Coronavirus (COVID-19)
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December 16, 2020
COVID-19 Vaccine: What You Need to Know
With COVID-19 cases on the rise in Indiana and across the country, a ray of hope exists with the anticipation of a vaccine approval in the coming days.
But that also means this vaccine will get approved in record time. These first COVID-19 vaccines will be approved for emergency use in less than a year.
For many, you may be ready to be first in line. Your only question is “When it’s my turn, where can I get it?” But maybe you are asking:
- Is the vaccine safe?
- Could it give me COVID-19?
- What about the side effects?
- Will it really work?
Dr. Christopher Weaver, senior vice president for clinical effectiveness and the executive for IU Health leading the vaccine planning and production, explains what you need to know in anticipation of the upcoming vaccine approvals.
Will the vaccines be safe? Has development been rushed?
Two vaccines are likely to be approved this month for emergency use by the Food and Drug Administration. The FDA gave emergency authorization to a vaccine from Pfizer on Dec. 11. It will review a similar vaccine from Moderna on Thursday, Dec. 17. Several more vaccines are in various stages of clinical trials.
As part of the federal project to accelerate vaccine development, the project Operation Warp Speed – regardless of political feelings – implies one thing: fast. But Weaver emphasized what wasn’t sped up in the timeline: safety.
"They are not skipping safety steps; they are not skipping the evaluation and the studying of the drug,” Weaver said. “The FDA is still putting the vaccine through the same hoops, so it will be safe and effective before we start injecting anybody and before it’s even shipped to us."
Weaver said the steps that were accelerated were on the manufacturing side. Instead of waiting for each step of the study or approval, companies produced millions of doses in parallel to studying the drug to be ready to deploy the moment it’s approved.
Even beyond the FDA, there are several more layers of review, Weaver said. Once a vaccine is approved by the FDA, a vaccine advisory committee for the Centers for Disease Control (CDC) will evaluate the data. Additionally, the Indiana State Department of Health has its own team of experts that will do an independent evaluation. And IU Health will do the same as well.
"Nothing about this, the speed of it or any of the political background, none of that gives me any concern at all with this vaccine," Weaver said. “We’re putting so many eyes on it. It’s so important to us when you think about what’s going on across our state and our country that it’s going to be safe, it’s going to be effective and it’s going to make a big difference."
Weaver said it’s equally important the vaccine is safe across all populations. Vaccine and clinical research history, even from years ago, is plagued with errors on racial lines that can still fuel skepticism today. He wants to make sure all populations know the vaccine is safe.
“It is really important to IU Health, to me, to all of us, that we get this vaccine to all populations and especially those at the most risk,” Weaver said.
With all the safety protocols in place – FDA, the state, IU Health and more, Weaver has a plea to Hoosiers: “We want to encourage you to come get the vaccine. Let us help protect you and your family members.”
How well will the vaccines work?
The Pfizer and Moderna vaccines announced promising results from clinical trials last month with efficacy rates near 95%. That means, for example in the Pfizer study, of the 170 COVID-19 cases, 162 of them were in the placebo group vs. 8 in the vaccine group.
"Those are extraordinary numbers for a vaccine," Weaver said. “Those numbers show you it is very effective.
The FDA had earlier set a bar of 50% efficacy. The seasonal flu shot effectiveness typically is between 30-60%.
Weaver also pointed to two other encouraging signs in the data from the clinical trials:
- The trials showed that participants who did get the virus were less likely to get hospitalized. No one who received Moderna’s vaccine developed a severe case of the disease.
- The number of adverse events were very low. “There’s a very low number significant adverse events,” Weaver said.
Should I worry about side effects to the COVID-19 vaccine?
Some people may experience mild side effects from the vaccine – headaches, aches, fever. What that’s not from, said Weaver, is the virus itself. It’s the vaccine working – when it’s injected into your body, your body creates antibodies to the virus.
"And those side effects are our body fighting and getting ready to fight the virus," Weaver said. "And that’s a successful vaccine. It means your body is gearing up, it’s your immune system giving you those side effects.”
Weaver said he doesn’t want people to shy away from the vaccine because of the side effects – "It’s a good thing. It means it’s working," he said.
Can I get the virus from the COVID-19 vaccine?
No, these vaccines do not and cannot give you COVID-19, said Weaver. In fact, after you get the vaccine, you will test negative to COVID-19 if you were to take a test.
When can I get the vaccine?
There will be a limited allotment of the initial vaccines. The first vaccines IU Health receives will go to healthcare workers, particularly ones who care for patients with COVID-19.
Healthcare workers and long-term care residents will receive highest priority and may have opportunity to receive a vaccine before the end of the year. From there, two groups may soon be eligible:
- Essential workers in industries such as food service, police and fire, utilities, and teachers
- Those with higher risk of severe disease, such as 65 and older or those with certain medical conditions
As manufacturing and availability ramps up, Weaver said vaccines will cascade through those groups and become available to general population late spring or early summer.
How much will it cost?
The vaccine will be free. Insurance information will be collected to charge the insurance company, but the patient will not pay.
How soon will the vaccine make a difference in the pandemic?
Just because a vaccine is approved doesn’t mean the pandemic will go away overnight. It will take months to reach the herd immunity levels needed to end the pandemic. But the good news isn’t only months away.
The first relief will be felt with the healthcare system – the number of workers sick or in quarantine has depleted resources across the U.S.
"The good news for us and across our country is the fact that right now health systems are more strained,” Weaver said, “The more we can get that group vaccinated, the more likely we are to have better staffing as we try to take care of individuals. That’s a huge first step."
Vaccinating the next groups – essential workers and high-risk individuals – may free up sectors of society and reduce the number of the patients with the worst outcomes. Weaver said effectively reaching the long-term care facilities, for example, may have drastic results since 50 percent of the deaths in Indiana are from long-term care facilities.
What should I do now?
There’s hope on the horizon for the end of the pandemic. But maybe that more than ever is reason to stay the course when it comes to safety measures, said Weaver.
"There’s an end to this, vaccines are going to be huge, but do not let your guard down and exacerbate the problem as we’re working toward that finish line," Weaver said.
It will take months to get through vaccinating the population to a point where the virus stops spreading.
"Wear your mask, social distance. All of that will be incredibly important," Weaver said.
He said that’s true whether you’ve had a vaccine or not – no vaccine is 100 percent effective and these simple steps will help particularly the most vulnerable populations.
How can I learn more?
Visit the COVID-19 Resource Center to learn more information about COVID-19, including latest on vaccine information as well as answers to testing and visitor policies.