Update, Dec. 14, 2020
Since this article was published, the FDA has authorized use of a COVID-19 vaccine and distribution is underway. Here’s our guide with the most up-to-date vaccine information.
Original article, Nov. 19, 2020
For nine months, the lives of Tennesseans have been turned upside-down by COVID-19. The pandemic hit suddenly, but knowledge about how to fight it — from preventive measures to treatments — has followed in waves. Many of us have been waiting for news of a vaccine that could help protect our loved ones and restore a sense of normalcy.
But there’s a lot of work yet to be done, and many questions that remain.
We asked Dr. Andrea Willis, chief medical officer, to share what we’re learning and what it could mean for our members and our communities.
Throughout the pandemic, we’ve heard a lot about efforts and progress toward a vaccine – and now there may be a breakthrough. What’s the latest?
Dr. Willis: We know several vaccines are under development by different manufacturers, and we’ve been following those trials closely.
The big news is that Pfizer announced results from the Phase 3 clinical trial of their candidate vaccine. They found it could be 95% effective in preventing COVID-19 infections. Less than a week later, Moderna announced its own early results, showing a 94.5% effectiveness rate.
The threshold for Federal Drug Administration (FDA) approval is 50%, so the effectiveness rates of the Pfizer and Moderna vaccines are impressive. It’s important to remember these trials are ongoing, and we haven’t seen all the data yet. But it’s encouraging that two promising vaccines could start to become available soon.
AstraZeneca, Johnson&Johnson and Novavax are also conducting Phase 3 trials right now to understand how effective their vaccines may be. So it’s possible there could be other viable options coming out, as well.
We’re monitoring all these developments and staying in contact with partners like the Tennessee Department of Health, so we can be ready to help our members once a vaccine is approved by the FDA.
You mentioned these are “Phase 3 trials.” What can you tell us about the process for getting a vaccine approved? In other words, how can we trust it will be safe and help keep people from getting sick?
Dr. Willis: Vaccines go through a rigorous development and testing process before they’re approved by the FDA for use by the public. One important component is making sure it can be manufactured with consistency and high quality.
What a lot of people want to understand is the clinical trial process. Here’s a quick summary:
- Phase 1 measures safety,
- Phase 2 measures immune responses, and
- Phase 3 measures disease prevention.
Phase 1 includes a small number of people, and it’s about testing safety — does the vaccine lead to adverse reactions or health risks? If not, then the drug company is looking to see if the vaccine produces an immune response in the body. That’s phase 2. If a vaccine candidate looks promising, it goes to phase 3.
In a phase 3 trial, the vaccine is tested in a randomized clinical trial with a large number of volunteers who either get the vaccine or a placebo. (Volunteers don’t know which they’re getting.) These trials average around 21,750 people, with a range of 5,000 to 65,600.
Some of the COVID-19 vaccine trials are including 40,000 people or more.
Phase 3 trials are meant to discover whether a vaccine really works. So, as I mentioned, the volunteers don’t know whether they got the vaccine or a placebo. There are scientists who monitor the volunteer group to protect their safety and to learn whether it’s effective. The big question, of course, is how well the vaccine actually helped prevent illness. All of this data is compiled according to rules set up before the trial began.
We’re starting to hear about these phase 3 results, and the early word is encouraging.
But it’s a long process to make sure a vaccine is safe and effective. The quest for a COVID-19 vaccine has been moving quickly, but scientists are still following the established process.
When a COVID-19 vaccine has successfully completed all phases of a trial and has been approved by the FDA, what would that mean for Tennesseans?
Dr. Willis: Tennesseans would have another tool to fight COVID-19, and that’s a great thing. But until enough people have immunity from COVID-19, we need to continue following the safety measures we’ve adopted this year.
We’ve read that vaccine availability will be phased in over time. Will people who work in health care, or people at high risk for severe cases of COVID-19, get access to it first?
Dr. Willis: We know every state will get an allocation of any vaccine that’s approved, and the Tennessee Department of Health has developed an initial distribution plan. It follows the national guidance. That means front-line health care workers and other high-risk people (like those with multiple ongoing health conditions) would be the first ones eligible for the vaccine.
We’ll have more to share on that in the coming months, and it will likely take a few months from the start of distribution until most people can get vaccinated. So, we’re optimistic, but we still have a way to go and I hope we’ll all remain committed to protecting one another as we wait.
What happens if multiple vaccines are approved by the FDA?
Dr. Willis: First, let’s recognize what a wonderful thing it is to have multiple COVID-19 vaccines in development, with some nearing approval. We could ramp up distribution and come through the pandemic sooner, with fewer illnesses and deaths.
There are also some interesting possibilities that come with different options. For example, we may discover that one works better for older people, while another is more effective in younger people. Or we could learn that a certain one has fewer side effects for people with specific conditions.
If we do have multiple vaccines available, we’ll recommend Tennesseans speak with their health care provider to find out which option is best for them.
How will BlueCross support members as a vaccine, or multiple vaccines, become available?
Dr. Willis: The federal government is purchasing vaccine doses, which would then be available to residents at no cost. However, providers can charge an administration fee – which BlueCross would cover under most plans for our members.
We’ll also work to help members get the information they need on COVID-19 vaccination, just as we’ve done with COVID-19 testing and treatment, as well as with the flu shot. And this is a collaborative process. Right now, we’re working on a project with Meharry Medical College to better understand why people might be hesitant about getting vaccinated for COVID-19 and what we can do to help.
I’ll also note that uninsured Tennesseans will have access to the vaccine at little or no cost, and we expect the government will pay providers to administer shots for the uninsured, as part of the CARES Act Provider Relief Fund.
That’s great to hear. What else should Tennesseans know about COVID-19 vaccination?
I’ll reiterate that while we’re optimistic, we aren’t at the end of the road yet. So, let’s help keep ourselves, our loved ones and our neighbors safe in the meantime.
Stay at home as much as you can. Don’t spend time indoors with people you don’t live with. Wear a mask if you go out in public. Wash your hands or use hand sanitizer when soap and water aren’t available. None of these steps are totally effective on their own, but they all add up.
I know it’s hard – but we can get through this together.