COVID-19 Vaccine Resources & Info« Return
FDA COVID-19 VACCINE APPROVALS
In January 2022, the Food and Drug Administration (FDA) granted full approval to the Moderna COVID-19 vaccine for individuals age 18 and older. The vaccine will now be marketed as Spikevax.
In August 2021, the FDA granted full approval for the Pfizer-BioNTech COVID-19 vaccine for individuals age 16 and over.
Both vaccines continue to be authorized for emergency use for certain younger individuals.
SAFETY & DEVELOPMENT 3.11.2021
How are vaccines developed and tested?
The most commonly used vaccines have been around for decades, with millions of people receiving them safely every year. As with all medicines, every vaccine must go through extensive and rigorous testing to ensure it is safe before it can be introduced in a country.
An experimental vaccine is first tested in animals to evaluate its safety and potential to prevent disease. It is then tested in human clinical trials in three phases.
After results of clinical trials are available, a series of steps is required, including reviews of efficacy, safety, and manufacturing for regulatory and public health policy approvals, before a vaccine may be introduced into a national immunization program.
The vaccine is given to a small number of volunteers to assess its safety, confirm it generates an immune response, and determine the right dosage.
The vaccine is usually administered to hundreds of volunteers, who are closely monitored for any side effects, to further assess its ability to generate an immune response. Data is also collected whenever possible on disease outcomes, but usually not in large enough numbers to have a clear picture of the effect of the vaccine on disease. Participants in this phase have the same characteristics (such as age and sex) as the people for whom the vaccine is intended. Some volunteers receive the vaccine and others receive a placebo, which allows comparisons to be made and conclusions to be drawn.
The vaccine is given to thousands of volunteers. Half receive the investigational vaccine and the others receive a placebo, similar to phase 2. Data from both groups is carefully compared to see if the vaccine is safe and effective against the disease it is designed to protect against.
How does an mRNA vaccine differ from previous vaccines?
mRNA vaccines are a new type of vaccine to protect against infectious diseases. To trigger an immune response, many vaccines put a weakened or inactivated germ into our bodies. mRNA vaccines instead teach our cells how to make a protein that triggers an immune response inside our bodies. That immune response, which produces antibodies, is what protects us from getting infected if the real virus enters our bodies.
How was the research and development process being accelerated without compromising safety?
Clinical trials evaluated COVID-19 vaccines in many thousands of study participants to generate scientific data regarding safety and efficacy. The FDA determined when the vaccines met required safety and effectiveness standards to be distributed and used in the United States under an Emergency Use Authorization (EUA) or licensure. After the FDA made its determination, the Advisory Committee on Immunization Practices (ACIP) reviewed available data then made vaccine recommendations to CDC.
After the COVID-19 vaccine was authorized for use, the CDC, FDA, and other federal partners began using multiple existing, robust systems and data sources to conduct ongoing safety monitoring.
Have Louisiana residents participated in the clinical trials?
The Pfizer/BioNTech and Moderna clinical trials for the vaccine included patients from across Louisiana. The evidence for the vaccine’s safety comes in part from the people in our own community.
Pfizer/BioNTech Clinical Sites
- Oschner Clinic Foundation | New Orleans, LA
- Benchmark Research | Metairie, LA
- LSUHSC-Shreveport| Shreveport, LA
Moderna Clinical Sites
- Benchmark Research| Metairie, LA
- Meridian Clinical Research| Baton Rouge, LA
Johnson & Johnson Vaccine Info
- The FDA granted Emergency Use Authorization (EUA) to the Johnson & Johnson vaccine, also known as J&J or Janssen, on February 27, 2021. EUA means the FDA has found the J&J vaccine to be safe and effective after rigorous trials and evaluation. J&J is the third COVID-19 vaccine to receive EUA, following the Pfizer and Moderna vaccines. The vaccines are how we put this pandemic behind us and get back to the places and people we love.
- Like the other vaccines, the J&J vaccine is 100% effective at preventing hospitalizations and deaths. That’s our most urgent, important goal. That’s why we need a vaccine in the first place. It’s the whole point.
- The J&J vaccine is taken in one dose, compared to two doses for the other vaccines. We know many people actually prefer a one-and-done vaccine — like young people, people who are afraid of needles, and people who work multiple jobs or have difficulty taking time off work. A single-dose vaccine may offer more protection faster than the other two vaccines, which require two shots three (Pfizer) and four (Moderna) weeks apart.
- The J&J vaccine is a more durable vaccine, which makes it easier to handle. It can last up to three months in the refrigerator, whereas the other vaccines must be stored at very cold temperatures.
What are side effects of the vaccine?
Many patients report no side effects; however, you may experience similar side effects of the flu vaccine, which are:
- Sore arm at the injection site
- Joint Pain
- Muscle Aches
Why is it important to get the COVID-19 vaccine?
Getting the vaccine has several benefits. The most important one being that we can safely establish herd immunity, so the population at large can be protected from the virus if a threshold of vaccination is reached. It’s a tall order, as experts estimate that roughly 70% of people in the U.S. (200 million) need to be vaccinated to reach this level of protection for COVID-19 specifically. This is especially important for vulnerable, high-risk groups, like the elderly and immunocompromised. You have the power to make a difference. Every person who gets vaccinated brings us closer to getting our lives back to normal.
Will the COVID-19 vaccine infect me with COVID-19?
No. None of the COVID-19 vaccines currently in development in the United States use the live virus that causes COVID-19. There are several different types of vaccines in development. However, the goal for each of them is to teach our immune systems how to recognize and fight the virus that causes COVID-19. Sometimes this process can cause symptoms, such as fever, but these symptoms are normal and are a sign that the body is building immunity.
Will the COVID-19 vaccines cause me to test positive on COVID-19 viral tests?
Vaccines in the United States won’t cause you to test positive on viral tests, which are used to see if you have a current infection. If your body develops an immune response, which is the goal of vaccination, there is a possibility you may test positive on some antibody tests. Antibody tests indicate you had a previous infection and that you may have some level of protection against the virus.
If I’ve already gotten sick with COVID-19, do I still need to take the COVID-19 vaccine?
Due to the severe health risks associated with COVID-19 and the fact that re-infection with COVID-19 is possible, people are advised to get a COVID-19 vaccine even if they have been sick with COVID-19 before. At this time, experts do not know how long someone is protected from getting sick again after recovering from COVID-19. The immunity someone gains from having an infection, called natural immunity, varies from person to person.
What agency recommends and determines the order of vaccine allocations when supply is limited?
The Advisory Committee on Immunization Practices (made up of nonpolitical, leading public health and medical advisors) is responsible for advising the CDC on population groups and circumstances for vaccine use. The CDC makes the official recommendations. Based on this guidance, state departments of health determine eligibility. Visit the Louisiana Department of Health’s website for the most current information about eligibility in our state.
What’s next if I am interested?
If you or a family member is interested in receiving the COVID Vaccine, CLICK HERE for the latest vaccine administration updates.
REFERENCES & RESOURCES
- American Hospital Association
- World Health Organization (WHO)
- Centers for Disease Control and Prevention (CDC)
- Advisory Committee on Immunizations
- Vaccine FAQs
ARTICLES & VIDEOS
- The Four Phases of Clinical Trials (Pfizer)
- Moderna Potential Vaccine Against COVID-19
- How Vaccines are Developed (U.S. Department of Health and Human Services)
- Years of Research Laid Groundwork for Speedy COVID-19 Shots
- New England Journal of Medicine Peer-Reviewed Data for Pfizer COVID-19 Vaccine Candidate
- Fauci wants people to know that one of lead scientists who developed the Covid-19 vaccine is a Black Woman
- Janssen COVID-19 Vaccine (Johnson & Johnson)