccine.
Not that he thinks that most Americans would have access to such a vaccine by then, even if one becomes available.
That probably won’t happen until the second or third quarter of next year, Dr. Robert Redfield has said.
Not so, says President Donald Trump. A vaccine could be released as soon as next month, he insists, and it will be distributed immediately to “a vast section of the country.”
It’s just one of the conflicting narratives on the highly anticipated COVID-19 vaccine.
In addition, U.S. officials and infectious disease specialists are already debating how to prioritize the initial distribution of the vaccine.
Many public health experts have weighed in on questions about the timeline for a vaccine, who should get first dibs, and concerns about whether such a rushed process can produce a safe and effective counter to the virus plaguing the world. Here’s what some of them had to say.
What’s being done to develop a vaccine?
The Trump administration has committed billions of dollars on several vaccine options.
That includes plans to spend about $1.5 billion to purchase 100 million doses of a vaccine from Moderna, the pharmaceutical company working with Emory University researchers and others. The vaccine has started phase 3 trials and is considered one of the furthest along in the process.
But phase 3 requires recruiting thousands of participants from diverse backgrounds. These participants also must consent to being tracked by researchers for the duration of the trial, which can last years. They’re randomly been split into groups that either receive the actual vaccine or a placebo. It can take months to simply enroll enough people for the trial.
Will a vaccine work?
Vaccination is widely considered one of the greatest medical achievements of modern civilization. Childhood diseases that were once commonplace — including polio, diphtheria and whooping cough — were either eradicated or made increasingly rare because of vaccines.
A vaccine works by training the immune system to recognize and combat pathogens, either viruses or bacteria. To do this, certain molecules from the pathogen must be introduced into the body — usually by injection of a weakened or dead form of the pathogen — to trigger an immune response.
A new class of vaccines is gaining traction as scientists work to produce a drug to fight COVID-19. Instead of introducing the virus and bacteria into the body, DNA and RNA vaccines give people the genetic code for a part of the coronavirus, such as its spike protein. The immune system then detects those proteins and amounts a defense.
One major advantage of this new method is that the vaccines can be constructed quickly. It can take months to produce conventional vaccines.
The first vaccine made available may not be the most effective. To win regulatory approval, a vaccine must prevent COVID-19 or decrease the severity in 50% of people who receive it, the FDA has said. Scientists are hoping for a vaccine that’s at least 75% effective. However, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said the lower efficacy could still significantly curtail the spread of the virus.
When will a vaccine be available?
Several experts, including Dr. Arthur Caplan, founding head of the Division of Medical Ethics at New York University’s School of Medicine, thinks it will be at least a year or more before there are enough vaccine doses for most Americans.
He believes there will initially be 20 million to 40 million doses available, calling larger estimates “crazy optimistic.”
Large-scale clinical trials have only recently started, and these trials can take months, if not years to complete.
Who will receive the first doses?
Health care workers and first responders likely will be first to get the vaccine, Caplan said, then doses will go to the U.S. Defense Department and next to people responsible for preparing and shipping the vaccines.
“You have to vaccinate them, or you won’t have anyone to distribute it,” he said.
Georgia’s Coronavirus Task Force is currently devising its plan for distribution. Just how many doses Georgia will receive will be based on population size and several other factors.
How long, after a vaccine, will it take for the world to get back to normal?
About 200 million Americans and 5.6 billion people worldwide would need to be vaccinated to end the pandemic, according to a New England Journal of Medicine article published earlier this month by a team that includes experts from Emory University and the University of Georgia.
The effort to widely distribute the vaccine will be up against a host of complex logistical challenges in the manufacturing and delivery of vaccines. Some potential vaccines require cold chain storage at temperatures ranging from -20 to -70 degrees Celsius. Ultra-low temperature freezers are not commonplace, and a vaccine requiring extremely low temperatures would likely require building giant cold-storage facilities or “freezer farms,” and then making sure these places could quickly deliver doses around the country.
“It’s not as simple as an on-off light switch,” said Glen Nowak, director of the Center for Health and Risk Communication at the University of Georgia. “It will be more like dialing a dimmer switch when it comes to a COVID-19 vaccine becoming available. The supply will increase over time and probably slower than many people would like.”
Dr. Walter Orenstein, associate director of the Emory Vaccine Center, said more study is needed on the most effective and efficient way to get people inoculated. He noted the federal government doesn’t have much experience distributing vaccines to adults. He thinks this process should involve getting assistance from pharmacies, private health care providers and hospitals.
Orenstein hopes organizations like the National Association of County and City Health Officials and the Association of Immunization Managers will be involved in distribution discussions.
All groups need to have access to the vaccine, particularly racial minorities since they’re being diagnosed with COVID-19 in disproportionate numbers and often have trouble getting medical care, he said.
“My hope is that barriers to access will be minimized, such as cost, and that it will be easy to be obtained,” he said.
Has the process been too rushed?
Caplan worries about the safety of potential vaccines. As scientists continue to pursue an effective one, the federal government appears to be “obsessed with getting there fast and early,” he said.
In a recent op-ed, Caplan wrote that it’s hard to believe a vaccine will be ready by the November election, unless, under political pressure, FDA Commissioner Steve Hahn approves an extremely limited supply of maybe only 100,000 doses.
The public is concerned, too. Recent surveys found anywhere between a third to half of Americans would not get an FDA-approved vaccine if it was available to them at no cost.
Nine drug companies recently pledged to not submit vaccine candidates for FDA review until their safety and efficacy is shown in large clinical trials.
Will the public trust the vaccine? And, if not, what then?
Scientists have suggested that about 70% of people must be immune, either by surviving the infection or by getting a vaccine, to achieve herd immunity and ultimately quell the pandemic. That would require many Americans to be willing to get vaccinated.
“Oftentimes, it is assumed by many experts that new vaccines will speak for themselves. That is, their benefits are so obvious and important, people will want to get vaccinated,” said Nowak.
But words like “warp speed” to describe a vaccine’s development and even the word “new” can create concern.
Nowak said there will need to be a massive effort to build trust for the vaccine and it should include training for health care providers and a hotline with clinicians standing by to answer questions about the COVID-19 vaccine.
“As much as we all want the COVID-19 pandemic to end, we can’t assume fast and widespread acceptance of COVID-19 vaccines,” he said. “We need to build trust and confidence in how these vaccines were developed and tested if we expect to achieve high acceptance.”