Vaccine FAQs

Vaccine Development and Approval FAQs

We understand some may be concerned about getting vaccinated. We assure you; your safety is our top priority.

While wearing masks and social distancing reduces your chance of exposure to the virus or spreading it to others, these measures are not enough. Vaccines will work with your immune system so it will be ready to fight the virus if you are exposed.

COVID-19 vaccination will help protect you by creating a process in your immune system known as an antibody response that may help keep you from getting seriously ill if you do get COVID-19. Additionally, getting vaccinated will also protect people around you, especially those at an increased risk.

Clinical trials are conducted in accordance with the standards set in place by the Food and Drug Administration (FDA). In partnership with the Louisiana Department of Health, vaccines that are distributed to LCMC Health will have met the safety and effectiveness standards set forth by the FDA and been approved for emergency use authorization.

This page will be updated with new information about the vaccine as it becomes available.

• The U.S. FDA is responsible for regulating vaccines in the United States.
• Clinical development is a three-phase process. During Phase I, small groups of people receive the trial vaccine. In Phase II, the clinical study is expanded and vaccine is given to people who have characteristics (such as age and physical health) similar to those for whom the new vaccine is intended. In Phase III, the vaccine is given to thousands of people and tested for efficacy and safety. Many vaccines undergo Phase IV formal, ongoing studies after the vaccine is approved and licensed.
• After approving a vaccine, FDA continues to oversee its production to ensure continuing safety. Monitoring of the vaccine and of production activities, including periodic facility inspections, must continue as long as the manufacturer holds a license for the vaccine product.
• For more information on the approval process: https://www.cdc.gov/vaccines/basics/test-approve.html

Emergency Use Authorization (EUA) occurs when the Food and Drug Administration (FDA) allows a drug or vaccine to be used during a public health emergency. The FDA may choose to grant EUA once studies have demonstrated the safety and effectiveness of a vaccine but before the manufacturer has submitted, or the FDA has completed its formal review of the license application. EUAs provide timely access to critical medical products during a medical emergency when there are no sufficient treatments or vaccines available.

Stopping a pandemic requires using all the tools available. Vaccines work with your immune system so your body will be ready to fight the virus if you are exposed. Other steps, like covering your mouth and nose with a mask and staying at least 6 feet away from others, help reduce your chance of being exposed to the virus or spreading it to others. Together, COVID-19 vaccination and following CDC’s recommendations to protect yourself and others will offer the best protection from COVID-19.

The vaccine process is happening faster because vaccine research and development, clinical trials, manufacturing, and plans for distribution are occurring at the same time. This method removes delays that occur when these processes are carried out one after the other. Steps to ensure safety are not being eliminated.

As of January 4, 2021, the Louisiana Department of Health has authorized COVID-19 vaccines to be available to the Phase 1-B, Tier One group which includes people 70 and older. We will be communicating vaccine updates directly to those eligible through the LCMC Health Patient Portal, so we encourage you to sign up for an account today or update your current one if it has been inactive.

At this time, there will be no direct cost to patients for the COVID-19 vaccine.

The vaccines contain synthetic mRNA, which is genetic information used to make the SARS-CoV-2 spike protein. The spike protein is the part of the virus that attaches to human cells. The spike protein alone cannot cause COVID-19. Once the spike protein is created it causes the immune system to make antibodies against the virus. These antibodies can provide protection if a person comes into contact with the virus. The mRNA vaccines are non-infectious and do not enter the human cell nucleus so it cannot be inserted into human DNA. Additionally, mRNA is rapidly broken down, and this theoretically reduces chances for long term side effects. The mRNA vaccines do not have the ability to cause cancer.

To date, no serious safety concerns have been reported by an independent data and safety monitoring board overseeing Phase 3 trials of the Pfizer and Moderna mRNA COVID-19 vaccines. Both vaccines met the safety requirements outlined by the FDA to seek EUA. In the safety analysis, patients were followed for 2 months after they received their second dose of the vaccine.

Yes. COVID-19 vaccination is especially important for people with underlying health problems like heart disease, lung disease, diabetes, and obesity. People with these conditions are more likely to get very sick from COVID-19.

Efficacy is a term used in clinical trials and describes the percent reduction of disease in a vaccinated group compared to a group that did not receive the vaccine. It shows how well a vaccine works in certain, often controlled, conditions.

Vaccine effectiveness is different. It measures how well a vaccine performs when it is used in routine circumstances in the community.

Yes. Clinical trials have evaluated potential COVID-19 vaccines in tens of thousands of study participants to generate the scientific data and other information needed by FDA to determine safety and effectiveness for adults of different ages, races, and ethnicities. Clinical trials are conducted according to the rigorous standards set forth by the FDA.

There may be side effects, but they should go away within a few days. Possible side effects include a sore arm, headache, fever, or body aches. This does not mean you have COVID-19. Side effects are signs that the vaccine is working to build immunity. If they don’t go away in a week, or you have more serious symptoms, call your doctor.

Because all COVID-19 vaccines are new, it will take more time and more people getting vaccinated to learn about very rare or possible long-term side effects. The good news is, at least 8 weeks’ worth of safety data were gathered in the clinical trials for all the authorized vaccines, and it’s unusual for vaccine side effects to appear more than 8 weeks after vaccination.

Current recommendations state the COVID-19 vaccine should be administered alone with a minimum of 14 days before or after administration of any other vaccine.

No. It’s impossible for the vaccine to give you COVID-19; it does not use the live virus that causes COVID-19.

No vaccine is 100% effective at preventing infection. The two vaccines that have been submitted to FDA for emergency use authorization have been reported to be over 90% effective. An effective vaccine will lower your risk of getting the infection and will also lower your risk of severe disease if you are infected. A goal of a COVID-19 vaccine is also to make it less likely that COVID- 19 can spread to others.

Yes. It typically takes a few weeks for the body to build immunity after vaccination. That means it is possible a person could be infected with the virus that causes COVID-19 just before or just after vaccination and get sick. This is because the vaccine has not had enough time to provide protection. If you have COVID-19 virus symptoms after getting the vaccine or at any time, you should contact your health care provider and consider getting tested for COVID-19.

Yes. We will still be following all safety recommendations such as masking and social distancing until there is a high enough vaccination rate that ensures we are closer to herd immunity and our policy changes.

Yes. Although you may have a period of immunity after having COVID-19, a vaccine may offer more protection.

Currently authorized vaccines, and most vaccines under development, require two doses of vaccine. The first shot helps the immune system recognize the virus, and the second shot strengthens the immune response. You need both to get the best protection.

It is recommended to receive both doses of the vaccine. If only one vaccine is received, immunity cannot be guaranteed.

The length of immunity following vaccination is not yet known for COVID-19. Given the novel nature of this virus and vaccine development, long-term data is not yet available to guide future vaccine protocols. You can visit the CDC website to learn more about vaccine safety standards: https://www.cdc.gov/vaccines/covid-19/

Not yet. More studies need to be conducted before COVID-19 vaccines are recommended for children aged 15 and younger.

Following the FDA guidelines, no one is excluded from receiving the vaccine, even those who are pregnant, planning to become pregnant or breastfeeding. The best advice is to talk directly with your healthcare provider about whether the vaccine is right for you based on your medical history and other risk factors you may have.

There are multiple social media reports that the COVID-19 vaccine can cause infertility. This claim is false and not supported by current research.

The only contraindication listed by the FDA for receiving the vaccine are severe allergic reactions after a previous dose of this vaccine or a severe allergic reaction to components of this vaccine. Studies have shown that immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the COVID-19 Vaccine. Be sure to talk to your healthcare provider about whether the vaccine is right for you.