Vaccine Development and Approval FAQs
COVID-19 vaccination safety and benefits
What is the vaccine approval process?
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
What is an Emergency Use Authorization (EUA)?
- 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:
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.
Why is the development of a vaccine critical to controlling COVID-19?
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.
Why is vaccine development happening so fast?
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
Distribution of the Vaccine:
When can I get vaccinated?
Will there be a cost associated with getting the COVID-19 Vaccine?
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.
Vaccine Safety and Side Effects:
How do the Pfizer and Moderna mRNA vaccines work?
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.
Will the COVID-19 vaccines be safe?
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.
Is it safe to get a COVID-19 vaccine if I have an underlying medical condition?
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.
What is vaccine efficacy?
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,
Are the COVID-19 vaccines rigorously tested?
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.
What side effects will the vaccine have?
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.
Are there long-term side effects from the COVID-19 vaccine?
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.
Can I get my flu shot or other vaccines at the same time as the COVID-19 vaccine?
Current recommendations state the COVID-19 vaccine should be administered
alone with a minimum of 14 days before or after administration of any
Can I contract COVID-19 from the vaccine?
No. It’s impossible for the vaccine to give you COVID-19; it does
not use the live virus that causes COVID-19.
Can I get COVID-19 after receiving the vaccine?
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.
If you develop COVID-19 symptoms after getting the vaccine should you quarantine?
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.
If I get vaccinated, do I still need to wear a mask and social distance?
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.
Should I be vaccinated if I’ve already had COVID-19?
Yes. Although you may have a period of immunity after having COVID-19,
a vaccine may offer more protection.
Why do I need two COVID-19 shots?
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.
For 2 dose vaccines, what happens if I only receive one dose of the vaccine
and not both?
It is recommended to receive both doses of the vaccine. If only one vaccine
is received, immunity cannot be guaranteed.
How long will immunity last after I get vaccinated? Will I need to be vaccinated
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/
Vaccines in vulnerable populations:
Can my child get vaccinated for COVID-19?
Not yet. More studies need to be conducted before COVID-19 vaccines are
recommended for children aged 15 and younger.
Is the vaccine recommended for pregnant women or those planning on becoming pregnant?
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.
Can the vaccine impact fertility?
There are multiple social media reports that the COVID-19 vaccine can cause
infertility. This claim is false and not supported by current research.
Can I get the vaccine if I am immunosuppressed or taking immunosuppressant
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.