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How are vaccines approved? What is the process?
Vaccines are approved by the Food and Drug Administration (FDA) after rigorous and extensive development in laboratories, as well as pre-clinical animal studies and testing on human volunteers, to ensure they are safe and effective. Monitoring of the vaccine and how it’s produced, including regular facility inspections, must continue for as long as the manufacturer holds a license for the vaccine.
Additionally, the drug sponsor follows a multi-layered approval process, which includes an investigational new drug application, clinical trials and presentation of data to a special FDA advisory committee.
What does the COVID vaccine do? Does it prevent me from getting COVID?
That is the intent. Instead of traditional vaccines, which may use the virus itself, the SARS-CoV-2 vaccine will use a protein on the outside of the virus. This means the vaccine can’t cause COVID-19 in a person, because it’s not using the virus that causes the disease. This stimulates your body’s immune system to mount a response as if it were a true infection, minimizing your risk of re-infection or disease should you encounter the same virus later.
How many shots are required?
The COVID-19 vaccine will require one dose or two, depending on which vaccine you receive.
Why are some of the COVID-19 vaccines two shots versus one shot?
The series and dosing for each vaccine is based on the initial results from the clinical trial data. Just because some vaccines may have one shot vs two, doesn’t mean that one is less effective than the other.
What happens if I don’t get the booster/2nd shot within the allotted timeframe? Will I still be considered vaccinated?
To best maximize the efficacy of the vaccine and to ensure an optimal effectiveness, it is highly recommended that you receive the second dose within the specified timeframe as directed by the manufacturer. If you don’t receive the second shot, you will greatly decrease the chance of the vaccine working.
I heard some of the vaccine trials were canceled – does that mean they’re not safe?
No COVID-19 vaccine trial has been canceled. Two trials were paused, which is normal for all clinical trials to take a closer look at symptoms participants develop to see if there are possible side effects. Sometimes the symptoms have nothing to do with the actual product. This process is in place to ensure that any product brought to the public is as safe as possible. Both trials that were paused were resumed once an independent safety monitoring board deemed the side effects not related to the vaccine.
How much will the vaccine cost?
There will be no direct cost to patients or employees at this time.
If I’ve already had COVID-19 and recovered, do I still need to get vaccinated?
Yes. There is not enough information currently available to say how long after infection someone is protected from getting COVID-19 again. In order to stop this pandemic, we need to use every tool available which includes the immunization, social distancing, handwashing and wearing masks.
Does Ochsner fully endorse the COVID vaccine and suggest all employees and patients receive the vaccine?
Ochsner Health fully supports and highly encourages widespread vaccination under the Emergency Use Authorization (EUA) for all employees and our patients. Ochsner will only recommend and administer vaccines that the Food and Drug Administration has certified as safe and effective for all patients and employees, including our most vulnerable populations. Ochsner’s contributions to the vaccine trials have helped illustrate their safety to the FDA. Large-scale vaccination of our community is the best way to keep everyone safe and to end the COVID-19 pandemic.
Why should I get the vaccine?
Stopping a pandemic requires using all the tools available. Just as we are wearing masks and social distancing, getting the vaccine will help us prevent the spread of the virus and reduce your chances of getting it. The benefits of the vaccine outweigh the risks of forgoing immunization.
What are the possible side effects of the vaccine?
Similar to the flu shot, the vaccine is administered in a large muscle like the upper arm or thigh. Like with any vaccine, allergic reactions may occur. Some may experience mild fever, muscle soreness, aches or redness at the site. These are signs of the immune response and is common and expected in some patients. For more answers to possible questions on side effects, please read this blog post.
Can I have the flu shot around the same time as the COVID vaccine?
Yes, there are no restrictions in receiving your flu shot at the same timeframe as the vaccine. Ochsner Lafayette General recommends everyone over 6 months get the flu shot.
Will I still have to mask and social distance after getting the vaccine?
Yes. Until herd immunity is reached and the majority of the United States has been vaccinated, hand washing, social distancing and masking should still be practiced.