Lately, there’s been an enormous amount of chatter in the media and across all corners of the internet about the speedy development of a vaccine for COVID-19, a potentially deadly disease caused by infection with the novel coronavirus. Indeed, the sooner we can create and deploy a safe and effective vaccine, the sooner this pandemic can be brought under control.
But the key words in any discussion of any type of vaccine are “safe” and “effective,” and given the unprecedented pace at which the various vaccines being developed are moving forward, that has raised some concerns about whether the resulting product will be safe.
During a press conference hosted by Newswise on Oct. 7, Dr. Susan R. Bailey, an allergist/immunologist from Fort Worth, Texas, who serves as president of the American Medical Association, said that “a safe vaccine that doesn’t do anything isn’t helpful, and a vaccine that works but has horrible side effects isn’t going to be helpful. They go hand in hand, and we have to have both.”
As with any treatment or medical intervention, every vaccine has potential side effects, and it’s unknown currently what those might be. It’ll take some time to find out for sure, as there’s just no way to speed up how the human body will respond to a vaccine. This is why vaccines — including the numerous coronavirus vaccines under development — must go through multiple stages of testing before they can be approved by the U.S. Food and Drug Administration.
While most vaccines take between five to 10 years to develop, the coronavirus vaccines have been estimated to be available within 12 to 18 months of the outreach of the pandemic. This amounts to “warp speed” results.
Because of the speed, some people are questioning whether they should become an early adopter of the vaccine. But the fact of the matter is that choice may be out of your hands to some extent, says Dr. Anuj Mehta, a pulmonary and critical care physician at National Jewish Health in Denver. He’s also a member of the medical advisory group of the Governor’s Expert Emergency Epidemic Response Committee in Colorado, which is helping develop the state’s public health plan and policies for dealing with the pandemic.
The GEEERC group is also looking to the National Institutes of Health and the Centers for Disease Control and Prevention for guidance on how to determine who gets the vaccine first as it drafts its plan for Colorado. Mehta also sits on the Colorado Department of Public Health and Environment’s vaccination task force, the group that will implement the plan once it’s finalized.
Though Mehta’s work is at the state level, Colorado’s plan could well be adopted by or influence what other states decide to do with their own COVID-19 vaccination plans. The group’s aim is also to “sync with federal guidelines as much as possible, but also provide some granularity,” specific to conditions within the state, Mehta says.
Initially, the amount of vaccine that will be available in Colorado, as with virtually every other state, will likely be small.The group is working through the specifics of which subsets of the population should take priority for getting the vaccine.
Because of this need to triage, it may be a long time before any person can go to their doctor’s office or a local pharmacy to get a COVID-19 vaccine shot like you do the seasonal flu shot.
The reason why is because once a safe and viable vaccine has been developed, it will take time for the manufacturing process to catch up to demand. The first few months it’s available, the vaccine will be a limited resource and will be deployed to those most in need first.
Who Gets the Vaccine First?
When the vaccine is ready, your eligibility to become an early adopter will depend on a careful calculation of a number of risk factors, and a local health authority likely will be managing who gets it first.
“You really need to break the general population down into specific subgroups” based on risk, Mehta says, so that you can strategically deploy the vaccine in a manner that saves the most lives.
Public health departments around the country and at the federal level have long had models in place to address the concern of pandemic influenza and availability of the flu shot. “Luckily, public health departments are not starting from scratch,” Mehta says, but rather are adapting those flu vaccine models to the current pandemic.
In short, those who meet certain criteria will get the vaccine first, while others at lower risk may need to wait. The following categories of people are likely to get the vaccine before others:
— Essential and emergency workers.
— The medically vulnerable.
— Those in high outbreak areas.
Essential and Emergency Workers
In determining who gets the vaccine first, groups like Mehta’s base their recommendations on careful analysis of how to best serve all members of the community. “We need to save the most number of lives,” Mehta explains. “We need to ensure equity across different populations, and we need to ensure ongoing function of society.”
This means that “those that are the crucial work force, such as health care workers and firefighters and emergency medical technicians” may be the first in line to receive the vaccine, he says.
“We need to think about the people who are at higher risk for getting the virus through their jobs,” such as nurses and care workers in senior living facilities. Workers who are showing up to provide an essential service and are at higher risk of contracting the virus because of their work “may require some higher prioritization,” Mehta explains.
“There’s also a concept called the multiplier effect,” also sometimes referred to as instrumental value, he says. This is “where a single individual may have the ability to save multiple other lives. This applies to health care workers and caregivers, and by protecting them, you can potentially actually save the most number of lives because they can continue to provide care for others.” Emergency room doctors, police officers and other first responders usually fall into this category.
The Medically Vulnerable
People who are at higher risk of catching the virus because of medical conditions, such as high blood pressure, obesity, being over age 65 and having heart disease, may also be prioritized to receive the vaccine earlier in its deployment. Again, this is an effort to save the most lives possible.
Those in High Outbreak Areas
If you live in a hot spot area with high positivity rates, you may be able to access the vaccine sooner. When high infection rates circulate in a community, deploying a vaccine could help curb transmission and lower those rates. This is why states and even counties in some places are developing their own plans for how to manage the rollout of a vaccine when it becomes available.
The pandemic is impacting everyone in the entire world, but it’s an intensely local phenomenon in terms of how it can best be managed.
[READ: Best Immunity Boosters.]
Other Barriers to Deployment
For the average, healthy 20- 30- 40- or 50-something adult who doesn’t work in a high-risk situation, lives in an area where transmission rates are relatively low and has no specific medical concerns, it may be a while before you can get the vaccine.
But even when manufacture of the vaccine itself ramps up, there could still be other potential barriers to vaccine deployment elsewhere in the supply chain. Mehta notes that we’re going to need an awful lot of vials to hold and transport doses. And millions of syringes will be needed to deploy the vaccine. You’ll also need lots of trained health care providers to administer those shots.
What’s more, some of the vaccines being developed require ultra-low cold storage conditions. “Some need to be stored at minus 80-degree temperature, so having enough systems in place to maintain that in a safe way” adds yet more complexity to the question of when a vaccine will be widely available to anyone who wants it, he says.
Overcoming Vaccine Hesitancy
“I think vaccine hesitancy,” or a reluctance to get the vaccine, which has been reported as potentially being as high as one-third of American adults, “is a real concern,” Mehta says.
Overcoming a distrust of vaccination — which has been a growing problem over the past decade or so in regards to some childhood vaccination protocols and seasonal flu vaccination — is critical to help curb the spread of COVID-19.
But concerns remain about how quickly vaccine options are being developed. During the news conference, Dr. Dushyantha T. Jayaweera, an infectious disease specialist and professor in clinical medicine at the University of Miami Miller School of Medicine who is working on a large-scale COVID-19 vaccine trial with Janssen Pharmaceutical Companies, a division of Johnson & Johnson, said “there is a fair amount of distrust about the vaccine, and that we are rushing through and that we will cut corners.”
But, he continued, “I can reassure everybody that that is not the case. We will follow these patients (in the clinical trial) very carefully for anything.” Other companies are also taking care to not cut corners, even as they race to develop the first effective vaccine.
In fact, the White House has recently approved more stringent guidance for Emergency Use Authorization of COVID-19 vaccines after the FDA published standards as part of a briefing for an advisory panel of vaccine experts. Vaccine developers must provide at least two months of follow-up data from at least 50% of trial participants after the final vaccine dose is administered. This means there’s unlikely to be an EUA before the end of November.
Bailey adds that “the AMA believes that it is critical that vaccine decision and therapeutic decision are based on science and evidence and not politics, ideology or some sort of arbitrary timeline. We think it’s incredibly important for the AMA to be completely transparent about the parameters that it’s using to evaluate and approve vaccines and to let us know every step of the way as the approval process continues. If physicians and patients don’t feel completely confident about the vaccine, there’s going to be an increase in vaccine hesitancy, which is already an issue, and we can’t afford to make that worse.”
With all that said, by the time a vaccine becomes something available at a local drug store or your primary care clinic, researchers should have plenty of data about its safety, efficacy and any potential longer-term effects. As essential workers receive the earliest doses of the vaccine, their outcomes will be added to the growing body of clinical trial data regarding safety and efficacy of the vaccine. By the time the general public can access the vaccine, we should know definitively how well and how safe the vaccine is.
Mehta notes that while we don’t know for sure when a vaccine will become available, you can be sure there will be data to support its safety and efficacy. Some vaccine companies began testing in humans as early as March and April of 2020, and more data is being collected daily.
Lastly, if you’re hoping that herd immunity — which is the concept that a population will develop resistance to infection based on enough people in the community having had the infection and thus building immunity via antibodies to fight off the disease — is the answer, Mehta says it won’t be.
To achieve herd immunity, some 60% to 70% of the population would have had to had the virus. And to achieve that, some 10% of the individuals infected would likely die, he says. That’s an “unacceptable number of deaths. I think it’s too high of a societal cost,” he says. So, a vaccine is really the only ethical way forward for controlling the spread of the virus and getting back to a more normal way of life.
Given all of this, if you’re medically eligible to receive the vaccine against COVID-19 when it becomes available to you, Mehta urges you to get inoculated. It could save not only your life, but a loved one’s too.
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